[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]
COMBATING THE OPIOID CRISIS: PREVENTION AND PUBLIC HEALTH SOLUTIONS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
SECOND SESSION
__________
MARCH 21 & 22, 2018
__________
Serial No. 115-112
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
_________
U.S. GOVERNMENT PUBLISHING OFFICE
30-951 WASHINGTON : 2018
COMMITTEE ON ENERGY AND COMMERCE
GREG WALDEN, Oregon
Chairman
JOE BARTON, Texas FRANK PALLONE, Jr., New Jersey
Vice Chairman Ranking Member
FRED UPTON, Michigan BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois ANNA G. ESHOO, California
MICHAEL C. BURGESS, Texas ELIOT L. ENGEL, New York
MARSHA BLACKBURN, Tennessee GENE GREEN, Texas
STEVE SCALISE, Louisiana DIANA DeGETTE, Colorado
ROBERT E. LATTA, Ohio MICHAEL F. DOYLE, Pennsylvania
CATHY McMORRIS RODGERS, Washington JANICE D. SCHAKOWSKY, Illinois
GREGG HARPER, Mississippi G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey DORIS O. MATSUI, California
BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida
PETE OLSON, Texas JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia JERRY McNERNEY, California
ADAM KINZINGER, Illinois PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida PAUL TONKO, New York
BILL JOHNSON, Ohio YVETTE D. CLARKE, New York
BILLY LONG, Missouri DAVID LOEBSACK, Iowa
LARRY BUCSHON, Indiana KURT SCHRADER, Oregon
BILL FLORES, Texas JOSEPH P. KENNEDY, III,
SUSAN W. BROOKS, Indiana Massachusetts
MARKWAYNE MULLIN, Oklahoma TONY CARDENAS, California
RICHARD HUDSON, North Carolina RAUL RUIZ, California
CHRIS COLLINS, New York SCOTT H. PETERS, California
KEVIN CRAMER, North Dakota DEBBIE DINGELL, Michigan
TIM WALBERG, Michigan
MIMI WALTERS, California
RYAN A. COSTELLO, Pennsylvania
EARL L. ``BUDDY'' CARTER, Georgia
JEFF DUNCAN, South Carolina
Subcommittee on Health
MICHAEL C. BURGESS, Texas
Chairman
BRETT GUTHRIE, Kentucky GENE GREEN, Texas
Vice Chairman Ranking Member
JOE BARTON, Texas ELIOT L. ENGEL, New York
FRED UPTON, Michigan JANICE D. SCHAKOWSKY, Illinois
JOHN SHIMKUS, Illinois G.K. BUTTERFIELD, North Carolina
MARSHA BLACKBURN, Tennessee DORIS O. MATSUI, California
ROBERT E. LATTA, Ohio KATHY CASTOR, Florida
CATHY McMORRIS RODGERS, Washington JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia KURT SCHRADER, Oregon
GUS M. BILIRAKIS, Florida JOSEPH P. KENNEDY, III,
BILLY LONG, Missouri Massachusetts
LARRY BUCSHON, Indiana TONY CARDENAS, California
SUSAN W. BROOKS, Indiana ANNA G. ESHOO, California
MARKWAYNE MULLIN, Oklahoma DIANA DeGETTE, Colorado
RICHARD HUDSON, North Carolina FRANK PALLONE, Jr., New Jersey (ex
CHRIS COLLINS, New York officio)
EARL L. ``BUDDY'' CARTER, Georgia
GREG WALDEN, Oregon (ex officio)
C O N T E N T S
----------
March 21, 2018
Page
Hon. Greg Walden, a Representative in Congress from the State of
Oregon, opening statement...................................... 2
Prepared statement........................................... 3
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 5
Prepared statement........................................... 6
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 7
Prepared statement........................................... 9
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 10
Prepared statement........................................... 11
Witnesses
Scott Gottlieb, M.D., Commissioner, Food and Drug Administration. 13
Prepared statement........................................... 16
Answers to submitted questions............................... 222
Anne Schuchat, M.D., Acting Director, Centers for Disease Control
and Prevention................................................. 23
Prepared statement........................................... 25
Christopher M. Jones, PharmD, MPH, Director of the National
Mental Health and Substance Use Policy Laboratory, Substance
Abuse and Mental Health Services Administration................ 34
Prepared statement........................................... 36
Sue Thau, Public Policy Consultant, Community Anti-Drug
Coalitions of America.......................................... 126
Prepared statement........................................... 128
Cartier Esham, Executive Vice President, Emerging Companies,
Biotechnology Innovation Organization.......................... 137
Prepared statement........................................... 139
Jeffrey Francer, Senior Vice President and General Counsel,
Association for Accessible Medicines........................... 146
Prepared statement........................................... 148
John Holaday, PHD, Chairman and Cofounder DisposeRX.............. 155
Prepared statement........................................... 157
Submitted Material
H.R. 5228........................................................ 50
Documents submitted by Mr. Lance
Statement of various groups.................................. 185
Statement of the National Association of County and City
Health Officials........................................... 190
Statement of the National Alliance of State and Territorial
AIDS Directors............................................. 191
Statement of the National Viral Hepatitis Roundtable......... 192
Statement of the American Liver Foundation................... 194
Statement of the AIDS Institute.............................. 195
Bipartisan letter to appropriators in support of full funding for
the Minority Fellowship Program, submitted by Mr. Butterfield.. 197
Documents submitted by Mr. Green
Statement of EVERFI.......................................... 203
Statement of Congressman Hakeem Jeffries..................... 205
Statement of Representative Ann Kuster....................... 207
Statement of the Campaign to Protect Patient Privacy Rights.. 209
Statement of the National Alliance for Medication Assisted
Recovery, Inc.............................................. 215
Statement of the Pennsylvania Recovery Organizations Alliance 217
Statement of Congresswoman Katherine Clark and Congressman
Hal Rogers in support of H.R. 5102......................... 220
March 22, 2018
Witnesses
Eric C. Strain, MD, Director, Center for Substance Abuse
Treatment and Research, Johns Hopkins University School of
Medicine....................................................... 228
Prepared statement........................................... 231
Kenneth J. Martz, PSYD MBA, Special Projects Consultant,
Gaudenzia, Inc................................................. 236
Prepared statement........................................... 238
Answers to submitted questions............................... 547
Brad Bauer, Senior Vice President of New Business Development and
Customer Relationship Management, Appriss Health............... 249
Prepared statement........................................... 251
William Banner, MD, PHD, Medical Director, Oklahoma Center for
Poison And Drug Information and Board President, American
Association of Poison Control Centers.......................... 260
Prepared statement........................................... 262
Michael E. Kilkenny, MD, MS, Physician Director, Cabell-
Huntington Health Department of West Virginia.................. 272
Prepared statement........................................... 274
Jessica Hulsey Nickel, Founder, President and CEO, Addiction
Policy ForumI60308.............................................
Prepared statement........................................... 311
Answers to submitted questions............................... 553
Carlene Deal-Smith, Peer Support Specialist, Presbyterian Medical
Services....................................................... 324
Prepared statement........................................... 325
Ryan Hampton, Recovery Advocate, Facing Addiction................ 327
Prepared statement........................................... 329
Answers to submitted questions............................... 557
Mark Rosenberg, DO, MBA, FACEP, FAAHPM, Chairman of Emergency
Medicine and Chief Innovation Officer, St. Joseph's Healthcare
System and Board of Directors, American College of Emergency
Physicians..................................................... 361
Prepared statement........................................... 363
Stacy Bohlen, CEO, National Indian Health Board.................. 371
Prepared statement........................................... 373
Answers to submitted questions............................... 561
Alexis Horan, Vice President of Government Relations, Cleanslate
Centers........................................................ 384
Prepared statement........................................... 387
Submitted Material
Statement of Titan Pharmaceuticals, submitted by Mr. Guthrie..... 408
Documents submitted by Mr. Burgess
Statement of the Addiction Medicine Foundation............... 410
Statement of the Addiction Policy Forum...................... 412
Statement of the American Academy of Addiction Psychiatry.... 414
Statement of the American Association of Colleges of
Osteopathic Medicine....................................... 416
Statement of the American Nurses Association................. 417
Statement of the American Osteopathic Association and the
Massachusetts Osteopathic Society.......................... 418
Statement of the American Society of Addiction Medicine...... 419
Statement of the Association for Behavioral Healthcare....... 421
Statement of the Coalition to Stop Opioid Overdose........... 423
Statement of the International Certification & Reciprocity
Consortium................................................. 425
Statement of Legacy Community Health......................... 426
Statement of the National Board of Certified Counselors...... 427
Statement of the National Council for Behavioral Health...... 428
Statement of the Partnership to Amend 42 CFR Part 2.......... 429
Statement of the Confidentiality Coalition................... 432
Statement of the Premier..................................... 434
Statement of America's Essential Hospitals................... 436
Article entitled, ``People with addiction issues should be
able to control their own health data,'' The Hill, March 3,
2018....................................................... 441
Statement of the National Governors Association.............. 446
Statement of the President's Commission on Combating Drug
Addiction and the Opioid Crisis \1\
Article entitled, ``Treating Behavioral Health Disorders in
an Accountable Care Organization,'' The Journal of
Accountable Care, December 2016............................ 455
Article entitled, ``Drug Interactions of Clinical Importance
among the Opioids, Methadone and Buprenorphine, and other
Frequently Prescribed Medications: A Review,'' American
Journal on Addictions, 2010................................ 469
Article entitled, ``Protection or Harm? Suppressing
Substance-Use Data,'' New England Journal of Medicine, May
14, 2015................................................... 489
Article entitled, ``Ten Steps the Federal Government Should
Take Now to Reverse the Opioid Addiction Epidemic, Journal
of American Medicine, October 12, 2017..................... 492
Statement of Ascension Healthcare............................ 497
Statement of Bloomberg Health Data Management................ 500
Statement of the American Academy of Neurology............... 507
Statement of the American College of Obstetricians and
Gynecologists.............................................. 509
Statement of the American Society of Addiction Medicine...... 515
Statement of the Electronic Health Record Association........ 526
Statement of Keith Pardieck.................................. 528
Statement of the National Association of Chain Drugstores.... 530
Statement of the National Coalition on Health Care........... 535
Statement of the Ohio State University College of Nursing.... 539
Statement of the United South & Eastern Tribes Sovereignty
Protection Fund............................................ 540
Statement of Patrick Kennedy................................. 545
----------
\1\ The statement can be found at: https://docs.house.gov/
meetings/IF/IF14/20180321/108049/HHRG-115-IF14-20180321-
SD037.pdf.
COMBATING THE OPIOID CRISIS: PREVENTION AND PUBLIC HEALTH SOLUTIONS,
DAY 1
----------
WEDNESDAY, MARCH 21, 2018
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:02 a.m., in
room 2123, Rayburn House Office Building, Hon. Michael Burgess,
M.D. (chairman of the subcommittee) presiding.
Present: Representatives Burgess, Guthrie, Upton, Shimkus,
Blackburn, Latta, Lance, Griffith, Bilirakis, Long, Bucshon,
Brooks, Mullin, Hudson, Collins, Carter, Walden (ex officio),
Green, Engel, Schakowsky, Butterfield, Matsui, Castor, Lujan,
Kennedy, Degette, and Pallone (ex officio).
Also Present: Representatives Walberg, McKinley, McNerney,
and Dingell.
Staff Present: Mike Bloomquist, Staff Director; Adam
Buckalew, Professional Staff Member, Health; Daniel Butler,
Staff Assistant; Zachary Dareshori, Legislative Clerk, Health;
Jordan Davis, Director of Policy and External Affairs; Paul
Edattel, Chief Counsel, Health; Margaret Tucker Fogarty, Staff
Assistant; Adam Fromm, Director of Outreach and Coalitions; Ali
Fulling, Legislative Clerk, Oversight and Investigations,
Digital Commerce and Consumer Protection; Caleb Graff,
Professional Staff Member, Health; Jay Gulshen, Legislative
Associate, Health; Ed Kim, Policy Coordinator, Health; Mary
Martin, Chief Counsel, Energy/Environment; Mark Ratner, Policy
Coordinator; Kristen Shatynski, Professional Staff Member,
Health; Jennifer Sherman, Press Secretary; Danielle Steele,
Counsel, Health; Austin Stonebraker, Press Assistant; Hamlin
Wade, Special Advisor, External Affairs; Everett Winnick,
Director of Information Technology; Jacquelyn Bolen, Minority
Professional Staff; Jeff Carroll, Minority Staff Director;
Waverly Gordon, Minority Health Counsel; Tiffany Guarascio,
Minority Deputy Staff Director and Chief Health Advisor;
Jourdan Lewis, Minority Staff Assistant; Tim Robinson, Minority
Chief Counsel; Andrew Souvall, Minority Director of
Communications, Outreach and Member Services; Kimberlee
Trzeciak, Minority Senior Health Policy Advisor; and C.J.
Young, Minority Press Secretary.
Mr. Burgess. The Subcommittee on Health will now come to
order.
The chair at this time would like to recognize the chairman
of the full committee, Mr. Walden of Oregon, 5 minutes for an
opening statement, please.
OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Mr. Walden. Thank you, Mr. Chairman. And thank you for your
great leadership on this issue.
Today marks the second of three legislative hearings
advancing collaborative bipartisan legislative solutions to
help combat the opioid crisis.
The impressive plague of opioid addiction and substance use
disorder in our country requires an unprecedented response. And
while this committee spearheaded the legislative efforts in
CARA and Cures under Chairman Upton that has already devoted a
record amount of Federal resource to address this crisis, we
know we must do more to meet the growing demand.
This epidemic knows no geographic, no political, nor any
socioeconomic bounds. I have held roundtables in my district in
Oregon. Places like Hermiston and Grants Pass and Medford. When
you talk to providers, to patients, to families, you can feel
the sting of this crisis in every community.
President Trump rightly called it the crisis next door, and
earlier this week, rolled out an ambitious plan. I was pleased
to see that several of his proposals overlap with the work of
this committee. And I know that working across the aisle and
with the administration, we can arm agencies, healthcare
providers, researchers, and patients with the tools they need.
We stand ready to work with the President and his
administration to put a stop to this crisis once and for all.
Over the span of 2 days, the Energy and Commerce Committee
will consider a range of bills from members on both sides of
the aisle, some 25 different pieces of legislation covering the
full spectrum of prevention and public health, and we will hear
from 19 witnesses.
The bills we consider today will strengthen the Food and
Drug Administration's ability to understand several aspects of
the opioid crisis, including the risk of long-term opioid use
and how authorities can better intercept dangerous illicit
products of international mail facilities.
We will hear about legislation that will facilitate the
efficient development of treatments for substance use disorders
and legislation that will encourage alternatives to opioids for
the treatment of pain. These are two areas of medicine that
have suffered from a lack of innovation and development, and I
am optimistic that we can take tailored steps to encourage
progress in the right direction.
Representative Latta's amendment in the nature of a
substitute to H.R. 4284, Indexing Narcotics, Fentanyl, and
Opioids, or the INFO Act, would create a public and easily
accessible electronic dashboard that would link to all the
nationwide efforts and strategies to combat this opioid crisis,
as well as create an inner agency substance use disorder
coordinating committee to review and coordinate research
services and prevention activities across all relevant Federal
agencies. This will be a tremendous resource for patients,
their families, and for our local communities.
Representative Mullin's amendment in the nature of a
substitute to H.R. 3545, the Overdose Prevention and Patient
Safety Act, which would allow for limited sharing of substance
use disorder treatment records between health providers and
place strong discrimination provisions in statute to protect
people seeking or receiving substance use disorder treatment. I
understand this issue is deeply sensitive, but it is important
that we have a thoughtful discussion about ensuring that
patients seeking these services receive parity and the same
quality treatment that is provided to patients with other
chronic disorders. Substance use disorder is a medical illness
and we must treat it that way. Removing the stigma of addiction
is one of the most important things we as Members of Congress
can do to respond to this national emergency and will
dramatically change how we prevent and treat this complex
disease.
Representative McKinley's H.R. 5176, Preventing Overdoses
While in Emergency Room, would provide resources for hospitals
to develop discharge protocols for patients who have had an
opioid overdose, such as the provision of naloxone upon
discharge and referrals to treatment and other services that
best fit the patients' needs.
I would also like to thank my colleague, Representative
Griffith, for leading a discussion draft that would authorize
Federal spport for a number of innovative activities in state-
based prescription drug monitoring programs.
These are just a handful of the solutions that our
Republican and Democrat colleagues have brought forth.
I would like to thank our four panels of witnesses that
will be here today, hopefully, weather permitting. And I look
forward to your feedback on these important issues.
And with that, I would yield the balance of my time, I
believe, to Mr. Guthrie.
[The prepared statement of Mr. Walden follows:]
Prepared statement of Hon. Greg Walden
Today marks the second of three legislative hearings
advancing collaborative, bipartisan legislative solutions to
help combat the opioid crisis.
The unprecedented plague of opioid addiction and substance
use disorder in our country requires an unprecedented response.
While this committee spearheaded the legislative efforts in
CARA and Cures that has already devoted a record amount of
federal resources to address this crisis, we can and must do
more to meet this growing need.
This epidemic knows no geographic, political, or socio-
economic bounds. I've held roundtables in my district in
Oregon--places like Hermiston, Grants Pass, and Medford--when
you talk to providers, patients, and their families, you can
feel the sting of this crisis in the community.
President Trump rightly called it the ``Crisis Next Door,''
and earlier this week, rolled out an ambitious plan. I was
pleased to see that several of his proposals overlap with the
work of this committee and I know that working across the aisle
and with the administration we can arm agencies, health care
providers, researchers, and patients with the tools they need.
We stand ready to work with the President and his
administration to put a stop to this crisis once and for all.
Over the span of 2 days, we will consider a range of bills
from Members on both sides of the aisle--25 bills, in fact,
covering the full spectrum of prevention and public health--and
we will hear from 19 witnesses.
The bills we will consider today will strengthen the Food
and Drug Administration's (FDA) ability to understand several
aspects of the opioid crisis, including: the risks of long-term
opioid use and how authorities can better intercept dangerous
illicit products at international mail facilities.
We will hear about legislation that will facilitate the
efficient development of treatments for substance use
disorders, and legislation that will encourage alternatives to
opioids for the treatment of pain. These are two areas of
medicine that have suffered from a lack of innovation and
development and I am optimistic that we can take tailored steps
to encourage progress with the right solutions.
Rep. Latta's amendment in the nature of a substitute to
H.R. 4284, Indexing Narcotics, Fentanyl, and Opioids (INFO) Act
would create a public and easily accessible electronic
dashboard linking to all of the nationwide efforts and
strategies to combat the opioid crisis, as well as create an
Interagency Substance Use Disorder Coordinating Committee to
review and coordinate research, services, and prevention
activities across all relevant federal agencies. This will be a
tremendous resource for patients, their families, and our local
communities.
Rep. Mullin's amendment in the nature of a substitute to
H.R. 3545, the Overdose Prevention and Patient Safety Act,
which would allow for limited sharing of substance use disorder
treatment records between health providers and place strong
discrimination prohibitions in statute to protect people
seeking and receiving substance use disorder treatment. I
understand this issue is a deeply sensitive one, but it is
important that we have a thoughtful discussion about ensuring
that patients seeking these services receive parity and the
same quality treatment that is provided to patients with other
chronic disorders. Substance use disorder is a medical illness
and we must treat it that way. Removing the stigma of addiction
is one of the most important things we as members of Congress
can do to respond to this national emergency and will
dramatically change how we prevent and treat this complex
disease.
Rep. McKinley's H.R. 5176, Preventing Overdoses While in
Emergency Rooms (POWER) Act, would provide resources for
hospitals to develop discharge protocols for patients who have
had an opioid overdose, such as the provision of naloxone upon
discharge and referrals to treatment and other services that
best fit the patient's needs.
I'd also like to thank my colleague Rep. Griffith for
leading a discussion draft that would authorize federal support
for a number of innovative activities in state-based
prescription drug monitoring programs (PDMPs).
These are just a handful of the solutions that our
colleagues, Republicans and Democrat, have brought forward.
I'd like to thank our four panels of witnesses for being
here today andtomorrow, and I look forward to your feedback on
these important issues.
Mr. Guthrie. Thank you, Mr. Chairman. Thanks, Dr. Burgess,
for moving forward with this leadership.
I have introduced, with Ranking Member Green, the
Comprehensive Opioid Recovery's Act, to approve treatment for
those suffering from opioid addiction. The treatment system is
fractured and complex, and patients with opioid use disorder
are not afforded the same comprehensive coordinated care that
patients with other chronic diseases receive. We must help all
Americans who suffer from opioid addiction.
The bill creates a new treatment structure that provides
coordinated evidence-based and patient-centered care. This bill
will also generate meaningful data that can be used to inform
standards and best practices moving forward.
Thank you again, and I yield back.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back.
The chair now recognizes the gentleman from Texas, Mr.
Green, 5 minutes for an opening statement, please.
OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Green. Thank you, Mr. Chairman, for holding the hearing
today. I want to thank Dr. Gottlieb and our other witnesses
from the Department of Health and Human Services and engaged
stakeholders for joining us today on this snowy morning.
One hundred and fifteen Americans die from overdosing on
opioids every day. The misuse of and addiction to opioids,
including the prescription pain relievers, heroine, synthetic
opioids like fentanyl, is a serious national crisis that
affects public health as well as the social and economic
welfare of communities throughout America.
The Centers for Disease Control and Prevention estimates
that the total economic burden of prescription opioid misuse in
the United States is $78.5 billion a year, including your cost
of healthcare, loss of productivity, addiction treatment, and
criminal justice involvement.
It is imperative that Congress and our public health
agencies advance policies that will help our fellow Americans
struggling with opioid addiction and prevent abuse and misuse
from happening in the first place.
One of the bills I am working on concurrently is a
discussion draft that would authorize the Food and Drug
Administration to consider the potential for misuse and abuse
when assessing the risk and benefits of a controlled substance
for purposes of approval.
It is important that our committee craft legislation on the
opioid crisis. And we give FDA clear authority to consider
potential misuse and abuse of a product when risk outweigh the
benefits.
I hope to hear from our panelists today on how we can best
tailor our proposal that will clarify the FDA authority, while
ensuring that it is targeting the controlled substances that
are fueling the opioid crisis.
The second bill I am working on is with both Congressman
Guthrie, Lujan, and Bucshon, is the Comprehensive Opioid
Recovery Centers Act, H.R. 5327. This bill creates a grant
program administered to the Department of HHS to fund
designated centers where individuals can obtain comprehensive
patient-centered care for the treatment of their addiction and
other substance use disorders.
Using the Comprehensive Opioid Recovery Centers Act, each
grantee would be required to provide, either directly or
through agreement with other entities, a set of range
coordinated evidence-based treatment recovery services.
Grantees would also be required to monitor and report on
the effectiveness of the programs, as well as provide outreach
to their communities on services they are providing.
I have been a lifelong proponent of increasing access to
healthcare in our communities. It is surprising to me to learn
how confusing and limited the options are for patients with
substance use disorder. I am hoping this legislation will help
transform our treatment system and help patients move easily,
navigate their options for care.
I look forward to asking questions of our panelists as to
how to make sure the purpose of this bill is carried out in the
most effective way.
While our committee is examining how best to combat opioid
abuse, I need to remind my colleagues on the critical
importance of ensuring Affordable Care Act coverage for the
essential benefits as part of the solution to this crisis.
We cannot help Americans struggling with opioid abuse if
they don't have health insurance coverage or have coverage that
does not provide the full range of essential health services
that are supposed to be guaranteed under the Affordable Care
Act.
I would like to share some concerns before I conclude. Many
members of our committee, including myself, are concerned about
the number of bills we are considering during our 2-day
hearing.
While we all agree on the magnitude of the opioid crisis
and the importance of concrete congressional action, I am
concerned that we will only be able to give brief attention to
many bills before us today and tomorrow due to the number of
bills we are considering, 25 in total.
While many of the bills are non-controversial and
bipartisan, there are bills that need to be improved before
they are ready for consideration before the House of
Representatives, and I hope the chairman will commit to work
with us on our concerns before bringing these bills up for
markup.
And I yield back the balance of my time.
[The prepared statement of Mr. Green follows:]
Prepared statement of Hon. Gene Green
Mr. Chairman, thank you for holding today's hearing on the
opioid crisis and public health solutions.
I thank our witnesses with the Department of Health and
Human Services and engaged stakeholders for joining us today on
this snowy morning.
One-hundred fifteen (115) Americans die from overdosing on
opioids every day. The misuse of, and addiction, to opioids--
including prescription pain relievers, heroin, and synthetic
opioids like fentanyl--is a serious national crisis that
affects public health, as well as the social and economic
welfare of communities throughout America.
The Centers for Disease Control and Prevention estimates
that the total ``economic burden'' of prescription opioid
misuse in the United States is $78.5 billion a year, including
the costs of healthcare, lost productivity, addiction
treatment, and criminal justice involvement.
It is imperative that Congress and our federal public
health agencies advance policies that will help our fellow
Americans struggling with opioid addiction and prevent abuse
and misuse from happening in the first place.
One of the bills I am working on, currently a discussion
draft, would authorize the Food and Drug Administration (FDA)
to consider the potential for misuse and abuse when assessing
the risks and benefits of controlled substances for purposes of
approval.
It is important that as our committee crafts legislation on
the opioid crisis, we give FDA clear authority to consider
potential misuse and abuse of a product when the risks outweigh
the benefits.
I hope to hear from our panelists today how we can best
tailor my proposal that will clarify FDA authority while
ensuring that it is targeting the controlled substances that
are fueling the opioid crisis.
The second bill I am working on, with Congressman Guthrie,
Lujan and Bucshon, is the Comprehensive Opioid Recovery Centers
Act, H.R. 5327. This bill creates a grant program administered
through the Department of Health and Human Services to fund
designated centers where individuals can obtain comprehensive
patient-centered care for the treatment of opioid addiction and
other substance use disorders.
Under the Comprehensive Opioid Recovery Centers Act, each
grantee would be required to provide, either directly or
through agreement with other entities, a set range of
coordinated evidence-based treatment and recovery services.
Grantees would also be required to monitor and report on
the effectiveness of these programs as well as provide outreach
to their communities on the services they are providing.
I've been a longtime proponent of increasing access to
health care in our communities. It was surprising to me to
learn how confusing and limited the options are for patients
with substance use disorder. I'm hoping this piece of
legislation will help transform our treatment system and help
patients more easily navigate their options for care.
I look forward to asking questions of our panelists as to
how to make sure the purpose of this bill is carried out in the
most effective way.
While our committee is examining how best to combat opioid
abuse, I need to remind my colleagues on the critical
importance of ensuring affordable health care coverage with
essential benefits as part of the solution to this crisis.
We cannot help American struggling with opioid abuse if
they do not have health coverage, or have coverage that does
not provide the full range of essential health services that
are supposed to be guaranteed under the Affordable Care Act.
I would like to share some concerns before I conclude. Many
Members of our committee, including myself, are concerned about
the number of bills we are considering during our two-day
hearing.
While we all agree on the magnitude of the opioid crisis
and the importance of concrete congressional action, I am
concerned that we will only be able to give brief attention to
many of the bills before us today and tomorrow due to the
number of bills we are considering, 25 in total.
While many of bills are non-controversial and bipartisan,
there are bills that need to be improved before they are ready
for consideration before the full House of Representatives. I
hope the Chairman will commit to work with us on our concerns
before bringing these bills to a markup.Thank you, Mr.
Chairman. I yield the remainder of my time.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back.
The chair recognizes himself for 5 minutes for an opening
statement, and acknowledge that we are convening our second of
three hearings to consider legislation addressing the opioid
epidemic.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
The efforts in the Comprehensive Addiction Recovery Act and
21st Century Cures have been impactful, but there is more that
Congress must do to tackle the crisis.
As to Cures, I would like to point out a recent story which
reported that some of the money approved by Congress remains
untouched, mostly at the Substance Abuse and Mental Health
Services Administration. If true, this should trouble all of us
here, because in communities across America, individuals are
suffering from addiction, overdose, lost loved ones. We cannot
allow agency inertia to get in the way of delivering those
dollars where they are, in fact, needed. This epidemic is in
our hospitals, in our living rooms, and on our streets. Our
partners at the Federal agencies must elevate to the challenge
and deliver these vital resources for the States and
communities that have been most impacted by this crisis.
As has previously been mentioned, this hearing is divided
over 2 days this week. We will focus on prevention and public
health aspects of the crisis. We are today going to hear the
role of the Food and Drug Administration and other segments of
the Department of Health and Human Services, including the
Substance Abuse and Mental Health Services Administration and
the Centers for Disease Control and Prevention, how they
interact and how Congress can do a better job in enabling these
agencies to do their work.
Today's hearing is a result of the Member Day that the
Health Subcommittee held last October where over 50 Members of
Congress, yes, this subcommittee, yes, the full committee, but
any Member of Congress was invited in to tell their story. And
we did hear their personal stories about how the epidemic has
affected their communities. I do want to commend these members
and their staffs and our committee staff for developing many of
the policies under consideration today, 25. I acknowledge that
that is a large number, but the crisis demands that we provide
the attention necessary. These bills today range from amending
laws relating to the confidentiality of substance use disorder
and patient data, to establishing comprehensive opiate recovery
centers, to streamlining and enhancing the tools for the Food
and Drug Administration to intercept illegal products in
international mail facilities. I would like to be able to
describe each bill in detail, but that task would take up more
time than I have allotted myself.
But I just want to point out that this challenge in front
of us does require a multifaceted approach. For example,
Representative Latta's bill, the INFO Act, embodies an all-
encompassing approach by directing the Department of Health and
Human Services to create a public and easily accessible
electronic dashboard linking to all nationwide efforts and
strategies to combat the crisis.
An all-hands-on-deck approach also means that we should
help interested stakeholders, such as biopharmaceutical
manufacturers, make the necessary investments in novel
treatments for the market. A bill that I am sponsoring will
require the Food and Drug Administration to provide more
clarity through guidance on how these stakeholders can utilize
the accelerated approval and breakthrough therapy programs to
expedite the availability of innovative therapies for pain and
addiction.
I am sure that many Members of Congress, especially those
who sit on this subcommittee, have heard from doctors, they
have heard from pharmacists in their districts about the
inefficiencies of the State-run prescription drug monitoring
programs. Representative Griffith's bill would realign
prescription drug monitoring programs under the Centers for
Disease Control to coordinate efforts to improve data
collection into physician workflow. Passage of this bill would
allow doctors to make better informed decisions leading to more
effective treatment for patients.
When narcotics, when opiates go unused, they frequently sit
in someone's medicine cabinet and instead of being properly
discarded and their disposal secured. Representative Hudson's
bill addresses this problem from the packaging and disposal
angle. His bill would direct the Food and Drug Administration
to work with manufacturers to establish programs for an
efficient return or destruction of unused schedule II drugs,
with an emphasis on opiates.
Many of us have seen the Centers for Disease Control's most
recent report on emergency departments' admissions. There were
30 percent increase from July 2016 through September 2017. Two
bills up for consideration would reverse that trend.
I again want to welcome our witnesses. And I will yield the
balance of my time to Mrs. Blackburn from Tennessee.
[The prepared statement of Mr. Burgess follows:]
Prepared statement of Hon. Michael C. Burgess
This morning, we convene for our second of three hearings
to consider legislation addressing the opioid epidemic. While
our efforts in the Comprehensive Addiction and Recovery Act and
21st Century Cures have been impactful, there is much more that
Congress can do to tackle this crisis. As to Cures, I would
like to point out a recent story which reported that most of
the money approved by Congress remains untouched, mostly at the
Substance Abuse and Mental Health Services Administration. If
true, this should trouble all of us here because in communities
across America, individuals and families are suffering from
addiction, overdose, and loss of loved ones.
This epidemic is in our hospitals, in our living rooms, and
on our streets. Our partners at federal agencies must rise up
to the challenge and deliver these vital resources for the
states and communities most hurt by this crisis.
This hearing, which will be split between today and
tomorrow, focuses on the prevention and public health aspects
of the crisis, particularly addressing the role that the Food
and Drug Administration, and other segments of the Department
of Health and Human Services, including the Substance Abuse and
Mental Health Services Administration, can play, and how
Congress can enable these agencies to better do its job.
Today's hearing is the result of the Member Day the Health
Subcommittee held last October, where over 50 bipartisan
Members of Congress--both on and off the Energy and Commerce
Committee--shared their personal stories on how the opioid
epidemic has devastated their communities. I commend these
members, their staffs, and our committee staffs for developing
many of the policies under consideration today. Twenty-five.
This is the total number of bills being reviewed. They range
from amending laws relating to confidentiality of substance use
disorder patient data, to establishing comprehensive opioid
recovery centers, to streamlining and enhancing the tools for
FDA to intercept illegal products in international mail
facilities. While I wish I could describe each bill in detail,
that task itself may take the full two days we have slotted for
this hearing.
The opioid epidemic requires a multi-pronged, comprehensive
approach involving almost all facets of our society. For
example, Rep. Latta's bill, the INFO Act, embodies an all-
encompassing approach by directing the Department of Health and
Human Services to create a public and easily accessible
electronic dashboard linking to all nationwide efforts and
strategies to combat the crisis.
An all-hands-on approach also means we should help
interested stakeholders, such as biopharmaceutical
manufacturers, make the necessary investments in novel
treatments for the market. A bill I am sponsoring will require
the Food and Drug Administration to provide more clarity
through a guidance on how these stakeholders can utilize the
accelerated approval and breakthrough therapy programs to
expedite the availability of innovative therapies for pain and
addiction.
I am sure that many members of Congress, especially those
who sit on this Subcommittee, have heard from physicians and
pharmacists in their district about the inefficiencies of
state-run prescription drug monitoring programs, or PDMPs. Rep.
Griffith's bill would realign PDMPs under the Centers for
Disease Control and Prevention to coordinate efforts that will
improve data collection and integration into physician
workflow. Passage of this bill would allow physicians to make
better informed decisions, leading to more effective treatment
for their patients.
When opioids go unused, they frequently sit in people's
medicine cabinets instead of being properly disposed,
increasing the likelihood of diversion. Rep. Hudson's bill
fights this problem from the packaging and disposal angle. His
bill would direct the Food and Drug Administration to work with
manufacturers to establish programs for efficient return or
destruction of unused Schedule II drugs, with an emphasis on
opioids.
Many of us have seen the Center for Disease Control and
Prevention's most recent report on emergency department
admissions due to opioid overdoses where there was a thirty
percent increase from July 2016 through September 2017. Two
bills up for consideration today aim to reverse this trend. A
bill introduced by Rep. Pascrell would establish a
demonstration program to test alternative pain management
protocols to limit the use of opioids in hospital emergency
departments. Another bill, introduced by Rep. McKinley, would
assist hospitals in developing protocols on discharging
patients after they overdose.
Clearly, we have our work cut out for us over the next 2
days as we examine the policies within these bills. But, it
will be a worthwhile exercise that will produce a well-thought-
out and well-vetted package of legislation to aid our public
health workforce in overcoming this public health crisis.
I again want to welcome our witnesses and thank you for
being here. I look forward to your testimony.
Mrs. Blackburn. Thank you, Mr. Chairman.
And another report that I saw yesterday was the AEI report
that goes through the cost per capita of the opioid epidemic.
It is $2,000 per person in Tennessee, is what it is costing us.
But I think the emotional cost is something that we will want
to visit with you all today about too.
Yesterday, I talked with a friend who was recounting how,
12 years ago, I sat with her, cried with her, talked with her
as she discovered a high school child had an opioid addiction
and how things have changed and the attention that is paid to
the issue now. And it is a heart-wrenching issue. And we thank
you all for being here and working with us on the issue.
And I yield back.
Mr. Burgess. The gentlelady yields back.
And the chair will yield back.
The chair now recognizes the ranking member of the full
committee, Mr. Pallone, 5 minutes for an opening statement,
please.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Mr. Chairman.
Today, we continue a series of hearings to address the
complex opioid abuse crisis that is devastating lives across
the country. While we have worked together to pass CARA and the
21st Century Cures Act, more must be done. And that is why I am
pleased that Congress agreed in the budget agreement to provide
a total of $6 billion in additional funding for efforts to
respond to the epidemic for fiscal years 2018 and 2019. Without
this funding commitment, many of the laws we have passed and
the bills being discussed during this hearing are nothing more
than empty words.
Over the next 2 days, we have a lot of bills to consider,
and I hope we can have a thorough conversation about all of
them. However, I am concerned that it will be difficult to
properly address all of the bills since there are so many. In
going forward, it would be nice if the Republican majority
scheduled multiple hearings so that we have the time to fully
evaluate the proposed solutions.
The bills we will consider during the next 2 days are
diverse and span multiple disciplines, and that is essential
because there is no single solution to the opioid crisis. No
single individual, group, field of study, or agency can solve
this problem alone. Everyone must do their part.
And one of the major ways we can impact the prevalence of
opioids available for abuse is to limit the importation of
synthetic opioids that have infiltrated our international
mailing facilities, and that is why I have introduced a bill,
the SCREEN Act, to expand FDA's authority to crack down on the
counterfeit drugs entering the country. Currently, FDA has
limited authority to act on parcels with mislabeled, unlabeled,
or counterfeit drug products. This bill will provide greater
oversight of packages in international mail facilities allowing
the FDA to refuse importation or destroy illegal drugs being
shipped into the country and recall and prevent distribution of
products that pose a danger to public health. Importantly, it
will also authorize resources for FDA to expand capacity to
meet this challenge.
It is unfortunate that the chairman chose not to notice
this bill for today's hearing since I have been working on this
issue for years, and I hope that we can still consider this
bill as we move forward.
We are also reviewing other important bills, such as H.R.
3692, the Addiction Treatment Access Improvement Act of 2017,
which will increase the number of providers that can treat
patients through the DATA 2000 waiver. Also, H.R. 5140, the
Tribal Addiction and Recovery Act, which would provide funding
to Tribes and Tribal organizations for substance use disorder
prevention and treatment efforts in Indian Country. And a
discussion draft that would enhance and improve State-run
prescription drug monitoring programs, known as NASPER.
I am not able to speak on every bill in such a short amount
of time, but I do want to highlight the concerns I have with
one of the bills under discussion today, and that is H.R. 3545,
the Overdose Prevention and Patient Safety Act, which I think
could dangerously erect a barrier to patients seeking and
remaining in treatment and, therefore, harm our efforts to
respond to this crisis. It would be nice if we could eliminate
discrimination for good in this country by simply passing a law
that makes discrimination illegal. But, unfortunately, that is
simply not the case. And, therefore, I do not think the
additions to the underlying text of the bill cures the issue of
the risk of stigma, discrimination, and negative health and
life outcomes that could result from a rollback of regulations
that protect a patient's privacy.
So I look forward to discussing each of these bills during
this and future hearings continuing to work towards finding
solutions to this very severe opioid crisis.
And I yield the remainder of my time to the gentlewoman
from California, Ms. Matsui.
[The prepared statement of Mr. Pallone follows:]
Prepared statement of Hon. Frank Pallone, Jr.
Today we continue a series of hearings to address the
complex opioid abuse crisis that is devastating lives across
the country. While we have worked together to pass CARA and the
21st Century Cures Act, more must be done. That is why I'm
pleased that Congress agreed to provide a total of $6 billion
in additional funding for efforts to respond to the epidemic
for fiscal years 2018 and 2019. Without this funding
commitment, many of the laws we've passed and the bills being
discussed during this hearing are nothing more than empty
words.
Over the next 2 days, we have a lot of bills to consider,
and I hope we can have a thorough conversation about all of
them. However, I'm concerned that it will be difficult to
properly address all of the bills since there are so many.
Going forward, it would be nice if the Republican Majority
scheduled multiple hearings so that we have the time to fully
evaluate the proposed solutions.
The bills we will consider during the next 2 days are
diverse and span multiple disciplines, and that's essential
because there is no single solution to the opioid crisis. No
single individual, group, field of study, or agency can solve
this problem alone, everyone must do their part.
One of the major ways we can impact the prevalence of
opioids available for abuse is to limit the importation of
synthetic opioids that have infiltrated our international
mailing facilities. That is why I have introduced a bill, the
SCREEN ACT, to expand FDA's authority to crack down on the
counterfeit drugs entering the country. Currently, FDA has
limited authority to act on parcels with mislabeled, unlabeled,
or counterfeit drug products. This bill will provide greater
oversight of packages in International Mail Facilities, allow
the FDA to refuse importation or destroy illegal drugs being
shipped into the country, and recall and prevent distribution
of products that pose a danger to public health. Importantly,
it will also authorize resources for FDA to expand capacity to
meet this challenge.
It's unfortunate that the Chairman chose not to notice this
bill for today's hearing since I've been working on this issue
for years. I hope that we can still consider this bill moving
forward. We're also reviewing other important bills such as
H.R. 3692, the Addiction Treatment Access Improvement Act of
2017, which will increase the number of providers that can
treat patients through the DATA 2000 waiver. H.R. 5140, the
Tribal Addiction and Recovery Act, will provide funding to
tribes and tribal organizations for substance use disorder
prevention and treatment efforts in Indian Country. And a
discussion draft that would enhance and improve State-run
Prescription Drug Monitoring Programs--known as NASPER.
I'm not able to speak on every bill in such a short amount
of time. But I did want to highlight the concerns I have with
one of the bills under discussion today. H.R. 3545, the
Overdose Prevention and Patient Safety Act could dangerously
erect a barrier to patients seeking and remaining in treatment
and therefore harm our efforts to respond to this crisis. It
would be nice if we could eliminate discrimination for good in
this country by simply passing a law that makes discrimination
illegal, but unfortunately that simply isn't the case.
Therefore I do not think the additions to the underlying text
of the bill cures the issue of the risk of stigma,
discrimination, and negative health and life outcomes that
could result from a roll back of regulations that protect a
patients' privacy.
I look forward to discussing each of the bills during this
and future hearings and continuing to work towards finding
solutions to the opioid crisis.
I yield back.
Ms. Matsui. Thank you very much, Mr. Pallone. And thank
you, Mr. Chairman, for holding this hearing. And thank you to
the witnesses for being here today.
I am pleased that we are taking on the issue of the opioid
epidemic in our committee. We are examining a lot of bills
today, and I think we are ahead of some of the other committees
in the House and Senate in doing so. I am glad we are moving
forward, but do want to make sure that we do it in a way that
avoids unintended consequences.
It is important that we take a comprehensive look at all
aspects of this problem, from opioid manufacturing and
distribution, to prescribing, to research and alternatives for
pain management, to access of substance use treatment and
services.
As we examine all the different factors that contributed to
where we are today, I hope we approach solutions with a shared
sense of responsibility. I know that the policy pendulum often
swings to extremes. So I think we need to be careful to avoid
creating new problems as we try to solve the problems facing us
today.
Lastly, as we examine an array of targeted solutions with
FDA, CDC, and SAMHSA today, I hope we take a holistic look at
this epidemic and assure we are making a coordinated effort to
provide solutions for families and prevent future strategies.
With that, thank you, and I yield back.
Mr. Burgess. The chair thanks the gentlelady. The
gentlelady yields back.
And that concludes member opening statements. The chair
would like to remind members that, pursuant to committee rules,
all members' opening statements will be made part of the
record.
And we do want to thank our witnesses for being here today
and taking the time to testify before the subcommittee. Each
witness will have an opportunity to give a summary of their
opening statement. That will be followed by questions from
members.
Our first panel today, we will hear from Dr. Scott
Gottlieb, the Commissioner of the Food and Drug Administration;
Dr. Anne Schuchat, Acting Director, Center for Disease Control
and Prevention; and Dr. Christopher M. Jones, Director of the
National Mental Health, Substance Use Policy Laboratory,
Substance Abuse and Mental Health Services Administration, and
a Pharmacist, as I understand, and from Georgia.
So we welcome all of you to our witness table today.
Dr. Gottlieb, you are recognized for 5 minutes, please.
STATEMENT OF SCOTT GOTTLIEB, M.D., COMMISSIONER, FOOD AND DRUG
ADMINISTRATION; ANNE SCHUCHAT, M.D., ACTING DIRECTOR, CENTERS
FOR DISEASE CONTROL AND PREVENTION; AND CHRISTOPHER M. JONES,
PHARMD, MPH, DIRECTOR OF THE NATIONAL MENTAL HEALTH AND
SUBSTANCE USE POLICY LABORATORY, SUBSTANCE ABUSE AND MENTAL
HEALTH SERVICES ADMINISTRATION
STATEMENT OF SCOTT GOTTLIEB, M.D.
Dr. Gottlieb. Good morning, Chairman Burgess, Ranking
Member Green, and members of the subcommittee. Thank you for
the opportunity to discuss FDA's role in combating the ongoing
crisis of opioid addiction.
Confronting this epidemic remains one of my highest
priorities. I am committed to reexamining all of our
authorities and further steps FDA can take, and I am grateful
for this committee's commitment to the role FDA has in
combating the epidemic and for your interest and additional
tools that could enhance FDA's ability to respond, such as
those that would support our work in the interdiction of
illegal drugs, including narcotics, inside the international
mail facilities.
To address this crisis, FDA is working across three broad
domains. First, we are taking steps to improve our medical
technology. This means better drugs to treat addiction through
medication-assisted treatment and new pain remedies that are
resistant to manipulation and misuse or aren't as addictive as
traditional opioids.
Second, we are pursuing measures to reduce the rate of new
addiction. This means trying to reduce overall prescribing and
the number of pills that get dispensed with each prescription.
So among other things, we are taking new steps to require
sponsors to provide education to providers and other healthcare
practitioners. We are also exploring ways to change how opioids
are packaged to allow better management of their prescribing.
One of the things we are considering is steps to require
sponsors to ensure prescribers provide specific documentation
for prescription above a specified amount. Such a framework
would be based on evidence-based guidelines that define the
proper length of treatment for a given indication.
Third, we are ramping up our efforts aimed at the
interdiction of illegal drugs, including narcotics. This
includes new authorities and resources aimed at our work in the
international mail facilities. There is a virtual flood of
dangerous products entering the United States through mail
packages that expose Americans to dangerous pills. We are
dealing with sophisticated bad actors that are aware of the
gaps and weaknesses in our tools and try to exploit them.
Primary responsibility for imported narcotics falls to
Customs and Border Protection. Anything believed to contain
controlled substances goes to CBP before packages are sent to
us at FDA. But we are still seeing more and more controlled
substances hitting our investigators. In fact, in one recent 6-
month period where FDA inspected 5,800 packages, 376 contained
controlled substances, including opioids.
I am increasingly worried that those sneaking opioids
through the mail will disguise them as ordinary drugs to evade
detection. It is estimated that less than one-tenth of 1
percent of the packages that contain drugs actually undergo the
physical inspection. The risk is that many illicit drugs are
slipping through our grasp.
As you know, we have prioritized our work in the IMFs and
invested to strengthen our presence and capabilities there, but
there is more that we must do. We have increased our staffing
and are seeking support to grow our footprint for interdiction
work still further.
Additional staffing is critical. But to maximize what we
can do, I want to focus on some additional authorities that we
have discussed with Congress. These include certain detention
and destruction authorities.
First, our operations at the IMFs routinely see packages of
unlabeled or partially labeled pills coming through the
facilities, some in boxes and blister packs, and many simply in
thousands of loose pills and huge boxes. We are required to
open every package, document the contents, and find supporting
evidence of the article's intended use as a drug in order to
detain, refuse, or destroy that article. Where the evidence is
insufficient, under our existing standard for destruction, we
often simply refuse entry and send the package back to its
source. It is not uncommon for our investigators to see the
same package again and again as shippers resend the same box a
second and even third time.
This process is not a deterrent. If FDA had the authority
to detain, refuse, and destroy unlabeled imported products that
are found to contain active ingredients or analogues that are
FDA-approved drugs, we could more quickly remove potentially
dangerous products from the supply chain.
Second, this is also a numbers game. The bad actors can
send in hundreds or thousands of small parcels via
international mail to individual recipients in the U.S. These
shipments are wholesale quantities of illegal, often
counterfeit drugs, that are intended for further domestic
distribution, and each package may violate FDA law. But they
know that FDA can't examine or stop them all, because current
law requires us to detain and pursue legal proceedings against
each package separately. They simply overwhelm our system with
volume. Improving FDA's authority so we can more efficiently
detain or refuse bulk shipments of individual packages from a
single source would create a big difference and better protect
Americans from dangerous imported substances.
And, third, while substances already scheduled are
generally referred to CBP at the border, when FDA-regulated
articles contain substances that haven't yet been scheduled,
FDA is responsible for that product. This is an issue with the
high volume of synthetic narcotics coming primarily from China.
Right now, we can't refuse or destroy these unlabeled products
or those without a drug claim, such as fentanyl analogues,
simply because they are articles of concern to DEA.
Extending FDA's ability to refuse, detain, or destroy
products in this gap right before DEA's scheduling takes place
would keep dangerous articles that currently are not easily
detained off the streets. These are just some of the tools that
could enhance our mission.
I appreciate your support and your interest in our work in
this effort, and I look forward to working close with you to
help safe lives.
[The prepared statement of Dr. Gottlieb follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. The chair thanks the gentleman.
The chair recognizes Dr. Schuchat, 5 minutes, for an
opening statement please.
STATEMENT OF ANNE SCHUCHAT, M.D.
Dr. Schuchat. Good morning, Chairman Burgess, Ranking
Member Green, and members of the Committee. CDC has vast
experience tackling epidemics, and I appreciate the chance to
talk today about our work fighting the Nation's opioid crisis.
At CDC, we are focused on using data for actions to inform
strategies to prevent opioid misuse, abuse, and overdose, and
to prevent health-related consequences of opioid use, including
the spread of infectious diseases, like HIV and hepatitis, and
the impact of opioids on mothers and babies. CDC leads
comprehensive prevention efforts by promoting responsible
opioid prescribing, tracking trends, and driving community-
based prevention activities to reduce opioid overdose deaths
and related harms.
America's opioid overdose epidemic affects people from
every community. The problem is getting worse. In 2016, more
than 63,000 people died of drug overdose, and preliminary data
indicate that the trend worsened in 2017. We have seen
increases in babies born withdrawing from narcotics. New data
suggests one baby is born with signs of neonatal abstinence
syndrome every 15 minutes, about 100 babies a day. We have also
seen a drop in life expectancy for the first time since 1993.
For every one person who dies of an opioid overdose, over 60
more are already addicted to prescription opioids, and almost
400 misuse them.
CDC supports State health departments providing resources
and guidance to implement evidence-based prevention
interventions so States can rapidly adjust as we learn more
about what works best in this very fast-moving epidemic. A
nimble Federal and State response is crucial.
CDC now funds 45 States and Washington, D.C., to advance
prevention, including by improving prescription drug monitoring
programs, or PDMPs, improving prescribing practices, gathering
timely high-quality data, and evaluating policies. We hope to
expand this funding to 50 States.
States are making progress in working toward more
comprehensive and effective monitoring through their PDMPs,
which is essential to improve clinical decision-making and use
data as a public health surveillance tool. With CDC funds, many
are increasing use by providers and pharmacists, enhancing the
timeliness of reporting, and integrating with electronic health
records.
For example, in North Carolina, they have integrated
prescribing data from the PDMP within the clinical workflow of
existing health information systems across the State.
Improvements like that show how we can make vital data
actionable with the goal of saving lives.
CDC is also leading improvements to the public health data
needed to understand and respond to the crisis. We improved the
timeliness of reporting, updating preliminary data on overdose
deaths, on our website every month. Through our funding to
States, we are ramping up our efforts to get more comprehensive
and timely data from emergency rooms, emergency medical
services, medical examiners, and coroners. We are tracking
nonfatal overdoses. And as you have heard, we recently reported
on the 30 percent increase across the country.
We also recently released data using toxicological and
death scene evidence from 10 funded States, allowing for a more
robust characterization of opioid overdose deaths. That
analysis found that fentanyl was involved in more than half of
the recent opioid overdose deaths.
CDC continues to educate providers and the public on opioid
use through the implementation of our Guideline for Prescribing
Opioids for Chronic Pain and the Rx Awareness communication
campaign. We are making the guideline more accessible to
clinicians through interactive training and a mobile app. The
campaign focuses on the risks of prescription opioids, and it
features real life accounts of individuals living in recovery
and those who have lost someone to this terrible problem.
In addition to our partnership with States, CDC believes
this epidemic requires a collaboration across sectors. We have
been working side by side with law enforcement, like the DEA,
to determine risk factors for illicit opioid overdose and
target implementation plans for community specific prevention
strategies. We draw on experts from across our agency to
address the many facets of the crisis. The comprehensive public
health approach is playing a key part in addressing the
epidemic. We didn't get into this epidemic overnight, and we
are not going to get out of it overnight. We need intensified
sustained efforts to reverse the epidemic.
Thank you.
[The prepared statement of Dr. Schuchat follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you, Doctor.
Dr. Jones, you are now recognized for 5 minutes for an
opening statement, please.
STATEMENT OF CHRISTOPHER M. JONES, PHARMD
Dr. Jones. Thank you. Chairman Burgess, Ranking Member
Green, and members of the committee, thank you for the
opportunity to discuss the opioid crisis and the Federal
Government response.
From the start of his administration, President Trump has
made addressing the opioid epidemic a top priority. And at
SAMHSA, we share the President's commitment to bringing an end
to the crisis. Families and communities across our Nation have
been impacted by increasing prescription and illicit opioid
abuse addiction and overdose. And the emergence of illicit
fentanyl and other potent synthetic opioids has only fueled the
crisis in recent years.
As the department's lead agency for behavioral health,
SAMHSA has been at the forefront of the response to the opioid
crisis. Under the HHS opioid strategy, our work focuses on
advancing prevention, treatment, and recovery services and
overdose prevention through funding to build State and local
capacity, providing education, training, and technical
assistance, and data collection analysis and evaluation to
track emerging trends, identify what works, and support the
integration of evidence into practice.
Today, I want to focus on several recent actions SAMHSA has
taken to enhance our response to the opioid crisis. In the area
of funding, SAMHSA distributed $485 million to States and
territories under our State targeted response to the opioid
crisis grants in May 2017. This funding supports State efforts
to reduce opioid overdose deaths and provide the full
complement of prevention, treatment, and recovery support
services.
In November of 2017, SAMHSA announced that it was accepting
applications for $1 million in supplemental STR grants to
expand and enhance those efforts in States hardest hit by the
epidemic. On Monday of this week, SAMHSA awarded supplemental
STR grants to New Hampshire, Massachusetts, and West Virginia.
SAMHSA also provides critical funding for treatment and
recovery services for specific high risk and vulnerable
populations, such as those involved in the criminal justice
system and pregnant and postpartum women.
In September 2017, SAMHSA awarded nearly $10 million over 3
years for new State pilot grants authorized by CARA that enable
outpatient based care for pregnant and postpartum women and
nearly $50 million over 5 years in new grants to support
residential treatment services for pregnant and postpartum
women.
SAMHSA has been a leader in efforts to reduce overdose
deaths by increasing access and availability to naloxone to
reverse overdose. In September 2017, SAMHSA awarded funding to
grantees in 22 States from programs authorized by CARA to
provide resources to first responders and treatment providers
who work directly with populations at high risk for opioid
overdose.
Developing a well-trained workforce and facilitating the
integration of evidence-based interventions into practice are
key goals of SAMHSA's education, training, and technical
assistance efforts. In January 2017, SAMHSA awarded $12 million
to create--I'm sorry, January of 2018, we awarded $12 million
to create the Opioid STR Technical Assistance program. This new
program is providing direct technical assistance to States and
local jurisdictions to support the implementation of evidence-
based practices that are tailored to the State-specific
context. And last month, SAMHSA released TIP 63, medications
for opioid use disorders, which now includes information about
all of the FDA-approved medications for the treatment of opioid
use disorder as required in CARA.
In addition, SAMHSA's providers clinical support system for
medication-assisted treatment, which provides national training
and mentoring to support clinicians interested in providing
addiction care, has also revised its DATA waiver training to
include information on all FDA-approved medications for
treatment of opioid use disorder.
Given the importance of providing clinicians and patients
with actionable information about opioid addiction and
pregnancy, last month, SAMHSA released clinical guidance for
treating pregnant and parenting women with opioid use disorder
and their infants. This guidance provides clear information on
a range of real-world scenarios faced by healthcare providers
who are caring for mothers and infants.
And in January 2018, SAMHSA issued a final rule pertaining
to substance use disorder treatment records, commonly referred
to as Part 2. As required in 21st Century Cures, SAMHSA also
held a public meeting in January to obtain feedback from
stakeholders on Part 2. The vast majority of those who spoke at
the meeting expressed their support for further aligning Part 2
and HIPAA, and acknowledge that congressional action would be
needed to achieve many of their goals.
In the area of data analysis and evaluation, SAMHSA is
standing up the National Mental Health and Substance Use Policy
Laboratory, created under the 21st Century Cures Act. The
policy lab, charged by Congress with supporting innovation,
evaluating promising approaches, and facilitating the adoption
of evidence-based policies is prioritizing its efforts on
opioids.
Finally, the President's fiscal year 2019 budget for SAMHSA
includes $15 million to reestablish the Drug Abuse Warning
Network, or DAWN, a national public health surveillance system
that will improve emergency room monitoring of substance use,
including opioid misuse.
SAMHSA is committed to combating the opioid crisis and
looks forward to working with Congress to advance this
important work.
Thank you for inviting me to testify, and I look forward to
your questions.
[The prepared statement of Dr. Jones follows:]
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Mr. Burgess. Thank you, Dr. Jones.
I want to thank all of our witnesses.
We now move to the question portion of the hearing. I am
going to recognize myself for 5 minutes.
And, Dr. Jones, let me start at your end of the table. You
saw the reports that were printed in the press in the past
couple of weeks. About $500 million was set aside in Cures for
the purposes of addressing this epidemic, and yet those funds
have yet to be directed toward State efforts.
So first off, is that as that was reported? Is that
accurate, what we were reading in the papers a couple of weeks
ago?
Dr. Jones. So I think it is important to clarify that the
money to the States under the STR program was distributed May
1. So the States have the money. The sort of bottleneck for
spending down the money is at the State level, largely due to
variations in how States go through their procurement process
to contract with providers to provide services. So the money is
not at SAMHSA. It is actually at the State.
Mr. Burgess. So let me just ask you, and I am sure the
answer will be yes, but will you work with any Member who feels
that they are having difficulty getting those funds accessed by
folks in their State? That is the whole purpose of putting the
money there in the first place, correct?
Dr. Jones. Absolutely. And we have put a process in place
to look at the implementation of STR more broadly where we have
our grants' management officials who are in regular contact
with the States to address questions that come up around can
these things be covered under this, as well as meeting
regularly and the assistant secretary to really help provide
leadership and top-down approach to helping the States advance.
I will also say the $12 million STR Technical Assistance
program, which I mentioned in my opening statement, is really
intended to support the States to achieve their strategic goals
under the STR program. And one of those is specifically looking
at how are we providing the services that the funding is
intended to provide. So I think the TA in particular will be
very helpful to the States in spending that down.
But we are certainly open and happy to talk to any Member
or constituent who has raised issues with being able to spend
down the money.
Mr. Burgess. Thank you.
And Dr. Schuchat had mentioned in her testimony about--I
think it was 100 neonatal abstinence cases a day that are being
now acknowledged. Did I get that correctly, Dr. Schuchat?
So the money that you have put forward in SAMHSA, I
appreciate that, but at 100 new cases a day, are we even coming
close to scratching the surface there?
Dr. Jones. Well, I think that what is important in looking
at neonatal abstinence syndrome is that it really is a
comprehensive approach. So some individuals may be prescribed
opioids for pain during their pregnancy, which may result in a
neonate being born physically dependent on opioids, others may
be misusing or using illicit opioids. And at SAMHSA, we
certainly have tried to put out guidance, as I mentioned, the
clinical guidance around treating parenting and pregnant women.
Mr. Burgess. I don't mean to interrupt you, but I am
running out of time. And I get that, and I appreciate that. But
at 100 neonatal abstinence cases a day that Dr. Schuchat is
talking about, I mean, that is a pretty big problem. And from
the perspective of for every neonate with a syndrome, there is
a mother who also has a problem. And with what we have given
you so far, are you able to meet that challenge?
Because many of us do have a concern that some of the
changes, the increase in maternal mortality that they reflect
around the country may be as a consequence of this opiate
activity.
Dr. Jones. So I will say I certainly think that we are
trying to put out money as quickly as possible and to help
advance evidence-based practices. The magnitude of the issue,
as Dr. Schuchat mentioned, continues to grow, and we need to
make sure that resources are commiserative with the scale of
the problem.
Mr. Burgess. Well, again, we may communicate more about
that, because it is an important topic.
And, Dr. Gottlieb, once again, I want to thank you for
including me in your visit to the International Mail Facility.
You testified to the fact that one-tenth of 1 percent of
packages are actually being inspected. Really, it is hard to
imagine the volume of stuff that is coming in that requires you
and CBP to inspect and intervene. Can you speak to that just a
little bit more about what your needs are?
Dr. Gottlieb. Thank you, Congressman. Thanks for joining us
on that visit to the JFK International Mail Facility. That
facility in particular, there is about a million packages a day
going through that facility. We get 2.4 million packages a day
going through the combined international mail facilities. And
based on estimates that are derived from some analysis we did
from 2004, we estimate that about 9 percent of all packages
contain some form of drugs, either prescription drugs,
counterfeit drugs, or controlled substances. And to your point,
we estimate that we are physically inspecting less than
probably 0.05 percent of them.
Now, we target packages. And we target certain packages for
x-ray, and then we target certain packages for physical
inspection. And so intelligence is key here in terms of
targeting the right packages. And we do do a good job of that,
but getting more information is better. But we know we are
missing packages.
And so, the key is getting more personnel into those
facilities, being able to operate more quickly and more
efficiently with our authorities, and getting better
intelligence in terms of targeting our resources more
effectively. And we could do more across all three domains.
Mr. Burgess. And it is just so important. The agent who
intercepted a flip-flop, sliced it open, and pulled out a
counterfeit passport, I was just astounded, number one, that
they picked it up, and, number two, who thought that was a good
idea in the first place?
With nothing implied, I would now recognize Mr. Green of
Texas, 5 minutes for your questions, please.
Mr. Green. Well, I appreciate that intro.
Dr. Gottlieb, I want to thank you for all your efforts and
seriously look at how FDA can play a role in combating the
opioid crisis facing our country. We must examine how we
prescribe and dispense opioid, how we can limit or deter
diversion, and how we can treat those that suffer.
In your testimony, you noted the majority of the people who
become addicted to opioids are first exposed through the lawful
prescription. Many of us on the committee have committed to
examining how lawful prescriptions have contributed to this
crisis and what steps Congress and Federal agencies can take to
reduce the rate of addiction from lawfully obtained opioids.
The FDA took unprecedented action last year when it
requested the withdrawal of an opioid treatment due to the
concern that the benefits associated with the product were
outweighed by the risk of abuse and manipulation. One of the
bills noticed today is a discussion draft that offered to allow
the FDA to take into consideration the potential risk of abuse
and misuse of making approval decisions. Currently, FDA
examines a drug for safe and efficacy for their intended use
when making approval decisions.
Will you discuss how FDA's approval and assessment of a
drug would change if the agency's authority was modified as
proposed in the draft?
Dr. Gottlieb. Thanks for the question, Congressman. As you
mentioned, we recommended the withdrawal of Opana ER earlier
this year based on a consideration around a risk that was only
manifested when that drug was used illicitly. In this case, it
was when the drug was crushed and injected, it created a
certain autoimmune phenomenon in particular that wouldn't have
been manifested if the drug was taken as intended.
We believe we have the legal authority to look at risks
associated purely with illicit use as a component of how we
assess risk and benefit both pre- and post-market. We exercised
that authority in this case. But I do think that this is an
opportunity for Congress to think about how that authority can
be tailored specifically against this challenge and
particularly with respect to controlled substances.
For drugs outside of controlled substances, if we are
trying to address an unlabeled use, a risk associated with an
unlabeled use, typically, we would use our REMS authority, and
that would be adequate. But in the setting of drugs that have
an abuse liability associated with them and are used in an
illicit fashion, having carefully constructed authority, I
think, could benefit the agency and benefit consumers.
Mr. Green. I understand that some stakeholders must be
hesitant to make modifications to the FDA's current risk
benefit assessment. As we continue to work on the legislation,
how would FDA recommend that we target this legislation to
ensure that we are appropriately targeting the controlled
substances that are fueling this opioid crisis?
Dr. Gottlieb. We can certainly tailor this kind of
consideration to controlled substances to scheduled products.
Congress clearly recognized that there needed to be certain
controls and certain special considerations with respect to
controlled substances in the formation of the Controlled
Substances Act. The Controlled Substances Act creates a lot of
controls on the prescription and prescribing of a narcotic that
don't exist for any other drug.
And so we have already crossed the Rubicon, if you will,
with respect to trying to create special considerations with
respect to controlled substances. I think this would just be,
you know, furtherance of that and basically just a
clarification of an authority that we not only believe we have
but we have exercised. And so it is an opportunity, I think,
for Congress to tailor that authority behind the specific
challenge that we face.
Mr. Green. OK. Thank you. And I am looking forward to
working with you and the FDA so we can make sure this
legislation is really a benefit and can do it. Thank you. And
we must closely examine how we can limit the ability of opioids
to be wildly prescribed as also abused and misused, while also
balancing the need to ensure accessibility for those who suffer
from more chronic pain, and I look forward to continue working
with you.
In my last minute, Dr. Jones, I would like to turn to talk
to a bill introduced earlier this week by Congressman Guthrie,
Lujan, and Bucshon, the Comprehensive Recovery Centers Act.
That seems like something that would be useful. But to create a
pilot program to support opioid treatment centers, or CORCs in
the legislation, we always have to have an acronym. Essential
requirement of CORCs in our legislation is a must-have,
dedicated outreach efforts in the community, including a large
public health system, criminal justice system, higher
education, and community partners.
Do you agree that this connectivity with the community
stakeholders is important?
Dr. Jones. Thank you for the question. I think that
providing comprehensive services for individuals who have
opioid use disorder is really critical to their success. As a
person in long-term recovery from opioid addiction, I am very
familiar with navigating the fragmented system. And so
providing that as a sort of a one-stop shop I think really sets
people up for success. And we need to make sure they have
access to evidence-based care like medication assisted
treatment, but housing supports, employment, other supports to
really make them successful in the long run is very important.
Mr. Green. Well, I am out of time. But I also know that we
have a network already of federally qualified health centers
and that we just need to expand to give them that opportunity
to see how they can treat the whole person, including their
addiction.
So, Mr. Chairman, I know I am out of time. Thank you.
And I will submit some questions.
Mr. Burgess. The chair thanks the gentleman.
The chair recognizes the Chairman of the Full Committee,
Mr. Walden, 5 minutes for questions.
Mr. Walden. Thank you, Mr. Chairman. I really appreciate
the work you are doing here and the other members of the
committee and our witnesses.
And, Dr. Schuchat, thank you for being back here before the
committee. At least two of the three, maybe all three of you
have been here on multiple occasions. So we really appreciate
your leadership at CDC and the work you have been doing.
As PDMPs have evolved in recent years, incorporating PDMP
data into a prescriber or pharmacist clinical workflow seems to
be the key to ensuring that the data are used effectively while
also increasing efficiency and saving time for providers. So,
Dr. Schuchat, what are the barriers currently that prevent more
States from incorporating PDMP data in the clinical workflow?
And aside from prescription dispensing data, what other
information can be collected by PDMPs, and how can this help
CDC's surveillance efforts?
So what currently do you find or do you hear from the
States create barriers?
Dr. Schuchat. Yes. We are making substantial progress,
particularly in selected States that have really integrated the
prescription drug monitoring program into the electronic health
record. Making it easy for clinicians is the only way to make
it work, making it universal so all clinicians are using it,
which involves registering them and getting them onboard. But
integrating it into the clinical workflow in the office or in
the pharmacy will make it a one-stop shop for folks. The
technology is not that complicated, but every State is starting
from a different place, and each State has different laws that
also get incorporated.
But in the past couple years, we have seen an increase in
the use of them in many States and an increase in the
attributes that they have so that people can get active
management. You get alerts when you are overprescribing or when
you have interactions with other drugs. That is a feature that
is very important. You can also link the data for public health
use and find the hot spots: Where are the providers that are at
the extreme level of prescribing and where are the counties
that have the higher use. So, really, it is about integrating
with electronic health record and also integrating with other
systems in the State.
There is also the cross-State lookup, the interstate
operability, which is--most States have that ability, but not
to look up with all other States. They have agreements with
neighboring States. So I would say that the barriers are very
insurmountable. It is attention, resources, and policies.
Mr. Walden. All right. Good. And I know our resident
pharmacist, Dr. Carter, and I were talking yesterday--or
Congressman Carter--about some of the issues he has
encountered. And I am sure he will dig into this deeply with
his great experience on this.
Dr. Gottlieb, thanks for the good work you are already
doing in this area and interdiction and everything else to give
us guidance and what you are doing through the agencies. I
think it is important to understand the role you see the FDA
playing in the fight against opioids. And I, again, commend
you.
Can you speak to the mission of your agency and how it fits
in the larger efforts of fighting this opioid crisis?
Dr. Gottlieb. I think we have responsibilities across
multiple domains. I think we have a responsibility to, and in
terms of places we can effect this crisis, I think we have the
opportunity to reduce overall prescribing, to rationalize
prescribing through things like education or application of the
REMS. We recently, as you know, extended our REMS authority to
all the IR drugs to try to rationalize prescribing, trying to
effect dispensing to make sure that when prescriptions are
written, the amount that is dispensed is appropriate for the
clinical circumstances.
We obviously have a role to play in interdiction. I have
talked about that here today. And I think we also have a role
to play with respect to new technology, trying to bring onto
the market abuse-deterrent formulations. We have taken steps to
do that, trying to bring onto the market drugs that don't have
all the abuse liabilities that are associated with opioids,
trying to create innovation for medically assisted treatment.
So we have taken steps to cross all those domains. Those
are the large areas where we are working.
Mr. Walden. Thank you very much. And we appreciate your
input and guidance on these various bills that are before the
committee today and tomorrow.
Dr. Jones, you mentioned in your testimony the listening
session on the topic of alignment of 42 CFR Part 2 and HIPAA
that was required by 21st Century Cures. Can you elaborate upon
those discussions at the listening session and explain how the
bills were examined, did they either align or conflict with
what participants were saying? And also, can you discuss the
enforcement authority for Part 2 infractions in comparison to
HIPAA enforcement?
Dr. Jones. Thank you. So from the listening session, again,
there is passion on this issue across the spectrum. But I think
there was a consistent recognition that, from the stakeholders,
that Part 2 may in and of itself--the constraints around
treating information differently may in and of itself be
stigmatizing, sort of reinforcing the idea that people who have
addiction or substance use disorders should be treated
unfairly.
I think on the side of addressing and making sure that
people have parity to healthcare, that people who have
substance use disorders should be given the best treatment that
they can. And often having all the information about the
patient is a really critical part of that. I think those were
sort of the common themes that were shared.
And from our standpoint, and we certainly are encouraged
that Congress is looking at better alignment of Part 2 and
HIPAA. And as I said in my opening statement, we do think, and
certainly from the listening session, it was fairly clear that
many of the folks felt that congressional action would be
needed. We have taken a lot of flexibilities that we can take
under our administrative rulemaking authority. I think it is
now at the point where Congress would need to take action.
Mr. Walden. I think so too.
Thank you to our panelists. Again, thank you, Mr. Chairman.
Thank you for your leadership.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman.
The chair recognizes the gentleman from New Jersey, the
Ranking Member of the Full Committee, Mr. Pallone, 5 minutes
for questions, please.
Mr. Pallone. Thank you, Mr. Chairman.
I wanted to start with Dr. Gottlieb. I wanted to thank you
for appearing before the committee again and for your forward
thinking when it comes to the opioid crisis this country is
facing.
And I have long been concerned about the number of illicit,
unapproved, and often counterfeit drugs that are entering our
supply chain through our mail facilities. I work with FDA and
my Democratic colleagues to provide the agency with additional
authority and FDASIA to help combat this problem, but
understand from you that more must be done.
So first question is would you discuss briefly some of the
problems related to illicit drugs that FDA is witnessing at our
international mail facilities? I know the chairman asked a
similar question, but maybe be a little more specific about the
drug packages. You said in your testimony that they are often
unlabeled or shipped with bulk and disguise. You want to talk a
little bit more about that more specifically?
Dr. Gottlieb. That's right, Congressman. One of the keys to
our ability to destroy packages or seize them is the ability
for us to establish intended use. And so when people who are
shipping drugs into the country engage in label stripping,
where they strip away the information from the package itself
or from the drug product, we often can't establish intended
use. And so we have to just return the package to the sender,
effectively, because we can't destroy it. We can't go through a
destruction proceeding because we can't establish it is a drug.
And our concern around this is that it is not a good
deterrent. And we often see the same packages coming back a
second and third time. In fact, sometimes, we will see packages
that will be sent back, and then they will come back in with
the same investigator's writing on it through the same mail
facility.
The other thing we are seeing is more and more small
packages. And so the shippers know that we have to initiate an
individual proceeding against each package. And so if you send
in sort of a bulk package with thousands of small boxes in it,
we would have to initiate a proceeding against each individual
box to establish that it is a drug, what the intended use is.
And this is often prohibitively difficult for us. So, again, we
are in a position of holding these packages in the
international mail facilities while we go through a
notification process to the consignee and then just returning
them to the sender, because we can do that based on an
appearance standard. We can't get to the ability to destroy
these packages because it is a higher standard, and we would
have to establish intended use. And so they are purposely
shipping these in in a way to evade our authorities. They know
what our gaps are, if you will.
Mr. Pallone. All right. Well, as I understand it, hundreds
of millions of packages go through international mail
facilities each year. But as you said--well, FDA only has the
resources to examine about 40,000 of these packages per day. So
that is why I introduced the bill I mentioned, H.R. 5228, or
the SCREEN Act, which would provide FDA with additional
authority and resources to combat this problem.
Mr. Chairman, I would ask unanimous consent to submit the
text of H.R. 5228 for the record for the hearing.
Mr. Burgess. Without objection, so ordered.
[The information follows:]
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Mr. Pallone. Thank you.
Dr. Gottlieb, in examining this issue, will you please
outline for me what key authorities or actions Congress could
take? I know you talked a little bit about it. But if you get
more specific about key authorities or actions Congress could
take to help you address the problem that you are witnessing at
our international mail facilities.
Dr. Gottlieb. Well, one authority would be to be able to
establish that product as a drug based on its chemical
composition, whether it has similar chemical composition to an
already approved FDA drug or is an analog of an FDA-approved
drug. If we were able to establish that a drug is a drug based
on chemical composition, then we could establish that as
misbranded under 505 just by looking at the labeling associated
with the product. And this would allow us to be more efficient
in making the determinations as to violative product and we can
then enter into a destruction proceeding.
Another efficiency that we can gain is changes to our
seizure authority. Right now seizure authority allows the FDA
to bring a lawsuit to seize a violative product. But a judge
must first make a finding of probable cause, if probable cause
exists. And I have been personally engaged in situations since
I have been back at the agency where we have gone through a
multi-week process to try to get a proceeding before a judge to
affect a seizure of a product that we had concerns around and
wanted to take off the market quickly. So we could go back to
the way FDA used to operate with respect to seizure authority
prior to 2006 and the agency operated this way for decades and
decades and allow us to affect a seizure based on an imminent
public health hazard standard, so we can go before a clerk in
the court and get an order to seize a product, and then have
the hearing before the judge after that. That would allow us if
there is an imminent public health hazard and we want to take a
product off the market in advance of the due process
proceeding, which obviously has to occur, it would allow us to
intervene more quickly.
FDA, there was a change in some law in 2006 that
unfortunately swept FDA in, I think inadvertently. I will leave
it to Congress to determine the legislative history. But if we
can revert back to how we used to exercise our seizure
authority, that would be helpful.
Finally, I would just highlight the ability to bundle
products coming in and treat a light shipment as one shipment,
if you will, for purposes of bringing a proceeding against it
rather than having to look at the individual boxes or packages,
because that is a gap that people who are intent on trying to
slip drugs into the U.S. are unfortunately exploiting.
And all of this is about getting to your point about how
many packages we look at each day, one of the keys is getting
more resources into those facilities and we have targeted more
resources to the IMF for money that we found inside the agency.
We are obviously looking to increase our capacity even further.
But even as we bring on more resources, we want to make sure
those resources are used in an efficient way. So a lot of these
authorities are aimed at making our people more efficient.
Right now an individual investigator in the IMF can open maybe
up to 15 packages a day. We want to make those individuals more
efficient so that they can be opening more packages and we can
get that 0.05 percent up to a more representative sample.
Mr. Pallone. Thank you. Thank you, Mr. Chairman.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back.
The chair recognizes the gentleman from Kentucky, the Vice
Chairman of the Subcommittee, Mr. Guthrie for 5 minutes for
your questions.
Mr. Guthrie. Thank you, Mr. Chairman. Again, thank you for
your leadership on this issue and for everybody's focus on this
issue, I appreciate it.
I am going to talk about a bill that Congressman Green,
Lujan, Bucshon, and I have introduced titled the Comprehensive
Opioid Recovery Centers Act or CORCs. We proposed a new
standard of care for the treatment of opioid use disorders. And
I would like to get your views on the importance of required
features of the CORCs from Dr. Jones from SAMSHA.
SAMSHA's new publication titled treatment improvement
protocol number 63, medications for opioid use disorder
repeatedly emphasizes the need for patient centered
individualized care in which the medications are prescribed to
a patient based on that person's clinical needs. Yet according
to a recent analysis of SAMSHA's data, published by Health
Affairs, fewer than 3 percent of all licensed substance abuse
treatment facilities in the country are able to offer all
three.
Most programs offer only one or two types of medications at
the most and some offer none at all. Do you agree, Dr. Jones,
do you agree that the current opioid addiction treatment system
is not offering a full range of medication options?
Dr. Jones. I would say that there are regulatory
constraints on how medications can be offered. So methadone
under current statute and regulation can only be offered
through opioid treatment programs. For buprenorphine you would
have to have a waiver so physicians, nurse practitioners, PAs
would have to have a waiver after receiving training to
prescribe buprenorphine in their limits on the number of
patients. Extended release, naltrexone or vivitrol which is the
antagonist version of the three medications can be prescribed
by anybody within their scope of practice.
So there are constraints in saying that every treatment
facility should be able to offer that because it may not be
possible for every treatment facility to be an opioid treatment
program. I think what is important is that we build the system
so that patients have access to the treatment that is most
appropriate for them. So it is not that everybody has to be an
OTP, but that there is some relationship for if methadone is
the best thing for that patient access that they would be able
to access that, same with buprenorphoine or naltrexone.
And we have seen opioid treatment programs increasingly
start to offer buprenorphine and naltrexone, recognizing that
patient preference is a really important part of the long-term
trajectory of someone with opioid use disorder.
Mr. Guthrie. Those options need to be available if somebody
presents to a center that only does one and it is not the best
treatment for them, they are not getting the best treatment.
That is what we are trying to look for in our bill. So we
appreciate your help on it as well.
Do you see the current fragmented, siloed approach as a
problem? I guess that feeds to the answer you just gave.
Dr. Jones. Fragmentation and siloing always works well. No,
no.
It clearly is a problem for individuals, because when
somebody comes in with opioid addiction, there is a lot going
on with that individual. So they may have legal issues, they
may have issues with safe and supportive housing, they may have
issues with family care. And we are really at SAMSHA with our
STR dollars and our other programs trying to build that system
which I think is analogous to what you are trying to accomplish
that allows that patient to receive those services in a
comprehensive manner where they are not trying to show up in
different places and say, oh, wait, you have to go here, you
have to go there. That there are places that are doing that.
And we are seeing States like Rhode Island that are
implementing centers of excellence, which are essentially
taking that model and putting that into place where people if
they are coming from the criminal justice system are connected
in to these centers of excellence so they can look at things
like insurance coverage, housing, employment, vocational
training. And we are seeing success with those areas. I think
we need to continue to scale up those types of interventions.
Mr. Guthrie. Well, thanks. I just had someone from
Louisville come in who said that they have a recovery center
that is trying to do the holistic complete person approach. And
so you really addressed it, but I just want to specifically
pull out one specific of all the comprehensives and that is job
training. One of the unique provisions of our bill is a
requirement that they provide job training and job placement
assistance. A recent analysis published by Brookings Institute
found that about one-third of the people who were no longer
looking for work had opioids being prescribed to them.
Do you agree that this focus on supporting successful
reentry into the workforce should be a valuable addition to
establishing long-term recovery? The relationship between work
and recovery I would like for you to address.
Dr. Jones. I think certainly people want to have purpose
and structure in their day. And so a job provides some purpose
and structure for individuals. I think that is an important
thing among the array of services an individual would need to
be successful.
Mr. Guthrie. Thank you. I am about out of time. That
completes--I can't really get to the next questions. So, I
appreciate you being here. We look forward to working with with
my fellow colleagues to move this bill forward. I appreciate
it.
Thank you. I yield back.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back.
The chair recognizes the gentlelady from California, Ms.
Matsui for 5 minutes for your questions.
Ms. Matsui. Thank you very much, Mr. Chairman.
Dr. Schuchat, thank you for your testimony today. I have
heard concerns about how increasing injection drug use is
resulting in increased incidents of HIV and hepatitis C. As you
look at solutions to the opioid epidemic, we should also
examine how the opioid crisis may have a cascading impact on
the rest of the our public health. That is why I am
cosponsoring eliminating opioid related infectious diseases act
discussion draft with my colleagues on the committee
Representatives Lance and Kennedy to support additional public
health surveillance activity at CDC on this topic.
Dr. Schuchat, what is a concurrence rate of opioid use in
infectious diseases?
Dr. Schuchat. The infectious disease complications of
opioid use are really are tragic and they were most
dramatically seen in Scott County, Indiana, where over 200
people developed acute infectious disease, acute HIV infection
and most had also hepatitis C. We have seen hepatitis C
increase 140 percent recently. We have seen particular
increases in young people. And we have recently seen multistate
outbreaks of hepatitis B and hepatisit A as well. Most recently
we have had salmonella associated with the kratom botanical and
we have also got a group A strep outbreak that is associated
with injection.
So injecting drugs and also other opioid use can lead to
these infectious disease complications, sometimes clustered and
sometimes throughout the Nation. We think it is really
important to improve surveillance and also to assure wraparound
services when we are dealing with addiction to make sure there
is infectious disease screening as well so that people who do
have hepatitis C or HIV can get into appropriate care.
Ms. Matsui. Thank you.
Dr. Jones, has SAMHSA done any work in this space?
Dr. Jones. Yes. So SAMHSA had funding programs in place for
colocation of HIV and hepatitis C services within substance
abuse treatment. Again, as Dr. Schuchat said, it is a really
important part to address the comprehensive issues of
individuals who are coming in. And now that we have curative
therapy for hepatitis C, it is really important that we are
testing people as they come in. And our funds have been put
into place to help build that system.
Ms. Matsui. Good, good.
Now the solutions to this epidemic will come from a lot of
different places and angles and requires to examine all of the
different problems that led us to where we are today. One of
the main ways that I have heard of are people becoming addicted
to opioids whether prescriptions or illegal started with
prescription opioids found in the home. Maybe it is left over
prescription drugs, a teenager has had their wisdom teeth
pulled, they got 30 day's worth of pills, but they only needed
one or two. And the bottle is still sitting in the medicine
cabinet.
Dr. Gottlieb, do you see potential for technology to play a
role in ensuring the efficient return or destruction of unused
opioids?
Dr. Gottlieb. I do, Congresswoman. I agree with your point
the chief risk of the liberal prescribing wasn't so much that
the patients would become addicted. Although, we know that that
happens, but that the excess meds feed the river of pills that
are coursing through our communities. And so we do see an
opportunity to try to inspire sponsors and others in the supply
chain to provide tools that could allow patients to dispose of
those pills. This can be something that Congress could provide
some authorities around, it is something that could be
encouraged by the provider community as well, but there are
tools to do that. We don't regulate the tools. Many of them
they are not medical devices, some of them allow the patient to
destroy the pills themselves or render them inert, but they are
available.
Ms. Matsui. OK. Thank you. UC Davis Medical Center in my
district of Sacramento houses an entire division devoted to
pain management, including a pain management clinic. The
doctors and researchers there participate in a program called
Project ECHO which allows experts in effective pain management
at UC Davis to remotely train less specialized doctors
practicing in remote or isolated areas.
Opioids is certainly one method of pain management and one
that can be very necessary. For example to improve a patient's
quality of life at the end of their life in hospice. However,
opioids are not the only option for pain treatment and more
should be done to explore both existing and new alternate
options.
Pain is not something that people should have to live with
but clearly taking the convenient way out by using opioids has
led to serious problems. However, there is a middle ground. We
shouldn't get rid of opioids completely, but we can better
understand when and how to use them.
Dr. Gottlieb, can you comment on any potential for FDA to
contribute in this area?
Dr. Gottlieb. We have taken a lot of steps in recent months
to try to use our tools, particularly our REMS authority to
increase provider education. I think it is a point well taken
that part of what got us here is a change in prescribing
patterns that led to more liberal prescribing. Many people who
became medically addicted, their first exposure was through a
lawful prescription, often that was for an immediate release
formulation of the drugs.
So we have take steps to expand our REMS authority that
asks sponsors to provide education to physicians to the
immediate release formulations of the drugs, which represents
about 90 percent of all the pills. We are looking at other
things that we can do, for example packaging, if we can get
more of IR drugs into blister packs that might encourage more
rational prescribing. Physicians might opt for a blister pack
that maybe had a 3 or 5 day unit of dose in it as opposed to a
30 day bottle. So we are continuing to look at other tools that
we could adopt and practices that we could pursue to try to
affect physician behavior here.
Ms. Matsui. OK. Thank you very much. And I yield back.
Mr. Burgess. The chair thanks the gentlelady. The
gentlelady yields back.
The chair recognizes the gentleman from Michigan, Mr.
Upton, former chairman of the committee to ask your questions.
Mr. Upton. Well, thank you, Mr. Chairman. And I appreciate
this hearing, and appreciate the good work by our distinguished
panel. I know we all have tremendous concerns about this. And
it is something that has grilled down to all of our
constituents.
I hosted a meeting in Kalamazoo at the WMed School, a place
where Dr. Burgess came for a hearing on 21st Century Cures a
few years ago. The governor's office, to our State mental
health folks, to our law enforcement people, treatment folks,
it is an issue that people really do care about. In fact, the
local sheriff, a good guy said that they knew that as we look
at these staggering statistics of people that have died because
of the overdoses that they had personally knew of at least 150
folks just in that county that they saved because of Narcan. By
having that available to their officers. And I have talked to a
number of--all of my Sheriffs in my six counties that I
represent. It is a standard procedure, sadly.
And one of the things that a number of us have discussed is
maybe somehow being able to reduce the cost of these lifesaving
drugs because it is a real financial burden, particularly in
rural areas where perhaps they don't have the resources to be
able to have that available as it reaches out.
A couple of things that I would like to ask this morning.
First of all, I want to commend our chairman, Greg Walden, this
is a huge issue. I have a list of just 20 some different bills
that are all bipartisan as far as I know that we intend to move
through this committee. He has reached out to our leadership.
We have time, I believe, that is reserved a little bit later
this spring to get the bills to the floor and hopefully provide
the time to get the Senate to be able to endorse and embrace
these and get them to the President.
I know a number of us on both sides of the aisle have had
personal discussions with the President about it. He cares
deeply about this issue and something where we could work on
together.
And a couple questions that I have, Dr. Gottlieb in your
written testimony for our hearing back in October you said that
the FDA strongly supports a transition from the current market
dominated by conventional opioids to one in which the majority
of opioids have meaningful abuse deterrent properties. Can you
update us on the FDA's efforts on the abuse deterrent
formulations in terms of where we are?
Dr. Gottlieb. We continue to take steps to try to help
transition this market including through the approval of some
additional drugs, we have abuse-deterrent features associated
with them. We have approved 10 in all. We also recently issued
guidance that lays out the pathway for how you can genericize
these abuse-deterrent formulations because you don't want to
create a monopoly market where there is no potential for
generic entry to compete with abuse-deterrent formulations out
there after the IP has lapsed on these drugs.
We are also taking efforts to reevaluate the nomenclature
in terms of how we refer to these to make sure that we are not
convening to prescribers something that isn't intended, that
there is not a perception somehow because these are an abuse
deterrent they can't be abused and people can't get addicted to
them. They are resistant to manipulation, that is the feature
that they have and we want to make sure we adequately conveying
that.
But ultimately to get to the essence of your question,
Congressman, we need to maybe a policy decision as to whether
or not we can make a determination that the advent of abuse
deterrent formulation lowers the rate of addiction over a
population, that if you converted the market to abuse deterrent
formulations, would you bring down the rate of overall
addiction. And we continue to collect data to make that
determination.
That is a determination we want to make as a matter of
policy and not have to do it in the context of each individual
occupation. We have some data forthcoming soon that will help
inform that question where we have looked at the conversion
rates to heroin addiction from prescription opioid use and
looked at whether or not areas where there was a higher use of
abuse-deterrent formulations had a lower conversion to the
abuse of street drugs. That kind of data is going to help us,
help inform our view and get closer to being able to make that
threshold determination.
Mr. Upton. So like Chairman Burgess and Ranking Member
Pallone indicated, the difficulty of identifying these packages
that are coming in, whether it is FedEx, UPS, Postal Service--I
sat down with my local law enforcement folks a number of months
ago, actually almost a year ago, and they described to me the
situation of west Michigan. There is literally one postal
inspector for all the packages that come into Grand Rapids,
which is the distribution point for the whole west side of the
State.
And they indicated one postal inspector is certainly an
issue. But as we look at fentanyl coming in, what type of
capabilities have you been able to provide for our local law
enforcement to identify fentanyl as you look at these tens of
thousands of packages that inundate all of these facilities
literally every single day.
Dr. Gottlieb. Well, Congressman, Customs and Border
Protection has primary responsibility in the international mail
facilities where we are for the controlled substances when they
are identified. But we do identify an increasing number of
packages that aren't perceived a controlled substance on first
blush. Either they get through a screen or through a dog that
is sniffing packages. And we are only X-raying in those
facilities 1 percent of the priority mail packages. I don't
want to get too detailed into the statistics of what we do in
there to reveal our weaknesses. But we are not looking at
everything, we are targeting what we do to packages that we
believe are more likely to contain controlled substances.
But with respect to fentanyl in particular, we have
scientific expertise and tools that allow us to identify
fentanyl analogs and we assist CBP in that effort in trying to
inform that process and inform the tools that they use in those
facilities to identify those drugs. But it is a challenge, I
will tell you that. And the vulnerability that I worry about
the most is this bad actor who dresses up an opioid as an
ordinary pharmaceutical product or an OTC product because that
is an area of vulnerability right now if you are looking to
evade detection.
Mr. Upton. I know my time has expired. Thank you.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back.
The chair recognizes the gentlelady from Florida, Ms.
Castor for 5 minutes for your questions please.
Ms. Castor. Thank you, Mr. Chairman. And thank you to all
of you for work on this public health crisis.
Dr. Jones, I want to continue on the line of questioning by
my colleague Mr. Guthrie from Kentucky on treatment. A 2015
study published in the Journal of the American Medical
Association found that 80 percent of Americans with opioid
addiction do not receive treatment. In your testimony you
identified the lack of treatment as one of the primary factors
in the growing opioid epidemic. You say, the lack of a health
system and healthcare provider capacity to identify and engage
individuals with opioid use disorders and to provide them with
high quality evidence based opioid addiction treatment, in
particular the full spectrum of medication assisted treatment.
It is well documented that the majority of people with the
opioid addiction in the United States do not receive treatment.
And even among those who do, many do not receive evidence-based
care.
In the last Health subcommittee meeting we had I asked Dr.
Colony from Brandeis University about this, he heads an opioid
research center, the head of the physicians for responsible
prescribing. In answer to my question he said, I think the only
way we are going to get there is a massive Federal investment
in the billions. We have to create a treatment system that
doesn't really exist yet. The majority of the State drug and
alcohol license programs don't offer buprenorphine, many don't
even have enough physician time. Many people often have to pay
from their own pocket for medication. If we really want to see
deaths start to come down, it has it to be easier to get
treatment than it is to get a bag of dope.
When someone who is opioid addicted wakes up, they are
going to need to use. They often have something by their
bedside. They will feel very sick when they start to wake up.
If they have got $20 and they know where to go get heroin even
with Fentanyl in it, that is what they are going to do. If
finding a doctor is more expensive and difficult we are not
going to see the overdose deaths start to come down. We really
have to build a system that doesn't exist yet. And I don't see
any other way than investing billions of dollars to create it.
And this is informed by a constituent back home in Tampa I
have been working with. A middle class family, this father has
come to Members of Congress because he doesn't know anywhere
else to turn. He has a 22-year old son who has been addicted to
opioids since he was 15 years old. They have good insurance. He
stated though even with good insurance he has personally
invested over $100,000 trying to help his son. He learned that
the cost to combat his son's addiction could be limitless.
As healthcare carriers are unwilling to fund addiction
healthcare beyond the point of immediate physiological safety.
His son as of December 2017 celebrated 4 months of good health
before relapsing again. And he has gone through so many
different treatment methods. Clearly there has to be a paradigm
shift here. I know there are some important bills. I like Mr.
Guthrie's bill with others on the recovery centers. The
workforce is a significant issue, Ms. Clark of Massachusetts
has a bill. But what do we have to do? It has to be something
much more extensive than we are even thinking about now.
If you could redesign a system now and really we are
spending so much on lost productivity and healthcare dollars
that don't really get to the heart of the problem. How would
you design the system now? What do we need to do for this
paradigm shift?
Dr. Jones. Thank you for the question. I think that you
raise a number of really important issues. And I think they are
the exact conversations that we are having at SAMHSA in
thinking about how are we being good stewards of the dollars
that Congress has given us as we are investing $1 billion over
the last 2 years, the President's budget up to $1 billion for
STR funds? How are we building that system? Because the system
is fragmented and too many times individuals are paying a lot
of money for ineffective care.
And so part of that is to actually look at the innovations
and how services are provided. And as I mentioned earlier
thinking about centers of excellence, or hub and spoke models,
or nurse care management models. Those are things that have
been studied in different States that have shown increased
retention, reduced drug use, improved outcomes. And that is how
we are trying to frame our dollars in how we are requiring
those dollars to be spent by States----
Ms. Castor. Is that just building on the current system or
is there something you needed like almost a VA type of system
for this healthcare emergency.
Dr. Jones. It is sort of enhancing the system that doesn't
exist so that the services are collocated and that the
evidence-based treatments, i.e., medications are being
provided. So moving away from a siloed fragmented system where
it may be an abstinence based approach that medications are not
even considered, to a system where medications are a central
component of what is being offered to patients, but that it is
also taking advantage of treatment on demand.
So when somebody comes in, that is again connection of the
emergency departments, where somebody experiences an overdose
or somebody has an infectious disease complication, using that
touch point in the health system to connect that individual
into treatment. That is the system that we are trying to build.
I will use Rhode Island as an example, they had a nice
study that came out in JAMA psychiatry recently where they
expanded medication assisted treatment within their
incarcerated population in Rhode Island within the Department
of Corrections. They offered all three medications, they were
able to do that within their regulatory schemes and they found
that there was a 60 percent decline in overdose deaths in the
first 6 months of 2017 compared to the first 6 months of 2016.
So Rhode Island is certainly a State that has been hard hid by
fentanyl and other illicit fentanyl analogs and they are seeing
that progress because they built the system. And as people are
coming out of incarceration they are connected into these
centers of excellence so they can continue to get those
supportive services.
And while certainly we put a lot of money towards
treatment, I don't think I can underscore enough the importance
of recovery support services. So we want patients to get on
medications, we want them to do well. But we also need them to
be successful in the long run in providing those supports
whether they be peer supports, recovery coaches, employment,
housing, legal services, those types of things, they are all
critical pieces to having that individual success in the long
run. There is a lot of structure that needs to be provided and
support that needs to be provided and I think we are building
the system but make sure the resources are there to really
amplify that system.
Ms. Castor. Thank you very much, Dr. Jones.
Mr. Burgess. The gentlelady's time has expired.
The chair recognizes the gentleman from Illinois, Mr.
Shimkus for 5 minutes for your questions please.
Mr. Shimkus. Thank you, Mr. Chairman. I will try to ask
quick questions, and get quick responses, and help my
colleagues and you all survive this long period of questions
and answers.
Dr. Gottlieb, in your testimony you talk about the
difference between addiction and physical dependence and part
of that is how long can physical dependence develop? In your
medical----
Dr. Gottlieb. I would defer to Dr. Jones. But it could
develop fairly quickly. Anyone who is prescribed opioids for
any sustained period of time is going to become physically
dependent on the drug, that is very different than being
addicted to the drug. Addiction is a state where you have more
than just a physical dependence on a drug, you have a
psychological dependence on a drug and you are engaging in
behavior that is not constructive in your life to get access to
the drug so there is a very specific----
Mr. Shimkus. In my experience when someone has addiction
they would tell me that their brain has been changed, this is
part of the debate, discussion with this individual was that
just said his brain--in essence he used the term pickled in
that he not only has this physical dependence, but his--can
someone comment about that and how quickly can that occur?
Dr. Jones. Individuals are very different and so they will
respond to medication or substance of abuse in very different
ways. I do think very have a robust set of research studies
that look at changes that do happen in the brain. And for some
individuals that change may occur very quickly, for others it
may take a longer period of time for changes in the brain to
occur.If we look at functional MRI studies it shows that brains
of people who are currently addicted light up in different ways
than people who are not exposed to substances. Even those
effects carry on many years even after they have----
Mr. Shimkus. Our challenge is to stop people from being
hooked and then deal with those who are addicted. That is why
there are a multitude of bills being presented to try to
address a lot of these different concerns. I also believe there
is a practice of pharmacy, there is a practice of medicine I am
sure you all would agree with that. I am also concerned in a
rush to judgment on some of the proposed positions because I
really want to ensure that those who have chronic pain do not
get thrown under the bus or are collateral damage in a response
on prescription because those with chronic pain in their lives
would be significantly changed if they can't have access or a
long set through a prescription through a doctor.
And so some of these short-term, get a new prescription
after 3 days, I am actually concerned about that from the
patient aspect of--and I want just to throw that on the table.
Dr. Schuchat, on the prescription drug monitoring debate, I
live in Illinois, three different States border my
congressional district, some have it some don't. How do we fix
this whole system so that we know and there can be
identification?
Dr. Schuchat. Right. We need interstate interoperability so
a clinician can easily essentially automatically have the
information about any place that a person has received a
prescription. We also need those systems to automatically
calculate what is the total dose that the person has gotten to
make sure you are not going too high. CDC's been funding 45
States to strengthen these prescription drug monitoring
programs, as well as hubs that will help with the----
Mr. Shimkus. We have done this under the meth debate and it
was somewhat successful when we allow and get the States act
together and we can get our act together, to be able to
identify this stuff.
Dr. Schuchat. Right. And most States are doing data
sharing. It is just we basically need to speed it up and we
need to make it very easy.
Mr. Shimkus. You need to help us figure out how we can do
that because I think----
Dr. Schuchat. I think the resources we have been getting
have helped but additional resources that are proposed will
help tremendously----
Mr. Shimkus. And let me finish on this one. I am sorry to
be so short. Fred Upton went down this rabbit hole on the long-
term aspects of different drugs that aren't addictive. And I am
going to go to Dr. Gottlieb, I think we talked about this
personally to about the CMS funding dilemma as far as how do
you get that on the actuary so these things get paid? Anyone
want to mention that?
Dr. Gottlieb. I can't speak specifically to the policies
related to CMS. I will tell you that there are a multitude of
products available that treat pain and you do want to see the
alternatives available as well.
Mr. Shimkus. And paid for and on an actuary.
Dr. Gottlieb. Yes. One of the challenges right now is that
the IR formulations of opioids are very cheap. Vicodin,
percocet are generic drugs and they are very cheap.
Mr. Shimkus. I yield back the balance of my time.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back.
The chair recognizes the gentleman from Massachusetts, Mr.
Kennedy for 5 minutes for your questions please.
Mr. Kennedy. Thank you, Mr. Chairman. I want to thank you
and the Ranking Member Green and all of our witnesses for being
here convening an important hearing during another historic
snowstorm in Washington. Took me a whole 30 seconds to wipe off
my car, but the government is shut down so grateful that you
all are here. Thank you.
The wind. Yes, the wind.
The heart of today's hearing is a simple question I believe
that is facing our government. Are we doing enough to combat an
opioid epidemic that is tearing families apart every single
day? I think that despite best efforts of many across
government legislative branch and others the answer is an
emphatic no. It is an answer that ends up being scrawled across
the headlines of our local papers far too often because
recently a headline in my own district read that Attleboro
quote, ``Attleboro sees 200 percent increase in opioid
deaths.''
And it was illustrated by every father, brother and sister,
son and daughter who will never again laugh or cry with a loved
one they couldn't reach help, get them the help they needed in
time. An answer written by police officers, fire fighters whose
resumes now include a line about being addiction counselors and
lifesavers in their own communities.
And as many of us are painfully and personally aware of
because we have watched friends and family struggle to overcome
this disease. And we know then that we have not done enough.
Because it isn't enough to offer local governments a one time
funding boost on one hand and then just turn around and cut
Medicaid, the single largest payer of behavioral health
services in the country by $800 billion with the other.
Is it enough to provide law enforcement with more Narcan
only to erode essential health benefits that would guarantee
treatment after a life has been saved? Is it enough to call for
more treatment beds only to oppose Medicaid lifetime caps and
work requirements that will create barriers to care for those
battling substance use disorder?
Hearings like this one are a positive step forward, but we
know that they are not enough and we know that there are
conflicting messages coming out of this administration. So
until our colleagues end an assault on Medicaid, an assault on
those that are seeking to make themselves and families heal and
better, again the largest payer of behavioral health services
in this country. The answer to that question is not going to
change.
So with that as an umbrella, I wanted to follow up a little
bit on what our colleague Chairman Burgess had commented about
earlier in his comments about neonatal abstinence syndrome,
which has been an issue that many of us have been focused on.
One of my colleagues from Massachusetts, Katherine Clark, made
a priority of her work in Congress.
Dr. Jones, you had I believe mentioned it a little bit
about the influence and the importance of parity when it comes
to some of these issues. Neonatal abstinence syndrome is an
issue that obviously affects as it impacts on newborns because
of addictions in pregnant women. We have a bill that is
bipartisan, that is bicameral and believe it or not has a CBO
score of zero that seeks to ensure that pregnant women are able
to get and newborns are able to get access to the mental and
baby health services that they need, including addiction
services. And I was wondering if you could expand a little bit
on, in your eyes, the importance of access to those services
and the importance of parity?
Dr. Jones. Certainly parity is a really critical component
to addressing the opioid issue, but more broadly mental health
and substance abuse issues. Through requirements set forth in
the 21st Century Cures Act, HHS, SAMHSA being a part of that as
well as Departments of Labor and Treasury have been working
through issuing different pieces of information that can
provide facts around parity violations, tools for health plans
and other to see if they are in compliance with parity. We have
been trying to put the tools in place to address parity more
broadly.
Mr. Kennedy. Do you believe there is sufficient enforcement
of those violations?
Dr. Jones. I would say I would defer that to colleagues who
are charged with the enforcement side, but we have been trying
to put out information on what are the expectations to
frequently asked questions around treatment limitations not
quantitative treatment limitations, step therapies or other
payment and reimbursement strategies, and then providing
examples of what are violations. But as far as the enforcement
actions, I would defer to those who are actually charged with
that.
Mr. Kennedy. Any additional witnesses want to comment on
the enforcement side?
Doctor.
Dr. Schuchat. Just to say that taking a holistic approach
as you mentioned is critical and the public health public
safety working together is critical, but the same issue making
sure the care is there for who need them. And we know that
wraparound service, comprehensive services work better than
fragmented ones.
Mr. Kennedy. And so cutting Medicaid by $800 billion, would
that strengthen or hinder those services?
Dr. Schuchat. It wouldn't be the best to comment on that.
Mr. Kennedy. Mr. Gottlieb.
Dr. Gottlieb. I used to work in Medicare 15--10 years ago
so I am not up to speed and can't comment on it.
Mr. Kennedy. Appreciate that.
Eight hundred billion dollars less than Medicaid though you
were there a little while ago. Eight hundred billion dollars
cut to Medicaid, will it strengthen or hinder the program?
Dr. Gottlieb. You can certainly do more with more in any
program. There is no question about that. If we are properly
using our resources we can always do more with more. So I think
it is an undebatable proposition.
Mr. Kennedy. Thank you.
I yield my 30 second overtime back.
Mr. Burgess. The gentleman's time has expired.
The chair recognizes the gentlelady from Tennessee 5
minutes for your questions, please.
Mrs. Blackburn. Thank you, Mr. Chairman.
And Dr. Gottlieb I want to come to you. The hearing we had
back in October, I went right down the dais with you all, NIH,
CDC, SAMHSA, DEA and said, ``Is there any Federal statute that
prohibits you from doing your job?'' And you spoke up and
talked about the international mail facilities and I thank you
for that. And I thank you for the subsequent work you have done
with my team, as we have worked to do the discussion draft to
address the issues with the international mail facilities.
And I want to talk with you for just a minute about section
2(a) of that draft, which looks at the unlabeled or minimally
labeled products that come through these facilities and to
include those active ingredients that are in some FDA approved
drugs and biologics. So let's talk about what authorities you
currently have when you encounter these products in the IMF and
how this bill will change that authority?
Dr. Gottlieb. Thanks a lot, Congresswoman. Thanks for your
support of our work on this and we are happy to work with your
office and provide technical assistance as you work through
these issues. Right now we have to, if we see a drug that we
believe is violative in the IMF, in the International Mail
Facility, we open a package or a package is pulled by CBP. It
comes to us for physical inspection, we open it and we find
drugs in it that we believe are counterfeit or illicit drugs,
we have to establish intended use. We have to establish that it
is a drug based on its labeling. And what we are seeing more
and more are minimally labeled drugs.
Sometimes we are seeing whole boxes of just pills with no
labeling whatsoever associated with them. And in that setting,
if we can't establish that it is a drug based on its intended
use based on its labeling effectively we have to return it. We
typically will return it to the sender based on an appearance
standard, which is lower bar. But if we wanted to destroy that
product or enter into some other kind of proceeding against it,
we would have to establish that it is a drug based on the
labelling.
And so what we have talked about is being able to establish
that as a drug based on chemical composition and then being
able to go from there to establishing as violative based on
some lapse in the requirements under 505, the labeling
requirements under 505 section of our statute which would be a
more efficient threshold for us to reach in the IMF. The
challenge is also that a lot of times the labeling is online.
So what we have is our investigators in these facilities going
online and doing a lot of research around these products to try
to find some link between the product and its shipper that can
establish the labeling. That is why we are only able to
physically inspect a small number of packages per investigator.
So this could make us far more efficient in those facilities.
Mrs. Blackburn. OK. Let's talk just a little bit about the
bulk, the shipment because the bill will address that and the
needed authority there when you have got that adulterated and
mislabeled, misbranded drugs that are identified in this bulk
shipment.
So, and you have mentioned a couple of times some of the
problems that exist there. And as we change that authority, how
will that speed up provide those efficiencies? You have talked
a little bit about intel, the need for intel, the need for
efficiencies. So when we change this, what would the agency
gain through the new authority?
Dr. Gottlieb. The agency would gain the ability to bundle
like packages so that we are not overwhelmed by the same
shipper shipping a lot of small packages in. We can bundle the
light packages from the same shipper and take one action
against them. We would also gain the ability to destroy more of
the packages as opposed to just returning them to sender.
So if we know something is clearly violative, believed to
be counterfeit, we can destroy it, which we think would be a
stronger deterrent than returning it back to the sender only to
see the same package come in again in another IMF through
another port of entry, or sometimes the same facility. So this
is really about gaining efficiencies in the IMFs and trying to
use our limited footprint, but nonetheless a footprint that we
are trying to grow to look at many more packages a day so we
can get to what we believe is a representative sample of what
is coming in.
We are never going to be able to inspect any significant
percentage of all of drug packages coming in. I think the key
is to make sure we are targeting our resources effectively.
That requires intelligence, but it also requires the ability to
work efficiently so that we can use the resources that we have
in a better way.
Mrs. Blackburn. Thank you. I yield back.
Mr. Burgess. The chair thanks the gentlelady. The
gentlelady yields back.
The chair recognizes the gentlelady from Colorado, Ms.
DeGette for 5 minutes for your questions please.
Ms. DeGette. Thank you very much, Mr. Chairman. I just want
to comment on this questioning and other questioning.
Dr. Gottlieb, I am really happy we are talking about
improving our assessments of what is coming in in the mail.
This committee had a hearing many years ago which was one of
those totally revelatory hearings about the importation of
drugs. And I can only imagine that the situation has greatly
worsened with the opioid crisis.
We have somewhere in the archives of this committee some
pictures of what it looks like at these mail facilities with
the overwhelming amount of drugs we have coming in and the tiny
number of people we have for enforcement. So I am happy we are
working on this and I will work with the majority on making
sure this bill works.
I did want to ask you, Dr. Schuchat, about the PDMPs, the
prescription drug monitoring programs, because those are really
a valuable tool to prevent the misuse and abuse of prescription
opioids and of course it is administered by the States. The
problem is that these systems can have a lag of a few hours to
almost a week before the prescription drug data is available. I
am wondering what the CDC is doing to help encourage real-time
opportunities for detection in the PDMPs?
Dr. Schuchat. Yes the real-time nature is critical so that
you get the information current today, not a week old or a
month old. The funding that we are providing to 45 States right
now helps them get there, but most of them aren't there yet.
Ms. DeGette. So what can we do to improve it?
Dr. Schuchat. Yes. The information technology is there, it
is getting the upgrades it to the systems that they have.
Ms. DeGette. If we can work with you on that let us know.
Dr. Schuchat. Absolutely. Absolutely.
Ms. DeGette. The other thing is some of the States, like in
my State in Colorado, they are putting together regional PDMPs
and that would seem to be something that you can really
encourage.
Dr. Schuchat. We think that the States have a good
platform, but having a national platform that they can plug
into will help with the interstate interoperability and getting
really the upgrades to everyone.
Ms. DeGette. OK. Dr. Jones, Dr. Burgess asked you about the
recent press reports about the SAMHSA funding of $500 million
from Congressman Upton's and my 21st Century Cures bill that
this whole committee worked so hard on. And we were really
proud that we got $1 billion to help expand States' treatment
programs. We have already had $15.7 million in Colorado. It has
already helped 22,000 people in Colorado. You said the States
are having trouble getting that money out. What can we do to
help encourage the States to be more efficient and get that
money out? And also, do we really need to give them more money
if they can't get the money that we have already given to the
treatment and prevention?
Dr. Jones. So I think that some of this is working through
the procurement process at the State and there are wide
variations and what that looks like at each individual State--
--
Ms. DeGette. I understand you said what the problem was.
What can we do to help?
Dr. Jones. Right. So I think one that can be done is to
share information where you hear that there are bottlenecks in
the system. We would like to----
Ms. DeGette. With you? Great.
Dr. Jones. Absolutely. We would like to engage on that. And
as we implement the technical assistance at the State level I
think that is also another place to engage and provide
information to SAMHSA.
Ms. DeGette. OK. And do you think that we need more money
right now or do we need to get this money out?
Dr. Jones. I think that when you look at the magnitude of
the problem while there have been challenges in getting the
money out, the scale of the epidemic is large and growing.
Ms. DeGette. You think it is worth getting more money?
Dr. Jones. It is important and certainly the 2019 budget
supports increases in funding for that.
Ms. DeGette. OK. Great.
Dr. Gottleib, I just want to finish with you. One of the
bills that we are considering would direct the FDA to issue
guidance outlining how and when the FDA would provide
accelerated approval and breakthrough therapy designation for
treatments to treat pain or addiction. Breakthrough therapies,
that is another bill that I worked on and it has really worked,
but sometimes--and we know that it can benefit patients, but we
need to make sure that it is not unduly taking a toll on the
FDA's resources.
You know in 21st Century Cures we also paired new pathways
with new funds. What has the experience with the agency been
with the resources required for accelerated approval pathways
and do we have appropriate resources?
Dr. Gottlieb. I will just say that pain is an immediate and
subjective endpoint. We can establish it fairly quickly with a
limited dataset using scales, analog scales that we have like
measure your pain from 1 to 6 or the smily face. With respect
to accelerated approval, we don't have a good prototype for an
objective buyer marker in this context. The issue with respect
to the approval of new pain drugs and drugs that might not have
all the abuse liabilities associated with opioids, is typically
not demonstrating efficacy. We could demonstrate that fairly
efficiently, I don't want to say small but in a very reasonably
sized clinical trial, dozens of patients not thousands and
hundreds of patients. The issue is more on the safety side.
We have not seen a drug in any pain drug for chronic
administration that hasn't had some liabilities associated with
it, some safety issues associated with it. So this has been
when you are administering one of the drugs over a prolonged
period of time, whether it is acetaminophen or the unsaid class
now gabapentin, certainly the opioids we have seen side effects
associated with just about every drug. So that is where we
usually require more robust data premarket to try to discharge
any safety concerns.
Ms. DeGette. Sort of the opposite of what often happens.
Thank you, Mr. Chairman.
Mr. Burgess. The lady yields back.
The chair recognizes the gentleman from Ohio, Mr. Latta, 5
minutes for your questions.
Mr. Latta. Thank you very much, Mr. Chairman and thank you
very much for our panel for being here today because as we all
know about every member in this committee represents the
district is having a real epidemic on their own.
Unfortunately Ohio, we all know what is happening there. We
are behind Florida and Pennsylvania, we saw in 2015, 3,050
people pass away, we saw in 2016 that number went up to 4,050,
in the fiscal year ending on June 30 of last year it was 5,232
people. So it is affecting lives across this country and it is
destroying too many families. And so many babies are being born
with complications with addiction issues and losing their
parents so it is truly an epidemic in this country.
With my legislation the INFO Act, that I have introduced it
is important, in my belief, is because one of things that I
have run across in my district and talked with professionals
out there, law enforcement, it is very difficult for
individuals out there to find especially from smaller areas
that I represent they doesn't have grant writers that can go
out and get help. So what we want to be able to do is have a
dashboard out there for these individuals to go to and not only
find help but also to find what really takes finding the money.
Dr. Schuchat if I could start with my questions to you, in
your testimony you stated that data are crucial and driving
public health action, timely high quality data can help public
health, public safety, and mental health excerpts under the
problem focus resources where they are needed most and evaluate
the success or prevention and response efforts. And I couldn't
agree more.
Making that data publicly available is a large component of
my bill the INFO Act because again I believe this crisis is
going to get worse and we need to fight it. Would you speak in
depth to how the data derives public health action results?
Dr. Schuchat. This has been a fast moving epidemic and we
have seen changes in the principle factors that are driving it
so the more timely our data are, the more rapidly we can target
interventions. In some States having timely, complete data
helps them identify hot spots with increased drug supply or
increased overdose occurrences and helps target the resources
that can be built there. Whether it is the wraparound services
or strengthening the Narcan distribution so we can resuscitate
people.
At the clinical level, it can be very important to know
what happened to your patient. And so one of the innovative
approaches being used right now in some States is after there
is a fatal overdose alerting anybody who gave a prescription to
the individual who overdosed in a period before the fatality so
that the clinician actually gets that reinforcing behavior that
sometimes prescriptions can be contributing to unintended
consequences.
We know from medical practice that feedback on how you are
doing helps you improve and most of us think we are doing
better than we are, so getting feedback into how you are
prescribing and the outcomes for your patients.
The other point of data is to know what works and how we
can scale that up, and so with all of the expansion, we hope,
of the medically-assisted treatment we need to really
understand more in a more timely way which approaches work best
for which kinds of patients. We are working with SAMHSA right
now to evaluate different courses of medically assisted
treatment and multiple outcomes for patients.
Mr. Latta. Dr. Jones, you also mentioned strengthening
public health data and reporting. Do you have anything to add
about how data can serve to combat this epidemic that we are
in?
Dr. Jones. I will just add that I think it is important the
more timely data we have the better we can help States as they
are thinking about how are they spending down dollars and where
are the needs, rural versus urban, different populations. The
more granular we can get and the more timely we can get we can
be more efficient and targeted with our resources.
Mr. Latta. Thank you.
And also Dr. Jones, the common thing and again as I
mentioned I hear in my district, is finding that grant
opportunities or other funding streams, which is very
difficult. And that is again why I introduced my legislation
this dashboard. How is SAMHSA currently putting out information
on their targeted grant programs to support prevention
treatment and recovery?
Dr. Jones. So we use a variety of different means to get
information out about grants. So we have a specific grant web
page on the SAMHSA website that is right at the top where you
can find information what are the application processes, we
also post on grants.gov so as a more centralized hub for
funding. And then we put out press releases or different
announcements to stakeholders who would likely be the potential
grantees so that they know that today SAMHSA announced X amount
of funding for this and then articulate who is eligible for
that.
After we make announcements of funding opportunities we
often hold webinars or calls with potential grantees to walk
through what is the intent, what are the deadlines, what do you
need to put in your application and to answer questions to
really help people be successful in their grant application.
Mr. Latta. OK. Thank you very much. Mr. Chairman, I yield
back.
Mr. Burgess. The gentleman's time has expired.
The chair recognizes the gentleman from New Mexico for 5
minutes for your questions, please.
Mr. Lujan. Thank you Mr. Chairman. Quickly, it is my
understanding that you had a very good hearing yesterday in O&I
specific to West Virginia, Mr. Chairman. And I just want to
thank you for holding that important hearing. I think it would
be fruitful to find out what is happening in other States as
well. In New Mexico our Attorney General Hector Balderas has--
--
Mr. Burgess. If the gentleman will yield. That was actually
oversight investigation so that was a gentleman from
Mississippi who actually chaired that committee.
Mr. Lujan. I apologize, Mr. Chairman. Well, Mr. Chairman, I
know that you share the goals of what was conducted in O&I as
well. All of these States are trying to get this level of data
including New Mexico and our Attorney General Hector Balderas,
the automation reports and consolidated order system, ARCOS.
The data is invaluable. And I think all Members and States
would benefit from seeing this data. I think that it is
important that the committee work together to make sure we are
able to being access that information.
Dr. Schuchat, I know that the opioid crisis put a major
issue that your agency has been dealing with over the past
decade or more correct?
Yes? I see a nod yes.
I also know the CDC has been concerned about the opioid
prescribing rates for quite some time as well. Is that correct?
Dr. Schuchat. Increased concern since 2010.
Mr. Lujan. Increased concern since 2010, not since before
2010?
Dr. Schuchat. No. There has been concern, but I would say
there has been accelerated concern as we saw some of the data.
Mr. Lujan. I appreciate the clarification. In fact, isn't
it true that you issued prescribing guidelines to providers
last year because of the concern that an over supply of these
drugs has contributed to the opioid epidemic.
Dr. Schuchat. Yes, in 2016 we issued guidelines for chronic
pain.
Mr. Lujan. As you know, this committee has been trying to
investigate some of the distribution trends regarding opioids
in certain communities. We have tried to understand where
increases have occurred and whether those increases represent
over distribution. So I would like to share with you a chart
showing some of the opioid trends in my district.
I think that there should be a hardcopy in front of you as
well. This chart is based on DEA's public ARCOS data. It showed
the total amount of hydrocodone and oxycodone a distributor
sent to the zip codes in my district from 2000 to 2016. As you
can see, the amount of oxycodone increased dramatically by over
400 percent between 2000 and 2012. So the question that I have
actually in my district population actually fell during this
time period. So what I am interested in understanding is which
of these numbers reflects true medical need of opioids in my
district?
Dr. Schuchat. There is excess opioid prescribing throughout
the country and what we have right now is a sixfold variation
from the highest prescribing counties to the lower prescribing
counties. We think we can decrease opioid prescribing
substantially with best practices about treatment both for
chronic pain and for other conditions because too many people
get started on opioids who don't need them and some people are
continued on opioids after the time where they are necessary.
Our prescribing guidelines from 2016 began a process to
improve prescriber practices, the upgrades to the prescription
drug monitoring programs and the consumer facing awareness
campaign, that we are running, should reinforce improving
practices. We have done this before with prescribing for
antibiotics in pediatrics where we did start to see decreases,
and we think we can do this again.
So I would not say that one of these numbers is the right
one. Currently in the United States we have threefold the
prescribing of opioids that they have in Europe but we do not
have threefold the pain that they have there.
Mr. Lujan. So, well you may not be able to identify now or
suggest that any of these numbers are correct, would you agree
that this trend is alarming and concerning?
Dr. Schuchat. Absolutely, it is terrible.
Mr. Lujan. And so does the CDC use this information to
identify trends in States so that they can alert us when there
is a problem?
Dr. Schuchat. That is right. And we issued a report last
summer of the county level opioid prescribing and shared the
data, the more granular data with the counties and States so
that they could take action at their hotter spot localities,
but we also think working with the healthcare professional
groups, the licensing groups, the education of our trainees
will help us get prescribing into better order.
Mr. Lujan. Mr. Chairman, as we can see, these trends in New
Mexico there is another slide that we have, we don't have it up
for the big screen today, it is consistent with the national
trends across the country and what is concerning to me is it is
only because of the attention that has been brought by one of
our colleagues on the Committee from West Virginia about a
small community and what is happening with distributors out
there, that now we have staff majority and minority that are
looking into this issue.
And which of the Federal agencies is supposed to be doing
this work? That is my concern. I don't know that they are doing
it because these problems are continuing to grow, get out of
control. And so we will continue to submit questions, take a
deeper dive and I want to thank the majority and minority staff
for the work that they are doing. These oversight hearings are
critically important and us making sure that we can do
everything that we can to get to the bottom of this. So Mr.
Chairman, thank you for the indulgence and to the staff I
appreciate the work on the issue.
Mr. Burgess. The chair thanks the gentleman. The chair
likewise appreciates the work of the staff on this.
I recognize Mr. Lance of New Jersey, 5 minutes for
questions, please.
Mr. Lance. Thank you very much, Mr. Chairman.
And before I ask questions, I would like to submit for the
record letters from various groups in support of legislation,
which I am working, eliminating opiate-related infectious
diseases, a letter from the National Association of County and
City Health Officials, a letter from the National Alliance of
State and Territorial AIDS Directors, a letter from the
National Viral Hepatitis Roundtable, a letter from the American
Liver Foundation, and a letter from the AIDS Institute.
Mr. Burgess. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Lance. Thank you very much, Mr. Chairman.
Dr. Schuchat, I note that in your testimony you mentioned
opiate-related harms of infectious disease and how surveillance
for viral hepatitis is limited. I commend you for that because
my questions are on this topic.
Why is understanding the scope of infectious disease
important with regard to the opiate's Federal response and how
does the work of the CDC dovetail into the broader strategy?
Dr. Schuchat. Yes. Many of the infectious disease
complications of opioid use or injecting drug use can have
lifelong consequences, not just for the individual, but also
for those they are in contact with. Clearly, hepatitis C can
lead to long-term complications, including liver failure and
cancer, and hepatitis B can be passed from mother to baby and
lead to chronic infection in the child as well. Of course, HIV
is treatable but at terrible consequences, injecting drug use.
While we have seen decreases in HIV in injecting drug use, we
are starting to see that pattern change right now with our
recent opioid problem. So improving surveillance for the
infectious disease complications of opioid use is very
important in order to better target resources and get screening
and care to those who need it.
Mr. Lance. Thank you. I hope you will review legislation I
just introduced with my colleague, Congressman Kennedy, on the
other side of the aisle on this committee, completely
bipartisan in nature.
My understanding is that currently CDC is running a
hepatitis C surveillance program in 14 States, including the
State I represent, New Jersey, at a cost of $3.2 million. The
current program is passive surveillance, but I have been told
by CDC that, with additional resources, the agency could plus
up to active surveillance.
Doctor, Could you please speak to the types of tools and
resources that the CDC could activate with additional funding?
Dr. Schuchat. Yes. The hepatitis C surveillance isn't wide
enough spread. And, in fact, broader surveillance for viral
hepatitis, the other types as well, could help, because we are
seeing consequences of hepatitis A outbreaks in addition to the
hepatitis C and B problem.
The problem with hepatitis C is that a single lab test
doesn't necessarily tell you if it is a new infection or an old
infection, and so the active surveillance approach, collecting
more data, could be very helpful in broadening from the 14
States.
Mr. Lance. Thank you. Congressman Lujan mentioned the
incidence of opiate abuse across the country, and I believe you
indicated in your response that it may vary, I guess this would
be county by county, up to a sixfold. Is that right?
Dr. Schuchat. It is the prescribing that varies sixfold,
but the overdose rates vary substantially as well.
Mr. Lance. Are those figures readily available county by
county?
Dr. Schuchat. Yes. We posted the figure last July, and it
is available from our website, for the county level data.
Mr. Lance. Thank you. I would be interested. I have not
reviewed that. I would be interested to know where the counties
I represent might stand in that. Thank you for that
information.
Dr. Gottlieb, you have spoken extensively to the challenges
the agency is facing when it comes to intercepting illegal
drugs at international mail facilities, and we have had a
discussion about that this morning. Can you give us any idea of
the sheer volume of unlabeled drugs that come into this
country?
Dr. Gottlieb. Well, if I may, Congressman, I brought some
pictures from our visit to the IMF at JFK, if we can just walk
through them.
Mr. Lance. Thank you.
Dr. Gottlieb. So this is the JFK International Mail
Facility. This just shows you the package volume coming into
the facility.
If we can go to the next slide. These are parcels that were
refused and subject to destruction under 708, the FDASIA
authority that was mentioned here today. And this is 318
parcels shown in the background, this photo.
Mr. Lance. This photo was taken recently?
Dr. Gottlieb. Recently. This is from the visit that
Chairman Burgess and I did to this facility.
These are about a million counterfeit and misprinted drugs
scheduled to be destroyed early this spring.
The next slide.
[Slide shown.]
These are, again, packages that were flagged for refusal.
We are going to send them back. And you see the red stickers on
them.
Next slide.
[Slide shown.]
I had mentioned that we see packages with unmarked tablets.
This is one such box that we saw that day of a box of purple
pills. I am not sure what they are. I wouldn't suggest trying
one.
Mr. Lance. I will not.
Dr. Gottlieb. Next slide.
[Slide shown.]
This is another shipment of unknown green pills that came
in from Hong Kong. This was shipped as cosmetics. These haven't
been tested. We are not sure what they are right now.
Next slide.
[Slide shown.]
This is another box containing loose blister packs, again,
with no labeling, so it is unable to determine what they are
based on labeling.
Next slide.
[Slide shown.]
This particular photo was taken at our Secaucus mail
facility. We have another IMF in Secaucus.
Mr. Lance. To the Nation, Secaucus is in New Jersey. And
the Kennedy Airport is owned by the Port Authority of New York
and New Jersey, a bi-State facility.
Dr. Gottlieb. I know it well. I grew up nearby.
This, again, is unmarked pills. And so this is typically
what we see when I am talking about the difficulty in
establishing labeling.
Next slide.
[Slide shown.]
When I talked about multiple shipments of boxes or small
boxes, this gives you a good indication. These are 10,000
separate boxes from one shipper.
Next slide.
[Slide shown.]
Just some more photos of those individual small boxes from
one shipper. This came into the Miami IMF, actually.
Next slide.
[Slide shown.]
This shows you what we are increasingly seeing, which is
small packages with a lot of different drug contents in them.
And since we take a risk-based approach in the IMFs, typically
we might not be opening for inspection the very small packages
where it looks like it might be for personal use.
The next slide.
[Slide shown.]
This, again, shows you an individual package, again, with a
potpourri of different drugs in it, including opioids. The
drugs on the far right with the green labeling are actually
narcotics.
Next slide.
[Slide shown.]
These are two individuals watching----
Mr. Lance. Who is the person on the left there?
Dr. Gottlieb. Well, we were bravely watching this package
being opened while the CBP official was masked. We braved it.
It is a fair point that the CBP officers, and our own, but
particularly CBP, which is the first line of defense looking at
the narcotics, do gown up and mask themselves because they
don't know what they are going to be cutting into.
This was a big box of different drugs that we opened right
off the line. So it had been x-rayed right when we were
standing there, and we opened it up and found a lot of
different kinds of drugs, including OTC products, which is
unusual to find and raises some suspicions.
Next slide.
[Slide shown.]
This is a teddy bear. We didn't set out to seize the teddy
bear, but--next slide.
[Slide shown.]
This is what we found inside the teddy bear. Again,
unlabeled drug products. This is actually counterfeit Viagra.
And then final slide, if we can go to it.
[Slide shown.]
This is our laboratory facility in the IMF. So when we talk
about trying to increase our footprint and improve the physical
resources that we have there, this would be something that we
would be looking to augment. And we have put some additional
resources into this recently, but this is the lab that we use
to do the testing in the JFK IMF facility.
Mr. Lance. Well, thank you. My time has elapsed. But I
point out how dramatic this is. And on a bipartisan basis, this
committee intends to get to the bottom of it and to rectify the
situation.
Thank you, Mr. Chairman.
Mr. Burgess. The chair thanks the gentleman.
The chair recognizes the gentlelady from Illinois, Ms.
Schakowsky, 5 minutes for questions, please.
Ms. Schakowsky. All right. Dr. Gottlieb, where were those
packages going? There were addresses on there.
Dr. Gottlieb. I don't know the consignees offhand. All
different places in the United States. I would just make one
more observation that these are volumes that are clearly
intended for secondary distribution. We are not typically
seizing, unless a package comes in and we have some targeted
information around it that would lead us to believe that it is
a violative package, it might contain illicit substances, we
wouldn't be looking at the small volumes. We are typically
opening up the big packages or the packages that come from
known locales or from shippers that we know to be shipping
dangerous products into the U.S.
Ms. Schakowsky. They are going to pharmacies?
Dr. Gottlieb. Pharmacies, overseas pharmacies?
Ms. Schakowsky. No. Directed to pharmacies.
Dr. Gottlieb. It wouldn't be commercial pharmacies. These
are typically going to illegal routes of distribution in the
U.S. Again, we are looking at volumes that are intended for
secondary distribution. That big box of purple pills isn't
going to an individual.
Ms. Schakowsky. Is there follow-up to the receiver of these
pills?
Dr. Gottlieb. Depending on what we find, sometimes we refer
hundreds of cases for investigation, and sometimes criminal
investigation, depending on what we find. And sometimes when we
hold up a package, we will then give a notification that it is
coming through and maybe do a dummy drop, if you will, to try
to find who is going to pick it up. A lot of times these are
going to drop shipment points. They are not going to an
individual's home or a business. So we will do investigations
off of what we are finding in the IMF, depending on what it is
and what our level of concern is. But we refer hundreds of
cases away from these.
Ms. Schakowsky. Thank you.
On the opioid issue, Advocate hospital system in the
Chicago area, I went to visit the Advocate Lutheran General
opioid unit, actually a substance abuse unit. And they provide
detox in their medically managed withdrawal unit. And it is an
inpatient process. They only have 12 beds. It is 4 to 7 days.
And many of the patients have mental health issues as well as
substance abuse, including depression, anxiety, an undiagnosed
mental health problem. But when the detox is over, there are
not enough programs available to provide essential ongoing
follow-up treatment. And so we talked about that.
So, Dr. Jones, I wanted to ask you, there is only a certain
number of substance abuse beds available in facilities there,
and there is a really long wait. Mental health resources for
people have been steadily declining in Illinois and around the
country. They were telling me that sometimes it takes 6 to 9
months to place somebody. So they do the detox. They say this
is not treatment. This is just getting them stable. And then I
said, and then what? In some cases, if a person is homeless,
they are just out on the street again.
So I am just concerned about, and we have heard the
President talk a lot about mental health, and we all talk a lot
about mental health, behavioral health. And so how do we really
address this problem once we find people in need and get them
sober?
Dr. Jones. I think it is a really important point that we
move away from the idea that we need more beds. The vast
majority of people who have an opioid use disorder can be
treated very effectively in the outpatient setting, whether
that be in an intensive outpatient treatment in combination
with medications or in an office-based setting with the use or
buprenorphine or naltrexone or methadone in an opioid treatment
program.
So we certainly want to make sure that beds are available
for those people who have, say, opioid use disorder with a co-
occurring serious mental illness, and they need that acute care
to stabilize before they are then moved into an outpatient
setting or some sort of community-based setting.
Ms. Schakowsky. I think it is real obvious what we need to
do. But my real question is what are SAMHSA or other HHS
agencies actually doing to address this problem. It is not
really mysterious on what we need more beds for detox, we need
more behavioral health outpatient. What----
Dr. Jones. So the STR dollars, which are the opioid
specific dollars that have gone out to States, are trying to
build the capacity to provide that treatment on demand and
moving away, again, from an inpatient treatment perspective to
the outpatient setting.
I think it is also important to clarify that detox is not
treatment. And if someone is detoxed, they absolutely should be
connected to ongoing care. In particular, you could take
advantage of the fact that they have been detoxed to induct
them into Vivitrol or extended release naltrexone, because
people need to be detoxed before they can be on that.
So we are putting dollars into States to build this system
of care that can provide care for people with opioid use
disorders. We are also making investments in workforce, because
we could have all the money in the world for----
Ms. Schakowsky. Exactly.
Dr. Jones [continuing]. Capacity, but if we don't have
people who can provide the care, we are not going to move the
needle. So part of our work on the workforce side is, again,
through our technical assistance that we are providing to the
States, money within that TA program can actually be used to
create teams that can train people to get a waiver to prescribe
buprenorphine that can address other workforce-related issues.
We have our providers clinical support system, which provides
that mentoring and training network.
We often hear from primary care doctors that they are
hesitant to engage with patients who have opioid use disorder
because they don't feel supported. They are not sure that they
can manage these patients, so we have a mentoring network that
can be used to help shore that up.
And then we are also looking at things like Project ECHO,
Centers of Excellence hub-and-spoke models that can handle,
really, the acute phase, get somebody stabilized, and then pass
them off to a primary care doctor who can manage them
holistically moving forward.
So those are the things that we are using our dollars to
invest in with the States. And through the TA, we are really
trying to support the rapid scale-up of those innovations,
because people are at such high risk of dying if they are
coming out of detox and they are not connected to treatment or
if they are on a waiting list. And human life is too great to
lose, and we should be building those systems that when
somebody is ready, they can get the treatment that they need.
Ms. Schakowsky. Exactly. Thank you so much.
Mr. Burgess. The chair recognizes the gentleman from
Virginia, 5 minutes for questions, please.
Mr. Griffith. Thank you very much, Mr. Chairman.
Dr. Gottlieb, you all are not the only ones who are looking
at some of these things. Am I correct in that? And the reason I
raise that issue is you have said several times you all don't
look at when the international mail facilities and so forth--
and I guess I am trying to figure it out, because we recently
had one of those drop sting operations in my district, but it
was for a small amount of fentanyl to what would appear to be
personal use for somebody who was just ordering it over the
internet and coming in. They said in the newspaper article that
was Customs. Would that have been you all as well?
Dr. Gottlieb. Customs has primary responsibility in the IMF
for things identified as controlled substances. We will
oftentimes work with them. We have criminal investigators that
will sometimes work with them. We provide certain expertise.
Mr. Griffith. But you focus on the big shipments. Is that
correct?
Dr. Gottlieb. So what Customs will do, they will x-ray all
the packages, and they will also do some detection, including
with dogs, to try to pull out the ones that they believe have
controlled substances. They will pull a certain number of
packages that they identify with pills that they believe are
for secondary distribution, based on either volume or where it
is coming from. They will pull them for physical inspection for
FDA in those facilities. They will only pull the number of
packages on a given day that they think we can physically
inspect inside each facility.
Mr. Griffith. All right. Let's talk about that. The
Blackburn bill is very interesting, and we heard comments from
Mr. Lance, and you showed us all those slides. So what I am
asking you is should we put into the Blackburn bill authority
for you all to say a shipment has to have this specific
labeling and give you the authority if that labeling does not
exist for all those pictures we saw of the boxes and boxes of
drugs that were unlabeled? You just automatically get to
destroy those. Wouldn't that be helpful if we added that in?
Dr. Gottlieb. Well----
Mr. Griffith. Yes or no, because I am running out of time.
Dr. Gottlieb. It would make us more efficient. The
Blackburn bill does provide for that, because it allows us to
make a determination that it is a drug based on chemical
composition, if I am remembering the bill correctly.
And then we go to the secondary question of whether or not
it is labeled appropriately. Most of these products wouldn't
be. They would be misbranded.
Mr. Griffith. And what I am indicating to you is if it is
not labeled at all, before you even get to try to test it, if
it comes in and it is not labeled----
Dr. Gottlieb. Information targeting, yes.
Mr. Griffith [continuing]. Destroy it.
Dr. Gottlieb. You are speaking about the information with
the manifest date and the information we have about the package
or the labeling on----
Mr. Griffith. Yes. You showed us pictures of all these
unlabeled items coming in. You didn't know what they were. The
purple pills, you weren't sure what they were. We know what
they are supposed to be, and so forth. Wouldn't you all like
the authority just to be able to say if it is not labeled in
accordance with what you have set forth in your standards, it
is coming from some foreign country, let's just destroy it?
Wouldn't that free up a lot of time for going after the folks
who might be shipping something in that is labeled but labeled
improperly?
Dr. Gottlieb. If it is not established that it is drug at
all----
Mr. Griffith. Yes. Not labeled, destroy it.
Dr. Gottlieb. I haven't contemplated it. There would be
dietary supplements----
Mr. Griffith. Think about it and get back to me.
Dr. Gottlieb. Thank you.
Mr. Griffith. I appreciate that.
Dr. Gottlieb. Thanks, Congressman.
Mr. Griffith. Dr. Schuchat, we have got a discussion draft
being considered to help the CDC and, in turn, the States build
upon it and improve the State PDMPs, the prescription drug
monitoring programs, to achieve maximum effectiveness. How
would that discussion draft help CDC?
Dr. Schuchat. Yes. We think that improving the State-
specific PDMPs and access to a national platform, that would
help them share data across States and have everybody benefit
from the upgrades that individual States have done would be
helpful. We need to make sure that we reflect the State-
specific laws and policies and that they need access to their
data to be able to use it and improve it, and we don't really
want the lowest common denominator State to be what a new
interoperable system would be. But greater attention to the
prescription drug monitoring programs and the flexibility to
improve them rapidly is important.
Mr. Griffith. All right. Now, I know this is going to sound
controversial, but you said something earlier that triggered my
brain to work on something.
Dr. Schuchat. OK.
Mr. Griffith. You said that some of these programs will
alert the healthcare provider if they are overprescribing an
opioid. Is that correct?
Dr. Schuchat. About high dose. If you have many different
types of opioids, you can't, in your head, calculate what is
the morphine milligram equivalent. In our guideline, we alert
people that, over a certain level, special attention is needed,
because the border between safely taking those medicines and
unintentionally overdosing is small. So we want clinicians to
recognize when the cumulative opioid level is very high so that
they can look into it and assess whether it is needed or not.
Mr. Griffith. All right. Yesterday on O&I, we were talking
with DEA and all the problems we are having there with
pharmacies and some doctors. Would it be helpful or would it
create problems if we shared that information when a doctor
consistently, or a healthcare provider, consistently is giving
too high doses out? Would it be helpful to share that
information with the DEA so that we can maybe identify more
quickly where we might have a problem? Try to educate first, if
it is not criminal, but then look at it if it is.
Dr. Schuchat. In most States, the medical boards would be
looking at this high-level prescribing. I think we do think
sharing information across systems is really helpful to alert
for whatever the issue is. But in terms of what the
prescription drug monitoring programs are doing is they are
looking at prescribing to the patient, not the pharmacy level
data. And Dr. Jones might have something to add there.
Mr. Griffith. Dr. Jones, you want to add to that?
Dr. Jones. I will just say the States are--because PDMPs
sort of fall under the rubric of practice of medicine, practice
of the health professions, they have different variations in
their State statutes. But many of them do have proactive
reporting. So it is looking at, you know, outlier prescribers
and either sending that, in some cases, to the medical board,
in some cases to law enforcement.
Mr. Griffith. OK. One of the issues yesterday was getting
the information to show that a healthcare provider, whether it
be a pharmacist or a doctor, was not following standard medical
procedures in order to get a show-cause order. Now, I was more
concerned with the ISOs, because I think they are not using
those effectively and should be more aggressive on that. But in
the show cause, this is information that could be very helpful.
And I would hope we could figure it out. I know it is a little
dicey.
And I appreciate your time and yield back.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman.
The chair recognizes the gentleman from North Carolina, Mr.
Butterfield, 5 minutes for questions.
Mr. Butterfield. Thank you, Mr. Chairman.
I too would like to thank you, Dr. Jones, for your
testimony today, and all of you, as that goes.
Dr. Jones, I appreciate the many counter programs that you
highlighted in your testimony earlier. This committee worked
diligently on a bipartisan basis on 21st Century Cures and on
CARA. One of those programs, the Minority Fellowship Program,
is not mentioned at all in your testimony. I believe it to be
appropriate to fully fund this bipartisan effort that we passed
in the first iteration of CARA.
Dr. Jones, through research, has HHS come to the conclusion
that there are significant behavioral health disparities in
diverse communities across the country?
Dr. Jones. We certainly know that health disparities and
social determinants of health play an important role in the
overall health as well as behavioral health for individuals.
And creating culturally appropriate interventions that are
evidence based are really important. Again, as I mentioned, we
have the State TA program for STR dollars focusing on opioids,
because we recognize that there are State-specific contexts in
which interventions are going to be implemented.
So I think that is certainly an important area, and it is
part of our overall rubric for how we think about dissemination
and adoption of evidence-based practices.
Mr. Butterfield. So this research is ongoing and continues
to be on your radar?
Dr. Jones. Absolutely. We continue to put out data and
analyses from our National Survey on Drug Use and Health around
different disparities that exist around behavioral health
issues, whether they be substance use or mental health, among
different racial ethnic groups, among different age groups,
among people with lower socioeconomic status in a variety of
different ways to really get a more comprehensive and holistic
picture of how different individuals in our country are being
impacted by these issues.
Mr. Butterfield. Very important.
This committee, Dr. Jones, unanimously approved the
reauthorization of the minority fellowship program and an
increase in its authorization. There is no other program that
will focus on preparing behavioral health practitioners to more
effectively treat and serve people of different cultural and
economic backgrounds. We have heard that at SAMHSA's Center for
Mental Health Services National Advisory Council meeting
recently, the newly appointed assistant secretary for Mental
Health and Substance Abuse expressed her support for this
program.
Why did HHS propose elimination of this program in the 2019
budget?
Dr. Jones. I will just say, some of the specifics of our
budget are still working through and, we have a budget and
brief that is out, but the other specifics are still in
process. We are committed to workforce development that is a
priority for the assistant secretary in making sure that
workforce development incorporates different racial ethnic
groups who may have different impacts and differential impacts
of substance use and mental health.
Mr. Butterfield. Well, considering the strong congressional
and bipartisan support for this program, I would ask that you
really take a serious look at reauthorizing and funding this
program.
Chairman Burgess, I would like to submit for the record a
bipartisan letter to appropriators in support of full funding
for the Minority Fellowship Program, if I can find it. Here it
is.
May I include it in the record?
Mr. Burgess. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Butterfield. Thank you.
Dr. Gottlieb, a number of your colleagues have highlighted
the tragedy of neonatal abstinence syndrome that occurs when a
mother takes prescription or illicit opiates during her
pregnancy, and her baby is born with a physiological dependence
to that drug. Far too many babies are born into a life that
begin with opioid dependency because their mothers used or at
least abused these drugs while she was pregnant.
Would you agree or disagree that there should be special
treatments for these newborns?
Dr. Gottlieb. Congressman, I would welcome the opportunity
to try to help any sponsor that is trying to develop treatment
that could specifically address this tragic condition.
Mr. Butterfield. Well, it is my understanding that there
are few options for treating opioid withdrawals in infants. If
that is not correct, I would like to know it. But it is my
understanding that there are few options for treating opiate
withdrawal in infants. And existing options for these babies in
the first month of life are not streamlined or standardized and
none of the currently used therapeutics are FDA approved for
the population.
Would you be willing to work with companies--you said you
would work with us, of course. But would you be willing to work
with companies and other stakeholders to help identify
incentives to accelerate research into this area?
Dr. Gottlieb. We would be delighted to work with sponsors
in this regard, Congressman. And I would be delighted to work
with Congress to see what additional incentives we can try to
craft to incentivize, you know, development for what is a very
small population but a critical medical need.
Mr. Butterfield. Let me address in closing the testimony
about the types of packaging and excess opiate disposal. Mr.
Hudson and I are working on legislation to help assist with the
FDA's efforts. Can you describe whether additional authority
could be helpful in those efforts to limit the number of
opiates dispensed to patients and to make it easier for
patients to dispose of leftover opiates?
Dr. Gottlieb. Well, we are actively contemplating what we
can do under our existing authorities to try to create pathways
to blister pack some of the immediate release formulations of
drugs. We have a working group that we stood up in the agency
looking at this question. This might be something that is hard
to reach under our current authorities to either mandate that
or to require to be offered as an option that, then, the
healthcare system could try to incentivize use of.
But we do believe, at a policy level, that if the IR drugs
were in blister pack formulations that were--the number of
pills that were appropriate for 3 days, 5 days, 7 days, I think
you would see more default prescribing for those shorter
duration uses. More physicians would opt for that. We see, in
other areas of clinical medicine where there is convenience
packaging, physicians will opt for that.
This is an opportunity, I think, for Congress to address
this. Congress could conceivably direct it to be done,
particularly for the IR drugs. But we will continue to work
within the scope of our authorities to see whether this makes
sense from a public health standpoint; if it does, how we reach
it based under our current authorities.
With respect to disposal, we think that there are a lot of
opportunities to provide for avenues to dispose of these drugs
for consumers. I think it would very clearly take more pills
out of circulation that didn't go on to be diverted. Because we
have developed data that shows a lot of pills are left over on
an average prescription.
Mr. Butterfield. Thank you. I yield back.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back.
The gentleman from Texas.
Mr. Green. Mr. Chairman, I ask unanimous consent to place
into the record a letter from EVERFI and also a statement by
Congressman Hakeem Jeffries on H.R. 449.
Mr. Burgess. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Burgess. The chair recognizes the gentleman from
Florida, Mr. Bilirakis, 5 minutes.
Mr. Bilirakis. Thank you, Mr. Chairman. I appreciate it.
Dr. Schuchat, the CDC released new prescribing guidelines
for opioid back in March 2016, yet a recently released report
by the agency indicates that, despite this change, ER
admissions due to opioid overdoses have since increased by 30
percent nationwide, the Midwest by 70 percent, and by 54
percent in large cities in 16 States.
What is CDC currently doing to address this issue?
Dr. Schuchat. Yes. We are funding 45 States and the
District of Columbia to strengthen their community-based
prevention work. We are particularly focused on the
prescription drug monitoring programs so that we can improve
prescribing and not have people start down the path toward
addiction to begin with. But we are also doing work in part of
the heroin response strategy on community level projects that
explore innovative approaches like having recovery coaches in
the emergency room to help people navigate into care from the
emergency room.
So this is a big problem. It is getting worse. But we are
supporting States, working with the medical community, trying
to have system changes, and also doing consumer outreach as
well.
Mr. Bilirakis. Why did we not see any type of an
improvement with these new prescribing guidelines?
Dr. Schuchat. We have actually started to see a decline in
prescriptions of opioids. The recent increase in emergency
department visits is likely related to the illegally
manufactured fentanyl that we have been hearing about through
the international mail facilities. While the prescribing is
starting to come down, it is actually still too high. So there
is a lot more room for improvement, and we are trying to scale
up the uptake of our guidelines through medical care, through
technology improvements, through academic detailing.
Mr. Bilirakis. What do you suggest we do as legislators?
Dr. Schuchat. Well, I think the focus on this is critical,
and the resources that have been coming in, are being proposed,
are also very important. There are some authorities that could
help speed things up. As you hear about the workforce gaps in
the medication-assisted treatment world, there are similar
workforce gaps in public health information specialists and so
forth. So there are some things like direct hiring authority or
loan repayment for certain kinds of these special needs that
really need to increase for us to turn the epidemic around.
Mr. Bilirakis. Thank you.
And I appreciate you holding this hearing, Mr. Chairman.
Dr. Gottlieb, in your testimony, you mentioned that FDA's
regulatory oversight over lawfully prescribed drugs gives your
agency some important opportunities to impact prescribing in
ways that can reduce the rate of new addiction, while making
sure patients with medical needs have access to appropriate
therapy, and that is all very important. We need a balance
there.
Would you discuss these opportunities, sir.
Dr. Gottlieb. Thank you, Congressman. I just want to echo
your closing statement about patients who have medical need. We
have to remember that there are a lot of patients with chronic
pain conditions, including patients with metastatic cancer pain
who require long-term use of opioids. In some cases, opioids
are the only drug that is going to work for certain patients,
particularly patients with metastatic cancer pain. So we need
to remember that in terms of what we do and how we titrate our
policies, that we don't lock those patients out of critical
drugs.
But we have taken steps with respect to the use of our
authorities, particularly under the risk management plans that
we promulgate, in conjunction with the prescribing of drugs, to
try to put in place certain measures that will try rationalized
prescribing and try to steer the provider towards more
appropriate prescribing.
So earlier this year, we updated our REMS to include all
the immediate release formulations of drugs. Previously, it was
just applied to the long-acting formulations, the higher dose
formulations of the drugs. But we know that most of the
prescribing and most of the new addiction is through
immediately released formulations of drugs. At least that will
be the first medications that patients use.
We also expand that to include, not just physician
prescribers, but anyone who comes into contact with the
patients. So, for example, nurses and pharmacists. So we
updated the education. And we also expanded it to include
education around alternatives. So instead of just educating
providers around the abuse liability associated with opioids
and the proper prescribing of opioids, we are now requiring
education to include alternative treatments for pain so that
they have a full complement, a full picture, of what the scope
of prescribing could be.
We are looking at other ways to try to steer prescribing in
a better direction. Packaging, I have talked about trying to
make potentially the education mandatory or make it mandatory
if you want to prescribe higher volume, longer duration drugs.
We are talking about maybe requiring sponsors to impose
requirements where physicians have to document if they are
prescribing certain patterns of use that we know comport with a
higher rate of addiction, potential addiction, from the use of
prescription products. So there is a range of things we can do.
I will say in response to the question you asked earlier on
what can we do to get at this problem, it is very clear there
is not a magic bullet here. There is no one solution. It is
going to be a complement of many steps that we all take working
together to try to effect a crisis of this magnitude.
Mr. Bilirakis. Thank you very much.
And I know my time has expired, Mr. Chairman, so I will
yield back. Thank you.
Mr. Burgess. Correct. The gentlemen's time has expired.
The chair recognizes the gentleman from New York, Mr.
Engel, 5 minutes for your questions, please.
Mr. Engel. Thank you, Mr. Chairman.
I am pleased to be the Democratic lead on two of the
bipartisan bills we are considering during this hearing: The
Poison Center Network Enhancement Act and the RESULTS Act. And
during this panel, I would like to focus on the RESULTS Act,
which is a bill I have introduced with Congressman Stivers in a
bipartisan way.
The goal of the RESULTS Act is to ensure that Federal
grants intended to treat mental health and substance abuse
disorders fund activities that are backed by sound evidence so
it will help build the evidence-based innovative interventions.
And while the concept is obviously straightforward, I want to
be sure that it is executed carefully.
As we work to end the opioid crisis, we need to ensure that
results drive decision making and that we always keep the door
open to new and innovative approaches that could be game
changers. And I hope that this discussion will help us strike
the right balance.
One of the objectives of the RESULTS Act is to ensure that
there are tools available for stakeholders looking to emulate
activities and intervention that have shown results and may
work in their communities. It is my understanding that SAMHSA
intends to use the National Mental Health and Substance Use
Policy Laboratory, or policy lab, created by the 21st Century
Cures Act, which we are all proud about here, to make
information about evidence-based mental health and substance
use disorder interventions available to the public.
So in light of the suspension of the National Registry of
Evidence-Based Programs and Practices, I am anxious to learn
more about what the plans are for the policy lab. So, Dr.
Jones, would you explain exactly what types of tools and
information will be made available to the public for the policy
lab? And when would you expect that policy lab to be fully
operational?
Dr. Jones. Thank you the for question. I think it is really
important that we are good stewards of our Federal dollars and
that we are helping support, whether it be community programs
or practitioners implement evidence-based practices. And that
is really the frame that we are using as we are setting up a
new resource center within SAMHSA, helmed by the policy lab, to
accomplish that goal.
So what we are doing now is we are actually going through
resources that already exist at SAMHSA that are broader than
just sort of a program-by-program listing, which is largely
what NREPP was, that can actually help facilitate communities
and practitioners to understand what the context in which they
want to implement an intervention based on that information,
sort of a needs assessment, what are the right interventions
that fit our needs, and then how do we actually implement that?
And so SAMHSA has spent quite a lot of time and resource in
creating different types of evidence-based toolkits around a
sort of community treatment or other mental health treatment
approaches or medication-assisted treatment or community-based
substance use prevention, where those resources are somewhat
buried on the website at SAMHSA. And we want to bring those to
the forefront, because they really do provide the roadmap for
how a community or a practitioner would implement evidence-
based practices.
So we have been culling through that information. We have
reached out to our colleagues across HHS who also have that
type of information that could be useful. And we are
synthesizing that in creating a website that we believe is
quite useful across the spectrum so people from the public who
are interested in these issues who are not expert in different
topics would be able to point and click into the specific
areas. So if they want to learn about youth substance use
prevention, they would be able to quickly identify what are the
fact sheets that might exist for that versus a community
implementation guide, which might not be the most appropriate
thing for them.
And similarly, we are doing that for clinicians. There are
a number of clinical guidance documents that SAMHSA has put
out. As I mentioned earlier, TIP 63 around medications. We have
the CDC opioid prescribing guideline. And putting that into
sort of a one-stop shop where individuals can get to that. We
are absolutely committed to advancing the adoption of evidence-
based practices. That is what has been asked of us by Congress
for the policy lab, and the assistant secretary as well is
committed to that.
Mr. Engel. Well, I am glad to hear it. Let me ask you one
more question. How will the policy lab help expand access to
evidence-based treatment and promote results-driven activities?
And the second part to that is how can we in Congress help
SAMHSA achieve those goals?
Dr. Jones. So certainly the charge that was given to the
policy lab is a tremendous step forward in helping us to do
that, to identify what is working and to help disseminate that
information. So one thing that we are doing specific to
medication-assisted treatment, with our STR opioid dollars,
there are quite a lot of natural experiments that are happening
in the States. Sort of a natural laboratory of people looking
at how do we initiate buprenorphine in the emergency department
and connect people to care? How do we scale up medication-
assisted treatment in the correctional population? How do we
look at these different systems of care?
And so what we are doing now is engaging with States to
actually evaluate those innovations and interventions. And the
plan would be to very quickly, once we identify what is
working, to then disseminate that information out. But also to
infuse it into our funding announcements so that we are
actually helping to drive evidence into practice through our
funding streams and not continuing to support non-evidence-
based practices to the money that we are putting out.
Mr. Engel. Thank you very much.
Thank you, Mr. Chairman.
Mr. Burgess. The gentleman's time is expired.
The chair recognizes the gentleman from Missouri, Mr. Long,
5 minutes for questions, please.
Mr. Long. Thank you, Mr. Chairman. Thank you for having the
hearing. And I thank the witnesses for being here today.
In Missouri, from 2012 to 2016, we experienced a 78 percent
increase in opioid overdose deaths. I experienced three of
those myself, people, friends of mine, lost children in their
20s in those same years, 2012, 2016. They were children from
Columbia, Missouri, University of Missouri; Springfield,
Missouri, 160,000 population; Kansas City, Missouri. So these
were not rural areas.
However, in that study that the Missouri Hospital
Association did that showed a 78 percent increase from 2012 to
2016, the biggest spike was in the rural areas. I do a farm
tour every year, an agricultural tour, where we tour through
our district. I have a lot of rural areas in my district. And
we were driving along on the bus one day, riding along in the
bus, and looking out. It was just picturesque. It was just
gorgeous. It looked like you could have a farmland ad on their,
pop on TV, even with the green fields and everything. And the
fellow leading the tour said that their number one problem in
that area was heroin addiction of the high school kids.
And so my question is this, for Dr. Schuchat, with that
sharp increase in the rural areas, how do we ensure that rural
areas are getting the resources they need to combat opioid
abuse? And what else do you think needs to be done to make sure
the rural areas can adequately address abuse?
Dr. Schuchat. Yes. Thank you for that question. It is a
terrible problem in some of the rural areas. One of the things
we have been doing is working with SAMHSA on evaluating the
distribution of naloxone to help wake people up who have
overdosed. And there are some gaps in rural areas in a lot of
States. So trying to make sure there is the naloxone
distribution, but also ability to link to care and the
recognition that, perhaps, you know, telemedicine may be
helpful for some of the treatments where there are low access
areas.
I think it is a big problem that is going to take a lot of
time, but the way that CDC is helping is by providing resources
to the State health departments and letting them improve their
data so they know where the hot spots are so they can improve
prevention, treatment, and recovery in the hot spot areas,
which in many places are rural.
Mr. Long. Dr. Jones, you care to elaborate on that?
Dr. Jones. Sure. I would just add that we have actually
worked collaboratively with CDC. We did a paper last year
looking specifically at drug overdose and drug use disorders or
substance use disorders in rural areas to highlight this
important issue.
With our STR dollars, again, looking at the system's
innovations is a way to help address some of the capacity
issues in rural areas. I will use Project ECHO as an example,
which started in New Mexico, which has historically had very
high rates of opioid addiction and overdose in very rural
communities that have very little infrastructure for
healthcare. And Project ECHO is at the University of New
Mexico. And they actually worked with the rural providers to
train them, to provide them with resources that really help
support them to provide addiction care in the community so that
the individual from the rural area didn't have to travel to the
academic medical center 2 hours away in order to get care.
So with our opioid State-targeted response grants, a number
of States are looking at that Project ECHO model, looking at
other innovative models that you can build that capacity in
those areas to address those issues. And I think, again,
underscoring the importance of the data to understand where do
we need to be targeting those resources is really critical, and
working with the States to analyze that data to say, you
thought you had a problem in city X, but it is actually city Y,
and we need to make sure that we are deploying resources to
that area.
Mr. Long. There is a fellow that sits behind you all
occasionally in here, comes in here, quite a few times. He has
a son that, I think when he was 19 or 20 years old a few years
ago, got out of rehab for his third time. They had, I believe,
Christmas, whatever dinner, and opened packages. And the son
went upstairs, and they found him on the floor in the bathroom.
And they thought he was dead. They got him to the hospital. The
EMTs revived him, got him to the hospital.
And he looked at his dad the next day in the hospital, and
he said, Dad, I knew when I got out of rehab that I couldn't do
the same amount of heroin that I used to do. But I can hardly
get it to melt on a spoon, and it about killed him. So they got
him on whatever drug it is, the high-price injection thing. I
say high price, $1,000 a month. YAnd he has done really, really
well since then.
Is it money? If you had all the money in the world, can we
attack this problem or not? If you had said, Dr. Gottlieb or
Schuchat or Jones, whoever, if you just sit there and write
checks all day, is there anything we can do that--what would be
the most effective thing we could do if you had an unlimited
budget for this problem?
Dr. Jones. Well, certainly, resources are helpful. But as I
mentioned earlier, a workforce is equally as important. And we
have a lack of sufficient workforce to address the addiction
and mental health problems that face our country. So I think--
--
Mr. Long. So if you had the money, could you hire the help,
or there is just nobody in those fields?
Dr. Jones. We have to think about how resources are used.
So part of that is to build that capacity, which is what we are
doing with the funding that we have now. So it is building the
workforce, it is building the systems, it is building the
infrastructure.
So many of the issues that we are talking about today are
really the things that we need to be doing to advance that. It
is just how do we more quickly scale those things up, and
resources are clearly a part of that.
Mr. Long. OK. I am way past my time.
I yield back. Thank you.
Mr. Guthrie [presiding]. I thank the gentleman for yielding
back.
And the chair recognizes Dr. Bucshon from Indiana for 5
minutes for questions.
Mr. Bucshon. Thank you, Mr. Chairman. I was a physician
before I was in Congress, so we have kind of seen this coming
for quite a while, and I am really pleased that now there is a
national attention on this issue.
Dr. Schuchat, I am interested in finding solutions to the
opioid epidemic partially by focusing on addressing the
underlying causes of the opioid use disorder and specifically
looking at innovative solutions to address acute and chronic
pain. Does the CDC collect statistics information about how
many Americans suffer from chronic pain or information related
to access to treatment?
Dr. Schuchat. That is not a core part of our surveillance
systems right now. We don't think that pain itself has
increased over the past few decades, but we have changed how we
were prescribing for pain with the availability of the longer
acting opioids.
Mr. Bucshon. Is there a need for more information, you
think, in that space?
Dr. Schuchat. There has certainly been an increase in
people with chronic diseases that we are tracking, and so I
think better understanding of pain and the different factors
contributing to it will be important, as well as access to
alternative approaches for pain management, which are safer and
perhaps more effective.
Mr. Bucshon. OK. Yes. Because pain is very subjective, and
it is sometimes difficult to put your finger on it. I can tell
you just doing the surgery that I did, the variance in the
amount of postoperative discomfort that people would claim to
have, that did have, but the severity of that is across an
entire spectrum. So that is difficult.
So information on people that truly have chronic pain
syndromes that may require long-term opioid treatment might be
important, because I think that is one of the concerns that I
think patient advocacy groups in that space are concerned
about, and information on the actual number and how we deal
with that might be helpful.
Dr. Schuchat. Yes. I think it could be helpful, but also
knowing what are the best approaches for that. Recently there
was a randomized control trial that compared opioids with
nonsteroidal anti-inflammatories for back pain and some other
things. And at a year out, people who were on the nonsteroidals
actually were doing better.
Mr. Bucshon. I know. I know that. I just read that.
Dr. Schuchat. Yes. So I think we have been taught that we
were undertreating pain, and people thought the way to treat
pain was with the opioids, and probably there are better ways
to treat many kinds of pain. But, of course, not all. And our
guidelines were not to take pain medicine away from people with
palliative care, metastatic cancer, and end of life, and so
forth. But there is a lot of overprescribing.
Mr. Bucshon. The treatment of pain itself, people become
tachyphylactic to the treatment, right? They get resistance so
they need more and more. And it may ultimately allow these
patients, like you pointed out, the pain actually initiated the
therapy in the first place is not the reason why they are
continuing to take the medication.
Dr. Gottlieb, successfully tackling the opioid crisis
requires, in part, ensuring that patients have access to
alternative effective treatments for chronic pain. I would like
to note the recent FDA education blueprint for healthcare
providers involved in the treatment of monitoring patients with
pain highlights the importance of provider awareness regarding
the range of therapeutic options for managing pain, including
nonpharmacological approaches and pharmacological nonopioid
therapies. And further, that nonpharmacological approaches
include the use of approved, cleared medical devices for pain
management.
And I know there are a number of existing medical
technologies on the market today, including spinal cord
stimulation, implantable drug pumps for nonopioid medications,
radiofrequency ablation, among a variety of other things.
Could you speak to your perspective on the role of medical
technology such as these and others in advancing the treatment
of pain and alleviating, partially helping with the opioid
crisis?
Dr. Gottlieb. Well, I think it plays a critical role. We
have over 200 approved medical devices for different pain
indications. About 10 of those are very novel technologies. And
I think that there is a lot of opportunity for medical devices
for a lot of different pain syndromes, particularly where you
have regional pain, where you might be taking a systemic drug
for what is a regional condition, a regional musculoskeletal
pain, in particular, where you might be able to address it with
a medical device that is delivering localized anesthesia. So
there is a big opportunity.
We are looking at what we can do through our policy tools
to try to incentivize development there. We are looking at
particularly some challenge programs and trying to get out
better guidance on the development of devices that could
address pain as a way to try to incentivize more development of
those kinds of products.
Mr. Bucshon. Do you think you have the tools that you need
in your toolbox to get some of these innovative products to the
consumer or are there barriers that are legislative that might
be necessary to help you along in that process?
Dr. Gottlieb. I would be happy to give that some thought,
Congressman. I can't say right now that there are limitations
in our review authorities where we don't have adequate
flexibility to make some accommodations here or think in
innovative ways. We do have flexibility under the medical
device statute, which allows us to titrate the regulatory touch
to the sort of complexity of the product and the risk inherent
in the product. We do have flexibility on the medical device
side of our house to address unique situations where we might
want to foster more innovation. So I can come back to you. I
will take it back to my folks. I have asked the question
internally, and we have come up with things that we think we
can do under our existing authorities.
Mr. Bucshon. OK. I appreciate that. Yes. The actual barrier
could be over at CMS at the end of the day, sometimes. I think
I found that to be true since I have been in Congress. So we
are trying to address that side of it also. Thank you.
I yield back.
Mr. Guthrie. I thank the gentleman for yielding back.
And the chair recognizes Mrs. Brooks from Indiana, 5
minutes for questions.
Mrs. Brooks. Thank you, Mr. Chairman.
Some time ago, in about 2015, Indiana, Scott County in
particular, experienced a horrific HIV outbreak. And I know the
CDC, a lot of different agencies, were very involved in helping
us curb that outbreak. And now most recently, we are seeing,
and papers are reporting, a massive increase in hep C cases
throughout our State, and in some of my counties I represent
specifically, and them being directly connected in many ways to
opioid abuse.
And so we know that the majority of these infectious
diseases are attributable to injection drug use, and we know
public health officials are focusing hard on these problems and
on solutions. But I guess I am curious, I want to come back to
the CDC. I believe we have talked about this in the past having
to do with the HIV outbreaks.
But can you talk to us about, Dr. Schuchat, what you are
doing to continue to monitor the infectious disease outbreaks,
particularly as we are not turning the tide on the opioid use,
and what kind of levels are we seeing nationally, and what
tools are available to States to help them react or to try to
get ahead of it maybe faster than we are right now? Because I
think we are losing another battle, in addition to the opioid
battle, but they are, I think, very related.
Dr. Schuchat. Yes. The Indiana outbreak in Scott County was
a wake-up call, and we did modeling to identify over 200
vulnerable counties around the country that could be just like
Scott County, in terms of outbreaks of HIV or hep C in the
context of the opioid use. We distributed that information to
the State and local health departments, but much more is needed
in terms of improving the surveillance for those infectious
disease complications of opioid use disorder. And also the
screening treatment and longer term care. The hepatitis C is
increasing in many areas, but we don't have as good
surveillance for it as we would like.
Mrs. Brooks. Can you talk to us, though, about surveillance
tools that either you use or do you need any additional
authorities? How are you surveilling for these outbreaks?
Dr. Schuchat. Yes. The surveillance is usually laboratory
based, that the labs do the testing, but there is often a need
for active followup to determine is it a new infection? Has it
already been reported somewhere else? So it is really
strengthening that public health front line infrastructure in
the labs and the health departments to be able to improve the
quality of surveillance and see the information back more
rapidly.
Mrs. Brooks. So that collaboration that you have with the
State and county labs in many ways and State health
departments, is there additional funding that as we are
hopefully getting ready to in this next budget provide a lot
more funding to State and locals who are on the front lines of
this, is this something that we need to make sure or that
SAMHSA and the grants they put out, that you all can make sure
there is more funding for this type of surveillance?
Dr. Schuchat. Yes. This type of surveillance does need to
be better supported. We are tracking some of the infectious
complications, but not all of them. And we are not doing it
quickly enough. We think that better data on prescribing,
better data on overdoses, and better data on infectious
complications will all help us turn the epidemic around.
Mrs. Brooks. Are there any other infectious diseases
specifically that we ought to be looking for, monitoring for,
and raising the level of awareness with our State and local
health officials?
Dr. Schuchat. Yes. I would like to signal the need for a
nimble and flexible public health response. We wouldn't have
expected hepatitis A to increase and associated with injecting
drug use, but it has. And we have had large outbreaks in
Michigan, in multiple States, California, many States around
the country, of hepatitis A. So we think that the broader
infectious disease complications of injecting drug use or of
the opioid epidemic would be helpful.
Right now, we have a group A strep, the flesh-eating
bacteria outbreak that is associated with the injection of
drugs. So I think----
Mrs. Brooks. Would you repeat that?
Dr. Schuchat. The group A strep, which people have heard of
as the flesh-eating bacteria, we are having an outbreak of that
that has been traced back to injecting drugs. It can come in
through the skin.
So I think just as we started this wave of overdoses with
prescriptions complicated later by heroin and most recently
fentanyl, in terms of infectious diseases, we have to have our
eyes wide open. I was talking to a colleague earlier about an
outbreak in Scotland of cutaneous anthrax that was associated
with injection drugs there. So we need to really look broadly.
And certainly, the viral hepatitis infections are the leading
ones that we have to be worried about.
Mrs. Brooks. Thank you. My time is up. And thank you all
for your work.
Mr. Guthrie. I thank the gentlelady for yielding back.
The chair recognizes Mr. Carter from Georgia for 5 minutes.
Mr. Carter. Thank you, Mr. Chairman. And I thank all of you
for being here.
Dr. Gottlieb, I will start with you. And I wanted to ask
you about something that former Chairman Upton asked you about,
and that is the abuse deterrent formulations. I know that in
your 2018 action plan, your plan states: Among our science-
based efforts, we will assist in the conversion of the market
toward wider use of opioid drugs with improved formulations
that are harder to manipulate and abuse.
I just wanted you to comment on that and what you see as
the role of these particular formulations in the future.
Dr. Gottlieb. We do think that there is an opportunity for
these drugs to potentially reduce the rate of overall abuse and
addiction in the market, and do see a potential opportunity
from converting more of the market to abuse-deterrent
formulations that are harder to manipulate in ways that allow
people who are trying to misuse them to get a dose dump, if you
will.
Mr. Carter. Right. One of the problems is getting coverage
for them. How can we assist you in that? I know that insurance
companies don't want to cover them because they are more
expensive and they are not on formularies. And if they are,
they are not on a top tier, and that causes the access to them
to be decreased.
Dr. Gottlieb. Yes. It is a fair point, and it is one that
we observe as well. Obviously, we don't have a direct line into
the coverage environment. I think where we could potentially be
helpful in the overall scope of that challenge is in trying to
facilitate avenues for claims that are more seductive to people
who are paying for these drugs.
And so that is why we are trying to move in the direction
of accumulating data that can allow us to make a determination
that when these drugs are used over a population, they do, in
fact, reduce the rate of addiction and abuse. And we are
continuing to collect that data.
I made the point before: We are going to have a make a
policy decision at some point whether or not, as a policy
matter, we think the totality of the data demonstrates that, as
you convert the market to abuse-deterrent formulations, you cut
down on abuse.
Mr. Carter. OK. Let me ask you about unit-dose packaging.
Some years back, you put Halcion under unit-dose packaging, and
it worked very well. And I am just wondering what the holdup
is. What will you base that decision on if you decided to go
that route with opioids? Is there something you have to base it
on?
Dr. Gottlieb. We would want empirical data, public health
data to demonstrate that, as you move toward blister packs,
you, in fact, are going to cut down on the rate of addiction
and abuse.
Mr. Carter. Hasn't that been proven with Halcion?
Dr. Gottlieb. Well, we would want to prove it in this
context, but you would also want those to be evidence-based
insofar as you would want to be blister packing drugs in unit
of doses that comport with what common prescribing is.
Mr. Carter. Right.
Dr. Gottlieb. And we are in the process of developing that
data. We now have very good data from our Sentinel database
that we will be making public at some point in the near future.
Mr. Carter. OK. All right. Thank you very much, Doctor. I
am sorry. I have just got so much time.
Dr. Jones, always good to see you. Thank you for being
here. Let me ask you something. I know that health professional
education is going to be extremely important, particularly as
it relates to doctors and to pharmacists. I remind you that
pharmacists are not law enforcement officers. It is unfair to
ask us to profile and say that this patient does not need this
pain medication.
I have often said that the only thing worse, as a
pharmacist, for me, than to fill a prescription that is going
to be diverted or used in an unwarranted way is to not fill a
prescription for a patient who truly does need it. So I just
give you that warning.
But I want to thank you and compliment you on your points
that you have made today about comprehensive complete
rehabilitation. I have often said that we have got two problems
here, two distinct problems. One is tangible. One is, how do we
get this under control? How do we limit the number of
prescriptions? How do we educate patients and healthcare
professionals about the danger of these drugs?
But the other is, what do we do with those people who are
addicted? And that is a big, big challenge. Addiction is a
lifelong challenge. And I appreciate the emphasis that you are
putting on complete rehabilitation and comprehensive
rehabilitation. That is so very important, and I want to thank
you for that.
Dr. Schuchat, I wanted to ask you, how many States right
now require doctors to look at PDMP before they write a
prescription for an opioid? I know that Georgia is starting
that July 1st.
Dr. Schuchat. Yes. I may need to get back to you on that. I
was going to say it might be 36, but let me double check.
Mr. Carter. OK. That will be fine.
All right. I have got one last question. As was mentioned
numerous times during this hearing--we had a hearing yesterday
in Oversight and Investigations with the DEA. And, Dr.
Gottlieb, you will be glad to know that they have made the top
of my list and replaced you now. So I am on them, OK.
But I just want to ask you: I realize you are not under
oath, and I realize it is a very uncomfortable situation to
talk about other agencies, but how do you interact with them?
Because I just don't think they are doing their job.
When you have pharmacists who are not filling prescriptions
for doctors, who have a legitimate license and they haven't
been for years, yet the DEA does nothing about them, can you
imagine how frustrating that is to us?
I can tell you that there are doctors in my community now
that the pharmacists won't fill their prescriptions because
they are out of control, yet they still have a valid DEA
license. They have a valid license. That is unconscionable that
that happens.
And I put that blame, yes, on the composite medical boards,
but also I put it on the DEA, because I am convinced that they
can do something about that. So I just wanted to ask you very
quickly, how is your interaction with that agency?
Dr. Gottlieb. Who is it for? Is it for me?
Mr. Carter. Anybody. All three of you. And if you could be
quick, because I have got one last thing. All of you.
Dr. Schuchat. Yes. We actually did an exchange with DEA and
are trying to strengthen the interactions, but I think you just
speak to the system needs improvement.
Mr. Carter. Oh, it does, so bad.
Dr. Gottlieb. I will just comment, Congressman, it is
actually very good right now. Historically, there have been
challenges if you go back 15 years, but right now we have a
good working relationship with them at a staff level and at a
leadership level.
And I have met with Mr. Patterson a number of times and
talked to him about things we could be doing together to
further expand our footprint together.
Mr. Carter. OK. Dr. Jones.
Mr. Guthrie [presiding]. We have got to run over time on
this. We need to move on because we have got another panel we
are going to bring forward. I appreciate the gentleman's
questions. And I now yield 5 minutes to the gentleman from
Oklahoma, Mr. Mullin, for questions.
Mr. Mullin. Thank you, Mr. Chairman.
And, buddy, if you want to, if I get time, I may ask your
questions.
Mr. Carter. Thank you very much.
Mr. Mullin. You are very passionate about this, and I like
that.
Mr. Carter. I am.
Mr. Mullin. But he is a guy that does 500 pushups and 500
situps every day. At his age, that is impressive. I had to get
there. Sorry.
Dr. Jones, I am going to be speaking to you most of the
time. I thank you for being here. I would like to thank the
whole panel for being here. My colleague Representative
Blumenauer and myself sent a letter to SAMHSA asking the
Assistant Secretary's thoughts on legislation, H.R. 3545, the
Overdose Prevention and Patient Safety Act.
Yesterday, I received this response from the Assistant
Secretary stating that SAMHSA is encouraged to see that
Congress examines the benefits of aligning part 2 with HIPAA. I
take this to mean that they are supportive of the committee's
efforts to align part 2 with HIPAA. Am I correct in saying
that?
Dr. Jones. Right. We do favor achieving greater alignment
between part 2 and HIPAA.
Mr. Mullin. I know the chairman had already mentioned this
to Chairman Walden, but I want to--and this letter that I want
to submit for the record, when--I found one part of it
extremely interesting, and I will quote from the letter.
It says: The practice of requiring substance-use disorder
information to be more private than information regarding other
chronic illnesses, such as cancer or heart disease, in itself
can be stigmatizing.
I know you already answered that, but would you like to
elaborate a little bit more on what you meant by that?
Dr. Jones. Well, I think it is just the issue of
marginalization. So, these protections were put in place to try
to reduce stigma, to make sure that people would be able to go
forward and receive treatment without concerns that they might
lose their job or people wouldn't provide care for them.
Mr. Mullin. Right.
Dr. Jones. I think we are in a different time in that there
is a movement among the recovery community to be more open
about being in recovery. As I shared today, I am in recovery.
And so the idea that we are somehow different or what it
might do in meaning that your healthcare providers might not
have all the information that would be relevant to providing
you with high-quality care just further stigmatizes the idea
that we are different in some way. And I think that was really
the point that she was trying to raise in the letter.
Mr. Mullin. I literally couldn't agree more with that. We
have placed a stigma, and unlike with other diseases, be it
through addiction or mental illness, it does seem to carry some
type of stigma with it, but it can be overcome. And the more we
talk about it and the more we try to allow everybody to see
what is happening with the patient, the better that patient can
be treated, because that is what it is all about.
I am going to do my good friend and colleague, Buddy
Carter, a favor and yield him the remainder of my time to you.
Mr. Carter. Thank you.
Dr. Gottlieb, I know that you talked about international
mail and what is coming through there. Can you speak about
domestic mail, particularly about mail-order pharmacies who are
sending 90-day supplies of many medications with the intention
of--they encourage patients to get a 90-day supply for a lower
copayment and they don't have to get it as often. Is that not a
concern as well that they are getting so much of these
medications through the domestic mail as well?
Dr. Gottlieb. Congressman, that question relates to just
the overall prescribing, I think, rather than the issue of the
illicit flow. I think you are talking about legal prescribing.
I am not sure that would be shipped through the domestic mail.
I think it would have to be picked up at the pharmacy under
the CSA, right? Yes. So, if it is prescription opioids that are
shipped domestically from a pharmacy to a patient, I think it
wouldn't be shipped through a domestic mail facility. They can
receive them? OK. They can receive them in the mail. The
prescription would be controlling the size in that
circumstance.
Mr. Carter. Right. Right. OK. Well, I just want you to be
aware that that is a problem too. You would be shocked at the
number of opioids that are going through our mail right now
that are coming from mail-order pharmacies, coming through the
VA, and many others like that. And that is something we need to
look at as well.
And I do appreciate the gentleman yielding his time.
The one last thing I want to say to all of you--and this
may be somewhat anticlimactic, but it is very important--
Representative Shimkus mentioned this earlier. Please be very
careful not to swing this pendulum too far.
I was a hospice consultant for many years. There are people
out there who have long-term pain. Hospice patients need these
medications. Let's, please, don't go so far that we hinder and
block access for those patients who truly do need it.
Thank you, Mr. Chairman. I yield back.
Mr. Guthrie. Thank you. I thank the gentleman from Oklahoma
for yielding back his time.
And I recognize the gentleman from North Carolina, Mr.
Hudson, 5 minutes for questions.
Mr. Hudson. Thank you, Mr. Chairman.
Thank you to the panel for your time today.
This is such an important issue. As has been said by many
of my colleagues, it affects all of our districts. It affects
people all across every demographic around this country, and so
I appreciate your great work and the time you have devoted
today to this hearing.
Dr. Gottlieb, in your testimony, you note, the FDA, through
its Sentinel database, is using data to assess prescribing and
usage patterns by medical indication and provider specialty.
You note this analysis is still ongoing. But can you talk more
about the Sentinel database and any preliminary findings FDA
has on potential overprescribing?
Dr. Gottlieb. What we have been able to do is use our
Sentinel database to look at prescribing by indication and look
at how many pills are being prescribed based on an indication.
We have looked across about 15 different common indications and
then look at how many pills are left over after the patient
completes the prescription.
And so we have been able to derive where we see excess
prescribing. We actually found a couple of indications where we
see patients seeking another prescription. But in the majority,
in the vast majority of the indications, there is excess
supply, and sometimes there is significant excess supply, which
leads to the problems that we have been discussing here today.
We are going to find a venue to make this information
public at some point in the future. It is proprietary
information, but we will be finding a way to publish this. This
is a very important tool for us, because this clearly informs
the policy decisions that we are making.
Mr. Hudson. I appreciate that.
You also mentioned FDA's reviewed published literature on
pills dispensed, used, and leftover by patients who were
prescribed opioids. Can you give me any specifics on the number
of pills leftover, or if not, have you been able to determine
how often pills are leftover?
Dr. Gottlieb. If I remember the data correctly, and I would
be happy to follow up with your office to get you a more
precise answer, we looked across about 15 indications, and in
all but two, there was leftover. And in most, there was a
significant percentage of the pills that were prescribed were
leftover. So it is a common phenomenon.
Mr. Hudson. Appreciate that, if you would help us get that
information.
But do you believe then that if consumers had easier access
to convenient disposal methods that would help mitigate this
oversupply of opioids?
Dr. Gottlieb. We do. We think that could help.
Mr. Hudson. Great. Well, we look forward to working with
you on that.
And if my colleague, Buddy Carter, would like some of my
time, I would be happy to yield.
Mr. Carter. Thank you. I thank the gentleman for yielding.
Just very quickly, Dr. Gottlieb, I wanted to also follow up
on what I believe one of the other Members on the other side of
the aisle had mentioned about when the drugs come through the
international mail system in there.
That seems to me like that is a perfect opportunity for a
sting operation. Follow it to the end, and do you ever do that?
I mean, find out where it is going. Yes, we need to attack the
supplier, but we need to attack the users as well. Are we doing
that?
Dr. Gottlieb. Yes, we are.
Mr. Carter. OK. Well, thank you. I appreciate that, because
that is so vitally important.
Dr. Jones, I wanted to ask you also, and I believe Dr.
Gottlieb mentioned it about the use of the opioids, the
immediate release, which are cheaper and used more frequently.
How do you educate physicians on the proper use of these
medications, and is there anything available for them to
understand exactly what should be used and when it should be
used?
Dr. Jones. So we do have educational programs, as I
mentioned earlier, the providers' clinical export system, which
focuses on medication-assisted treatment but also on opioid
analgesic prescribing for pain. So, really, it is essentially a
roster of experts who can provide training on the appropriate
use of medications, whether they be for treatment or pain.
We also, in our opioid STR grant program, allow States to
use funding around education on CDC's guidelines specifically.
So we are trying to work across agencies to make sure that we
are not putting out conflicting messages but that the CDC
guideline, the 12 recommendations are really the blueprint for
moving that forward and States can use those STR dollars to
educate clinicians.
We are, again, trying to do this holistically. We are
trying to look at the pain side but also on the addiction side,
so that providers, if they are facing that issue, whether it be
on pain or addiction or co-occurring pain with someone who has
addiction, they are equipped to have that interaction with the
patient.
Mr. Carter. Right. Thank you very much.
One last thing, Dr. Schuchat, I just wanted to ask you, do
you monitor prescribing rates in different regions or different
areas?
Dr. Schuchat. Yes. We have been using some proprietary
databases in order to do that, and we issued a report last
summer on county-specific levels of prescribing.
Mr. Carter. Right. When you see that, do you give that to
the DEA or to any other agency and say, ``Look, there is a
spike here, will you please check it out?''
Dr. Schuchat. We actually gave it to the public as well as
to the health departments and other partners. So it is in the
media. So it was very well publicized. But it was somewhat
delayed, so we were talking, it was 2015 data that we reported
last year.
Mr. Carter. Right. Thank you very much. And I yield back.
Mr. Guthrie. The gentleman's time is expired.
Mr. Walberg, from Michigan, is recognized for 5 minutes.
Mr. Walberg. Thank you, Mr. Chairman.
And my colleague from Georgia, are you out of questions?
Mr. Carter. That is all I have got.
Mr. Walberg. I want you to know, I would be willing so that
I get some support in the future myself too. I appreciate
that--without having to do 500 pushups.
In my townhalls in my district, I am constantly hearing
from families who have been impacted by this issue
aggressively, and it touched their lives. So I appreciate, Mr.
Chairman, not only the opportunity--since I don't sit on this
august subcommittee but have deep interest in it--to be able to
sit here today and thank you for putting this hearing together.
Earlier this Congress, I introduced Jessie's Law, with
Congresswoman Debbie Dingell. It is named in memory of a
Michigan resident, Jessie Grubb, who tragically died of an
opioid overdose in 2016.
Jessie's parents informed the hospital that she was a
recovering addict. And despite informing the hospital of her
history with this addiction, the information never made it to
her discharging physician, and that made all the difference in
the world. Jessie was unknowingly discharged from the hospital
with a prescription of oxycodone, which ultimately led to her
death the following day.
It is a heartbreaking and entirely preventable story, I
think. And it is why we need to pass Jessie's Law, so medical
professionals are equipped to safely treat their patients,
prevent overdose tragedies, and ultimately save lives.
Dr. Jones--and I would open it up to the other two
panelists as well, if you would care to comment, Jessie's Law
aims to help healthcare providers more easily identify patients
who have substance abuse disorder.
The bill is focused on patients who have already
consented--and that is the key. They have consented to share
this information with healthcare providers. This is critical to
ensure that mistakes such as what tragically happened to Jessie
never happen again and we avoid medical errors that lead to any
unnecessary deaths.
Now, this, to me, as uninitiated interested party in this
whole situation, seems to be pretty straightforward. And I am
surprised that it isn't currently happening.
Could you describe what this information currently looks
like in the patient's medical records and what the barriers
might be for healthcare providers to see the information
quickly, efficiently, and deal with it?
Dr. Jones. I think, certainly, as I have mentioned
throughout the conversation today around part 2, equipping
healthcare providers with information to understand what is
going on with their patients is really important. And often
people in recovery have to be their own advocates to self-
disclose that they have an addiction.
And the population of that information in electronic health
records is pretty varied in how that information may be there.
And in some cases, it may still be in paper charts depending on
the practice setting, and so it may be very difficult for a
clinician to have that information.
I think what you are advocating for in the bill complements
the work that we are trying to pursue within the department and
provides an additional tool for clinicians to have really
important information. I think we have to think about how do we
do this in complement with equipping providers with the
knowledge of what to do when they have that information.
So we want them to have it. We want them to be accessible.
But we also want them to be able to make informed decisions
based on having that knowledge. And I think that goes hand in
hand with our training efforts around understanding what is
addiction, understanding what is the role of pain management in
people who have opioid addiction in particular so that you are
not--even if you are trying to do the right thing, you are not
having an unintended consequence of someone dying from an
overdose because you didn't understand as a clinician what risk
that was putting the patient at.
Mr. Walberg. But a discharging physician, wouldn't they, if
they had the records in front of them, and I guess that is my
concern, if they had in front of them, knowing that this person
had voluntarily notified that they were a recovering addict,
wouldn't they automatically not give the opioid under
discharge?
Dr. Jones. I would not assume that. I will speak from my
own personal experience. I had a colonoscopy, which I am sure
everyone likes to talk about.
Mr. Walberg. I am trying to forget it.
Dr. Jones. But I had a colonoscopy. I disclosed to the
gastrointestinal surgeon who was performing it and an
anesthesiologist who was there, and I said: You know, I am in
recovery; I want to do this without medication.
And the anesthesiologist said: Well, it is propofol; it is
not addictive.
And I am an educated person. I am a pharmacist. I
understand that that was not a good choice for me.
But I had to, in that moment, be my advocate and be very
stern to say, ``No, this is, I made my decision, this is how I
want to proceed,'' while getting pressure from the
anesthesiologist that, ``Well, you need this.''
Partly I think she was probably interested in getting paid.
If she didn't deliver the medication, she wouldn't get paid.
But I would not assume that just because the information is
there, while critically important, we have to make sure that we
are packaging that with education on then what do you do.
So we put out guidance from SAMHSA on how do you manage
pain in patients who have co-occurring substance-use disorders
and pain conditions to really try to help move that forward for
clinicians. I think the CDC guidelines as well have specific
callouts around people who have addiction and how do you manage
pain in those individuals.
Mr. Walberg. Any additional comments?
Mr. Guthrie. Thank you. The time is expired.
Mr. Walberg. I appreciate that. Thank you.
Mr. Guthrie. Thank you for yielding back.
I now recognize the gentleman from California, Mr.
McNerney, 5 minutes for questions.
Mr. McNerney. I thank the majority for allowing me to wave
on.
I thank the panel. It has been very informative, and I
don't know a whole lot about this subject.
But, Dr. Gottlieb, I am working on a bill that would give
the FDA the authority to ask opioid manufacturers to examine
long-term efficacy of an opioid drug, and these studies would
take place after the manufacturer receives approval for the
drug from the FDA. Does the agency currently have this
authority?
Dr. Gottlieb. We have authority to request post-market
studies that aren't mandated as a condition of approval on a
basis of safety considerations, not purely on an efficacy
consideration, Congressman.
Mr. McNerney. Do you think it would be helpful for the
agency to have this authority?
Dr. Gottlieb. Well, one of the questions that continues to
come up around opioids is the issues associated with their
long-term use. A lot of these have not been studied for chronic
administration, yet they are chronically administered.
And so there are certain important questions that we could
answer by properly studying the chronic administration, looking
at the efficacy over time, whether efficacy declines, and what
the complications of that is.
Mr. McNerney. Well, how would the agency use the
information then it receives from those studies?
Dr. Gottlieb. Well, if we had such studies, if they were
collected in the same way we do under the authorities we have
to look at to request post-market safety studies, we would seek
to make the results public.
We would seek the ability to incorporate it into labeling
as well so it can inform the provider and inform the healthcare
system. That is typically how we handle post-market safety
studies under the authorities we have right now to request
post-market studies.
Mr. McNerney. Very good. And you think that will be useful
too late in fighting the opioid epidemic?
Dr. Gottlieb. We certainly think that having more
information around the long-term efficacy of these drugs could
be very useful to prescribers, could be very useful to our own
regulatory decisionmaking, yes.
Mr. McNerney. Thank you.
In your opinion, do you think that building a southern
border wall and using the death penalty would be useful in
fighting the opioid epidemic?
Dr. Gottlieb. Congressman, I certainly think that there are
things we need to do from the standpoint of deterrence and
interdiction. I have talked about what I want to do here today,
which is to step up our work in the international mail
facilities.
I stick to my knitting, and I stay within the scope of
where I can affect this crisis. And for us, interdiction is a
key component of trying to address the overall crisis.
Our footprint is in the international mail facilities in
that regard and on the dark web, actually. I haven't talked
about that today, but we do a lot of investigative work on the
dark web to target rings that are bringing in, for example,
illicit fentanyl.
Mr. McNerney. Dr. Schuchat, do you have an opinion on that?
Dr. Schuchat. All I will say is that having good data about
the factors that are driving the epidemic is important, and the
most recent wave of overdose deaths has been associated with
the illicit products that are coming in from other countries.
Mr. McNerney. Well, Dr. Schuchat, and you mentioned data
several times in your testimony. Can we refer to this as Big
Data, and are you considering using tools such as artificial
intelligence and data mining?
Dr. Schuchat. The data that we need is complex. We need it
locally for rapid response. We need it at the State level to
target resources. We need it nationally to understand the
trends and to actually understand what strategies are improving
things and what strategies are making them worse.
In terms of the automated learning kinds of issues, that
can be really important for things like medical examiners and
coroners and coding of the death certificates. We are using
some systems now to take the natural text and try to extract
information in more timely ways so that we can even just figure
out for the emergency department visits or the overdose deaths
which ones are drug associated and, of the drugs, which drugs
were around.
Mr. McNerney. Well, the war on drugs that started in the
last century has been not only a tragic failure but very costly
and actually counterproductive. There have been lessons
learned, but I am afraid there are lessons that haven't been
learned or are being ignored.
Can you assure me that we will benefit from the lessons
learned from that undertaking?
Dr. Schuchat. My highest priority is rapid quality data so
that we don't make mistakes. And if we have unintended
consequences like we have experienced with the overprescribing
of opioids, we find them rapidly and take action quickly. So I
think we need to have good data that provides evidence-based
interventions.
Mr. McNerney. So what about putting more people in jail or
taking those sorts of hardline actions?
Dr. Schuchat. Well, I guess, I can make a comment that I
think I have seen very innovative work in the drug courts in
terms of alternative approaches to getting people into care
rather than sentencing. So there is a lot of innovative work
going on at local levels around the country.
Mr. McNerney. Thank you.
I yield back.
Mr. Guthrie. Thank you. The gentleman yields back.
The gentlelady from Michigan, Mrs. Dingell, is recognized
for 5 minutes for questions.
Mrs. Dingell. Thank you, Mr. Chair, and thank you for
letting all of us wave on.
And I actually had some of the same questions my colleague
from Michigan had, so I won't go there. But I think, in
Michigan, we are working in a very bipartisan way on a very
serious issue.
And as you know, for me--most of you do. I know two of you
do--this is a very personal issue. Having a father who was
addicted to opioids when I was growing up, long before anybody
understood the power of these drugs or what it did to people,
but living with a man who is in chronic pain and every doctor
says he needs to have serious pain medicine, I see both sides
of this.
And I am very active on this issue, as you know. And more
and more people are coming to me, the oncologists, and saying:
We can't deny people.
I had someone scream at me last week about how we were
denying people who needed pain to get by, and they weren't
getting it. So what I really do know is that we need to be
doing the research.
Dr. Gottlieb, do you agree that developing more nonopioid
pain medications is an important part of solving the opioid
epidemic?
Dr. Gottlieb. It could certainly help, Congresswoman. We
are working with sponsors on that.
Mrs. Dingell. And thank you.
And I think that promoting more research into nonopioid
pain medications is one of the most important things we can do
to ensure that people that are legitimately suffering from pain
still get the relief that they need. We have got to make sure
pendulums don't swing that far.
That is why I have introduced H.R. 5002, the ACE Research
Act, with my friend and colleague from Michigan, Fred Upton.
This legislation provides NIH with new, flexible authorities to
conduct innovative research on ways to respond to public health
threats, like the opioid epidemic.
I know that NIH isn't here today to discuss this, but it
really is essential that we give them the tools they need to
support much-needed research into these nonopioid pain
medications.
Dr. Gottlieb, can you talk about how FDA works together
with NIH on this type of research and how giving NIH more
flexible authorities, like those envisioned in the ACE Research
Act, will help us find new drugs faster?
Dr. Gottlieb. Well, thank you for the question. I think
that there is a critical need for more translational research.
We do see new classes of drugs, new potential classes of drugs
with new mechanisms that might not have all the addictive
qualities of opioids but offer some of the same pain relief.
And so it is important--these are in early development. We
don't fully understand the issues associated with these
mechanisms and potential safety issues. And so having the
translational research in place and the scientific foundation
to better develop these products is going to be critically
important.
We are working closely with NIH on these efforts, and so we
have been partnering with them on the things that they are
doing to try to foster and facilitate early research into some
of these new mechanisms. So they are a very important partner
to us.
Mrs. Dingell. I think it is really critical.
I am just going to make an editorial comment off the books
too, that one of the things that I know is really happening is
that people with legitimate pain are being stigmatized.
And they go to get their prescriptions filled; they are
feeling like they are dirty somehow. We have to have that
compassion, but we also have to educate kids at the early age:
This is complicated. We are dealing with something really
complicated. So I thank all three of you for the work that you
are doing. We just have to accelerate it.
One thing I am also concerned about is that we are doing
everything we can to treat children who are born with an opioid
dependence and how we can stop that situation from happening in
the first place. Two thousand women a month report using heroin
or misusing painkillers while pregnant, which is a staggering
number.
This question is for Mr. Jones of SAMHSA. I blew that
pronunciation. Sorry. Your testimony notes that you recently
released a new clinical guidance document regarding how to best
treat mothers and their infants who are born addicted to
opioids.
How do you recommend to best treat a newborn with an opioid
addiction, and how are you disseminating that clinical guidance
to providers?
Dr. Jones. So, again, I think there are different
situations in what is the best treatment. I think we are still
also learning what is the best treatment. I think, several
years ago, there was a focus on using morphine or methadone or
even buprenorphine to withdrawal, that the neonate would be
placed in the NICU, so high acute care, high, expensive, longer
stays.
And now we are learning that rooming in with the mother in
a regular floor in a quiet environment tends to improve
outcomes and shorten the duration of treatment. And so, along
with NIH and others across HHS, we are working on an action
plan around the Protecting Our Infants Act, sort of an
implementation plan which gets to some of these issues.
In the clinical guidance, what we really focused on there
is that, again, there are a variety of situations that
clinicians may come across. So it is not that there is a one-
size-fits-all, but we present different vignettes that allow
them to navigate different situations that they may come
across.
Mrs. Dingell. Thank you. I will yield back.
Mr. Guthrie. I thank the gentlelady for yielding back.
Seeing no others here for questions, I will dismiss the
first panel. We appreciate you for being here and taking the
time to testify before the subcommittee. And we will bring, of
course, our second panel as we transition. So thank you very
much for being here.
Thank you. The subcommittee will come back to order.
I appreciate the opportunity for all of you to be here and
so each of you will be given the opportunity to do an opening
statement, and it will be followed by questions from members.
And I will introduce each witness, and I will call in for your
opening statement.
I will make sure I say this correct, Thau or Thau?
Ms. Thau. It is Thau.
Mr. Guthrie. Thau, OK. I am glad I asked. So Ms. Thau, she
is a Public Policy Consultant, Community Anti-Drug Coalitions;
Ms. Cartier Esham, Executive Vice President, Emerging
Companies, Biotechnology Innovation Organization; Mr. Jeffrey
Francer, Senior Vice President and General Counsel, Association
for Accessible Medicines; and Dr. John Holaday, Chairman and
Cofounder DisposeRx. We appreciate you being here today.
And, Ms. Thau, you are now recognized for 5 minutes to give
an opening statement.
Ms. Thau. Thank you so much to these----
Mr. Guthrie. Your microphone, please. You have to activate
your microphone, please. There you go.
STATEMENT OF SUE THAU, PUBLIC POLICY CONSULTANT, COMMUNITY
ANTI-DRUG COALITIONS OF AMERICA
Ms. Thau. Thank you so much. My name is Sue Thau. I am the
Public Policy Consultant for Community Anti-Drug Coalitions of
America, CADCA. CADCA is the national nonprofit organization
whose mission is to build and strengthen community coalitions
to create safe, healthy, and drug-free communities.
It is on behalf of the more than 5,000 CADCA coalition
members that I want to thank you all for the opportunity to
testify today on behalf of H.R. 449, the Synthetic Drug
Awareness Act. This important legislation would require the
Surgeon General to report to Congress on the public health
effects caused by synthetic drug use among 12- to 18-year-olds.
We applaud H.R. 449's focus on youth who disproportionately
suffer the negative consequences of drug use because of its
deleterious effects on the developing brain.
Preventing or delaying substance use is the single most
critical tool in stopping the pathway to addiction and
overdose. Primary prevention to stop substance use before it
starts is the most cost-effective way to deal with the
addiction issues facing our Nation.
Research shows that, for every dollar invested in
prevention, between $2 and $20 in treatment and other
healthcare costs can be saved. Substance-use prevention has
historically been underresourced and underutilized in combating
drug issues, including the current opioid epidemic, with most
of the emphasis on funding being directed towards downstream
approaches that deal with the problem after it has already
reached crisis proportions.
This Surgeon General's report will be invaluable in
garnering more attention and resources to address the synthetic
drug issue. The best example of Surgeon General's reports that
have changed the course of a public health crisis were on
smoking and health.
These have provided universally accepted scientific
findings that increased awareness, changed social norms, and
built broad support for tobacco prevention, cessation, and
control programs that ultimately resulted in major population
level reductions in smoking among Americans, most notably
youth.
Given that more potent and deadly synthetics are being
designed almost daily to skirt the Controlled Substances Act
and that these drugs are increasingly accessible and available
in communities across the entire Nation, this report could not
be more timely.
To achieve population level reductions in substance use, a
data-driven community coalition infrastructure is needed to
plan, implement, and evaluate comprehensive strategies
throughout multiple community sectors.
Raising awareness through this report would be incredibly
useful at the community level, as it would provide critical
science-based information needed to help prevent drug use,
intervene with those who have started using, and treat those
who become dependent on synthetic drugs.
Communities would use the report to not only raise
awareness but to plan and implement a mutually reinforcing
combination of evidence-based strategies that are laid out in
more detail in my written statement.
These include providing information, enhancing skills,
enhancing access and reducing barriers to programs and
services, changing consequences and incentives, changing the
physical design of the environment, and modifying and changing
policies and laws.
This type of synergistic action is what resulted in the
massive reductions in tobacco use we have witnessed over the
past 55 years. This multiple-strategies-across-multiple-sectors
approach is currently how the Drug-Free Communities Program
housed in the Office of National Drug Control Policy has
achieved major population level reductions in reducing 30-day
use of alcohol, tobacco, marijuana, and prescription drugs in
12- to 17-year-olds.
Drug-free community coalition grantees working to combat
youth synthetic drug use will find this report extremely useful
and use it to raise awareness with scale and scope among
community sectors such as parents, youth, schools, and
healthcare providers.
This report would also further the ability of community
coalitions to design a robust set of locally appropriate and
evidence-based interventions capable of resulting in
population-level reductions in youth use of synthetic drugs.
CADCA and its members are proud to support H.R. 449. Thank
you for the opportunity to testify today, and I am happy to
answer any questions you may have.
[The statement of Ms. Thau follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Guthrie. Thank you. I appreciate your testimony.
I will now recognize Ms. Cartier Esham, who doesn't look
like she could be the childhood friend of our own Thomas
Massie, and a proud Kentuckian. So you are now recognized 5
minutes.
STATEMENT OF CARTIER ESHAM, EXECUTIVE VICE PRESIDENT, EMERGING
COMPANIES, BIOTECHNOLOGY INNOVATION ORGANIZATION
Ms. Esham. Thank you, Chairman, and thank you, members of
the committee. Thank you, and thank you for the opportunity to
speak with you today about policy solutions put forward by this
committee to address America's opioid crisis.
As mentioned, my name is Cartier Esham, and I work for the
Biotechnology Innovation Organization. BIO is the world's
largest trade association representing the entire ecosystem of
biotechnology companies from the entrepreneurial to the
multinational companies.
Our members are dedicated to the development of the next
generation of biomedical breakthroughs for the millions of
patients suffering from diseases for which there are no
effective cures or treatments.
It is this mission focused on innovation that guided the
development of BIO's objectives and policy proposals designed
to change the paradigm of how we treat pain and addiction in
this country and eliminate prescription opioid drug abuse in
the future.
They include advancing our scientific understanding of pain
and addiction diseases; ensuring that patients have knowledge
of and access to the right treatment at the right time with the
right support and without stigma; and stimulating R&D for
innovative treatments that improve care and prevent abuse.
The current state of innovation for the next generation of
pain and addiction therapies holds promise. There are currently
125 clinical development programs looking at novel chemical
entities in the pipeline today, 87 percent of which are for
nonopioid treatments.
However, less than 4 percent of total venture investment in
the biopharmaceutical sector is being directed into companies
whose lead product is a novel pain therapy. This is even
significantly less for companies working on novel treatments to
treat addiction.
By comparison, this is 17 times less than funding we see
for the development of oncology drugs. We need to develop and
support a more conducive policy environment focused on changing
the paradigm of how we treat patients suffering from pain and
addiction to realize the full potential innovation could have
in creating an America free of prescription opioid addiction.
I would like to highlight three bills today under
consideration that, if enacted, would help make these goals a
reality. The bill focusing on FDA opioid sparing that would
enable FDA and stakeholder collaborations to discuss and
develop guidance on ethical and efficient data collection for
opioid sparing and availability of that information to patients
as part of the label of a product would be extraordinarily
helpful.
Enactment of this legislation would provide FDA,
biopharmaceutical companies, and investors with an improved
understanding about how data sources can be utilized to support
demonstrations that a novel therapy reduces opioid use.
BIO believes the same approach focused on other critical
areas, such as improved approaches for evaluating pain,
utilization of innovative clinical trial designs would also
further improve drug development and review processes for
better and safer pain and addiction treatments.
We also support the legislation under consideration that
would enable better utilization of accelerated approval and
breakthrough therapy pathways. Enactment of this legislation
would, again, provide FDA, as well as the biopharmaceutical
industry, investors, and other stakeholders with a greater
understanding of what is required to meet the criteria to be
able to participate in these pathways and ensure that processes
intended to expedite approval meet the unique needs of pain and
addiction.
These actions would serve as critical signals to not just
biopharmaceutical companies but their investors that the
development of pain and addiction therapies that are safer,
improve quality of care, and reduce the use of opioids is a top
priority.
Lastly, we also wanted to highlight the Advancing Cutting-
Edge Research Act. This is legislation that would provide NIH
with a much needed transactional authority to better enable
them to more efficiently distribute funds to conduct or support
research required to respond to public health threats such as
the current opioid crisis.
In our written statement, we also call for the development
of a transparent and focused research strategy to ensure that
we continue to advance our understanding of the biology of pain
and addiction and develop tools that would improve the
diagnosis and treatment of these diseases.
BIO strongly believes that innovation is a key component of
efforts to address the opioid crisis. We look forward to
working with the committee to put forward policies that will
change the paradigm of how we treat pain and addiction, improve
patient lives, and advance our ability to achieve our shared
goal of eliminating prescription opioid drug abuse in the
United States.
Thank you.
[The statement of Ms. Esham follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Guthrie. I thank you for your testimony.
I now recognize Mr. Francer for 5 minutes for an opening
statement.
STATEMENT OF JEFFREY FRANCER, SENIOR VICE PRESIDENT AND GENERAL
COUNSEL, ASSOCIATION FOR ACCESSIBLE MEDICINES
Mr. Francer. Thank you, Mr. Chairman, members of the
committee. I am Jeff Francer, Senior Vice President and General
Counsel of the Association for Accessible Medicines. AAM's core
mission is to improve the lives of patients by advancing timely
access to affordable FDA-approved generic and biosimilar
medicines.
Generic and biosimilar medicines serve as the backbone of
prescription drug savings and now represent greater than 89
percent of all prescriptions in the United States at only 26
percent of total drug expenditures. We, therefore, save
patients, payers, and taxpayers nearly $5 billion every week.
AAM commends the subcommittee for its continued efforts to
address the public health crisis of opioid prescription drug
abuse and this excellent hearing. We are also encouraged by the
continued focus of the administration, including FDA
Commissioner Scott Gottlieb, on addressing this challenge.
Ensuring patients' safety is of the utmost importance for
generic drug and biosimilar manufacturers. Enhanced prescriber
training, patient prescription adherence, safe storage, proper
disposal, all can help prevent medication abuse and ensure that
patients get the full benefit of safe, effective, more
affordable generic medicines.
It is critical that we combat the misuse of prescription
drugs while also maintaining the legitimate, uninterrupted
access to patients who need medical treatment. Generic drug
manufacturers play a key role in producing affordable FDA-
approved therapies for the treatment of patients.
Importantly, under the Hatch-Waxman amendments that govern
the approval of generic medicines, our manufacturers create
bioequivalent versions of brand name drugs using the same
labeling, and if necessary, the same or equally protective
safety programs.
Typically, generic drug manufacturers do not promote drugs
to physicians or directly to patients as the brand name
manufacturers do. Moreover, once our companies sell generic
drugs to the wholesaler, the company does not control the
further sale of the medicine to retail pharmacies.
Currently, three large purchasing consortia made up of
wholesale distributors and retail pharmacies control the sale
and destination of 90 percent of the generic medicines in the
United States. AAM believes that a comprehensive approach to
the opioid crisis should help ensure responsible drug
promotional activities as well as prescribing.
My written statement outlines our recommendations in full,
but let me take a moment to summarize. AAM and its members
support a range of collaborative strategies and public policies
to reduce drug abuse while ensuring appropriate access to
medicines for patients who need them.
Specifically, we support expanding and improving
prescription drug monitoring programs; enhancing initiatives to
assist physicians and other prescribers; and the proper
prescribing of prescription drugs, particularly opioids;
mandatory ongoing training for providers on best practices in
pain management; reducing the potential for divergent and
fraudulent prescribing by requiring the use of electronic
prescribing for controlled substances; consideration of a 7-day
limit on prescriptions of opioids for acute pain; and proper
disposal of unused or unwanted prescription drugs through
national DEA take-back days.
Lastly, I wanted to share with the subcommittee how AAM and
its members are partnering with leading national organizations
dedicated to promoting public health and preventing abuse.
Last year, AAM approached EVERFI, a leading provider of
electronic training for our Nation's colleges and universities.
We asked the organization to develop a module to help students
understand the importance of safe use, storage, and disposal of
prescription drugs.
With AAM's financial support, EVERFI has developed and made
available a prescription drug abuse prevention curriculum free
of charge to any college in America in order to help this at-
risk demographic make healthy decisions. More than 36,000
students have already taken this course since its launch just
last fall.
In addition, AAM and EVERFI have brought together national
business leaders and pharmaceutical supply chain partners to
fund the rollout of a K through 12 prescription drug program to
some of the hardest hit communities in our country.
In conclusion, we look forward to continuing to work with
the subcommittee to help address this national opioid crisis
and help ensure the proper prescription and use of FDA-approved
medicines. I would be happy to answer your questions.
[The statement of Mr. Francer follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Guthrie. Thank you for your testimony.
And, Dr. Holaday, you are now recognized for 5 minutes for
an opening statement.
STATEMENT OF JOHN HOLADAY, PH.D., CHAIRMAN AND COFOUNDER
DISPOSERX
Mr. Holaday. Thank you, Mr. Chairman, and for the committee
for giving me the opportunity to be before you today. My name
is Dr. John Holaday. I am the Chairman and CEO of DisposeRx,
the country's leading site-of-use medication disposal company.
Our president, William Simpson, was unable to attend because of
weather problems today.
Our country is in crisis, not only from opioid addictions
but from the dangers of prescription drug abuse. Drug overdose,
as you know, is the leading cause of accidental death in the
United States.
And the failure to properly dispose of unused or expired
prescription drugs from our home medicine cabinets, managed-
care facilities, hospitals, hospices, and others dramatically
contributes to the rapid increase of prescription drug abuse,
accidental poisonings, opioid overdoses, and the pollution of
our Nation's public drinking water supplies.
National policies have long encouraged improper drug
disposal. None of the methods currently recommended for drug
disposal are convenient, responsible, secure, and, most
importantly, do not prevent diversion of controlled substances.
None of these methods incorporate an education component which
is directly related to the success of any such program. There
is a better way.
DisposeRx is invested in developing a solution that can
help eliminate one of the root causes of prescription drug
misuse and abuse, which is exposure to unused, unwanted
medications in the home.
DisposeRx is the gold standard for at-home drug disposal.
We have developed a product that safely, conveniently, and
securely allows customers to dispose of their unused
medications in their own home when it is convenient to them.
This ensures that there is no time lag between dispensing and
disposal, eliminating the opportunities for diversion.
Consumers are reaching out for a solution that is simple
and safe to use. Data have shown that items returned to drug
take-back locations often include such things as nasal sprays,
Flintstone vitamins, ointments, and creams.
A survey of the Journal of Drug Abuse revealed that 1.4
percent of consumers returned their unused medications to the
pharmacies or take-back kiosks. In fact, 54 percent threw their
medications in the trash and more than a third or 35.4 percent
disposed of their medications in the sink or the toilet.
And what is more surprising is that fewer than 20 percent
of patients reported having received any education as to
correct disposal methods. The CDC states that the best way to
curb opioid addictions is to stop their diversions from
medicine cabinets.
DisposeRx provides patients with an easy solution for drug
disposal. Each packet contains a patented blend of nontoxic
ingredients that will create a viscous gel when mixed with warm
tap water. Simply take your pills, add some water, pour in the
contents of the packet, shake it up, and within 30 seconds to a
minute, the drugs are dissolved and permanently sequestered in
a gel from which they can't be extracted for abuse and won't
leech into landfills.
The components of this sequester the gel so it can't be
diverted and it can't be extracted. Our product is the most
tested and trusted product in the market today. We have been
subjected to rigorous third-party testing for extractability
and environmental friendliness.
Extractability testing has shown that, once sequestered,
our patented cross-linking polymers, using commonly available
household solvents, cannot be extracted or the contents cannot
be extracted. So it is nontoxic, and the majority of the
components are listed as generally regarded as safe by the FDA.
It is not dangerous nor harmful to the environment.
Incorporated into the mission of the DisposeRx team is the
commitment to educating the community on the cycle of
medication management. This begins in the pharmacy. We realize
that successful drug disposal is dependent upon the inclusion
of targeted instruction and patient education. Cleaning out the
medicine cabinet will become second nature if the mechanism to
do so makes it a realistic and obtainable goal for the
consumers.
One of the examples is the time that it took between
legislation of seatbelt use and the decrease in deaths from
automobile accidents. And the same thing occurs with tobacco
and other matters that really require legislation in order to
jump start the people to start adopting changes in behavior to
save their lives.
In closing, we are proud to be bringing patients and
families a simple and effective solution for drug disposal. We
are honored to be working with a team at Walmart, as they are
the leading retail pharmacies that have been the first to
supply a consumer site-of-use solution that is both fighting
our Nation's opioid epidemic as well as the dangers of
prescription drug overdose.
Our mission is to solve the problem of drug disposal. We
focus on driving patient education with simple and safe
solutions. We fundamentally believe this education of the
patients is important in the process, and we remove some of the
barriers facing safe disposal and encourage the adoptions of
nontoxic site-of-use home solutions.
Thank you very much for your attention.
[The statement of Mr. Holaday follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Guthrie. Thank you. I appreciate your testimony.
That concludes all witness testimony. We will now move to
member questions. And I will now recognize myself for 5 minutes
to begin the questioning period.
Ms. Esham, thank you for being here today. And in your
testimony, you mention the importance of ensuring patients
suffering from pain or addiction were able to receive the right
treatment at the right time with the right support without
sigma. I could not agree more, which is why I introduced the
Comprehensive Opioid Recovery Centers Act.
Can you please expand on your statement and elaborate on
what specific coverage and reimbursement barriers that prevent
patient center decisions?
Ms. Esham. Certainly. Thank you. And I would like to
commend you for the legislation that you are putting forward.
As a resident, a person that grew up in Kentucky, having a
multifaceted, multidisciplinary approach to treating addiction
and making it easier for people to get that help is critically
important, so I want to thank you for that work.
In direct response to your question, there are a multitude
of proposals and recommendations that we have put forward, but
it is our assessment and our recommendation that there are
specific barriers and practices that need to be examined and
removed and things that are basically precluding access to
patients for alternative nonopioid treatments, safer
treatments, et cetera.
And that includes looking at or removing barriers that are
based on root or administration, so bundling practices that
make it difficult to get alternative--nonopioid alternative
medicines, step therapy requirements, fail-first requirements.
There is a multitude of steps that we think we could take. But,
again, there are barriers that exist, and we need to examine
them in a holistic way to make sure people are getting the
right care.
Mr. Guthrie. Thank you. I appreciate your answer.
And, Dr. Holaday, can you please explain--I like the
demonstration there--but can you please explain why the cross-
polymer technology is such an effective method of
sequestration?
Mr. Holaday. Certainly. Our product is made up of things
which one often derives from corn, generally recognized as
safe, so it is actually edible should you choose to do so. But
the secret sauce enables these polymers to form rapidly over
time after dissolving the drugs that are exposed to them in
water.
So, without telling you what the entire product is made of,
about five or six different ingredients that, when mixed
together, along with one particular key, rapidly forms the gel
from which these drugs cannot be extracted for abuse, and they
also won't pollute landfills.
Mr. Guthrie. That is an effective method there. That is for
sure.
So, Mr. Francer, one of the bills being considered today
would give FDA additional authority to require modifications to
packaging of opioids or that opioids be dispensed in
conjunction with the convenient disposal method. I think it
makes a lot of sense, but do you have any concerns about these
additional measures impeding access?
Mr. Francer. So, first and foremost, we support a science-
based method of regulation. And I think Dr. Gottlieb indicated
before that they want to develop data on how these different
features could affect the protectiveness of patients.
We would support such power for the FDA to protect the
public health. We would want to make sure that there is equal
application across both the brand and the generic. And we would
want to make sure that opportunities for gamesmanship and the
patents of packaging don't harm access to the generic drugs.
But, overall, we would be happy to work with the committee to
provide technical assistance to ensure access.
Mr. Guthrie. Again, thank you for your answer, and that
concludes my questions.
I will recognize Mr. Green for 5 minutes for questions.
Mr. Green. Thank you, Mr. Chairman.
We heard from our first panel that--Dr. Gottlieb--the
majority of patients who will become addicted to opioids are
first exposed to a lawful prescription. I know that all of us
here today are exploring creative solutions to addressing the
opioid crisis, including addiction abuse and misuse.
I know many of us were pleased to see the FDA take action
last year when it requested the withdrawal of an opioid
treatment due to the concern that the benefits associated with
the product no longer outweigh the risk of abuse and
manipulation.
Mr. Francer, one of the bills noticed today is the
legislation I am offering. It would allow FDA to take into
consideration the potential risk for abuse and misuse in making
approval decisions. This seems to be an important and unique
decision that the agency should take into account when
approving controlled substances.
I understand that some stakeholders may be hesitant to make
modifications to the FDA's current risk-based assessment. And
as we continue to work on this legislation, how would the AAM
recommend that we target this legislation to ensure that we are
appropriately targeting the controlled substances that are
fueling the opioid epidemic?
Mr. Francer. I think it is entirely appropriate to consider
the risks of misuse and abuse, and we would be happy to support
the development of legislation in that regard.
Mr. Green. I think you answered my second question from the
chair saying that will you continue to work with us and our
colleagues to perfect all the legislation that we are
considering today.
Mr. Francer. Absolutely.
Mr. Green. Thank you.
Mr. Simpson, effective and safe medication disposal is a
critical piece of the puzzle in order to reduce access to
addictive prescription drugs, including opioids. Mr. Simpson,
as you notice in your testimony, easy access and leftover
prescription opioids is a dangerous way people become addicted.
Improper disposal from our homes, hospitals, managed care
facilities, and hospice centers is critical in addressing
misuse and diversion. Mr. Simpson, you noted that the drug
take-back efforts and the kiosk may not be utilized as often
because it requires individuals to identify and visit locations
outside their homes, which may be inconvenient, time consuming,
and difficult to certain individuals.
Dr. Holaday, I apologize. That was for the previous panel.
Well, that concludes the questions, Mr. Chairman.
Mr. Holaday. I must say I am not as young or handsome as
Mr. Simpson who was unable to be here today because of weather,
but I would be delighted to answer your questions, sir.
Mr. Guthrie. I just want to say that this committee has a
bill on the floor in the House, so people are going and coming.
Mr. Green. That's why we are running back and forth.
Mr. Guthrie. So it is an honest mistake.
Mr. Holaday. No problem. I will answer Mr. Simpson's
question, though.
Mr. Green. OK. Well, then I will finish it. I thought we
were just messed up.
Mr. Holaday. Surprisingly, as you pointed out, people are
not inclined to get in their cars and drive to take-back
facilities to bring their products to a place where they could
be destroyed. They are more likely to do that at home.
We were surprised to find out from some studies of Egan and
colleagues that in studying five counties in Kentucky and
looking at all the drugs that were dispensed and then looking
at all that came back to take-backs and kiosks, less than
three-tenths of a percent of the drugs that were dispensed came
back. Most of those were Flintstone vitamins and the like. Only
5 percent of those were drugs of abuse.
So take-back facilities are not really very effective.
Often they cause liabilities for the facilities, like the
pharmacies and others. They also are often diverted from these
take-back facilities, as you may know.
We think if one can offer a safe solution that is at home,
permanent, and biodegradable, and environmentally friendly,
that will stop a lot of the losses and the difficulties of
other programs. But I must say we are all for anything that can
help stop the cycle of addiction and overdose that begins in
the medicine cabinet, including ours and others.
Mr. Green. Thank you, Mr. Chairman.
Mr. Guthrie. The gentleman yields back.
I now recognize Mr. Shimkus, 5 minutes for questions.
Mr. Shimkus. Thank you, Mr. Chairman. Thanks for being
here. I know it is a long day. And I know a lot of you are
sitting in on the first panel, which I appreciate.
What I have been trying to get my arms wrapped around, I
mean, we do have a pharmacist on the panel with this,
obviously, the prescriptive authority, and then the legal
authority to destroy and who that is, especially in the case--
and I know we have a bill that is going to address hospice
issues when the prescribee passes. And I think it is a very
good debate to have the attending nurse there being able to do
this in whatever manner. And I think there is a lot of exciting
things going on in that issue.
So it really is a debate on, for me, and this line of
questioning, who--is there things that we need to clear up in
law as far as who we can designate to do that, who is
authorized to do that, who can we educate? Is there an
educational aspect of this aspect and is there ambiguity in the
law that prohibits this from occurring?
And so I will just go, Ms. Thau and then just down the
table, and then I will go to my second question.
Ms. Thau. Yes. I can't speak about ambiguity in the law. I
can say that a lot of our coalitions have worked with long-term
care facilities. I can give you an example in Fayette County,
Ohio, where somebody went to take their loved one's
prescriptions. And when they were told they couldn't have them,
they said, but this is our inheritance, because they obviously
intended to sell them. So it is a gigantic problem, and our
people are working piecemeal community by community trying to
make sure that those medications are actually withdrawn and are
not diverted.
Mr. Shimkus. Yes, great.
Anyone else want to weigh in on this? Dr. Holaday?
Mr. Holaday. I would say that we were surprised when we
began this quest several years ago to find that there is no
mandate by the FDA, the DEA, EPA or others to take care of
leftover drugs and to encourage their disposal in a safe way.
We think that this is an important aspect of managing the
entire cycle of drugs from their dispensing to the time that
they are gotten rid of. And that if they were properly managed
at the end, that could prevent a lot of the divergence. Seventy
percent of opioid addicts get started with leftover drugs in
medicine cabinets.
Mr. Shimkus. Yes. Look at the hospice patient who may be on
painkillers and other addictive drugs. And so if there is a
million in our country and there is five pills per individual,
that is 5 million uncontrolled addictive drugs that could be--
and our culture does have a challenge with ownership. You are
prescribed nine pills, you use four pills, and by golly, those
are your five pills. Right? Paid for by you or your insurance
company or whatever. And so that is the educational part that I
kind of mentioned in that outline.
So I appreciate that. I think that is something we have to
wrestle with some authority by a healthcare professional whose
got primary care to be able to have the authority to take and
seize and destroy. I think I would support that.
Ms. Thau, obviously, we are pulling out all the stops on
the opioid crisis. Earlier, I had mentioned the meth issue.
There is still cocaine, there is new synthetic drugs. I don't
want them to get lost in this whole debate. So you want to
comment on these other aspects, given the time left?
Ms. Thau. Yes, absolutely. Thank you so much. I think what
is really important is that we have an addiction crisis in this
country. It is it not just an opioid crisis. When coroners look
at what is on board when people have overdosed, it is opioids,
it is fentanyl, but it is also marijuana, alcohol, Ambien,
benzodiazepines; you are absolutely right, meth and cocaine are
back.
So what we really need is a permanent infrastructure for
prevention, intervention, treatment, and recovery support that
is not so drug specific, so that when we sort of fix this
opioid problem, we do--and a lot of you were around for the
whole Combat Meth Act. You know, oh, well, we dealt with that,
and then all the money for that went away. So we really do need
permanent infrastructure for the entire continuum of care for
this issue for all drugs.
And there is no MAT for stimulants, by the way. So it is
fabulously important that there is for opioids, but for cocaine
and meth, there is no equivalent for medication-assisted
treatments.
Mr. Shimkus. Thank you very much.
My time has expired. Thank you, Mr. Chairman. I yield back.
Mr. Guthrie. The gentleman yields back.
The gentlelady from California, Ms. Matsui, is recognized
for 5 minutes for questions.
Ms. Matsui. Thank you, Mr. Chairman. And thank you to all
the witnesses for being with us today.
We have heard a lot of discussion today about how to
address the opioid crisis, how to treat patients with opioid
use disorders, and what can be done to ameliorate the impact of
the crisis in our communities. However, I also believe that we
must be focusing on the roll of primary prevention and what
steps we can take to bring awareness to addiction,
implications, and how opioid usage and addiction can be
prevented in the first place.
I appreciate that Ms. Thau from the Community Anti-Drug
Coalitions of America--CADCA, right? --is here testifying and
can speak to the importance of prevention efforts and community
strategies.
Ms. Thau, what more can be done and should be done to move
upstream to prevent opioid misuse in the first place?
Ms. Thau. Thank you so much for the question. Just like
there are no simple solutions in general for the opioid
problem, when it comes to prevention, it really does take a
whole community. So it takes all of the sectors: parents,
schools, law enforcement, the healthcare community, youth
providing, working together to do everything literally from
raising awareness, providing information, building skills in
youth, doctors, parents, and getting rid of unused and unwanted
medication.
We also have worked in two States to give out 300,000
Deterra packets, which are basically different packets than Dr.
Holaday talked about, but that actually render drugs inert. But
we have to do everything we can to decrease access and
availability and change social norms.
And I just want to give you a great example in Carter
County, Kentucky. They, 10 years ago, had a horrible overdose
problem, but also the schools came to the coalition and said,
listen, we have 23 percent college and career readiness. So
they did everything I have talked about across their community.
And from 2006 to 2016, their 30-day misuse of prescription
drugs for 10th graders went from 12 percent, which is two or
three times the national averages, to 1 percent. And that is
literally through doing a comprehensive communitywide approach
that involved everybody. And they did change social norms.
Chairman Guthrie, you are from Kentucky. So they did this
gigantic media campaign called Forget Everything Your Mama Told
You About Sharing, and it was done with scale and scope.
Because that was one of the problems, people were sharing their
meds. So when you do things across--and they did school-based
prevention programs, they got a substance use counselor in the
schools.
Ms. Matsui. It was a multisector, everybody.
Ms. Thau. They did everything across all the sectors. And
interestingly, not only did their use rates go down
exponentially, like for 10th and 12th grade, from 12 percent to
1 percent, but that college and career readiness score went
from 23 percent in 2010 to 76.5 percent in 2016, and their
graduation rate went from 81 percent to 98.8 percent. So there
are major secondary effects when we can reduce the initiation
into drug use and stop kids from using in the first place.
Ms. Matsui. OK. Keeping the same vein, I have a few
questions about the roll reports by the Surgeon General play in
bringing awareness to public health issues and impact lives of
all Americans, how these reports can help prevention efforts in
the longterm. Today, we are considering H.R. 449, the Synthetic
Drug Awareness Act, which would require the Surgeon General to
report to Congress on the public health impacts resulting from
the usage of synthetic drugs by adolescents age 12 through 18.
Synthetic drugs are designed to evade the Drug Enforcement
Administration's scheduling regime, and drugs like synthetic
cannabinoids, such as Spice and K2, are only increasing in
prevalence among youth. I think having a report on use access
and use of synthetic drugs can bring heightened awareness to
this issue, just as other important Surgeon General's reports
have, such as the famous 1964 report on smoking and how it has
served as a critical tool in acknowledging the deadly health
impacts of smoking.
Ms. Thau, can you explain why providing information through
reports like this is important to have information collected
through this kind of report would be used in the future?
Ms. Thau. Oh, absolutely. People around the country are
looking for science-based information that can be paired down
into what I will call snackable bites, where people can
actually take things out of the report and use them to raise
awareness with scale and scope. And I don't think we know
enough about the effects of all of these synthetic drugs, how
they affect the brain, health. They have some horrible,
horrible side effects. They are very addictive. And I think a
report like this would do a lot to bring awareness to the issue
that people across the country could actually use to educate
parents, the healthcare community, youth, schools, and
everybody else that comes into contact with youth.
Ms. Matsui. Thank you very much. I yield back.
Mr. Guthrie. Thank you. The gentlelady yields back.
The gentlelady from Tennessee, Mrs. Blackburn, is
recognized for 5 minutes of questions.
Mrs. Blackburn. Thank you so much. And we appreciate your
patience today and for all of you being here.
We do want to get legislation finished that is going to
make resources or provide resources that can help with
addressing this on the education prevention, the medically
assisted treatment and, of course, the rehab and recovery. And
to that end, Ms. Thau and Mr. Francer, I want to talk with you
about the education component.
In the mid-1980s, I was chairman of the board for the
American Lung Association in Middle Tennessee. And, Ms. Thau,
you are need nodding your head. I think you know where I am
going. We developed what was called the School Health
curriculum. And we raised the money. We paid for teacher in-
service training so they could come take this, and then teach
this curriculum in K through 3 on the dangers of smoking and,
likewise, the dangers of secondhand smoke. And it was an
incredibly successful program.
And over the past couple of months, I have lamented a
couple of times that we didn't seem to have that type
infrastructure that had a scalable program that we could work
through schools and begin to--and it sounds, Mr. Francer, like
you are moving this way--look at K through 3, look at
elementary, at middle school, at high school and provide the
education that is necessary to, first of all, realize addiction
is a disease, and then secondly, to be very specific about
these Schedule II drugs, the opiates, the psychotropics, what
it does, and the effect that it has on your body.
And I would like to hear from the two of you. You are
talking about Carter County, Kentucky. Is there something that
is scalable? And, Mr. Francer, to you, is there a curriculum?
And do you have a way to scale and to get your curriculum into
schools and communities?
And, Ms. Thau, we will go with you first.
Ms. Thau. Absolutely. Carter County used something called
Generation Rx curriculum, it is a ninth grade curriculum, but
they didn't do it in schools. They did it through the Boy
Scouts, churches, and youth groups. They also did life skills
training, which is a science-based, evidence-based program, in
third through ninth grades. So there are the tools.
One of the issues is, unless the schools are part of the
larger conversation and the coalition, they don't necessarily
want to own this. And I don't know at this point without safe
and drug free schools, which we lost the funding for a while
ago, unless we can show schools that spending time on this is
going to increase educational outcomes, which I think we can
do, they are not all that interested in spending the time on
doing it. It is a little bit hard to get into the schools at
this point. But with this epidemic, I think we have an amazing
opportunity to bring them back into the fold as full partners
in prevention.
Mrs. Blackburn. Sir.
Mr. Francer. Well, if there is anything this hearing today
has shown is that we need to take an all-hands-on-deck approach
to this problem. And I think that one of the keys is early
education, as you mentioned.
We have partnered, as I mentioned in my testimony, with a
company called EVERFI, which is one of the largest online
educational providers. They have developed this curriculum with
experts. They started in colleges and universities, and now
they are beginning to go younger. And speaking for myself, I
remember growing up with drunk driving education early in life
and the type of education that you discussed. And so I think
that the more, the better, and it is going to take all of us in
a comprehensive way to approach this problem.
Mrs. Blackburn. Thank you.
Ms. Thau, I have to tell you, I saw the Deterra bag
recently, and it is so simple to use. And I thought then for
older patients how easy that would be, just to put the unused
portion of that prescription, close that top, and throw it
away. And then you have eliminated a big part of that problem.
So I appreciate that you all are giving those out, making them
available.
Ms. Thau. Thank you so much.
Mrs. Blackburn. I yield back.
Mr. Guthrie. I thank gentlelady for yielding back.
The chair now recognizes Mr. Lujan for 5 minutes for
questions.
Mr. Lujan. Mr. Chairman, thank you very much. And, Ms.
Thau, and all our witnesses, thank you so much for being here
today. And thank you for working so tirelessly with my team
over the last few months, and your expertise has been
invaluable.
In your testimony, you state that, ``Primary prevention to
stop substance use before it ever starts is the most cost
effective way to deal with the addiction issues facing our
Nation.''
You continue to say, ``Research shows that for each dollar
invested in prevention, between $2 and $20 in treatment and
other health costs can be saved.''
Substance use prevention has historically been
underresourced and underutilized in combating drug issues,
including the current opioid epidemic. Most of the emphases in
funding have been directed towards downstream approaches that
try to deal with the problem after it has already reached
crisis proportions.
While I know that we are here to talk about H.R. 449, I was
hoping to chat with you a little bit about prevention in
general. As you might know, I have had the honor and pleasure
of working with my colleagues, of course, Mr. Guthrie, our
chair, Mr. Green, Mr. Bucshon, on the Comprehensive Opioid
Recovery Centers Act. I am pleased that we can work across the
aisle on important issues to better integrate, coordinate, and
ensure quality at our substance use disorder programs across
the Nation.
As we drill in on prevention, though, in your expert
opinion, does a substance use disorder program need to include
prevention in order to be comprehensive?
Ms. Thau. Yes. I would say absolutely in general it does.
And especially if you are going to do something with
comprehensive recovery centers and you want strong linkages
with the community, two things: The same community conditions,
not a lot of access and availability. Social norms where people
don't necessarily think that it is a great thing to use. The
same things that keep kids from using are what keep people in
recovery in recovery.
So we need to develop, I think, community conditions that
are conducive to both preventing use in the first place and
keeping people clean and sober when they reenter.
That said, addiction is a family disease. So there is
universal prevention, which is aimed at everyone who hasn't
used, and then there is selective prevention for very high-risk
kids who haven't used yet, like the children of drug abusing
parents. So I would say you definitely would want programs
involved in these comprehensive opioid recovery centers for the
children of people who were getting recovery services at a
minimum. And I would also hope that those centers would have
strong linkages to the community prevention coalitions that
were doing the environmental strategies and the other work in
the community to build down the demand for drugs.
Mr. Lujan. While I understand the world of prevention
efforts is broad, let me attempt to drill in and ask you to
help me narrow in in a few areas. So if I were to ask you to
narrowly focus prevention efforts in this bill, where would you
recommend that we start? How would we be able to narrow this?
Ms. Thau. One, I would probably have linkages to the drug-
free communities' coalitions in the same places where these
centers were going to be housed so that they could work
together. And two, I would figure out how to have selective
programming for the kids of parents who were being treated in
the centers, both for treatment and recovery support.
Mr. Lujan. I would also like to ask your opinion about two
other areas, again, as we narrow in on prevention. Do you think
it would be reasonable to begin with individuals who are using
opioids appropriately for pain management but not addicted, as
well as individuals whose family struggle with substance use
disorder but who are not addicted themselves, as a narrowing
area----
Ms. Thau. No, I definitely think so. So dealing with people
who are using opioids and are at high risk for becoming
addicted is an indicated approach. So, basically, it is
screening, brief intervention, figuring out if somebody does
need a referral to treatment. And then, yes, absolutely.
Mr. Lujan. And then one last question as my time is about
to expire. Do you know of any data suggesting that these would
be effective prevention efforts?
Ms. Thau. Yes. There is a lot of data saying that selective
interventions, as well as indicated interventions, are very
effective.
Mr. Lujan. Mr. Chairman, again, I want to acknowledge your
leadership and the work that you have done in this space.
And, Ms. Thau, I look forward to working with you on
compiling that data so that we can continue to have these
conversations with all the staffs involved. And again, thank
you for your expertise.
Mr. Chairman, thanks for this important hearing.
Mr. Guthrie. Thank you. It has been a pleasure for us to
all work together on these issues.
The chair now recognizes Mr. Latta from Ohio, 5 minutes for
questions.
Mr. Latta. Thank you, Mr. Chairman. And thanks very much
for our panel for being here today, it is really important, on
this issue and lifesaving is what we have to be doing out
there.
Ms. Esham, if I could start with you, I strongly support
using data to help combat the opioid epidemic, which is why I
introduced the INFO Act. Would you elaborate on Bio's
recommendation to utilize data to better understand clinical
pain and addiction and improve medical decisionmaking?
Ms. Esham. I will certainly try. And I have actually been
learning a lot myself today. And I think as we have heard from
the various panels, there is a lot of data collection being
done.
I think our recommendations are not basically designed to
say that there is not data or the data is not being collected,
as much as to ask the question how can we use data to inform
and improve how we treat patients suffering from pain and
addiction. And so our recommendation is really calling on NIH
perhaps to take the lead and work with other governmental
agencies and look at the data that exists to determine, are we
able to use that information to help us determine what
treatment works best for a particular patient? Are we treating
people in a way that delineates acute pain from chronic pain?
Are we able to identify and make sure we are treating people
that have psychic pain in the appropriate way? How can we learn
about what the optimal duration is for specific treatments? And
we have many others that are outlined in my written testimony.
The bottom line is, how can we use data to provide better
care today and inform how to provide better care in the future
as we have new treatments coming online? And so that is
something, I think, that would bear critical information that
could really help us examine how we could not only mitigate the
opioid epidemic, but just treat patients better.
Mr. Latta. OK. Thank you.
Dr. Holaday, and thank you for coming in today. The
committee is focused on improving prescription drug disposal as
an important strategy to help reduce diversion and the
resulting misuse or abuse. At the same time, it is important
that safe disposal of prescription drugs is not impeded by
strength as approaches develop. How should we ensure that the
disposal system standards are sufficiently rigorous to
providing meaningful improvement and safety?
Mr. Holaday. What we have done with our own product was to
have it evaluated by a third-party laboratory to ensure that
once the drugs were sequestered in this product, that they
could not be extracted. Although my Ph.D. Is in pharmacology,
the guys on the street that want something out of these are
going to be far more creative. And what they will do is they
will use vodka or other sources to extract and or inject opioid
drugs in others.
I think there needs to be, if you will, a fundamental focus
on making sure that the drugs left over in the medicine
cabinets are disposed of by some manner that is convenient. We
think an at-home solution is the best one. We think we have got
an appropriate way of getting rid of them, but that will also
prevent diversion for abuse and also prevent pollution of
landfills and water supplies.
Mr. Latta. Let me just follow up on that. Do you think a
disposal system review process that would be conducted in a way
that is efficient--because again, when things get started,
sometimes there is always a question on that review, but should
it be efficient--how do we do it without necessarily raising
the cost out there?
Mr. Holaday. I wouldn't recommend that this be something
that is demanded in terms of rigorous for evaluations of
products that may remove products, such as assessments of
whether something is effective or not. I do think, however,
that much in the same way that the 1970 Poison Prevention Act
required the childproof closures be put on all drugs, it was
legislated; before then it was available, but nobody used it.
After legislation, within 2 years, there was a 45 percent
reduction of childhood deaths from leftovers or from drugs in
medicine cabinets.
And we think that something should be legislated to
encourage the use of a system, perhaps at home, we believe, for
getting rid of leftover drugs that they wouldn't be available
for abuse or diversion.
Mr. Latta. Well, Thank you very much, Mr. Chairman. I am
going to yield back the balance of my time.
Mr. Guthrie. I thank the gentleman for yielding.
The chair now recognizes Mr. Pallone from New Jersey, the
ranking member of the full committee, 5 minutes for questions.
Mr. Pallone. Thank you.
I wanted to ask Mr. Francer some questions. The committee
has heard concerns from FDA regarding the public health
concerns associated with illicit, unapproved, or counterfeit
drugs entering our supply chain. And as Commissioner Gottlieb
noted on the first panel, these could be products that do not
have, or don't contain the right active ingredient, the wrong
amount of an active ingredient, or toxic ingredients. And I am
obviously concerned about the potential risk this poses to
patients, but also about the impact on our supply chain.
I have long been concerned about the number of illicit
drugs entering our supply chain and worked with the FDA and
many in the generic industry to strengthen FDA's authority in
FDASIA, and most recently introduced H.R. 5228, the SCREEN Act,
which provides FDA with greater authority and resources.
So, Mr. Francer, obviously you are aware of this issue of
illicit or unapproved drugs entering the supply chain through
these international mail facilities, but can you describe
briefly how this impacts the integrity of the supply chain?
Mr. Francer. Sure. And I think like everyone who sat
through the first panel, I thought it was extremely concerning
to see that deaths from illicit opioids are increasing.
Ensuring the safety and integrity of the supply chain is
critical. It is one of the features of what keeps drugs safe in
our country. And we are supportive of enhancing the FDA's
ability to do its job and specifically to try to get at these
illicit drugs that are trying to get into our country.
Mr. Pallone. Well, many of us have talked about how there
are millions of these packages that come in through
international mail facilities every day, and the FDA only has
the resources to inspect a small fraction; I think about
40,000. And the bill I mentioned, my bill would provide FDA
with additional authority and resources to combat this problem.
I don't know if you have looked at the bill, but would you
support, you know, the types of things that we have in the bill
to provide FDA with additional authority and the resources for
enforcement in trying to address some of this? I don't know if
you want to specifically mention some of the things that we are
trying to accomplish.
Mr. Francer. Yes. We are looking at the bill. We are
supportive of the concept, and I am happy to work with you and
your staff.
Mr. Pallone. What about the resources aspect? We really
haven't talked much about that. I know that Commissioner
Gottlieb said he did need additional resources. Have you looked
to see what all the agencies are always reluctant to say
anything more than we need more resources, so if you ask them
how much they need, they won't tell you because they probably
think they shouldn't. You have any idea what we would be
talking about?
Mr. Francer. I don't know. I would try to get an answer
from the FDA.
Mr. Pallone. Yes. I know it is hard to get an answer from
them on something like that.
All right. Well, then I just would ask that--anybody else
want to comment on this, any of the other panelists? I still
have 1 1A\1/2\ minutes.
All right. Let me ask Ms. Thau. I am interested in your
perspective on the importance of prevention and finding
prevention services, if you wanted to comment.
Ms. Thau. Yes. I would love to. So I think one of the
problems here is because of the tremendous death toll and the
horrific way this is presenting in our society, everybody is
really moving downstream. And so we are not doing much about
prevention, really, in this. And it would be like with the
smoking stuff, only doing cessation and not doing the truth
campaign and not raising the price of cigarettes and stopping
advertising, or for polio just building more iron lungs. So we
really do need to move upstream.
The point is there is no silver bullet in prevention
either. It really does take a comprehensive, communitywide
approach that involves everybody. It doesn't take a lot of
money, but it actually does take concerted effort in doing a
needs assessment, figuring out why kids are starting, what they
are starting with, how they are getting the drugs. For are the
most part we know it is from the medicine cabinets and from
friends and families. So we do need to do a lot more raising
awareness, education, reducing access and availability,
changing prescribing practices. And the point is, all of that
together is really what is going to solve this upstream.
Mr. Pallone. Well, I think I agree with you. I am sure you
realize that many of us, all of us probably, on the committee
are so frustrated because we see the opioid problem getting
worse. And we know that we need additional resources for
prevention and enforcement, and that is why I am happy that the
budget deal has that extra $6 billion. But there is no easy
answer. And I always go out of my way to say, look, I don't
have any easy answers, because I don't want anybody to think
the committee is going to magically pass some bill or throw
some money and that is going to eliminate the problem. But
thank you so much.
Thank you, Mr. Chairman.
Ms. Thau. Thank you.
Mr. Burgess [presiding]. The gentleman yields back. The
chair thanks the gentleman.
The chair recognizes the gentleman from Oregon, the
chairman of the full committee, Mr. Walden, 5 minutes for
questions, please.
Mr. Walden. Well, thank you, Mr. Chairman. Again, thanks to
all of our witnesses on these various panels. I think you will
hear from all the committee members how concerned we are and
how helpful we want to be to all of you and the people in our
communities that are dealing with this terrible, terrible
situation.
As you may know, we are also doing an investigation through
our Oversight Investigative Subcommittee arm and have been for
well over a year, and it is pretty disturbing what you learn on
that side of this as well. The goal is then to get to good
public policy and try and help people back home. So I just
appreciate your comments today, all of you.
And, Ms. Thau, how can community-based prevention and
multisector coalition approaches effectively reduce the rates
of youth substance abuse, especially prescription opioids? And
I was meeting with some people from Oregon this morning in my
office. And voters legalized marijuana in Oregon. I just came
from a meeting with some of the community action folks, and
they talked about a young kindergartner who they thought maybe
had been born drug-addicted and all, and later realized, later
in the afternoon of meeting with this young girl, that she was
just actually high on marijuana from the morning; that that is
what they think it was. And you see that happening, you see
this happening.
And so, we all want to get our hands around--obviously, the
adults in the room are part of the problem, but what can we do
from a community-based prevention multisector coalition
approach?
Ms. Thau. Well, basically what we can do is get everybody
around the table, all 12 sectors, as I mentioned before:
parents, the schools, law enforcement, the faith community,
youth serving organizations. And then we really do need to do
what we call the strategic prevention framework. We need to
look at how the problem presents in a community, who is using,
where they are getting, how they are accessing what they are
using, what the social norms are, and then do is a strategic
communitywide plan where everybody has a part in implementing
it. And then evaluate where you are.
And I can tell you I have three case studies, one of which
I talked about a minute ago from the epicenter of the opioid
epidemic, so Carter County, Kentucky; Scioto County, Ohio,
where Dreamland, the book, was actually written about; as well
as Jackson County, West Virginia.
Mr. Walden. There you go.
Ms. Thau. These are places a decade ago where people were
dying of fentanyl overdoses. Like in West Virginia and Jackson
County, they had 17 overdoses in this tiny thing of fentanyl a
decade ago. And they built the coalition, and they have been
able to build down demand and stop the pipeline to addiction by
lowering the usage rates among their youth, and it is
exponential reductions. So they have seen less need for
treatment and fewer people overdosing.
Now, there are always going to be people who use and we
always need treatment and recovery. But the point is that the
fewer people who start using, the fewer people who are going to
get in trouble downstream. So it is critical, I think, that we
do everything we can to build this comprehensive community
capacity.
Mr. Walden. I was with an oncologist yesterday from Oregon,
Dr. Bud Pierce. And he talked about years ago, years ago, they
had to take 8 hours of mandatory education on pain management,
where they were told that it would be malpractice not to
prescribe opioids and manage the pain. You think about how far
we have come to now realizing what a horrible thing we have
built as a result, in part by that false knowledge and a push
from the government, frankly, in how we reimburse. That was one
of the criteria, what kind of smiley face do you have on pain
when you left the hospital or wherever.
And it strikes me that this new Veterans Department study
that showed that people who took Tylenol or that type of pain
reliever, in this study, reported less pain than those who were
on opioids. Now, that really makes you stop, and you wonder, do
we need all of this? Are there alternatives that are better in
terms of pain management?
So it seems to me we have got an addicted age group here,
if you will, and to get to where you are at is preventing that
from ever starting with these children is a goal. Do you have
anything else you want to add, or any of the other panelists?
Anybody else?
Well, at least nobody disagrees with that analysis, so
thank you for that. I really appreciate you being here on a
snowy day.
Mr. Chairman, with that, I will yield back.
Mr. Burgess. The gentleman yields back, and the chair
thanks the gentleman.
The chair now recognizes the gentleman from Virginia, Mr.
Griffith, 5 minutes for your questions, please.
Mr. Griffith. Thank you very much, Mr. Chairman. I
appreciate you all being here and appreciate your testimony.
Iapologize for not being here when you all started your
testimony because I was on the floor with some others, as you
have heard earlier, on another bill.
But we are working on a lot of bills here today. And I have
to tell you I was really interested in hearing this, because
last week, my 18-year-old stepdaughter had her wisdom teeth out
and was prescribed oxycodone. She took two of them. The rest of
the prescription is at home. So you all talked about how that
is where the danger starts.
Dr. Holaday, I am going to let you respond first. And I
have to tell you, I have a 12-year-old and a 10-year-old at
home too. And your product reminds me a little bit of a
completely different subject, but not only will it help us get
rid of a problem, but for my 10- and 12-year-old, I think that
would be fun, the way it fizzes up.
But can you go back in and explain a little bit about how
the polymers work? And you said you could eat the stuff, and I
was assuming that you meant you could eat it before it was
mixed with the oxycodone. But maybe once it is mixed with the
various polymers, with the secret sauce as you called it, it is
inert afterwards. But I would suspect it has still got some
negative properties.
But can you explain some of that? And then I will open it
up for anybody else to discuss. Otherwise, we might look at it
and what do I do now. When I go home this week, what do I do
with that remnant prescription?
Mr. Holaday. First thing you do is go to Walmart, they will
give you a free packet of this product----
Mr. Griffith. So they will give me that.
Mr. Holaday [continuing]. That you would put into your
prescription vial with some water, shake it up, and throw it
away.
The idea for this is so simple. When you buy flowers, there
is always a little packet with the flowers. You put it in the
water and preserve them. Why not, when you get a prescription
for an opioid or an abusable drug, get a little packet,
something, by which you can then dispose of the product safely
and conveniently?
Mr. Griffith. Well, if Walmart is giving it to me--now, we
did not get our prescription at Walmart. Will they still give
it to me?
Mr. Holaday. Yes.
Mr. Griffith. And if they are going to give it to me, what
is the cost? It can't be a whole lot if they are giving it
away.
Mr. Holaday. It is a very small cost. Retail, this is $1.50
per packet.
Mr. Griffith. So if I were in a community without a
Walmart, could I purchase it somewhere or buy it on the
internet?
Mr. Holaday. We are putting arrangements together to have
this purchasable online through a facility that is going to
make this available in units of six. But again, the price would
be less than $1.50 per packet and less than 10 bucks for a six
packet of product.
Mr. Griffith. That is a pretty cheap fix for a serious
problem.
Mr. Holaday. And it is permanent.
Mr. Griffith. That's great. Now explain to me, it combines,
it forms polymers. And once it does it--because you said it was
then safe to go in the landfills. I don't know if it was safe
to put in the water supply or not, I don't remember if you said
that or not. But tell me how that works, and is it basically
inert once you go through that process?
Mr. Holaday. It is basically inert, and then what happens
is it biodegrades. So one of my colleagues calls me up about 7
or 8 months ago and said, oh, unfortunately, we have got mold
growing in our product. That is not nice. But this is
biodegrading, so the drugs and its contents and this matrix
that we have got is all biodegradeable. I am not the genius
that came up with the secret sauce; I just had the idea. So the
chemical engineer that came up with this actually mixed it
first in his kitchen. You hear those types of stories. Then he
spilled some on the driveway and his wife was upset because he
couldn't get it off. But this is a permanent and simple
solution to a lot of issues that begin with drug abuse in the
medicine cabinet.
Mr. Griffith. Well, I have already texted my wife. I will
call her when I get out of here and say, OK, go to Walmart and
get this stuff. And again, tell me what the name is.
Mr. Holaday. Pardon?
Mr. Griffith. What should she ask for?
Mr. Holaday. DisposeRx.
Mr. Griffith. DisposeRx. DisposeRx, got it.
Mr. Holaday. I have got several packets, I will leave----
Mr. Griffith. Because I think if she showed up and asked
for the secret sauce, they might not know what she was talking
about.
I have got a little bit of time left. Does anybody want to
add anything that they think we ought to be looking at or other
folks ought to be looking at?
Yes, ma'am.
Ms. Thau. I just want to add too that when we gave out the
300,000 Deterra deactivation packets throughout Florida and
D.C., that was 13.5 million pills that were just gone. And when
we went back and did a study, 90-something percent of the
people were like, this is great. Exactly, we don't have to
leave the house. We just sort of get rid of it and we are done.
It is inert and it is not subject to abuse in any way.
So anyway, I would also say it is a very good way to get
rid of unused and unwanted meds without leaving your home.
Mr. Griffith. Well, thank you all very much, and thank you
for your time today on this very serious subject.
I yield back.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman.
The chair recognizes the gentleman from Florida, Mr.
Bilirakis, for 5 minutes of questions.
Mr. Bilirakis. Thank you, Mr. Chairman. And I want to thank
the panel for their patience this afternoon; appreciate it so
very much.
This question is for the panel. I know there is no silver
bullet in solving this opioid crisis. However, if you had one
recommendation, one suggestion in addressing this crisis, what
would that be? If you had any suggestions for us, one
particular suggestion.
Let's start with you, ma'am. What would that be?
Ms. Thau. Mine would be a lot more investing in multisector
prevention to basically stop use before it starts and reduce
population level rates of initiation of all drugs.
Mr. Bilirakis. Very good. Thank you.
Ms. Esham. I think what we are focused on is really, again,
everybody is talking about today there are serious problems we
have to address today, but we don't have to accept the status
quo. So, a lot of what we are trying to think about is how can
we change the future, still treat pain, treat addiction better
in the future.
And so I think, in those terms, a lot of the
recommendations we outlined are really designed to create
collaborations and engagement with the regulators as well as
people developing these innovative drugs to make sure that
there is a signal to investors that this is a top priority and
this is something we should be investing in, and that we are
able to, in a most efficient way possible, provide these
alternatives to opioid treatment and better treatment for
addiction in the future. So I think that is what we are focused
on.
Mr. Bilirakis. Thank you. Thank you.
Mr. Francer. I would say it is about education. And we just
talked about the end user education, the patient education. It
is also the prescriber education. And we just talked about how
the physicians and the other prescribers, their education is
changing as we speak, and we have to encourage that.
Mr. Bilirakis. Would you mandate the schools and the
curriculum in the schools prevention and the effects of opioid
and drug use and even alcohol use? Would you make sure that
that is mandated in the schools?
Mr. Francer. We are hoping to support some voluntary
programs that colleges, universities, and now even high schools
can implement. And these are online training, so it has
obviously got a huge economy of scale. And I don't think----
Mr. Bilirakis. Training the students, the teachers?
Mr. Francer. In terms of the types of behaviors that we
have been talking about today, proper disposal, what do you do
if you have extras, who do you give them to, who shouldn't you
give them to? But really, truly, it is not up to me to decide.
I think right now, it is very much a decentralized decision
with colleges, universities, and secondary schools.
Mr. Bilirakis. I would start even earlier. I would start in
maybe in the middle schools, elementary schools. The chairman
just mentioned the child on marijuana in the elementary school.
That is really scary.
Yes, sir.
Mr. Holaday. I would like to echo my colleagues. Education
is going to be key. It is part of our passion. As we tell
people about what we do, we work with sheriffs' offices with
various high schools and others to tell people about the best
way to get rid of drugs and stop the cycle of addiction and
overdose is to get them out of your medicine cabinet. And the
most convenient way to do that is through a home solution,
whether it is ours or others that are available.
We also think that it might be useful for it to be
considered that, much like the Poison Prevention Packaging Act
of 1970 that required child-resistant closures, that something
also perhaps be legislated that requires a means by which to
dispose of a drug be dispensed with that drug, particularly for
those that are abusable, including opioids, benzodiazepines,
Adderalls, and others which can be addictive and abused.
Mr. Bilirakis. Thank you very much.
I have a little more time, Mr. Chairman.
State and, in some cases, local level PDMPs undoubtedly are
a critical tool used to support the fight against the current
opioid epidemic. However, challenges exist in the current
system, such as the lack of interoperability with health IT and
the lack of true real-time data reporting. These challenges are
preventing clinicians, both prescribers and dispensers, from
having access to all the information needed to make the best
clinical decision.
Would having standardized information available in real
time to prescribers and dispensers aid in ensuring appropriate
medication is being prescribed and dispensed? That would be for
Mr. Francer, please.
Mr. Francer. We support increased use of these programs and
increased operability, I think. It is especially interesting
here where we have D.C, Maryland, and Virginia, you don't want
patients to be able to take advantage of weaknesses in the
system.
Mr. Bilirakis. So you would agree that it would?
Mr. Francer. Yes.
Mr. Bilirakis. OK, very good.
OK. I will yield back, Mr. Chairman. Appreciate it.
Mr. Burgess. The chair thanks the gentleman.
The chair recognizes the gentlelady from Indiana, Mrs.
Brooks, 5 minutes for questions, please.
Mrs. Brooks. Thank you, Mr. Chairman.
I think we have talked about education throughout. I have
heard you all mention the importance of education. And
something that the committee has been exploring, but I know
there is always hesitation. Even, Mr. Francer, I know you
noticed that mandating any type of education is controversial.
No one really likes anything mandated. However, we are at a
crisis, and we have been sitting here all morning--although, I
will tell you that I wouldn't say--and I was just looking at
the CADCA website. I wouldn't say we get a lot of calls from
constituents about this. Our newspapers pay attention to it, we
know we all talk about it as elected officials, but because of
the stigma of drug addiction still, I wouldn't say that we all
get flooded with phone calls about bills we are proposing and
so forth.
But one thing I know and we are certainly talking about is
how do we reduce the number of prescriptions that are written?
Of course, we want people who have legitimate pain and who have
gone through surgeries or who have chronic illness or cancer
and so forth that have pain, but I really do feel strongly that
prescribers of all type need more education. I know med schools
are doing a better job now, but there is still a lack of
education out there on the amount of prescriptions. Indiana has
a 7-day law now. And there can be exceptions for that, but the
prescriber just has to say what the exceptions are.
So I am really curious about a bill that we are working on
to potentially require of all prescribers 3 hours of continuing
medical education about opioids, for all prescribers, not just
about prescribing, but about identifying addicts, their own
patients and/or how to help them get into recovery. So I am
just curious, it obviously could put a dent in the use of your
product, Dr. Holaday, but I think it is critically important,
and I applaud you and the others for those types of products,
but why do we have so many leftover prescription drugs in our
medicine cabinets to begin with? What a waste of resources in
so many ways. And I applaud your product.
But, Mr. Francer, talk to me about 3 hours prior to, say, a
DEA license renewal, over a 3-year period.
Mr. Francer. The FDA already requires some amount of
education, not necessarily 3 hours, but they have a risk
management program for certain types of opioid products. And I
think Dr. Gottlieb would like to expand on that, which we would
applaud. I think that it doesn't seem unreasonable to expect 3
hours before you get your DEA license approved, given the
amount of risk involved.
Mrs. Brooks. From CADCA point of view?
Ms. Thau. Well, we totally agree with you. We support it,
and we also think that some of that education should be about
understanding addiction as well. Because there is very little
training in medical schools, and everybody should actually be
asked whether they have a substance use disorder before they
are actually given anything that could cause them to relapse,
and a lot of people do not ask the question.
Mrs. Brooks. Does the data show, though, that people admit
they have a substance use disorder?
Ms. Thau. Well, I think that they do to their doctors. And
I don't know if you had heard Dr. Jones when he said he had an
anesthesiologist when he was having a colonoscopy--because he
is in recovery, he told that to the committee. He had to demand
that they not actually give him Propofol, because they kept
saying it wasn't going to be dangerous. So people, I think,
need a lot more education.
Mrs. Brooks. And the education, and I know that is what
CADCA is very focused on, is creating those coalitions in our
communities and so forth. And I do think that over the years,
whether it was Mothers Against Drunk Driving or Students
Against Drunk Driving, there was that impact that was made for
a whole generation really younger than me, I might say. It
really wasn't as effective at my age group, but it certainly
has been for the younger generation.
But yet, we don't really have a set protocol of education
for young people right now back to that point. Is there
anything that has been proven that really is very effective in
our schools?
Ms. Thau. Yes, there is a lot of evidence-based prevention
of the issue or two; one to say yes, I think it was,
Congressman Bilirakis, do we need something that is mandated
even in school base stuff? We were trying so hard with every
child succeeds act not to put too many restraints and
requirements on schools and school districts that they can
decide how to use Title IV, and there are a hundred different
uses for it. And drug/alcohol education and intervention is one
of them, but it is not required. And I think that at this point
it should be, and then schools should be working with their
broader communities. The schools can't own this by themselves,
but they do definitely have a piece of this.
Mrs. Brooks. Thank you all for your work.
I yield back.
Mr. Burgess. The gentlelady yield back. The chair thanks
the gentlelady.
The chair recognizes the gentleman from North Carolina, Mr.
Hudson, 5 minutes for questions, please.
Mr. Hudson. Thank you, Mr. Chairman. And thank you to the
panel for braving the storm to be here today. It is a really
important topic and it is one that touches all of our
constituents all across the country in all demographics. And it
is one that deserves our attention, and so I appreciate you
being here to help us understand this problem more.
Dr. Holaday, glad to see you here. I am proud to say that
DisposeRx is a company based in my district in North Carolina.
And you are on the front line helping to fight this epidemic,
and so I welcome you here today particularly.
In your testimony, you noted that 70 percent of people
studied do not use the drug take-back programs, such as mail
back envelopes; and further, that take-back programs dispose of
only about 0.3 percent of controlled substances that are
dispensed.
Do you think the end users don't use this program because
they just don't see a need or don't want to dispose of their
medication? Or you think it is because of the inconvenience?
Mr. Holaday. First, I would like to thank you, sir, for
your leadership in working with the opportunities to prevent
drugs in the medicine cabinet from finding their way into
abuse, misuse, and pollution. And so we are a proud North
Carolina company in your district.
I think that the numbers of people that use take-back
facilities and kiosks are small, first of all, because it is
inconvenient. You have to get in your car and go do something,
that you are likely to say, why would I want to do that? I have
got enough opiate in case I ever need it. I will just leave it
in the medicine cabinet.
But things have to change. What we do is disruptive. It
changes the way people do things, just like seatbelts. Just
like other changed behaviors, recycling.
So we think with appropriate education that we can train
people that they have got leftover drugs that are a problem for
them, for their families, and for others. Oddly, I know of a
real estate agent that told me stories of people that would
follow her around and go to housewarmings and go to the
medicine cabinets and take out the leftover drugs. So the
urgency to get these drugs out of circulation is a real one.
It is inconvenient to go to take-back facilities and kiosks
because people don't want to do that. They are not very
effective. Often the products are diverted from that, and it is
a liability for the pharmacies. If you do it at home, then you
prevent that liability. Throw it in the trash, it biodegrades,
and it is not usable for anybody to abuse.
Mr. Hudson. In our first hearing on this opioid crisis here
at the Energy and Commerce Committee at the end of February, I
know the story of a woman I talked to who said that she had
moved her prescription opioids from medicine cabinet to
medicine cabinet over 5 years that she moved from apartment to
apartment.
You mentioned that less than 20 percent of patients have
reported receiving education from their provider on how to
dispose of unused medications. I heard you testify earlier that
you think education is a key element here. What exactly should
the provider be educating their patients about when they give
them a prescription for an opioid? What is the nature of what
education they need to receive?
Mr. Holaday. I think that begins with the physician that
prescribes the drug to begin with, talking about not only pain
relief, but also the problems that total with prescriptions not
used and how you ought to get rid of it. I think that Dr.
Carter might agree that the pharmacist has a role, a very
important role in educating the people that come to the
pharmacy and say, look, you are taking home a product that is
toxic, you will need it for your pain relief, but when you are
done with it, get rid of it so it is not going to cause further
problems.
Mr. Hudson. Does anybody else on the panel want to touch on
that?
Ms. Esham. I will. I think if you think about what is
happening and some of the comments made earlier, I think what
you want to have as we say, you want patients to have knowledge
of and access to all available treatment. So if you present
yourself and you are going into a postsurgical situation and
you tell your doctor you are an at-risk person for addiction,
you want that doctor to be able to clearly tell you here is an
alternative and have that discussion. If you are a person that
is going in to have a procedure being treated for pain, you
want the ability to say I have children at home, is there an
abuse-deterrent formulation.
And the public should not be solely responsible for that.
You want to have a very informed provider community that is
able to help ensure that people are making the best choices
possible.
Mr. Hudson. Right. Anybody else want to chime in? I have
got 30 seconds.
Ms. Thau. I think we also have to really inform the public
on exactly the questions to ask; what to do with this stuff?
And just to end, a lot of our coalitions are working with
realtors because in open houses people are going through
medicine cabinets and actually stealing people's medications.
So there is also a need for locked medicine cabinets and,
you know, whatever else we can do to keep these medicines out
of the wrong hands.
Mr. Hudson. Great. Well, I appreciate all your testimony
very much.
And, with that, Mr. Chairman, I yield back.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman.
The chair recognizes the gentleman from Georgia for 5
minutes for questions, please.
Mr. Carter. Thank you, Mr. Chairman.
And thank all of you for being here. We really appreciate
your participation in this.
Dr. Holaday, I will start with you and, first of all, thank
you for this very innovative product that you have come up
with. This is certainly something that we can find very useful.
I can tell you, as a practicing pharmacist for many years,
I wished I had a dollar for every time someone tried to bring
their medication back to the pharmacy, saying ``Here,'' a loved
one had passed or whatever and, ``Will you dispose of these for
me?'' And, of course, we can't do that. By law, we can't do it,
and I don't want to do it. There have been some take-back
programs that have worked well, and some of the local police
agencies had had some programs that worked well, and some of
the drugstore chains have had some that worked well.
But this is a safe and convenient way to get rid of it. One
of the things, as you know, that we don't want to encourage is
to have them flush everything. It can cause a lot of problems
environmentally, particularly with some drugs.
I am telling my age here, but I can remember, I was a
nursing home consultant for many years, and I had to do drug
disposal at the nursing homes. And we would burn them and flush
them and everything. That was a long time ago, but it is a
serious problem.
But I do thank you for what you have come up with and do
encourage people, because it is safe; it is convenient. We have
always encouraged them to create a slurry and put in the trash
as opposed to flushing it. So it is very innovative, and I
congratulate you on that and thank you for that.
I wanted to go next to Ms. Esham and ask you, one of the
things that I have been concerned about and that I have been on
the pharmaceutical manufacturers about is the fact that there
is a big gap between what physicians can write for for pain
relief and what they can't write for.
Once you get past ibuprofen and tramadol, you go to the
opioids, and there is really nothing in between. Now, you could
argue you could use Neurontin, but, I mean, basically there is
nothing in between. So I have been trying to encourage them,
you know: You have got to come up with something innovative.
Over the years of practice I have been in pharmacy, I have
seen them come up with nothing short of miracles in the
innovation they have come up with through research and
development. But there is a big gap there.
One of the things that--and this is not necessarily a drug,
but what we talked about before was the abuse deterrent
formulations of opioids and how that can help. I just wanted to
ask you, do you find that Medicare coverage creates some
barriers sometimes to this?
Is that something that you have noticed that perhaps they
are requiring a prior approval or you have got to try something
else first? Are these barriers that cause us not to be able to
use these medications more?
Ms. Esham. The short answer is yes. At BIO, a majority of
our membership are actually small, emerging companies that rely
on venture capital. So, again, you have to take into account,
if there is a lack of understanding or an understanding that
you will not be able to get your products covered in the
market, you are not going to get strong investment into those
therapeutic areas.
And particularly when we look at pain and the addiction
space, I think CARA went a long way to try to address some care
limits for people suffering from addiction. But is there more
work to do? Yes, and we stand ready to do that.
In terms of practices, I think, there are barriers in the
way that pain medication is often bundled at hospitals. It sort
of prevents, again, alternatives or full discussion and full
access to the array of medicines available.
There are fail-first protocols in place that we think need
to be reexamined. Step therapies, again, we think, need to be
reexamined. Basically what we want is a smart patient/doctor
informed decisionmaking process and not have outdated or
outmoded approaches to coverage that are actually getting in
the way of providing that best care.
Mr. Carter. Right.
Mr. Francer, I wanted to ask you, as part of CARA, we allow
for the partial filling of C2 prescriptions. And I was really
in favor of that and think that that is something that we need
to do. Have you had any experience with it? Does it seem to be
working better?
Mr. Francer. I don't. Happy to try to get back to you after
the hearing though.
Mr. Carter. OK. Well, I really do think that that was
something that we needed to do. And right now, it is up to the
patient and to the physician. But even if we can extend it to
where the pharmacist might have some input on that as well, I
think that could help as well.
But, again, I want to thank all of you. This is the boots
on the ground, if you will. And this is the type of thing that
we need. And all of you are doing great work in helping us with
what is obviously a big problem and obviously a problem that is
not going to have just one solution. It is going to take all of
us and many solutions to help with this. So thank you.
And I yield back, Mr. Chairman.
Mr. Burgess. The chair thanks the gentleman.
The gentleman yields back.
And, Mr. Francer, I am going to recognize myself 5 minutes
for questions now. And, too, my apologies; I was with Mr.
Griffith on the floor doing a bill between our panels.
Let me ask you, when you get back to Mr. Carter on the
partial filling issue, I would like for you to share that
information with our office as well. I would probably have a
different perspective than Mr. Carter, having written a lot of
prescriptions myself.
I kind of want to know that my patient has filled what I
ask them to fill, and if they didn't, perhaps I need to know
that because I might be asked to refill. So, anyway, I would
appreciate your follow-through on that.
Now, Ms. Esham, I will just ask you: I have been on this
committee now since January of 2005. One of the first hearings
that I was here for was a hearing on why doctors don't
prescribe enough pain medicine.
So I was intrigued, in your testimony, you said the
importance of ensuring that patients suffering from pain or
addiction are able to receive the right treatment at the right
time with the right support without stigma, and so I certainly
agree with you on that.
You have any other thoughts that you would like to share
with the subcommittee in that regard?
Ms. Esham. So I would like to highlight a couple things in
addition to the coverage barriers and the NIH data analysis
proposals we have put forward.
Again, going back to my earlier statements about the
importance of signaling to investors that the development of
treatments that are better, that provide improved quality of
care, and are safer are our top priority. There are lots of
ways to create an environment that will stimulate investment.
And at the FDA, there are development issues as we look
over lessons learned of some innovative treatments that maybe
have not been able to obtain approval. We have identified some
problematic areas that we think would benefit from
collaboration and discussion and perhaps additional guidance.
For example, when you talk about benefit-risk assessment,
we want to make sure we understand that the context of
presenting and proving that your drug is safer, or provides
better care, how that benefit-risk assessment will be done in
the context of existing options.
We need to find better ways to develop medicines for broad
chronic pain indications. So, right now, you have a lot of
requirements. You have to do many, many trials. And, again, so
people are like, ``Well, maybe I can't spend that much money in
this risky environment to do that many trials for a single
indication.''
Additionally, I think we really need to look at how we can
better measure and assess pain. So this is both in a clinical
trial setting as well as in the clinic. Are we really doing the
best we can?
Are we diagnosing in the best way possible to understand
what the needs are of a patient with acute pain versus patients
with chronic pain versus a patient that has psychological or
psychic pain? So there is a lot of work that we think would
benefit from collaboration and further guidance in those areas.
Mr. Burgess. Well, we heard Dr. Gottlieb address that issue
about the datasets that we have for assessing pain.
I will tell you that I am old enough to remember the
introduction of a compound called Stadol that was supposed to
be the answer to providing pain relief without any of the
untoward side effects of opiates, and it turns out it was
probably just as bad, if not worse.
So I am always very skeptical when someone says, ``Oh, I
have got something now here that you can now use for pain that
has none of the stigma or the side effects.''
And, again, I think we heard Dr. Gottlieb address that.
But can you just talk a little bit more about some of the
ways where you might think that private sector, Congress, and
the FDA could work together as far as developing some of these
novel approaches?
Ms. Esham. So, again, we find there is a lot of value,
again, in just holding public--where you have a topic, you hold
a public meeting, you bring the best and brightest together to
discuss critical issues. And then the next step that is
critical to making this impact change is to come up with
recommendations for change and get public reaction and expert
input on that and then implement change.
Mr. Burgess. That is what we are doing.
Ms. Esham. It is really wash, rinse, and repeat, right. We
have done this before.
And I would like to, just if I can indulge for a moment, we
did just put out a report really examining the historical state
of innovation for pain and addiction treatments that you,
particularly as a physician, may find interesting in the sense
of really looking at targets that didn't work but really
highlighting some new ways and new thinking that we have that I
think do hold, again, a lot of promise.
Again, sometimes not everything turns out the way you had
hoped, but I think there are a lot of exciting things in the
pipeline.
Mr. Burgess. Very well.
And, Dr. Holaday, before we finish up, I don't know if I
heard the answer to Mr. Griffith's question. You have got this
stuff emulsified in the gel. Is it inert at that point, or
could you use it as a Jell-O shot if you were so inclined?
Mr. Holaday. It is inert. And if you were to swallow the
whole thing, pills and all, you would just pass it through
because nothing extracts from this once it has been formed. It
is a gel. It is an inert gel. It is biodegradable.
Mr. Burgess. But if you chewed it, would you release the
active compounds?
Mr. Holaday. No, you would not.
Mr. Burgess. So the active compounds are indeed----
Mr. Holaday. They are chemically and physically bound, or
sequestered, in a matrix from which they can't be extracted.
Mr. Burgess. OK. And I am just asking for a friend. I was
not going to chew the emulsified pills.
Mr. Green, did you have a redirect?
Mr. Green. No.
Mr. Burgess. You have been sitting here so patiently.
And I will yield back my time. Seeing that there are no
other members wishing to ask questions, I once again want to
thank our witnesses for being here today.
I would also like to submit for the record a statement from
the Substance Abuse and Mental Health Services Administration
expressing support for Congress, examining the alignment of
part 2 with HIPAA.
Mr. Burgess. That is the wrong one.
We are not going into recess.
Mr. Green. I did that earlier, Mr. Chairman.
Mr. Burgess. Oh, we are going into recess? Oh. That is
right. We have got to do this all over again.
The subcommittee will now go into recess, and we will
reconvene for the third and fourth panels tomorrow morning at
10:00 a.m.
The committee stands in recess.
[Whereupon, at 3:12 p.m., the subcommittee recessed, to
reconvene at 10:00 a.m., Thursday, March 22, 2018.]
[Material submitted for inclusion in the record follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
COMBATING THE OPIOID CRISIS: PREVENTION AND PUBLIC HEALTH SOLUTIONS,
DAY 2
----------
THURSDAY, MARCH 22, 2018
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:02 a.m., in
room 2123 Rayburn House Office Building, Hon. Michael Burgess
(chairman of the subcommittee) presiding.
Members present: Representatives Burgess, Guthrie, Upton,
Shimkus, Latta, McMorris Rodgers, Lance, Griffith, Bilirakis,
Long, Bucshon, Brooks, Mullin, Hudson, Collins, Carter,
Walden(ex officio), Green, Engel, Schakowsky, Matsui, Castor,
Sarbanes, Lujan, Schrader, Kennedy, and Eshoo.
Also present: Representatives Walberg, Tonko, and Johnson.
Staff present: Mike Bloomquist, Staff Director; Adam
Buckalew, Professional Staff Member, Health; Daniel Butler,
Staff Assistant; Karen Christian, General Counsel; Zachary
Dareshori, Legislative Clerk, Health; Margaret Tucker Fogarty,
Staff Assistant; Adam Fromm, Director of Outreach and
Coalitions; Caleb Graff, Professional Staff Member, Health; Jay
Gulshen, Legislative Associate, Health; Peter Kielty, Deputy
General Counsel; Ed Kim, Policy Coordinator, Health; Mark
Ratner, Policy Coordinator; Kristen Shatynski, Professional
Staff Member, Health; Jennifer Sherman, Press Secretary;
Danielle Steele, Counsel, Health; Austin Stonebraker, Press
Assistant; Hamlin Wade, Special Advisor, External Affairs;
Everett Winnick, Director of Information Technology; Jacquelyn
Bolen, Minority Professional Staff; Jeff Carroll, Minority
Staff Director; Waverly Gordon, Minority Health Counsel;
Tiffany Guarascio, Minority Deputy Staff Director and Chief
Health Advisor; Tim Robinson, Minority Chief Counsel; Samantha
Satchell, Minority Policy Analyst; Andrew Souvall, Minority
Director of Communications, Outreach and Member Services;
Kimberlee Trzeciak, Minority Senior Health Policy Advisor; and
C.J. Young, Minority Press Secretary.
Mr. Burgess. I ask all of our guests to please take their
seats. The Subcommittee of Health will come to order. I want to
welcome everyone to our second day of our hearing on Combating
the Opioid Crisis through Prevention and Public Health
Solutions. I want to thank our witnesses for taking time to
testify before the subcommittee today. The good news for you is
you don't have to listen to us, we spoke yesterday.
So we will hear from you this morning. Each witness will
have the opportunity to give an opening statement that will be
followed by questions from members. As I mentioned to some of
you as we started, the brief housekeeping detail, we will have
a vote on the floor probably around 10:30 to 10:40 and the
committee will recess briefly when we have to go vote on the
floor.
But today we are going to hear from Dr. Eric Strain, the
Director for the Center for Substance Abuse Treatment and
Research at Johns Hopkins University; Dr. Kenneth Martz,
Special Projects Consultant, Gaudenzia; Mr. Brad Bauer, Senior
Vice President of New Business Development and Customer
Relationships; Dr. William Banner, Medical Director of the
Oklahoma Center for Poison and Drug Information and the Board
President of the American Association of Poison Control
Centers; and, Dr. Michael Kilkenny, Physician Director, Cabell-
Huntington Health Department of West Virginia. We appreciate
all of you being here today. Dr. Strain, you are recognized for
5 minutes to summarize your opening statement, please.
STATEMENTS OF ERIC C. STRAIN, MD, DIRECTOR, CENTER FOR
SUBSTANCE ABUSE TREATMENT AND RESEARCH, JOHNS HOPKINS
UNIVERSITY SCHOOL OF MEDICINE; KENNETH J. MARTZ, PSYD MBA,
SPECIAL PROJECTS CONSULTANT, GAUDENZIA, INC.; BRAD BAUER,
SENIOR VICE PRESIDENT OF NEW BUSINESS DEVELOPMENT AND CUSTOMER
RELATIONSHIP MANAGEMENT, APPRISS HEALTH; WILLIAM BANNER, MD,
PHD, MEDICAL DIRECTOR, OKLAHOMA CENTER FOR POISON AND DRUG
INFORMATION AND BOARD PRESIDENT, AMERICAN ASSOCIATION OF POISON
CONTROL CENTERS; AND, MICHAEL E. KILKENNY, MD, MS, PHYSICIAN
DIRECTOR, CABELL-HUNTINGTON HEALTH DEPARTMENT OF WEST VIRGINIA
STATEMENT OF ERIC STRAIN
Dr. Strain. Thank you. Thank you, Chairman Burgess, Ranking
Member Green, and members of the subcommittee. Thank you for
inviting me to participate in today's hearing and for devoting
2 full days to legislative solutions to address the opioid
crisis and the scourge of addiction in our communities, a topic
which has been the focus of my professional career.
My name is Eric Strain. I am a physician who practices as a
psychiatrist and conducts substance abuse research, and I am
the director for the Johns Hopkins Center for Substance Abuse
Treatment and Research. I have seen the devastating impact of
drug abuse and the current federal regulations that limit the
use and disclosure of patients' substance abuse treatment
records and I am pleased that this Congress is taking a
proactive step to update the law to be more in keeping with
modern-day, multidisciplinary medical practice and the best
patient care.
The Amendment in the Nature of a Substitute to H.R. 3545 as
offered by Representative Mullin will enhance our ability to
share vital health information in a timely manner. Though well
intentioned at its enactment more than 40 years ago, 42 CFR
Part 2 is outdated and, worse, it can result in harm to
patients and impedes the relationship between providers and
their patients. Full alignment of federal privacy rules with
HIPAA for the purposes of treatment and healthcare operations
will ensure that patients with substance use disorders receive
accurate diagnoses, integrated and coordinated treatment, and
patient-centered care.
Under 42 CFR Part 2, substance use disorder records must
remain separate and segmented from any other medical record and
cannot be shared with a patient's primary care provider or
other specialist without the express written consent of the
patient. Obtaining this consent can be a challenge under a
variety of scenarios and the current segmentation of records
runs counter to the idea of holistic and coordinated treatment
of the patient. Not knowing a patient is in substance abuse
treatment increases risks, for example, with medication
interactions or in delivering care under an emergency
situation.
It also can interfere with effective integrated care. Let
me give you an example. The Johns Hopkins Center for Addiction
and Pregnancy is a substance abuse treatment program that helps
pregnant women and their babies and includes substance use
staff as well as OB-GYN, pediatrics, and psychiatry. This
multidisciplinary program needs ready communication between
providers. Full information is essential to support clinicians'
efforts to care for the pregnant woman pre-term and then both
patients, the mother and her child, postpartum. This example
clearly demonstrates the varied teams of caregivers such as
neonatologists, obstetricians, case managers, et cetera.
Our healthcare system does not put records for other
medical conditions such as HIV and AIDS in a separate and
protected system. We don't put a patient's social history
behind a wall and tell other providers they can't have ready
access to information about what may be sensitive topics. The
various workarounds that are offered introduce more impediments
in an already busy healthcare system and further contributes to
the perception that substance use is different from all other
medical care.
In my opinion, continuing to consider substance abuse
disorder information distinct from other medical information
actually perpetuates stigma. Concerns about inappropriate
release of information are addressed in the Mullin amendment
which includes vital antidiscriminatory language as well as
protections against criminal prosecution.
Finally, I have reviewed Jessie's Law as well and I support
any effort to promote dialogue that encourages coordination of
care and the sharing of necessary information so long as it is
paired with the Mullin amendment. Jessie's Law relies on
patient-volunteered information and it is my experience that
through no fault of the patient, patient-volunteered
information is sometimes inaccurate or incomplete, or places a
large burden on the patient.
Therefore, as I have already expressed, a system that
relies on consents or patient-volunteered information is
fundamentally flawed. Healthcare providers are on the front
lines of treating opiate and other substance use disorders. We
are uniquely positioned to help but we cannot do so without an
unobstructed view of a patient's medical records. You have an
opportunity to move us forward in these efforts and help those
on the front lines of treating people who suffer from drug
abuse.
I urge the committee to report out legislation amending 42
CFR Part 2 that allows the responsible sharing of patient
records for the purposes of treatment and healthcare
operations. Thank you and I would be pleased to answer any
questions you may have.
[The prepared statement of Dr. Strain follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you, Dr. Strain.
Dr. Martz, you are recognized for 5 minutes, please.
STATEMENT OF KENNETH MARTZ
Mr. Martz. Good morning. Thank you so much, Chairman
Burgess and Ranking Member Green, for this opportunity to come
here and testify on this important issue. This is an issue that
is affecting 23 million Americans who are in recovery from
substance use disorder and who have had their experience with
treatment and are now working through the system in addition to
those who are actively in substance use disorder.
I am Dr. Ken Martz. I am a licensed psychologist. I am
working with Gaudenzia. I have been working in multiple States
in private practice and in State government settings, in public
settings as well as private, for 25 years. This has been my
life's work and my passion and I love this work and I really
appreciate this opportunity.
42 CFR's protections are critical to maintain, to ensure
that people enter treatment for substance use disorder. This is
something we know from SAMHSA, which has studied this
extensively, and they find that the top reasons why people do
not go to treatment continue to be fear of stigma. What will my
employer think? What will my neighbors think? What harms will
come of me if I disclose those secret harms and guilts and
shames? The research finds that this fear of impacts is a
primary reason.
And the Congress recommended this as well, back in 1972,
they stated that, ``The conferees wish to stress their
conviction that the strictest adherence to the provisions of
this section is absolutely essential to the success of all drug
abuse prevention programs.'' This was echoed by the Supreme
Court as well, which affirmed ``like the spousal and attorney
client privileges, the psychotherapist patient privilege is
rooted in the imperative need for confidence and trust.''
Treatment by a physician for his physical ailments can
often proceed successfully on the basis of physical examination
and the results of diagnostic tests. Effective psychotherapy,
by contrast, depends on the atmosphere of confidence and trust
in which the patient is willing to make a frank and complete
disclosure of facts, emotions, memories, and fears. For this
reason, the mere possibility of disclosure may impede the
development of the confidential relationship necessary for
successful treatment. I urge you to remember the wisdom of
these chambers.
Oddly, it is funny. We walk in here today and the news of
the day is about hacking and data breaches and Cambridge
Analytica with a new focus on there being death penalty for
those who have a substance use history and have sold a drug. So
if my child hands over some drugs to his girlfriend, she dies,
he is now potentially at risk. We don't know what the laws will
change in the future. This has a chilling effect on people
being willing to attend treatment.
The impacts on patients, I know you know you are hearing
from many healthcare organizations that find this very
inconvenient, but this is not about inconvenience. This is
about patient care. This is about patient health and being able
to access exactly what they need. If we want to discuss
coordinated care the best way to do that is direct conversation
with the patient and direct conversation therapist-to-therapist
which is not impeded by 42 CFR protections. It actually gives
the patient the respect of being involved in that process.
If you are going to share my information about my trauma
and my trauma histories, please do me the respect of asking me
and letting me know where it is going to go to before it gets
shared to thousands of other people potentially having access.
Now, put simply, some of the important protections included
that once they are labeled it can affect clinical decision
making for a lifetime. It cannot be amended and you cannot fix
things like prison time or loss of employment.
These are professionals we are talking about like teachers,
physicians, government workers, who may avoid treatment for
fear of harm, for fear of being disclosed, and therefore they
may get worse because they didn't get the care that they needed
because they have delayed. The stigma is still alive long and
strong.
Looking at some recent comments, one was said, overdose is
nature's way of taking out the trash. Oh my gosh. Overdose is
nature's way of taking out the trash.
I have plenty of compassion for those who deserve it. I
have no compassion for those who made their own problems such
as dopers, pedophiles, and murderers.
It is hard to even say these words. These are the levels of
stigma that is out there today that our clients are facing on a
daily basis and it is very difficult to identify and manage
these harms that may arise. Eliminating these Part 2
protections will brand these individuals with like a scarlet
letter so they when they walk in the door they can be
identified immediately as having this problem, as having this
history as well as the risks associated.
Stigma affects all of us in many different ways. Remember
that making these changes is every time we make these changes,
every time changes are made as a provider I need to learn about
them, I need to train the field and, worse, tell the client
that every day what they told me yesterday in private is no
longer private today. In all my years, I can't tell you how
important this is. And if there was only one other thing that
you could possibly do, and in addition to this I would be happy
to answer other things, please get rid of that IMD exclusion.
It is harming people and stopping care. Thank you.
[The prepared statement of Mr. Martz follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you, Dr. Martz.
Mr. Bauer, you are recognized for 5 minutes, please.
STATEMENT OF BRAD BAUER
Mr. Bauer. Thank you and good morning. Chairman Burgess,
Ranking Member Green, and members of the Health Subcommittee,
thank you for the opportunity to testify today on the role of
Prescription Drug Monitoring Programs or PDMPs in combating the
opioid crisis as well as the PDMP discussion draft from
Representative Griffith and Ranking Member Pallone.
My name is Brad Bauer and I am Senior Vice President with
Appriss Health and have responsibility for our State and
Federal PDMP solutions. We provide a common platform and
software solution for 42 of the 52 established PDMPs throughout
the United States and U.S. territories. State-based PDMPs
continue to evolve and innovate in the face of our nation's
opioid crisis. While each State faces unique challenges brought
on by the crisis, tremendous progress has been made within a
few critical areas each of which have been identified by
government and research organizations as best practices to
ensure effective and impactful PDMPs.
First, the ability for States to share PDMP data with other
States provides prescribers and pharmacists with a more
complete view of the patient's controlled substance history. In
2011, the National Association of Boards of Pharmacy created a
PMP Interconnect with technical assistance from Appriss Health
to allow States to securely and efficiently share data in real-
time at no cost to the States.
[Slide shown.]
Mr. Bauer. As you can see on the monitors, the numbers of
states participating has grown rapidly to 45 PMPs today. For
the remaining States not currently participating, policy issues
not technology are the only barriers. Most recently, Florida
passed legislation allowing the State to share their PDMP data
with other PMP Interconnect states effective July 1st, 2018.
Second, and probably the most impactful developments for
State PDMPs, has been integration of PDMP data and analytics
within the electronic health record or pharmacy dispensation
system to enable one-click or in some cases no-click access for
prescribers and pharmacists. The majority of States are moving
in the direction of active integrations of their data and
analytics within clinical workflows with about 20 percent of
providers currently having access to integrated PDMP reports.
However, broader adoption has been slow due to the need for
funding to cover costs of integrations. Integration of PDMP
data and analytics promotes efficient and consistent use of
PDMPs by providers when making clinical decisions. For example,
Ohio has seen a 1000 percent increase in usage of the PDMP as a
result of their statewide PDMP integration effort.
States are also in the process of transforming their basic
PDMP systems into substance use disorder platforms that deploy
the capabilities necessary to impact the epidemic and bend the
overdose death curve down and not just drive down the number of
controlled substances prescribed. States like Indiana, Oregon,
Michigan, Delaware, Iowa, Ohio, and Virginia are just a few
examples of States that have already taken steps to transform
their PDMPs.
Examples of new developments in PDMP capabilities include
inclusion of additional data sources such as history of
nonfatal overdoses; drug court information and toxicology data;
patient-at-risk scores to help a practitioner quickly assess
the risk and engage the patient accordingly; the ability to
refer patients to treatment, often referred to as a warm hand-
off within the PDMP; and facilitation of care team
communications.
All these capabilities and clinical tools are designed to
help the practitioners identify prescription drug overdose
sooner versus later, mitigate the chance of an illicit drug
encounter, and engage with their patients and assure they have
and receive the help they need. The PDMP discussion draft from
Representative Griffith and Ranking Member Pallone would
incentivize States to continue to improve their PDMPs through
evidence-based prevention grants along with evaluating
interventions to prevent overdoses and implementing new
projects to respond to the evolving crisis in innovative ways.
As you have heard one of the panels yesterday, the Centers
for Disease Control is engaged in a number of these activities
but the legislation authorized would help to improve on CDC's
work. Second, the draft would establish grants for an enhanced
surveillance of controlled substance overdoses which would
authorize and provide funding for an existing CDC program to
collect more comprehensive, timely, and quality data on
overdoses.
We would recommend that this data be incorporated into the
PDMPs. This discussion draft would allow states to continue
their PDMP innovations to provide prescribers and pharmacists
with a near instantaneous access to interstate PDMP information
combined with the clinical tools to intervene in a meaningful
way when a patient presents with a possible risk overdose
misuse.
Thank you for your leadership on this critical issue facing
so many communities and for the opportunity to address the
committee today. I look forward to your questions.
[The prepared statement of Mr. Bauer follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you, Mr. Bauer.
Dr. Banner, you are recognized for 5 minutes.
STATEMENT OF WILLIAM BANNER
Dr. Banner. Chairman Burgess, Ranking Member Green, and
members of the subcommittee thank you for the opportunity to
testify in support of the reauthorization of the National
Poison Center program entitled, Poison Center Network
Enhancement Act of 2018. This legislation was first enacted
into law in 2000 and has been reauthorized three times. The
measure before the subcommittee today would reauthorize the
poison center program through fiscal year 2024.
My name is Dr. Bill Banner and I currently serve as the
President of the American Association of Poison Control
Centers. I am also the medical director of the Oklahoma Center
for Poison and Drug Information. For over 30 years, I have been
privileged to care for critically ill children, currently
practice in the pediatric intensive care unit at Baptist
INTEGRIS Medical Center in Oklahoma City. I also happen to be
downsizing to a home in Congressman Mullin's district.
The Nation's 55 poison control centers operate 24/7/365 to
cover all U.S. States and territories and receive three million
calls annually including about 70,000 calls a year for
exposures to opioids. Nearly one quarter of our calls come from
emergency rooms and urgent care facilities. Calls are answered
by highly trained medical professionals with 24-hour oversight
from physicians who are board certified medical and clinical
toxicologists, many of whom are trained in addiction medicine.
We handle calls related to over 430,000 products and substances
and their related toxicities.
Poison control centers are on the front lines of the opioid
epidemic handling approximately a half million cases of opioid
misuse and abuse since 2011. That is an average of 192 per day,
every day. We assist first responders and hospital personnel.
[Slide shown.]
Dr. Banner. As you can see from the slide, the percent of
opioid exposure calls from healthcare facilities to poison
centers are on the rise and we believe this will continue in
2018. We deliver countless hours of education on topics like
identifying emerging drugs of abuse and the safe storage and
disposal of prescription opioids. Through national surveillance
activities, poison centers have identified trends involving
fentanyl and other opioid analogue penetration into communities
which is then shared with Federal, State, and local
enforcement.
Centers also educate on the proper use of naloxone. With
the rise of heroin mixed with the more potent fentanyl, the
administration of naloxone has become far more complex and
dangerous for emergency responders to administer. Centers also
contribute to medical education on pain management,
prescribing, and addiction treatment. Consultation with a
poison control center can also significantly decrease the
patient's length of stay in a hospital and decrease hospital
costs. In fact, poison control centers save more than $1.8
billion annually including $382 million in Medicaid and $307 in
Medicare per year.
Poison center data can often be utilized to identify new
and emerging drugs of abuse faster than virtually any other
resource. For example, this past summer, the Georgia Poison
Control Center, which serves Subcommittee Carter's district,
was the first public health entity to detect and respond to a
novel opioid outbreak. Yellow pills stamped with Percocet that
in fact contained a mixture of two synthetic fentanyl analogues
that could have remained undetected indefinitely and racked up
untold fatalities but for the work of the Georgia center.
This unique capability exists at every poison center in the
country. Centers are also a critical resource for emergency
preparedness and response. For example, centers have served in
response to Zika, Ebola, synthetic cannabinoids, e-cigarettes,
H1N1, marijuana abuse and misuse, carbon monoxide, toxic
exposures following national disasters, and even the social
phenomenon, the so-called Tide Pod Challenge.
Additionally, each center has an educator working to
increase public awareness on the dangers of poisoning and
opioid misuse. In fact, this week is National Poison Prevention
Week. Examples of education outreach surrounding the opioid
crisis include presentations to parent groups regarding
medicine literacy and substance misuse prevention as well as
participation in local community events.
In summary, poison control centers are a unique combination
of clinical care, cost effectiveness, public health
surveillance, and interaction with those on the front lines of
the opioid crisis from first responders to law enforcement and
everyone in between.
I want to thank Representatives Brooks, Engel, Barton, and
DeGette for their continued support and bipartisan introduction
of this critical legislation. It is a proven, highly efficient
network most deserving of full congressional support and
reauthorization. I am happy to answer any questions you may
have. Thank you again for this opportunity.
[The prepared statement of Dr. Banner follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you Dr. Banner.
The vote on the floor has been called. But, Dr. Kilkenny,
let us hear from you and then we will recess until after votes.
So you are recognized for 5 minutes.
STATEMENT OF MICHAEL KILKENNY
Dr. Kilkenny. Chairman Burgess, Ranking Member Green, and
members of the subcommittee thank you for inviting me today to
testify on behalf of local health departments across the
country that are facing unprecedented threats in the form of
opioid-related death and disease.
My name is Michael Kilkenny. I am the Physician Director of
the Cabell-Huntington Health Department in Huntington, West
Virginia. I am representing health departments today as a
member of the National Association of County and City Health
Officials, NACCHO. More than a hundred Americans die each day
from overdose with a staggering economic toll impacting the
workforce of this generation and threatening generations to
come.
My State has Nation leading rates of overdose death,
Hepatitis B, Hepatitis C, and neonatal abstinence syndrome. My
county along with 28 other counties in my State and 220
counties across the Nation face the real threat of catastrophic
HIV outbreaks. These challenges, however, create remarkable
opportunities for us to save lives and prevent disease.
In 2015, Huntington leaders implemented a comprehensive
opioid response plan that is changing those statistics at home.
With help from CDC we started the first sanctioned harm
reduction program in West Virginia. We trained and supplied all
our law enforcement agencies with naloxone. Cabell County
community members and first responders reversed more than 2,500
overdoses last year, saving countless lives and a new Quick
Response Team is linking overdose survivors to treatment.
Without Federal support we would not have been so successful.
Regarding infectious disease, the opportunity to prevent is
now. In my county we have been able to decrease new Hepatitis C
cases by 60 percent, using harm reduction strategies and
training from CDC. And CDC assistance in surveillance has
allowed us to identify and implement specific strategic
measures to prevent an HIV outbreak. The Eliminating Opioid-
Related Infectious Diseases Act of 2018 authored by
Representative Leonard Lance of this committee would provide an
additional $40 million to CDC, money needed for Hepatitis C and
HIV surveillance activities that help local health departments
stop outbreaks before they occur, especially infections
associated with injection drug use.
On behalf of NACCHO I would like to suggest the bill be
expanded to include surveillance of Hepatitis B. Opioid
overdose from prescription and illicit drugs require special
surveillance and rapid intervention to address emerging drug
threats.
Fentanyl, a particularly deadly opioid due to its potency,
struck my city and other parts of our Nation especially hard in
2016. It remains the drug most frequently found in overdose
autopsies from my county. Any street drug product might contain
fentanyl, and neither users, police officers nor public health
officers know if it is there or not. A bill to improve fentanyl
testing and surveillance authored by Representative Ann Kuster
addresses this threat with assistance to public health
laboratories in detecting fentanyl and its many analogues.
NACCHO recommends that in addition to agencies named in
this bill, CDC should be included in these efforts. I also
support the pilot program authorized in this bill which would
allow point-of-use testing that could save lives and modify
drug use behavior. Local health departments like mine are
working 24/7 to save lives and reduce the risk of opioid
overdose and the risk of life-threatening infections.
In closing, I hope that Congress will make an increased
investment in funding for CDC and other public health agencies
engaged in this fight. We have seized our opportunity in
Huntington and we are succeeding. NACCHO represents nearly
3,000 other local health departments, big and small, ready to
fight this opioid epidemic and we need your ongoing help. Thank
you.
[The prepared statement of Dr. Kilkenny follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you, Dr. Kilkenny.
Again, the chair observes we do have a vote on the floor.
So we are going to take a recess so members can go and be
recorded on a procedural vote on the floor of the House and we
will reconvene immediately after votes where we will start the
member questions. So thank you all for your testimony. We stand
in recess.
[Whereupon, at 10:30 a.m., the subcommittee recessed, to
reconvene at 11:12 a.m., the same day.]
Mr. Burgess. I call the subcommittee back to order. Again I
want to thank our witnesses for their testimony. We are going
to move into the question portion of the hearing, but I do want
to recognize the gentleman from Texas for his unanimous consent
request.
Mr. Green. Thank you, Mr. Chairman. I request unanimous
consent to enter into the record a statement from
Representative Ann Kuster who actually sat through some of our
hearing yesterday in support of her draft under consideration
to improve fentanyl surveillance and testing as well as bills
featured as part of the Bipartisan Heroin Task Force
legislative agenda for 2018. I ask unanimous consent the
statement will go in the record.
Mr. Burgess. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Burgess. And the chair will recognize himself 5 minutes
for questions.
Dr. Banner, in your testimony you referenced the difficulty
of treating fentanyl with naloxone. Could you elaborate on that
just a little bit?
Dr. Banner. That is a pharmacologic and toxicologic
problem. As you, I am sure, recognize fentanyl's potency means
that naloxone may at times be required to give increased doses
to reverse it because it is binding to the mu receptors. And I
know I am not talking to most of the people in the room, but--
--
Mr. Burgess. Just talk to me. It is OK.
Dr. Banner. The mu receptor affinities are so high----
Mr. Burgess. That is why I am sitting in this chair.
[Laughter.]
Dr. Banner [continuing]. With that affinity it takes a lot
of naloxone sometimes to reverse them. Plus, if they are
chronically using fentanyl and they get their body burden
increases then the apparent duration of action of fentanyl can
exceed the duration of naloxone and you may have to give a
repetitive dose. And the third issue is that there are pretty
good case reports where reversing fentanyl produces such a
surge in adrenalin that you actually can get noncardiogenic
pulmonary edema, or a flooding of the lungs with fluid, and
that of course can convert a life-threatening situation into a
life-threatening situation. So, we feel like that has upped the
ante quite a bit.
Heroin reverses pretty easily and it has, the duration of
action of heroin itself is 7 to 8 minutes so it is a rapid
high. If you get in trouble you reverse it and then the
naloxone usually covers it. But drugs like methadone when they
are involved or some of these fentanyl derivatives can really
prolong the toxicity and therefore the need for repetitive
doses and it makes it more complex.
Mr. Burgess. All right, thank you. The way you are in your
testimony that administration of naloxone is far more complex
and dangerous for emergency responders to administer, I
misinterpreted it. I thought for some reason it would be
dangerous to the ER doc, but you are saying it is dangerous to
the patient----
Dr. Banner. Yes.
Mr. Burgess [continuing]. During the administration
episode. Very good. Thank you for clearing that up.
And, Dr. Kilkenny, let me just ask you. We started this
week in another subcommittee, the Oversight and Investigation
Subcommittee, with the acting administrator of the Drug
Enforcement Administration and focusing more on the enforcement
side of this equation. And your State obviously came up for
some discussion because of the delivery of pharmaceutical
product to locations that seemed far in excess of the
population that would be making itself available to that retail
establishment, and I am trying to say that as carefully as I
can.
But then in your testimony you talked about in 2016
fentanyl sort of bumped up. Were you aware in your communities
that this problem of the excess delivery was occurring? Was
that something that was novel when it was discovered? Just let
us know what you saw on the ground as those years were
unfolding.
Dr. Kilkenny. Because I live there and I have seen the pill
mills operating and I knew when I was practicing how that
worked, I was not surprised to know that there was an
overabundance of supply to very small towns that were servicing
certainly the vehicles parked in those parking lots had license
plates from all over the country. So I was aware of that
practice, but I wasn't aware of the staggering numbers until
they came in later.
That distribution I think temporally occurred before the
big switch to injection drug use that we saw using heroin. And
there was always fentanyl around, but in 2016 something
appeared to us to happen in the supply chain. And we saw----
Mr. Burgess. Let me just interrupt you. The supply chain of
fentanyl is not coming through the supply chain, right?
Dr. Kilkenny. We are talking about the illicit supply
chain.
Mr. Burgess. Illicit, OK.
Dr. Kilkenny. The illicit supply chain of fentanyl seemed
to change really remarkably in the second half of 2016 and the
entry of the fentanyl analogues really picked up then. That is
when we started seeing a massive increase in overdoses and
overdose death.
Mr. Burgess. That seems to have been catalyzed by the
initial excess distribution phenomenon that was happening in
your neighborhoods.
Dr. Kilkenny. I certainly do not argue with that iatrogenic
component that this started with prescription drugs.
Mr. Burgess. And I guess our frustration when we talked to
the DEA on Monday was it seems like there was a blinking red
light on the dashboard, why didn't anybody check the engine,
you know what I mean? I always lived in fear of the DEA when I
was in practice. I thought they knew everything about me, every
prescription that I wrote, every patient that I treated. Then
it turns out on Monday we hear that they really weren't paying
that much attention and it was startling information to me.
Dr. Kilkenny. Apparently not, but I don't think we as
physicians were as red-flagged as we should have been while we
were prescribing under the pain as the fifth vital sign rule.
Mr. Burgess. Sure.
Let me recognize Mr. Green from Texas 5 minutes for
questions. I have some additional questions that I may try to
get to at the end. But, Mr. Green, you are recognized for 5
minutes.
Mr. Green. Thank you, Mr. Chairman, and I want to welcome
our panel here today. I want to thank all our witnesses for
joining us.
We agree that the opioid epidemic is a multisided problem
and will require a multipart solution. As part of the solution
it is essential that we expand access to treatment. We must
also identify strategies that encourage individuals with
substance use disorders to seek and remain in treatment. I am
concerned that the proposed proposal to roll back protections
under code federal regulations titled 42 Part 2, commonly known
as Part 2, would do the opposite.
Dr. Martz, in your testimony you state that if patients
with substance use disorders are afraid their treatment records
will be used against them they will not enter treatment. Could
you explain the important role of confidentiality plays for
individuals with substance use disorders in retaining and
entering treatment and working towards recovery?
Mr. Martz. Thank you. It plays a critical role. If you are
working to decide whether or not I am going to enter treatment,
whether or not I am going to deal with the issues that are most
relevant in treatment that is a critical protection to have. We
know that folks will not come to treatment if they are afraid
of what the impacts will be.
So, for example, I worked with parole and probation for
quite some time and there would be some question of, someone
goes and they are having a holiday party, and they go and they
show up and there is drinking there, not a surprise. But then
they start to have cravings.
So the work of treatment has to do with having a safe space
to be able to discuss these issues clearly and directly
without, rather, having to say oh no, I didn't have any
problems and nothing was going on here, so that for fear that I
would disclose it to somebody else. You know, it is a role
like, more like a priest/penitent relationship than just other
roles.
Mr. Green. Why are the heightened protections provided
under Part 2 critical to creating the safe environment for
treatment for individuals with substance use disorder that you
describe in your testimony?
Mr. Martz. It is critical for the safety. One of the key
elements in terms of treatment is that there is a therapeutic
alliance and sometimes it takes weeks or months to build a
relationship. I have had clients that were with me for 6 months
before they suddenly say all right, now I am going to tell you
the truth about what is really behind this, so it takes time to
build a relationship. It takes time to have that safety and
anything that is going to damage that safety such as fear that
this will be disclosed, it will impact that and prevent them
from entering or staying in treatment or working on the
critical elements within it.
Mr. Green. According to a letter submitted to the Committee
from the Campaign to Protect Patient Privacy Rights, rolling
back the Part 2 protections to the HIPAA standard will
contribute to the existing level of discrimination and harm to
people living with substance use disorder and will only result
in more people who need substance use disorder treatment being
discouraged and afraid to seek the health care they need during
the nation's worst opioid crisis.
Dr. Martz, will you discuss how rolling back Part 2
protections to HIPAA standard harms efforts to create a safe
treatment environment and potentially leads individuals with
substance use disorder not to enter or remain in treatment?
Mr. Martz. Thank you. Many of our folks have dealt with
trauma, for example, and so one of the things that is a really
critical difference between HIPAA and 42 CFR is that with 42
CFR when I disclose to my clinician I know that it is private
unless I sign and get information that it will be shared with
somebody else. When I share with my clinician about the sexual
trauma and assault that I faced previously that is a private
conversation and before that gets shared with multiple other
people without my knowledge, which is what the standard would
be under HIPAA, that is a problem.
So when information comes back to me from some other
clinician that gets the information from the clinical record
rather than having that conversation with me directly when I am
not ready to share it, it is a severe damage to the trust that
is needed for a relationship for treatment.
Mr. Green. Thank you. I support strongly the efforts to
expand access to treatment, encourage individuals to seek and
remain in treatment. I am concerned the proposed changes to 42
CFR Part 2 misses the mark.
And in my last few seconds, in my earlier life I did
probate work and in Houston, Texas the probate judges are also
the mental health judges. And I was honored, I think, when the
judge decided he wanted to appoint me to be on the mental
health docket for about 3 weeks, and this is before HIPAA. It
was in the '80s and we still had that protection, though I
don't know if it was under state law or federal law at that
time that even the lawyers we had to destroy all our
information.
And believe me it would have been really difficult to get
people in treatment if they knew that would be available to
potential employers and that. Now, if there is a danger we all
have a responsibility to that whether you are a medical
professional or what. But just that average letting people know
someone is under care, it really bothers me.
Thank you, Mr. Chairman. I know I have run out of time.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman. The chair recognizes the gentleman from
Kentucky, the vice chairman of the subcommittee, Mr. Guthrie,
for 5 minutes.
Mr. Guthrie. Thank you, Mr. Chairman. I appreciate the
opportunity to be here and all the witnesses being here. I am
going to focus my questions to direct them to Mr. Bauer who is
from back home. We have had several Kentucky witnesses over
yesterday and today and have been fantastic witnesses, but only
says that we have a big issue in our State like surrounding
States and then it is spreading. So that is why what we are
doing here is so important to make sure that we move forward.
But I am going to focus on the Prescription Drug Monitoring
Program. So when providers check their PDMPs or Prescription
Drug Monitoring Program, to Mr. Bauer, what is the evidence
that this actually changes their prescribing or dispensing
behavior resulting in improved patient outcomes and lives
saved?
Mr. Bauer. I thank you, Vice Chairman, for the question.
Today with the PDMP programs one most impactful issue with the
program is integration of that information into workflow. And
we are finding that that really helps to enable efficient
access to the PDMPs, so the PDMPs are checking. There are 40
States that have mandated use laws in place today which mandate
the checking of the PDMP in one way, shape, or form.
So we have seen the use of the PDMPs having an impact on
the overall volume of opioids prescribed. We think that is in
conjunction with policy at a State level as well. From an
outcomes perspective there are current studies that are
underway, one of which is Appriss Health has a study underway
to understand the actual outcome of checking the PDP on opioid
death, the death curve. So that study is not completed yet. We
are about 3 to 4 months into that study.
Mr. Guthrie. Thank you. And also you mentioned that some
States are turning the PDMP into a substance use disorder
platform. Can you elaborate on what that means and how it would
help someone who might be at risk of addiction or substance
misuse?
Mr. Bauer. Sure. When PDPs were first formed many years ago
they were more of a diversionary tool that was used to
understand drug diversion. The programs have since morphed into
more of a public safety tool.
So, today, information in the form of data, prescription
data, is sent to the prescriber or pharmacist for review.
States are now moving past that what they call the phone book
of data trying to understand within that information what is
the issue with this patient or what is the risk that this
patient represents from an overdose perspective. And we are
moving that into more of a substance use disorder platform to
provide the clinicians, the prescribers, and pharmacists more
clinical information so they engage with their patient while
that patient is right there in front of them versus trying to
read through a phone book of data in the 20 or 30 seconds that
they have.
So, adding additional datasets such as nonfatal overdose,
providing for referral of treatment while they are in their
PDMP, a peer-to-peer communication, et cetera, are all clinical
tools that are designed to truly engage that patient before
they go to an illicit drug event.
Mr. Guthrie. OK, thank you. And I have a final question for
you. PDMPs are not only critical to prescribers for identifying
beneficiaries that are high users, but also in avoiding
potentially dangerous drug interactions. It is my understanding
that for the most part PDMPs are not allowed to have data or
are prevented from having data on patients receiving methadone.
On the other hand, buprenorphine prescribed in an office space
setting is typically filled at a pharmacy which is then
submitted to PDMPs. So why are methadone and buprenorphine
treated unequally when it comes to PDMPs, and can we do
anything to include this information but still protect patient
privacy?
Mr. Bauer. Thank you for that question. What we find today
from the PDMPs as far as collecting that data such as methadone
or buprenorphine prescriptions, buprenorphine, for example, is
a prescription that is actually prescribed and typically picked
up at a retail pharmacy therefore reported to the PDMP.
Methadone on the other hand is typically administered within a
substance use, a clinic and therefore by law not reported to
the PDMP.
So that is the difference as far as----
Mr. Guthrie. Well, could somebody get methadone at a
methadone clinic and also have a prescription for
buprenorphine, or are they interactive?
Mr. Bauer. The short answer is it is possible.
Mr. Guthrie. I guess just to the question because I am
about out of time, I know the idea for the methadone is patient
privacy. Can we address that?
Mr. Bauer. Yes. Obviously we want to take privacy into
consideration from a PDMP perspective obtaining that methadone
administration, administered methadone is critical to
understanding the overall risk of that patient.
Mr. Guthrie. OK, thank you. And I have 5 seconds, I yield
them all back.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back. The chair recognizes the gentlelady from
California, Ms. Matsui, 5 minutes for your questions, please.
Ms. Matsui. Thank you. Thank you, Mr. Chairman. And I want
to thank the witnesses for being here today.
Dr. Martz, thank you for your testimony. I have been a
champion of building greater education and awareness about
HIPAA privacy regulations particularly as it applies to tricky
mental health situations, because I recognize the necessary
balance between patient privacy and access to information for
purposes of quality treatment. I appreciated your nuanced
understanding of the importance of confidentiality for patients
suffering from a substance use disorder and the different ways
a stigma plays into the situation.
I am also sympathetic to the caregivers and doctors who are
trying to better serve patients and to stories of patients who
are harmed because the provider didn't have the right
information to make the right clinical decision. I am hopeful
that working together we can find the appropriate path forward
on this issue. From your perspective, how well do you think
patients know their rights under HIPAA and specifically under
42 CFR Part 2 and the recent SAMHSA update?
Mr. Martz. Thank you for the question. Patients are pretty
widely available and it is usually one of the very questions
that will be asked, who is going to get this information? And
even if they don't ask that up front, it is our responsibility
as clinicians to immediately give them that information about
what you are going to be sharing, what are the limits of
confidentiality and what are the conditions under which is
would be released or excluded.
One of the challenges with the multiple changes we have had
in the last year now from SAMHSA is that every time it comes
out of the change we have to identify the regulation, we have
to update our forms, we have to retrain the field, and re-have
that conversation with the client which is very damaging to the
relationship that has been built.
Ms. Matsui. Right. So the familiarity among the doctors and
caregivers need to be updated. So do you think it would be
meaningful for HHS to conduct more education and awareness?
Mr. Martz. Absolutely, across the field not only treating
clinicians but also physicians and other allied professionals
that are interacting so that we better coordinate the care.
Very often, the problems that are found from confidentiality
are really training issues rather than actual burdens.
Ms. Matsui. Sure. Well, do you think there are certain
situations or circumstances under which sharing a patient's
substance use records would be beneficial to their coordinated
care? So, for example, in the case of accountable care
organizations that are specifically targeting comprehensive
services for those with multiple conditions such as substance
use disorder co-occurring with something like diabetes or
depression?
Mr. Martz. Yes. And it is very common to coordinate care
and it is actually an expectation of myself and all the
clinicians that I have worked with that we are to coordinate
substance use, mental health, medical conditions. The
difference is that there is a protected element for them to
discuss the private areas and it is a clinical issue to engage
them to have that trust to open the relationship and dialogue
with the other clinicians to maintain that constant
communication.
Ms. Matsui. OK. Well, thank you.
Dr. Strain, thank you for your testimony. As I mentioned
previously, I am committed to advancing coordinated patient
care without sacrificing patient privacy, especially around a
sensitive and stigmatized disease. Recently, SAMHSA released
some regulations that broadened rules about re-disclosure and
42 CFR Part 2. Do you think that it has been helpful to
providers;. Alternatively, did it go far enough?
Dr. Strain. So I thank you for that question,
Representative. I think that we haven't gone far enough. I
think that we need to provide a mechanism whereby information
can be more seamlessly shared between providers who are not in
a substance abuse treatment program and those who are in a
substance abuse treatment program. I think that at the end of
the day, I am interested in seeing us do better in terms of
coordinating care across those two foci, and the current
barriers make that difficult.
Ms. Matsui. Yes. So in your testimony you provided some
very compelling examples particularly if a patient is
incapacitated. For things like asking patients about history of
substance use, what type of training do doctors currently
receive about best practices?
Dr. Strain. So training by physicians is variable by
medical school. There is not a national standard for training,
a Federal standard, but there is increasing amounts of training
in medical schools and by, for physicians in terms of substance
abuse and education and it is a critical part. It has become a
critical part especially in the current climate.
Ms. Matsui. I can see that we need more, probably,
continuing education about this. Generally, if a patient is
incapacitated or unconscious your testimony implies there is no
way for a doctor to know if a patient has a history of a
substance use disorder. Is that absolutely true? For example,
can a doctor make inquiries of next of kin?
Dr. Strain. I am sorry?
Ms. Matsui. Can the doctor make inquiries of next of kin?
Dr. Strain. Certainly the doctor can make inquiries of next
of kin to attempt to determine that if they are available.
Mr. Guthrie [presiding]. Thanks. I know we are pushing up
against votes for another round of votes----
Ms. Matsui. OK, thank you.
Mr. Guthrie. Thank you. The gentlelady yields back. I now
recognize the gentleman from Virginia, Mr. Griffith, 5 minutes
for questions.
Mr. Griffith. Thank you very much, Mr. Chairman.
Over here, and I am going to continue, Dr. Strain.
Doctor, you were just talking about what the doctor can
find out by asking the next of kin. And one of the issues that
we dealt with, not opioid directly related but dealing with
violent tendencies and violence that we were trying to deal
with in CURES and in some other things, was trying to figure
out how we keep privacy for individuals but at the same time
have some family involvement where the family is actually
involved in a person's life, because if they have a significant
mental illness and maybe also a drug addiction on top of that
it is sometimes very difficult for the family to get
information because of the HIPAA laws.
So Dr. Martz raises good points, but how do we reach that
balance where particularly if you are living in the home with
parents or a sibling that they can have enough information to
know whether, A, they are in danger, or B, how they can be of
most assistance to their beloved family member? Any ideas for
us?
Dr. Strain. Thanks. It is a critical question,
Representative Griffith. And it really comes down to, I think,
the provider-patient relationship and that judgment that occurs
in that relationship in terms of where do I treat patients, and
where do I go in terms of when I have information that I
believe has reached a critical point where I need to bring in a
family member and inform them that? And there can be instances
where I may do that even if the patient is saying I don't want
you to do that.
So obviously, for example, if there are issues of abuse of
a child or a parent or things like that I may be compelled to
do so, or if somebody is reporting that they are suicidal or
homicidal. But at the end of the day, it does distill down to I
think that relationship and the provider having determination
of where do they need to go with the information that they are
receiving. I think that trying to create a systematic answer to
that may be challenging.
Mr. Griffith. Well, we found it to be a challenge but we
are still working on it, because obviously with the number of
violent situations we have had in our country, these tragedies
that have occurred, we are trying to figure out what is both
right for the patient and right for society as a whole.
Switching gears and continuing to talk about the opioid
tragedies that are afflicting us, Dr. Kilkenny, you work in
Huntington and Cabell County. Do you find that, because in O&I
we had an earlier hearing this week on pill dumping and
particularly into a couple of towns in West Virginia, do you
find that those drugs coming into the small towns outside of
your community--about 56 miles away was one of them, Kermit,
and the reason I know that is because it is only about 53 miles
from my district in western Virginia.
Do you find that that has a spillover with the patients
that you are seeing that some of those folks are coming from
those rural areas where all these drugs were dumped?
Dr. Kilkenny. I think the evidence in West Virginia
indicates that the current injection drug use, the illicit
trade was spawned by an overprescribing and then a more
responsible set of prescribing.
Mr. Griffith. So it would be reasonable to conclude that
your testimony would also affect my district, which is about an
equal distance although it takes longer to get through the
mountains to get to mine from Kermit or from the other towns,
that the problems would be very similar. It would be reasonable
to make that conclusion, would it not?
Dr. Kilkenny. I think that Virginia, West Virginia,
Kentucky, Tennessee, any of the Appalachian districts in those
states are going to be affected the same as we are.
Mr. Griffith. Yes. That is pretty much my district.
Mr. Bauer, thank you for being here as well and thank you
for saying some nice things about our draft legislation on
PDMPs. I was really pleased to see the graph that showed that
just a few years ago there were only a couple of States, one of
which was my State in Virginia in 2011, but that now we have
more than 40 States and all of the States continuous to my
district are now there, because at one point Martinsville had
the highest per capita use of--and there is a formula that you
would know, the morphine----
Mr. Bauer. Equivalents.
Mr. Griffith [continuing]. Equivalents of any place in the
country and North Carolina was not a part of it. So hopefully
that will be of some help. Can you explain further what we need
to do to get all the States on the same page so that we are
able to compare apples to apples, because I understand in some
of the PDMPs that there is a difference in the data. Can you
give us a few seconds on that?
Mr. Bauer. Yes, I can. Thank you for that question. So
today as you know there are 45 States that do share data
securely and efficiently with each other. It is up to the
States' purview as to what State they wish to share data with.
Typically it is the surrounding States and then another
concentric circle.
The States that are not sharing data today it is truly a
policy issue. The example I mentioned in Florida, Florida just
recently passed legislation that will enable them to share,
effective July 1st of 2018, California is the same way. So
these are certainly policy issues that are involved in not
being able to share data right now.
Mr. Griffith. And I am out of time so I have got to yield
back, but I would love to know if we can get everybody on the
same page. I appreciate it, thank you.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman. The chair recognizes the gentleman from New
Jersey, the ranking member of the full committee, Mr. Pallone,
5 minutes for your questions, please.
Mr. Pallone. Thank you, Mr. Chairman. I have some questions
of Dr. Martz. I would like to thank all the witnesses for
joining us today. I stated in my opening statement yesterday
that I was concerned that H.R. 3545, the Overdose Prevention
and Patient Safety Act could dangerously erect a barrier to
patients seeking and remaining in treatment and therefore harm
our efforts to respond to the opioid crisis.
According to the Substance Abuse and Mental Health Services
Administration, the disclosure of records of individuals'
substance use disorders has the potential to lead to a host of
negative consequences including loss of employment, loss of
housing, loss of child custody, discrimination by medical
professionals and insurers, arrests, prosecution, and even
incarceration.
So, Dr. Martz, I am hoping you can help us better
understand these consequences. The first question, I understand
from your testimony that you have worked in a number of States
in a range of settings and served a diverse mix of patients.
Based on that experience, can you provide some context on the
issues facing individuals with substance use disorder that make
Part 2 heightened confidentiality protections important?
Mr. Martz. Thank you. Thank you. I think, and in response
to your question I may have to respond with a brief note from
the last listening session of SAMHSA, some notes that were
submitted regarding 42 CFR from the folks that are affected
here.
``Dear Administrator Hyde, I have a criminal record and
attending recovery. I don't want my history to become a burden.
I realize individuals have discussed good medical care for me
will be compromised if all medical professionals cannot see my
treatment records, but available to ones who must see them. I
don't want to risk losing my family or my job or my housing due
to someone knowing or finding out I have been treated with
addiction. I don't want my past to jeopardize my future because
I am doing the right thing. I am writing to ask privacy
protections for patient records be maintained. I do not wish
for this to be a lifelong burden. My privacy records are very
important. I am soon applying for a job and I fear I will never
have the chance to better myself in society otherwise. Thank
you so much for even considering. We know we are but little
value to society, but even if we were to become trash men one
day it would be the best for us and for free men.''
There are a stack of these letters coming from these
individuals. I also worked in the Pathways to Pardons project
in Pennsylvania where we worked with folks seeking clemency,
and there were many folks who were seeking clemency because
they couldn't get jobs, they couldn't become nurses, they
couldn't get promoted. They had various challenges that they
couldn't work with. So even many, many, many years later there
is a lifelong stigma attached.
Mr. Pallone. All right. Now a recent study published in the
Journal of Addiction Medicine found that a significant portion
of the study population of ED physicians at Johns Hopkins had
low regard for patients with substance abuse. For example, 54
percent of survey responders indicated that they agreed that
they, ``prefer not to work with patients with substance use who
have pain,'' and 54 percent agreed that patients like that
irritate me.
So, Doctor, is this unique to the physicians in the survey
or do individuals with substance use disorders sometimes face
stigma and discrimination from medical providers?
Mr. Martz. Absolutely. There is an old term for, in the
profession in some areas what is called a GOMER, Get Out Of My
ER. There is just such an absolute disdain. And even in recent
weeks and months as I mentioned, there were a couple quotes
just out there from recent providers some of which I mentioned
before, for example, ``Jail, the best way to beat addiction.''
``Why is this a problem? Opioids are eliminating the bad
folks in our communities--smiley face.''
``If they would stop reviving them there would be less
usage.''
The level of stigma and vitriol out there is widespread and
which is what we are trying to protect our folks from, because
some of the discrimination will be overt but some will be
covert and use other reasons to say you are fired and we are
not going to use you, but rather than saying oh, it is because
you have a history of this.
Mr. Pallone. And then my last question deals with the
dramatic increase, the presence of substance use treatment
records in electronic health records and health information
exchanges a lot of these records will be increasingly
vulnerable to cyber attacks and breaches. One of my Republican
colleagues noted in reference to our committee inquiry to the
healthcare cybersecurity that as technology becomes
increasingly integrated with all levels of health care, cyber
threats pose a challenge to the entire sector.
You want to just explain the impact of such risk? There was
a recent Ponemon Institute survey that found that half of HIPAA
organizations expose patient data at some point and improper
disclosures on patients with substance use disorder. I know we
are almost out of time so quickly if you could.
Mr. Martz. Absolutely. Cybersecurity has been a growing
threat. We know, for example, in February 2015, an Anthem Blue
Cross Blue Shield organization had 37.5 million records stolen.
Russell Branzell, president and CEO of College of Healthcare
Information Management, has said that health care is ground
zero for cyber attacks. According to the Department of Health
and Human Services, while all industries face this growing
threat, the size and scope of the attacks on the healthcare
industry have accelerated rapidly in the past few years. This
is valuable information that can be bought and sold. And so
cyber attacks are a serious risk and have been growing rapidly.
Mr. Pallone. Thank you. Thank you, Mr. Chairman.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman. The chair recognizes the gentleman from Indiana,
Dr. Bucshon, 5 minutes for your questions, please.
Mr. Bucshon. Thank you, Mr. Chairman. First of all, I just
want to respond a little bit to this study about ER doctors.
There are people who come to the ER legitimately drug seeking
trying to get legal ways to get drugs. This is nothing to
people who are drug addicted. They are treated just like
everybody else. But if you have ever spent any time in an
emergency room, and I have because I was a heart surgeon, there
are legitimately large numbers of people trying to get legal
prescriptions or legal narcotics through coming to the
emergency room.
And it is honestly insulting for studies to try to show
that the ER physicians are in some way not treating patients in
an ethical and moral way. It is just not right. And let me just
also comment on what it is like to be a physician--and my wife
is an anesthesiologist by the way also--and have patients
taking unknown medications or have an unknown medication
history. This is a really serious problem. If you as a surgeon
you don't know if they are on opioids, benzodiazepines, and in
many cases certain dietary supplements.
I have had myself, personally, two patients who almost bled
to death after heart surgery because they were taking
supplements for vascular health. And my wife tells me every
day, she is still in practice, she still has patients that have
unexplained difficulty in being anesthetized with narcotic or
benzodiazepine-based anesthetic agents, and looking at the
medical record there should be no reason for that and the
reason is is because it is undisclosed.
So, look, there is a balance here and Dr. Martz makes some
great points. But I just wanted to point that out that it is a
difficult problem for medical providers and we need to find a
balance.
Dr. Strain, I know there are concerns that if we amended
the statute to allow substance use disorder treatment
information to be disclosed it could be used in criminal
proceedings, cause someone to lose their housing, employment,
or even child custody. Does the amendment to H.R. 3545 include
safeguards to prevent this from happening?
Dr. Strain. Thank you, thank you for those comments and
thank you for the question. Absolutely, my understanding is
that there are safeguards within the Mullin amendment that does
prevent those sorts of concerns.
Mr. Bucshon. Yes. And many people with substance abuse
disorder also struggle with mental illness or have comorbid
conditions such as diabetes or hypertension. How does 42 CFR
Part 2 prevent quality care coordination?
Dr. Strain. So it is a great question. And the dilemma as
you actually illustrated earlier is that the provider may be
seeing a patient who is in substance abuse treatment and not
know about that and then can't coordinate their care in terms
of infectious illnesses or other medical problems that have
arisen related to their substance abuse. And the patient may
not be telling them about that or may not be fully disclosing,
for example, what medications they are on through their
substance abuse treatment program.
We want to be holistic about treating people. That is at
the end of day that is what we should be striving to do and
right now we are segmenting out this part.
Mr. Bucshon. Yes. I also want to point out that, again as a
physician, family members may not know the medical history of
their loved one and I think Congressman Griffith was talking
about that. And we tried to, in a mental health bill a year or
two ago we tried to change HIPAA a little bit to allow parents
who have adult children who have severe mental illness to have
some minimal access and we couldn't get that done because of
the privacy issues. In fact, in your State I think had a State
senator whose son had an episode and tried to kill him and then
subsequently killed himself and so the system failed both of
them, really.
But if you look at, for example, the directed donor
program, say you are going to have your hip or your knee done
and you want family members to donate blood and put it in the
blood bank for you, there is a pretty substantial instance of
that blood being rejected by the blood bank because of a blood-
borne problem, usually hepatitis history, and family members
don't necessarily know that their family member has had that
history and they don't want that disclosed and I understand
that.
I think we should look back to what happened in the '80s
and the '90s with HIV and the critical issue we had there with
privacy. And we have worked through that I think and maybe this
is where we are going with drug addiction also. We clearly
don't want people discriminated against for any reason, but we
also want to be able to have holistic medical care that
includes knowledge of a patient's addiction history. I yield
back.
Mr. Carter [presiding]. The gentleman yields. The chair
recognizes the gentlelady from California, Representative
Eshoo.
Ms. Eshoo. Thank you very much, Mr. Chairman, and thank you
to all of the witnesses. It is good to have you here on a
subject that is really wrecking communities and wrecking
people's lives and there is enormous loss of life surrounding
this issue. Over the last at least month or 5 weeks, I have had
five friends and my sister, so six individuals that have shared
with me the following:
They had hip replacement surgery. And I am directing this
to Dr. Strain. They were sent home with a bottle of 100 tablets
of either Oxycontin or Percocet. Now a hundred tablets of
either is, I think, over the top. I am not a physician but that
is a lot of pills. Why is that the case? Why is so much being
prescribed?
Dr. Strain. So----
Ms. Eshoo. I would think, excuse me, that if you are not an
addict you may have a new hip, but by the time you are finished
with your recovery you will be an addict. So is there a
kickback on these drugs? Can you enlighten us as to why so much
is being prescribed? And this is the second most common surgery
in the country. Number one is cataract surgery; number two, hip
surgery.
Dr. Strain. So certainly if we were having this
conversation even 5 years ago I would have said the reason that
there is large numbers of pain pills being prescribed is
because the medical profession has had it drummed into its head
that we need to be more aggressive about treating pain. And
that is something that goes back 15 years and 20 years.
Ms. Eshoo. Well, I think it is important to stay ahead of
pain, but a hundred?
Dr. Strain. I agree. I think that that----
Ms. Eshoo. And these were all, they were different
hospitals that they were discharged from.
Dr. Strain. The current CDC guidelines do not recommend
doing that. The current thinking by other professional
organizations is not to be prescribing those sorts of amounts
of pain medications. I don't know the particulars of these
situations, but it is alarming to hear. And I think that the
medical profession hopefully is----
Ms. Eshoo. But what would you suggest? What would you
prescribe?
Dr. Strain. Well, first of all----
Ms. Eshoo. I am not asking you what prescription you would
write and how many pills you would prescribe, I am speaking in
terms of policy.
Dr. Strain. In terms of policy I would say that there
should be a much lower of medicines prescribed whether it is
oxycodone or whatever. I would follow things like the CDC
guidelines for a week, reevaluating the patient, using non-
opioid medications for the treatment of pain. I should
parenthetically note I am not a pain treatment doctor. I am a
psychiatrist by training. But I think a lot about this because
of this issue and my recommendations would be along those
lines. Did I answer your question?
Ms. Eshoo. Well, does CDC have guidelines now on this?
Dr. Strain. Yes.
Ms. Eshoo. They do.
Dr. Strain. Yes. They issued guidelines about a year ago.
Ms. Eshoo. It seems to me they are not being, they either
don't know about it or that they are just not paying any
attention to it.
Dr. Strain. Well, I think that----
Ms. Eshoo. Do you have any suggestions that have, excuse
the expression, more teeth in it?
Dr. Strain. Well, I think that from a systems level what we
could do, I think that we need to continue to be aggressive in
our education of all healthcare providers about this, but I
don't----
Ms. Eshoo. We really have a crisis obviously on our hands,
but it seems to me that in the system itself, professionally,
we are creating a whole other wave of it.
Dr. Strain. I think though I like to hope that we are
turning the corner on that and not doing that.
Ms. Eshoo. Well, let me just switch gears because I don't
have very much time left. I am an original cosponsor of
Congressman Lance and Kennedy's bill which makes investments in
CDC's surveillance of injection drug related infections. What
barriers currently exist to states implementing drug related
infection surveillance systems today?
Dr. Strain. Are you asking me that question or----
Ms. Eshoo. Well, whomever wants to answer.
Dr. Strain. I think you were commenting on this bill.
Dr. Kilkenny. Thank you. I think I can speak to that. The
barriers are probably mostly manpower. We need more people to
do the adequate case tracking and we need more communication
amongst the agencies to not the same level of communication
that this end of the table is talking about, but communication
in the public health sectors to basically identify the risk,
the risky individuals, and case-track them and work that
epidemic with the methods that we use. It is a labor-intensive
method.
Ms. Eshoo. I am not so sure I understand the answer, but I
know we are going to have the opportunity, Mr. Chairman, to
submit questions to the witnesses and I will do that.
Mr. Carter. Sure. Thank you.
Ms. Eshoo. I will yield back. Thank you everyone.
Mr. Carter. The gentlelady yields. The chair recognizes
the gentleman from Florida, Mr. Bilirakis.
Mr. Bilirakis. Thank you. Thank you, Mr. Chairman, I
appreciate it. I thank the panel for their testimony.
Mr. Bauer, Florida law as of January 1st, 2018 requires
that all controlled substances dispensed to an individual be
reported as soon as possible, but no later than the close of
the next business day to afford its PDMP the electronic Florida
online reporting of controlled substances evaluation. If the
controlled substance is dispensed on a Saturday and the
pharmacy is closed on Sundays it could result in a 48-hour
latency. Does typical notification latency range from 2 hours
to 7 days depending on the State?
Mr. Bauer. Thank you for that question. Today there are 43
States that require submission of controlled substance
prescriptions no later than 24 hours. There is one State that
is real time, Oklahoma, and there are, the remaining States are
either on a 7-day to 8-day cycle.
Mr. Bilirakis. OK, thank you. And yes, elaborate a little
bit, as far as how important that is.
Mr. Bauer. Absolutely. The timely submission of information
is extremely important. The 43 States that do submit the
information no later than 24 hours, there are typically
multiple submissions that are made of the dispensation when it
leaves the pharmacy. For example, when it comes into our system
we append that information. We provide our logic as far as
appending that to the right patient and make that information
available within about 5 minutes' time. So it is very much near
real time that once that information is received by the PDMP,
in the case of Florida that information is made readily
available within about 5 minutes' time.
Mr. Bilirakis. Very good. I know it is critical. I
understood that many States are able to share PDMP data across
State lines. However, even if States are connected to an
information hub, isn't it true that those States do not
necessarily have across State line information for all other
States connected to the hub? Is that true?
Mr. Bauer. Yes. Today the 45 States that do participate in
PMP Interconnect, for example, can share with all 45 States
should they wish. It is up to the discretion of the actual
state as to what States they wish to share information with.
Again most States, in fact all States share data with at least
their border states. Most draw another concentric circle and
others look at different migration paths as far as the I-95
corridor or the I-65 corridor or the Northeast states as far as
sharing information.
Mr. Bilirakis. OK. I think I know the answer to this
question but I am going to ask it. Can any State PDMP actually
stop the fraudulent prescriptions from leaving the pharmacy if
the patient obtained multiple prescriptions within the same
day, potentially, across State lines?
Mr. Bauer. Yes. That is a great question. Built into
today's PDMPs there are very efficient and effective ways where
the States are actually proactively sending alerts based on
various thresholds of the data both within their State and
combined with multi-state data.
So, for example, understanding if a patient is traveling
from State to State to State accumulating prescriptions from
multiple providers or multiple dispensers, that information can
be made available via an alert is what we call based on
specific thresholds that states set so those alerts are sent
out proactively to the actual prescriber or pharmacist that is
checking on that patient.
Mr. Bilirakis. What are we doing to call out those five
States that aren't participating?
Mr. Bauer. Yes. That is a great question. Again it is more
of a policy issue. California and Florida are addressing those
issues as we speak. Florida will be online hopefully by July
1st, California later this year. The remaining States actually
are in process, meaning the actual MOU, the memorandum of
understanding that is required to share data among States is in
review. The only States that are an exception to that are
Nebraska and Hawaii. Those States have not yet engaged on the
MOU process. But Washington State and Wyoming have.
Mr. Bilirakis. Very good, thank you. I yield back, Mr.
Chairman, appreciate it.
Mr. Burgess. Will the gentleman yield to the chair for just
a second?
Mr. Bilirakis. Yes, I will. Yes, I yield.
Mr. Burgess. I wanted to make the gentleman aware that in
the appropriations bill that will be on the floor of the House,
the NASPER language in the fiscal year 2018 omnibus bill, just
to draw attention to the fact that it will promote these
Prescription Drug Monitoring Programs including implementation
of activities described in the National All Schedules
Prescription Electronic Reporting Act of 2005 that was this
committee's product, and include, as amended, by the
Comprehensive Addiction and Recovery Act of 2016 and this shall
include efforts continuing to expand and enhance the utility of
PDMPs in States and communities making them more interconnected
real time and usable for public health surveillance and
clinical decision making. The CDC shall use $10 million of the
funds provided to conduct an opioid nationwide awareness and
education campaign.
So that is a little bit different now we have actually got
NASPER, which we have worked on in this committee as long as I
have been on this subcommittee, is actually receiving funding
in this appropriations bill should it pass in a little while.
So I now recognize the gentleman from New Mexico for 5
minutes for questions.
Mr. Lujan. Thank you, Mr. Chairman.
Mr. Martz, I would like to thank you for being here today,
sir, all the witnesses who are with us today. My questions
today will specifically be for Dr. Martz.
Yesterday I was taken aback by the conversation about how
providing individuals who continue to face stigma and
discrimination with heightened Part 2 protections, which
include the right to decide with whom to share their substance
abuse treatment records, stigmatizes individuals with substance
use disorder. I was surprised to hear SAMHSA echo this
accusation in the final rules modernizing Part 2 regulations.
Those rules explicitly acknowledge the stigma and
discrimination faced by individuals with substance use
disorder.
All of America's antidiscrimination laws from Civil Rights
Act to Americans with Disabilities Act to the Fair Housing Act
provide heightened protections for populations like individuals
with substance use disorder who face stigma and/or
discrimination because of who they are. And, frankly, I am
having a hard time understanding the argument that these
protections stigmatize these individuals.
So, Dr. Martz, please describe the stigma and
discrimination that individuals with opioid use disorder face.
Mr. Martz. Thank you. It is an excellent question and a
critical area because and to the points earlier this is not
limited to the ERs. This is stigma that goes across the way.
One in four families has someone in the family now with
substance use disorder, and so very often my experience of
substance use disorder is cousin Joey who has been stealing
from us. And so stigma runs deep and it is very different from
the aspects of other medical conditions which are very unique
to the substance use disorder which, for example, there are
still crimes associated.
So you don't get thrown in jail for having depression. You
don't have your kids taken away for your acne. You don't have a
loss of your job because you have a heart attack. So, medical
conditions are not all the same and so there are reasons why
there may be some segregation even though there are ways to
coordinate that care effectively. These stigma issues are
critical and to suggest that the stigma is caused by these laws
is a little bit of a misunderstanding.
For example, we don't have laws protecting
antidiscrimination in the workforce because we are creating
stigma in the workforce, we have laws protecting things like
gender and race and ethnicity and religion because these things
have been discriminated against in the past. And so even if we
have come a long way as we have with HIV, we have not yet come
that far with substance use disorder and so it still maintains
a critical protection.
Hopefully some day in the future we will understand that
these are brothers and mothers and sisters and children that we
are talking about here and can move beyond that discrimination,
but we are just not there yet. We need that protection
desperately.
Mr. Lujan. So a yes or no question, is that stigma and
discrimination the result of heightened protections provided by
the Part 2 protections?
Mr. Martz. No.
Mr. Lujan. I was also taken aback by something in Dr.
Strain's testimony. In his discussion of rolling back Part 2
for payment purposes he states that, ``patients could retain
the ability to keep their substance use disorder treatment from
their health plans by choosing to pay out-of-pocket for
services which is a right guaranteed under HIPAA.'' To me this
means that a person's ability to protect the privacy of their
substance abuse treatment record would be based on their
income, their ability to pay out-of-pocket for treatment. If
you are rich you can keep it private.
Dr. Martz, is it appropriate to make a person's ability to
keep their substance use information private based on a
person's ability to pay cash for treatment?
Mr. Martz. Thank you. My gosh, that is such a fundamental
civil right to be able to be private, have my own and disclose
at my own pace when I am ready and when I am able. That
shouldn't be something that is only available to the rich who
can afford it. Many folks that we deal with are police officers
and teachers and students and all walks of life so should have
these opportunities should they choose to use that option.
Mr. Lujan. One thing that I was struck with as well is I
learned that it was estimated that 20 million people in the
U.S. have some form of substance use disorder. Currently, four
million people are seeking treatment as has been reported, but
the fear of not being provided confidentiality is one of the
primary reasons people do not seek treatment.
So, Mr. Chairman, I know that this is an important part of
the legislative package that we have, and I certainly hope that
we take this into consideration as we try to make things better
versus taking protections away from individuals. And I yield
back.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back. I am sure ICD-10 has not one but fifteen different
codes. The chair now recognizes the gentleman from Illinois,
Mr. Shimkus, 5 minutes for questions.
Mr. Shimkus. Thank you, Mr. Chairman. And it is great to
have you here. We have had 2 days of hearings and as I
mentioned yesterday it is just not, I mean we are focused on
opioids but there are a lot of other addictive drugs out there
and challenges.
So I am going to be brief because I want to focus on what
Gus Bilirakis was saying and to, really, Mr. Bauer on the
Prescription Drug Monitoring Programs. One way we can shame the
five States is to call them out, and we can do it ourselves and
we use the bully pulpit to say, you guys need to start sharing
information. We have got to stop the easy access especially
across State lines or in other areas.
A good example, so I really live in the St. Louis
metropolitan area, I am from Illinois. Illinois has one,
Missouri does not. St. Louis County has one which really makes
it very difficult to make sure we have the procedures in place
to be able to access them when a State doesn't allow the States
to have the memorandum of understanding and work through those
processes.
We have seen these type of things when they can communicate
in the meth challenges. We have seen that be successful. We
need your help in figuring out how to really force this
national communication across state lines to address this. I am
curious if you can expand on ways we can help ensure that these
multiple systems are working together as opposed to creating
new burdens and confusions.
Mr. Bauer. Sure, another excellent question around
interoperability and states being able to share data among
themselves. I think today with the current PMP Interconnect
system, for example, that is facilitating about 18 million
transactions a month with 45 sStates, again I stated earlier it
is more a matter of policy and I think we are making some
significant progress with Florida coming on board and the
remaining States are making, I think, measurable progress
towards that.
So I think it is not out of the question that all remaining
States that are not currently sharing data can share data.
There is a very effective means to do that today with a single
MOU in place to accommodate for different state laws and
security concerns as well.
Mr. Shimkus. When someone has been prescribed legally and
they go to the pharmacist, they should be able to get that
dispensed but they shouldn't be able to go across the state
lines and there should be a red flag saying, hey, it has
already been filled. And that is what we need to work on and
that would be helpful.
Mr. Chairman, in lieu of time and other colleagues, I am
going to yield back so you can give them a chance to ask.
Mr. Burgess. The chair appreciates the gentleman. The chair
recognizes the gentlelady from Indiana for 5 minutes for your
questions, please.
Mrs. Brooks. Thank you, Mr. Chairman. And thank you to our
colleague from Illinois for yielding.
I want to ask you, Dr. Banner, I am the lead sponsor on
H.R. 5329, a bipartisan bill to enhance our poison control
centers in the country of which there are 55, I understand,
across the country. But most people probably don't realize that
the poison control centers field about three million calls, but
more recently about 192 calls a day on average on the opioid
misuse and abuse, and I really want to talk about the
importance of not only the hotline but what the service that
poison control centers provide.
How can poison control centers work with the educators,
caregivers, people who call, children, others, what is poison
control center's role? I think it is one of those you know the
number and you rush there, and I have had to use it once or
twice when my kids were young as well. I hate to admit it, but
we all do at some point. And, but what is the role of the
poison control centers with education?
Dr. Banner. We so very much appreciate your sponsorship and
involvement in this. If we have a couple of hours I could
really explain this to you. We have a very multifaceted
approach to education. Personally, I have emergency medicine
residents rotating with me at all times in the poison center
and in the ICU and we are educating them. I am teaching in the
College of Pharmacy as part of my responsibilities at the
poison center and I think the other 54 centers are similar. We
are actively engaged in that level of education.
The certification requirements for a center is to have an
educator who is principally pointed at the public and, too, the
National Poison Prevention Week is one of their big times, but
they are engaging kids at the elementary and early-on levels
about the dangers of things. And as we have evolved, they have
incorporated more about substance abuse into those educational
packages and teaching teachers, et cetera.
Did you have something else to add?
Mrs. Brooks. Well, I want to just, in your written
testimony you actually mention that actually a quarter of calls
to our poison control centers come from healthcare facilities.
And so, and just your testimony now about rotating residents in
and so forth, there is a significant need, is there not, to
continue to increase the education of poison issues leading
injury cause, by the CDC in this country, of death with our
medical professionals?
Dr. Banner. This was a simple job back in the '90s. The
explosion that has occurred with bath salt drugs, synthetic
cannabinoids, synthetic opioids has just changed the landscape.
And I would agree with you, the reason we get about 25 percent
of our calls from other healthcare professionals is because the
level of training of the medical toxicologists and the people
working in the poison centers is very, very unique.
And the other issue is Oklahoma has a lot of rural
hospitals as do many of the poison centers, and my ability to
reach out to a physician in a very rural hospital who has never
seen this before, and I have, is very helpful. Plus, I am a
critical care doctor. The vast majority of the doctors that are
medical toxicologists are trained in emergency medicine or
critical care and we are reaching out to rural areas with high
level, intensive care, emergency medicine, and toxicology all
at the same time and providing that and educating them at the
same time.
Mrs. Brooks. In fact, in our bill we are directing HHS to
implement call routing based on a caller's actual location
because that is not necessarily how you receive that
information now. Is that correct?
Dr. Banner. That is correct. When this was initially funded
back in 2000 it was reasonable to have where your area code.
And since then, area codes, now people are taking their phones,
particularly the military they are moving all over the country.
And one of the benefits of a regional poison center is I am
speaking to a doctor that I know in that area and if I am
suddenly faced with a caller who happens to have the Oklahoma
area code and they are in California, I can't really say you
need to go down to Dr. Such-and-Such at this hospital, because
I don't know them.
So the geo-routing, it sounds fairly simple. It is a little
more technically complicated, but it is something we really
need because we have got to, we have the regional resources to
help people and it is where they are at right now, not where
they used to live.
Mrs. Brooks. Thank you for your leadership in this area.
And on behalf of citizens in Indiana and across the country and
my colleague from Oklahoma, we really appreciate your advocacy
for poison control centers.
Dr. Banner. Thank you.
Mrs. Brooks. I yield back.
Mr. Burgess. The chair thanks the gentlelady. The
gentlelady yields back. The chair recognizes the gentleman from
Texas for a unanimous consent request.
Mr. Green. Thank you, Mr. Chairman. I would like to ask
unanimous consent to enter in the following letters from NAMA
Recovery-the Campaign to Protect Patient Privacy Rights and the
Pennsylvania Recovery Organizations Alliance, into the official
record.
Mr. Burgess. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Burgess. The chair recognizes the gentleman from
Oklahoma, 5 minutes for your questions, please.
Mr. Mullin. Thank you, Mr. Chairman.
Dr. Banner, good to see you here. We were taking little
friendly wagers up here to see if you had your boots on or not.
I said yes and you probably got your cowboy hat outside too. So
I do appreciate the knowledge that you bring and thank you so
much for coming up here. I know it is hard to leave our
beautiful state especially where we live, right?
Dr. Banner. That is right.
Mr. Mullin. Dr. Martz, I want to dig in a little bit on
some stuff that you have been saying. And I respect your
opinion, but I have a problem with the fact that you are trying
to push it off as facts. When we start talking about privacy--I
just want a yes or no here because you kept referring back to
this--is it legal for treatment to be shared with an employer
right now? The answer to that is no, so is it legal? Yes or no.
Mr. Martz. There are conditions with which you can really
make a release.
Mr. Mullin. Only if the individual has consent. Don't mix
words with me, yes or no. Is it legal or no?
Mr. Martz. In that condition, no.
Mr. Mullin. Right. I am an employer. I have several hundred
employees. It is completely illegal. Second, I am also a
landlord. Is it legal for treatment information to be shared
with a landlord? Yes or no.
Mr. Martz. No.
Mr. Mullin. No. It is absolutely not. Is it legal for
information to be shared in a criminal case or a divorce
hearing?
Mr. Martz. No.
Mr. Mullin. No. So what you are saying about privacy is
completely irrelevant to what we are trying to do here. This is
about patients. It is not about opinion or maybes. It already
is illegal and under this legislation it stays illegal.
So when you are testifying with us, please be a little bit
more factual on what you are saying instead of making a broad
statement like that and drawing fears into people. We bring you
here because you are considered an expert. Please be that
expert. I know you have a wealth of knowledge up here, but you
are misleading us and the panel when you don't put facts with
it.
Second of all, you start talking about the stigma that is
put in place and you referred back to SAMHSA several times. I
sent out a letter to the assistant secretary asking for their
information on our bill and what their thoughts were. Let me
read you a quote that came out of it. This is my favorite
letter that when they sent it back they said, ``The practice of
requiring substance use disorder information to be any more
private than information regarding chronic illness such as
cancer or heart disease may itself be stigmatizing.`` That is
from SAMHSA. Pretty plain and simple there that they think,
itself, it shouldn't be treated any differently.
Now let's talk about the fines, because you brought up
fines about this. How many, underneath Part 2, how many
penalties have been issued underneath Part 2 for violation of
Part 2?
Mr. Martz. On Federal or State level, because there will be
sanctions against licenses on the local level.
Mr. Mullin. Federal.
Mr. Martz. Federal, not that I am aware of.
Mr. Mullin. Two. How many has been brought up underneath
HIPAA?
Mr. Martz. That is outside of my scope.
Mr. Mullin. Let me just kind of put this out there, 173,426
since 2003. Now why is that?
Mr. Martz. There are----
Mr. Mullin. Because you talked about this in your opening
testimony and I just want to make sure that we are factual here
so you understand what we are talking about. A lot of people
want to talk about privacy and about not providing or not
separating or why Part 2 and HIPAA needs to be separated, but
underneath Part 2 the penalty is $50 if that information is
mishandled with the patient, $50. It is not worth the court's
time to deal with it. It is only two cases. Underneath HIPAA it
ranges between $150,000 per violation and a maximum of $1.5
million per year.
This is about patients. What we are trying to do here is
treat the patient. But how can he treat the patient when the
doctor can't see all the medical information? How can he do it?
And the reason why I am so passionate about it because it
touches my family, we are currently dealing with it. I
currently dealt with this situation yesterday over the phone
because we have a family member that has a disorder of being
addicted to drugs because it started with an elective surgery
and now her life is completely ruined and she keeps going to
doctors and they keep prescribing her stuff.
And they can't see her complete record and how many times
she has been in treatment, so every time she goes in they start
diagnosing, or prescribing her more pain medicine because she
is in pain. Well, what is the difference between pain and a
withdrawal? Because at some point you start coming off of it
and you start having withdrawals and guess what, that is
painful too and so we are talking about combining those two.
Are you following me on this? So what is wrong with my
legislation that allows a patient to be treated completely? And
don't tell me about the stigma because it is not about stigma.
It is about treatment. It is about getting the patient back to
who the person they were before.
Mr. Martz. Thank you for your passion and information. I
fully agree with the points that you are making. I would add
respectfully a couple of points in addition to that. In good
clinical care and for the treatment of the use disorder, OK,
for the----
Mr. Mullin. Make it short because I didn't know I was
already over time.
Mr. Martz. Sorry. Thank you, that it is critical to have
that patient be involved in that collaboration so that there
can be the best collaborations. And even in----
Mr. Mullin. They are seeking more treatments because they
are addicted to drugs.
Mr. Martz. Which will all be noted in the PDMP where they
will all have access to that already, information.
Mr. Mullin. Which is important for the doctor to have the
same information. That is why we are trying to see, or trying
to compare the two and make sure that both of them are combined
so the doctor can give the patient the treatment they need.
That they need, they are professionals just like you are a
professional. I yield back.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back. The chair recognizes the gentleman from Georgia,
Mr. Carter, 5 minutes for your questions, please.
Mr. Carter. Thank you, Mr. Chairman, and thank all of you
for being here. And this is a great panel and I appreciate your
participation here.
Mr. Bauer, in 2009, as a member of the Georgia State Senate
I sponsored the legislation creating the Prescription Drug
Monitoring Program in the State of Georgia, so I am very
interested in it. I appreciate you throughout your testimony
clearing up the fact that when States are sharing information
they are not sharing it with all States, they are only sharing
it with certain states. And initially that was a little
confusing, so I hope my colleagues understand that just because
you are sharing information you are not sharing it with all
States. You are only sharing it with States that you choose to
share it with and I just wanted to make sure we got that
straight.
Mr. Guthrie asked you a question, Mr. Bauer, about who is
mandated to see this information that is on the PDMPs and you
answered him and said 40 states mandate. Mandate who to see it,
pharmacists or doctors?
Mr. Bauer. Predominantly prescribers. So the 40 States that
have a mandated use law or statute, typically that is a
prescriber. In a handful of states it also includes the
dispenser which would include the pharmacist.
Mr. Carter. I am not sure I agree with that but I will take
your word on that. In fact, in the State of Georgia when we
created it, it was the pharmacist who had to look at it.
Starting July 1st, the doctors will have to look at it and I
think in most cases it is for the pharmacists and not for the
doctors. But anyway will you clarify that for me and follow up
in my office on that?
Mr. Bauer. Yes, sir.
Mr. Carter. I appreciate that very much. Also I wanted to
ask you, I have had a number of companies come into my office
who are showing me how they can incorporate the PDMPs with the
electronic health records so that we are not disrupting
workflow, and that is certainly something that is important and
certainly something that we have experienced in the pharmacies
when we are trying to incorporate the PDMPs with our workflow.
It is a disruption and the more we can incorporate it into our
workflow the better the program will work, and I am sure that
is the case with physicians as well and I know it is the case
with pharmacists.
Also I wanted to ask you, cash prescriptions, are they
being included in your PDMPs?
Mr. Bauer. Yes sir, all prescriptions, controlled
substances, typically Schedules II through V, including cash,
are required.
Mr. Carter. OK. And let's talk about Schedule V
prescriptions because sometimes that can cause a problem
particularly with patients who are getting medications that are
Schedule V and not necessarily medications of abuse. For
instance, epilepsy patients may get some Schedule V
prescriptions and sometimes this can cause a disruption in
their therapy as well.
Have you experienced anything with that? Is that something
that you are looking at to make sure that we don't disrupt that
therapy?
Mr. Bauer. That is a great question. From a PDMP
perspective that is not something that we weigh in on. That is
typically a state policy decision that is made. Our
responsibility is to collect the information.
Mr. Carter. OK. All right, one last question, you talked
about methadone with I believe it was Representative Guthrie
again. You said the methadone clinics were not required to
report to the PDMPs?
Mr. Bauer. Any methadone administered in a clinic.
Mr. Carter. What about in pharmacies? I am required in
Georgia to----
Mr. Bauer. If it is filled by a pharmacy that is reported
to the PDMP.
Mr. Carter. If it is filled by a pharmacy, but if it is
filled by a clinic it is not?
Mr. Bauer. Correct.
Mr. Carter. There we have it. For a while we didn't have
the VA reporting and that was a problem, now hopefully they are
online as well.
I want to go to you, Mr. Banner, because one thing that has
concerned me and I just wanted to get your opinion on it was
the use of naloxone and the dependency that it seems to be
getting. I know we have had some situations where some of the
ambulances have been carrying so much of it and actually had to
administer so much that it is bankrupting, literally, some of
their budgets and that they have had to stop and only carry a
certain amount on that. Do you see that sometimes happening?
Dr. Banner. We definitely have areas where there are spikes
that are concentrated activities and that is concerning in and
of itself. But yes, for a lot of reasons there are a lot of
shortages of a lot of drugs and that pushes prices up and that
is a problem. I think it is going through a this-should-work-
for-everything phase and we know it only works for the opiate
receptor interaction drugs.
Mr. Carter. Right. But I think one of the problems too is
that users are getting dependent on it knowing that oh, if I
OD, they are going to come rescue me and I will be OK.
Dr. Banner. Yes. I think it does encourage people in some
ways to push the envelope.
Mr. Carter. Exactly, exactly. Thank you. And also thank
you, you mentioned something that throughout these hearings I
have not heard anyone mention: synthetic marijuana. That has
been a big problem in Georgia. Thank you for mentioning that
because we want to continue that as well. And I know I am out
of time and I yield back.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back. The chair recognizes the gentleman from New
Jersey, Mr. Lance, 5 minutes for your questions, please.
Mr. Lance. Thank you very much, Mr. Chairman, and my thanks
to the distinguished panel. We have been back and forth in
several hearings today, several of the subcommittees and of
course votes on the floor. I want you to know this is an
incredibly important topic to the entire nation and you are
among the great experts on it.
Dr. Kilkenny, could you speak briefly about the opioid
crisis and the rise of infectious disease rates and how the two
issues are linked?
Dr. Kilkenny. Yes sir. Blood-borne pathogens are spread by
sharing blood and injection drug use. When people who are
engaged in injection drug use are sharing syringes or other
materials of injection they are often sharing blood. So there
is a clear correlation between those blood-borne pathogens that
would be Hepatitis B, Hepatitis C, and HIV, and injection drug
use.
Mr. Lance. How have your efforts been successful in
bringing together community partners in Huntington to address
infectious diseases associated with the opiate epidemic?
Dr. Kilkenny. The city of Huntington has a remarkable
history of working together against common threats. And with
the opioid epidemic reaching a level that it impacts every
family, we have no problem getting every entity aligned in a
strategy against it. So we have brought in virtually every
other entity in the community into the strategic plan.
Mr. Lance. Thank you. I have introduced legislation
regarding the opiate issue and infectious diseases and my
cosponsors are Congressman Kennedy on the other side of the
dais. This is completely bipartisan and I hope that you as the
experts might have the opportunity to review the legislation.
I think there is a growing awareness among the various
avenues we have to pursue that there is a significant
correlation between the opiate crisis and infectious disease
rates. And we are in this battle together and I am sure we will
overcome and conquer based upon our joint efforts both
bipartisan and bicameral in nature here on Capitol Hill, but
also with leading experts across the country including this
distinguished panel.
Thank you, Mr. Chairman. I yield back the balance of my
time.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman. The chair would recognize Mr. Walberg of
Michigan, not a member of the subcommittee but my understanding
is you want to waive on for questions. Is that correct?
Mr. Walberg. That is correct.
Mr. Burgess. The gentleman is recognized for 5 minutes for
questions.
Mr. Walberg. I appreciate, Mr. Chairman, the opportunity to
join the August subcommittee. I have a great interest in this
and a personal interest and I appreciated hearing what I have
been able to listen to today about the fuller subject that we
are addressing. And of course there has to be compassion. There
has to be a willingness of a patient to seek help, first and
foremost, but there also has to be certainly a willingness of
the medical profession and society in general to reach out and
solve the problem as well.
Earlier this Congress, I introduced Jessie's Law with
Congresswoman Debbie Dingell in an effort to try to find a
solution to something that tragically took place in Michigan
with Jessie Grubb, a resident who had been doing very well in
beating her addiction and growing was involved in a sports
accident injury in preparation for a marathon and had a
surgery. Her family as well as Jessie herself notified the
attending physician, the surgeon, of her problem with
addiction, but it didn't reach the attention for some reason of
the discharging physician and so she was sent home from the
hospital with a prescription of oxycodone which she ultimately
overdosed on the next day and lost her life.
So we want to find a solution to that. And, Dr. Strain, we
are currently examining both Jessie's Law and H.R. 3545, the
Overdose Prevention and Patient Safety Act. Can you elaborate
on the major differences between the bills and, if so, why it
would be helpful to have both?
Dr. Strain. First, I am sorry for that loss and for the
family, for you and how you have had it impact you as well. It
is a tragedy. I think both bills have value. I want to just be
clear, I think that both have great value. I think that both
illustrate the fact that as a physician I teach my residents
and interns when in doubt get more data, and that is something
that we are in a situation now where we may not know about how
to get more data.
So I could, for example, have seen Jessie and not known
about her addiction history if she didn't tell me about that. I
think that as I understand Jessie's bill, I think bringing
together stakeholders who can look at how could something like
this not happen in a medical record again is a worthwhile thing
to do and to see if there is some way that that can be
codified. I don't think it is enough. I think that we have a
situation right now where we have got a whole treatment system,
substance abuse programs that could be taking care of somebody
and I may not know about that.
And it is artificial at this point if I could say, if I
could take a moment to say it is artificial. I could know
somebody has got a substance abuse treatment, substance abuse
problem documented in the record, but it is only if they are in
a particular program that I may not know about what is going on
in that program.
So I have plenty of patients with substance abuse problems.
I have asked them, they have told me. I have it documented in
my records. Those records can be accessed by obstetricians, by
orthopedic surgeons, by whoever. They can get access to that
information in my record but they can't get access to the
treatment records, which is artificial.
Mr. Walberg. So what will give that access? What are the
additional things we need to do?
Dr. Strain. I think the Mullin amendment does that. I think
the Mullin amendment, 3545, does that.
Mr. Walberg. It is mandatory and automatically shared with
any and all who need to know that?
Dr. Strain. Well, with the proper protections in place as
they are required, yes, which Representative Mullin pointed out
in his questions, I think.
Mr. Walberg. OK. Thanks for the opportunity to ask those
questions. I see my time is about expired. I will yield back.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman. The chair recognizes the gentleman from New
York, Mr. Engel, 5 minutes for your questions, please. And the
chair would observe that was the vote being called. So we will,
after Mr. Engel we will recess and reconvene with the next
panel.
But, Mr. Engel, you are recognized.
Mr. Engel. Thank you. Thank you, Mr. Chairman. This week,
Congresswoman Brooks and I introduced the Poison Center Network
Enhancement Act, a bill that will reauthorize the Nation's
poison center programs for an additional 5 years. Speedy access
to poison centers through the national toll-free number, again
800-222-1222, is an essential resource for all Americans,
especially parents who can take solace in the fact that there
are 55 poison centers across the U.S. available 24 hours a day,
7 days a week, 365 days a year.
These centers are a smart public health investment. They
offer real time, lifesaving assistance while at the same time
saving hundreds of millions in federal dollars by helping to
avoid the unnecessary use of medical services and shortening
the amount of time a person spends in the hospital if
hospitalization due to poisoning is necessary. Most of us
already know about much of the work poison centers do thanks to
a magnet on the refrigerator displaying the poison center phone
number. But many may not know about the critical role poison
centers are playing in the fight to end the opioid crisis.
Since 2011, our Nation's poison centers have handled nearly
200 cases per day involving opioid misuse. Data from poison
centers has helped detect trends in the epidemic and experts
have helped educate Americans about the crisis in ways they
could potentially save the lives of their loved ones. For
example, the Upstate New York poison center used the New York
State Fair to educate New Yorkers about proper use of naloxone,
the overdose reversal drug. This bill would ensure that these
important activities continue.
I was proud to co-author the last poison center
reauthorization in 2014 and I am proud to be part of this
legislation. I want to thank Congresswoman Brooks for working
with me for this important bill as well as Congresswoman
DeGette and Congressman Barton for being the original
cosponsors.
Dr. Banner, let me ask you this in light of what I have
said. Thank you for your being here and for sharing your
expertise. This bill would authorize additional funding for the
poison control center grant program. Would you talk about how
this funding will help build capacity at poison centers and
enhance their ability to respond to the opioid crisis?
Dr. Banner. I appreciate everything that you have done,
Congressman, and you know on behalf of the poison centers I
really appreciate you. We hope to continue this fight. We hope
to expand our educational activities as we go forward. We have
a big state, so do you, and getting reaching out, particularly
rural areas where education is critical, is difficult and
expensive and so having extra funding and improving our funding
base helps us in those outreach activities.
We are also actively seeking the first responders to get a
hold of the poison control center as part of naloxone
administration. As the good gentleman from Georgia pointed out,
it could be misused or overused and we want to actively
supervise and help in that program and our ability to continue
that activity is very critical. So we see a lot of
opportunities reaching out to minority communities where these
are problems as well is an important issue for us. So we thank
you.
Mr. Engel. Well, thank you, Dr. Banner. You mentioned in
your testimony that poison centers have helped identify trends
in the opioid epidemic. How do you think that this information
in poison centers could help us as policymakers respond to the
crisis more effectively?
Dr. Banner. Well, I think it already has in a lot of ways.
This is the kind of data when you see it, it may be coming from
the CDC and we work closely with them. Every 8 minutes we
upload from all 55 centers into a central database. Plus,
conversations, we have our listservs and there is a lot of
human intelligence going on where we are identifying things
very early.
The increasing Oxycontin, a lot of our recognition of those
came from the NPDS database which is that contributory public
health surveillance activity that we do. So we are constantly
updating that database so that the FDA, the CDC, can be
monitoring activities. We do that in real time for some acute
events, but we also are looking over long terms. Every year we
publish and people rely upon it heavily to look at trends in
what drugs are becoming more prevalent and identifying new
substances.
So I think you do rely upon us. You might not know it came
from a poison center, but our data is there and it is I hope
really helpful in guiding you to see where the future lies.
Mr. Engel. Well, thank you very much and thank you for your
good work. And thank you, Mr. Chairman. I yield back.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back. The chair recognizes the gentleman from Virginia
for a unanimous consent request.
Mr. Griffith. Mr. Chairman, I would request that we
introduce into the record a letter from the President and CEO
of Titan Pharmaceuticals, Inc., related to the therapeutics for
select chronic diseases and related to opioids.
Mr. Burgess. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Burgess. And the chair wishes to thank this panel. You
have been very informative. It has been a lively morning and
that is what we wanted and so we appreciate your expertise and
your sharing it with us. We are going to take a recess. This
panel may be excused and we will reconvene 10 minutes after the
vote series on the floor with our fourth and final panel. So
the subcommittee stands in recess.
[Whereupon, at 12:44 p.m., the subcommittee recessed, to
reconvene at 1:24 p.m., the same day.]
Mr. Burgess. We do want to thank all of our witnesses for
being here this afternoon and for taking the time to testify
before the subcommittee. Each witness will have the opportunity
to summarize their opening statement followed by rounds of
questions from the members.
And this afternoon, for our fourth and final panel of this
2-day hearing, we are going to hear from Ms. Jessica Hulsey
Nickel, Founder, President, and CEO, Addiction Policy Forum;
Ms. Carlene Deal-Smith, Peer Support Specialist at Presbyterian
Medical Services; Mr. Ryan Hampton, Recovery Advocate, Facing
Addiction; Dr. Mark Rosenberg, Chairman of Emergency Medicine
and Chief Innovation Officer, St. Joseph's Healthcare System,
Board of Directors in the American College of Emergency
Physicians; Ms. Stacy Bohlen, CEO of the National Indian Health
Board; and Ms. Alexis Horan, Vice President of Government
Relations, CleanSlate Centers.
Again thank you all for being with us today. Ms. Hulsey
Nickel you are recognized for 5 minutes.
STATEMENTS OF JESSICA HULSEY NICKEL, FOUNDER, PRESIDENT AND
CEO, ADDICTION POLICY FORUM; RYAN HAMPTON, RECOVERY ADVOCATE,
FACING ADDICTION; CARLENE DEAL-SMITH, PEER SUPPORT SPECIALIST,
PRESBYTERIAN MEDICAL SERVICES; MARK ROSENBERG, DO, MBA, FACEP,
FAAHPM, CHAIRMAN OF EMERGENCY MEDICINE AND CHIEF INNOVATION
OFFICER, ST. JOSEPH'S HEALTHCARE SYSTEM AND BOARD OF DIRECTORS,
AMERICAN COLLEGE OF EMERGENCY PHYSICIANS; STACY BOHLEN, CEO,
NATIONAL INDIAN HEALTH BOARD; AND, ALEXIS HORAN, VICE PRESIDENT
OF GOVERNMENT RELATIONS, CLEANSLATE CENTERS
STATEMENT OF JESSICA HULSEY NICKEL
Ms. Hulsey Nickel. Thank you so much, Chairman Burgess and
Ranking Member Green.
[Disturbance in hearing room.]
Mr. Burgess. Ms. Hulsey Nickel, you are recognized for 5
minutes, please.
Ms. Hulsey Nickel. Thank you so much, Mr. Chairman, for
your leadership on this important issue that is facing so many
families and communities nationwide. My name is Jessica Hulsey
Nickel and I am the President of the Addiction Policy Forum. I
started the Addiction Policy Forum to bring patients, families,
stakeholders across the country together to advocate for a
comprehensive response to addiction including prevention,
treatment, recovery support, overdose reversal, criminal
justice reform and law enforcement, and also bring a voice for
families. We have one goal, to help create a world where fewer
lives are lost to addiction and help exists for the millions of
Americans who need it.
I am grateful to be with you today to discuss key
legislation and how it will help address the addiction crisis.
I know firsthand the devastating impact that substance use
disorders has on families and communities. I lost both of my
parents to addiction, and their substance use disorders meant
for me and my little sister homelessness and foster care and
being wards of the state until I was 10, and then being placed
with our grandparents, and I lost both of my parents far, far
too young.
Every day we lose 174 people to drug overdoses in our
country. One hundred seventy four--that is like a plane crash
every day. It is important to put real faces to the scope of
this crisis and the real families and communities that are at
the epicenter, so we wanted to share with you some of the
stories from our families.
First up is Doug and Pam who lost their daughter Courtney
when she was just 20 years old. He describes Courtney as a
shining star. The room lit up when she walked in and everyone
loved her. Doug writes, we were told that because it is not a
matter of life or death there would be no coverage for
treatment. On the advice of our local authorities we asked her
to leave our home and canceled her insurance. By doing this she
would be homeless and then could be eligible to receive
treatment. Courtney died alone, away from our home, and the day
before she was scheduled to go into a treatment facility.
Lorraine describes her twin brother Larry as amazing,
charming, funny, popular, and the most talented drummer you
have ever heard. Larry died from a drug overdose leaving behind
his 1-year-old son and Lorraine became a single parent
overnight.
Jennifer lost her son Dylan when he was just 19 years old.
She says to us, every day when I walk into my house I see
Dylan's shoes sitting on the floor where he kicked them off and
his jacket draped over the bannister where he left it. He will
never have the chance to get married, to have kids, to travel,
to do all the things that a 19 year old should have
experiences.
And then Amy who runs our Massachusetts chapter, she lost
her son Emmett when he was just 20 years old. In college
studying computer science, Emmett had six overdoses reversed at
his local hospital, but treatment was not initiated and the
family was not notified. Each of these overdoses was an
opportunity to engage him in the help that he needed.
As a community of families, patients, and key stakeholders,
we are so pleased to see the comprehensive approach that this
committee is pursuing with the legislative proposals that are
being considered. I would like to address three pieces of
legislation in particular that will help us respond to this
crisis.
First off, the Comprehensive Opioid Recovery Centers Act of
2018, we have an enormous treatment gap in this country. Of the
21 million people that need treatment for a substance use
disorder, only about ten percent will receive it. Can you
imagine if ten percent of Alzheimer's or ten percent of cancer
or ten percent of diabetes patients received treatment?
Our current healthcare system has many systemic issues that
continue to limit the effective and sustainable implementation
of evidence-based practices to treat substance use disorders.
For example, there is a lack of integration between general and
specialty care. There is a lack of screening for substance use
disorder in health care. There is inconsistency providing all
three FDA-approved medications for opioid use disorder.
The Comprehensive Opioid Recovery Centers Act will help
address these barriers through the development and promotion of
integrated care models based on best practices which will build
a pathway toward a comprehensive healthcare infrastructure that
must be achieved to ensure that everyone suffering with a
substance use disorder has access to quality treatment. This is
a preventable and a treatable illness.
The Addiction Policy Forum supports the quick enactment of
CORC, the Comprehensive Opioid Recovery Centers Act which will
help fill the need for coordinated, comprehensive care for
patients. Many thanks to Congressman Guthrie and Congressman
Green, for their leadership on this bill.
I would also like to address the TEACH Act--Treatment,
Education, and Community Help Act to Combat Addiction. There is
an alarming lack of substance use disorder education in medical
school curriculums and among current physicians. According to
the 2016 Surgeon General's report, only eight percent of U.S.
medical schools have a separate required course on addiction
and only a handful of medical schools have robust curriculum on
the diagnosis and treatment of substance use disorders.
Often, healthcare providers do not feel prepared to deal
with what is commonly perceived as a difficult patient
population, and because of the lack of education for students
and experienced practitioners patients can be denied access to
a large portion of evidence-based treatment options. Physicians
around the country also report not having enough training on
the prescribing of pain medications and alternative treatments
for chronic pain. This particular gap in physician education in
the midst of a worsening opioid epidemic must be addressed.
The TEACH Act incentivizes the development of evidence-
based education and curricula. The legislation would fund
educational institutions be centers of excellence and substance
use disorder education and require such institutions to
collaborate with the stakeholders in their community who are
really on the front lines of this crisis. We are supportive of
the TEACH Act and I thank Congressman Bill Johnson and Paul
Tonko for their work on this legislation.
And, finally, just very briefly, we are also very pleased
to see the Preventing Overdoses While in Emergency Rooms, the
POWER Act. This makes me think of Emmett and his mom, Amy, and
how we can do a better job of equipping our emergency room
physicians and all of our providers and emergency room
departments to address nonfatal overdoses and to use this as an
intervening moment. This is a high priority for the Addiction
Policy Forum and we are in support of the POWER Act and
grateful for this committee and your commitment to these
issues.
And I just wanted to express on behalf of all of the
families that your focus on this issue in such a comprehensive
manner that includes all six of the key components--prevention,
treatment, recovery, support, overdose, reversal--the focus
means the world to us. We have millions of families that are
struggling, some alone, some trying to come together and really
fight for better responses. And so I am here to also transmit
that heartfelt thank you for your leadership and focus on these
issues.
So thank you so much for having me today.
[The prepared statement of Ms. Hulsey Nickel follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. We appreciate your testimony. Of course we
also focused on enforcement during one of our first panels and
as well as scientific discoveries to try to expand the universe
of medications to treat pain.
Ms. Deal-Smith, you are recognized for 5 minutes, please.
STATEMENT OF CARLENE DEAL-SMITH
Ms. Deal-Smith. Good afternoon, ladies and gentlemen. My
name is Carlene Deal-Smith. I am a Native American of the
Navajo tribe from Farmington, New Mexico. I am employed with
Presbyterian Medical Services Totah Behavioral Health
Authority. I work with homeless individuals who have substance
abuse problems.
Due to my own struggles with alcoholism I am able to assist
with what they are struggling with. I understand the impact
substance abuse has on their lives, understand them when they
say nobody cares, the low self-esteem, and the unemployment
they suffer with. The relatives, we call our clients relatives
because that is how we relate to them, totah has a program that
helps them get their life back.
It takes months, maybe sometimes years for them to achieve
sobriety, and being their peer support you have to be
consistent with being available to them. Each day is a new day.
It doesn't matter if they had a bad day yesterday. Being a peer
support you have to model being healthy by your own recovery. A
hard day in sobriety can be achieved when you model you are
taking care of yourself. Being healthy is the key to help the
relatives that still suffer.
I come to you today to show my support for peer support
programs. These programs offer more than just support, they
offer jobs and independence. Thank you.
[The prepared statement of Ms. Deal-Smith follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. The chair thanks the gentlelady for her
testimony.
Mr. Hampton, you are recognized for 5 minutes, please.
STATEMENT OF RYAN HAMPTON
Mr. Hampton. Thank you, Mr. Chairman. Mr. Chairman, Ranking
Member Green, and members of the committee, my name is Ryan
Hampton. I would like to thank the committee for inviting me to
speak on the Ensuring Access to Quality Sober Living Act on
behalf of Facing Addiction with NCADD, which represents over
800 community organizations and 75 regional affiliates across
the United States, a network now reaching over 35 million
Americans.
As a person in sustained recovery and a member of the
recovery community, it is an honor to speak about the impact
that H.R. 4684 will have on Americans with substance use
disorder. I spent a decade struggling with an addiction to
heroin. Addiction is not the result of bad decisions, but
rather a health condition that is exacerbated by drug use. I am
one of millions of Americans affected by it.
Addiction affects people from all backgrounds,
constituencies, races, classes, religions, and party
affiliations. It does not discriminate. However, unlike other
chronic illnesses like cancer and diabetes, we do have a
solution. We are not struggling to find a cure. This issue is
one that we can address together and prevent further loss of
life. One of the ways we can do this is by supporting ethical
guidelines for recovery housing.
The person you see sitting in front of you today is in
remission from the potentially fatal illness of addiction in
spite of the broken system that we have in place. Long waiting
lists, abstinence requirements for housing, unscrupulous
operators, and unethical treatment practices all undermined my
recovery. Some facilities discriminate against harm reduction
measures and medication assisted treatment. That is a barrier
to access and it kills.
I went through multiple treatment centers, detoxes, and
sober living homes before I was finally able to sustain my
recovery. Not everyone has been so lucky. I am here today
because my friend Tyler died of a heroin overdose in a sober
living home. Because there was no naloxone on site and because
the home staff weren't trained to deal with overdoses, my
friend lost his life.
Not having naloxone in a sober living home is like refusing
to put lifeboats on an ocean liner. It doesn't mean that you
are planning on a shipwreck. It means that in case of a
disaster the passengers will make it safely to land. When I
heard how Tyler had died I was outraged and I approached my
congresswoman, Judy Chu. Thanks to her help, the support of
Facing Addiction and the National Alliance of Recovery
Residences, I stand before you today asking for bipartisan
support of H.R. 4684 as a solution. I know it is not a silver
bullet, but it will help get best practices in recovery housing
implemented across the country.
Tyler's death was 100 percent preventable and H.R. 4684
addresses the changes we need in order to ensure that recovery
homes are doing what they are supposed to do, saving lives and
not endangering Americans. Recovery should never be about luck
and it shouldn't be a guessing game for people who are in
desperate need of help. H.R. 4684 is a step in the right
direction that will for the first time allow SAMHSA to develop
best practices that can be disseminated to states and help
people and prevent more tragic overdoses like the one that
killed my friend.
Quality, access, care, and choice are key parts of the
existing NARR standards for recovery residences. Quality means
defining the essential elements of a properly operated recovery
residence. Access means providing a road map for developing the
full spectrum of recovery housing to better match needs and a
blueprint for housing providers to rise to the occasion. Care
means evaluating the peer support components of a residences
recovery environment. Choice means empowering informed recovery
housing choices with regard to placement and resource
allocation.
Everyone should have equal access to recovery support
services. Not just prevention and treatment, but continuing
care that includes peer support and housing. The 2016 Surgeon
General's Report on Alcohol, Drugs, and Health, and the White
House Commission on Opioids final report both recommend the use
of peer recovery supports and recovery housing. Providing
ethical and safe housing and support post clinical services is
linked to higher rates of recovery.
Without these measures in place we will continue to lose
people like Tyler. Millions of Americans who access treatment
and continuing care ask for help in good faith. We must ensure
that their safety net is strong, safe, and ready to catch them.
And, Mr. Chairman, on a personal note, to close I would
like to say that not a single day goes by where I do not think
about the friends that I have lost and the people that I have
loved that are gone from this crisis, and I showed up to
testify today for them, because of them, and in memory of them.
Thank you.
[The prepared statement of Mr. Hampton follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. And the committee thanks you for your
testimony.
Dr. Rosenberg, you are recognized for 5 minutes, please.
STATEMENT OF MARK ROSENBERG
Dr. Rosenberg. Thank you, Mr. Chairman. My name is Dr. Mark
Rosenberg and I am the chairman of Emergency Medicine at St.
Joseph's University Medical Center in Paterson, New Jersey. I
serve on the board of directors of the American College of
Emergency Physicians.
So on behalf of St. Joseph's University Medical Center and
its 170,000 visits in the emergency department per year, the
38,000 members of the American College of Emergency Physicians,
and the great State of New Jersey, I would like to thank the
committee for this opportunity to provide testimony in support
of two bills: ALTO, the Alternative to Opioids in the Emergency
Department Act; and POWER, Preventing Overdose While in the
Emergency Room Act.
There are two cornerstones to ending the opioid epidemic,
prevention and treatment, and they are represented by these two
bills that I am supporting today. The prevention program is
Alternative to Opioids, or ALTO, and the treatment program is
MAT or the POWER Act, and both are necessary to stop the
continued opioid misuse, abuse, and overdose.
Prevention, H.R. 5197 ALTO, was developed by my team at St.
Joseph's University Medical Center in New Jersey in 2016 to
address the variation in prescribing habits and to decrease the
reliance on opioids by emergency physicians. We started the
program with a very simple premise, the best way to avoid
opioid misuse and addiction is to never start a patient on
opioids. The ALTO program is evidence-based protocols using
nonaddicting and therapies that target receptor sites and
enzymes that mediate the pain. An example is a patient with
back pain. Instead of giving them opioids I give them a layered
treatment of therapies that include nonaddicting medication and
trigger point injections resulting in better pain management
and improved patient experience of care.
I am proud to say that after 2 years of implementation at
St. Joseph's, the ALTO program has witnessed tremendous
success. In the first year there was a 57 percent reduction of
opioid use and by the end of the second year there was over an
80 percent reduction of opioid use. These statistics reveal
that education, evidence-based clinical treatment protocols,
can have a dramatic impact on the fight against opioid
addiction and overdose. More importantly, ALTO program can save
lives and already there are emergency physician acceptance
across the country to use ALTO protocols.
Emergency Department-initiated MAT, or medical assisted
treatment, represents the treatment arm of the equation. Let me
give you a moment to tell you about every single patient
addicted or dependent on opioids or heroin fears going into
withdrawal. Patient in withdrawal experiences a feeling of
being sick with chills, sweats, GI symptoms, and agitations.
These patients either have to do another dose of opioids to
stop the withdrawal or they need medical assisted treatment to
stop feeling sick and stop the withdrawal.
ED-initiated medical assisted treatment alone has shown
positive results in getting patients with substance use
disorders into addiction treatment. But MAT, plus a warm hand-
off, yields the best opportunity for success in getting
patients into addiction treatment as well as decreasing the
need for inpatient addiction treatment services.
H.R. 5176 requires that healthcare sites have two essential
ingredients that emergency physicians would like: Providers
that are trained and licensed to provide MAT, and number two,
agreements with community providers and facilities to continue
services--the warm hand-off.
We appreciate what Congress has done to help the opioid
epidemic. The $6 billion included in the Bipartisan Budget Act
of 2018 will be very helpful in turning the tide against opioid
misuse. We urge you and your colleagues to not only authorize
H.R. 5197 and H.R. 5176, but to support full funding of these
programs as well. This is one of the biggest healthcare
challenges of our generation. It took many years to get to this
crisis point and unfortunately it will take some time to
resolve the epidemic.
But we are on the right track. Provide us with ALTO and MAT
tools and funding and emergency physicians will be able to
provide a better future for our patients as well as society.
Thank you.
[The prepared statement of Dr. Rosenberg follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you, Dr. Rosenberg.
Ms. Bohlen, you are recognized for 5 minutes, please.
STATEMENT OF STACY BOHLEN
Ms. Bohlen. Thank you, Chairman. Chairman Burgess and
Ranking Member Green, members of the subcommittee, on behalf of
the National Indian Health Board and the 573 federally
recognized tribal nations we serve, thank you for holding this
important hearing. And in my native language I say, miigwech. I
am Stacy Bohlen. I am the chief executive officer of the
National Indian Health Board and an enrolled member of the
Sault Ste. Marie Tribe of Chippewa Indians in Michigan.
The current opioid epidemic represents one of the most
pressing public health crises affecting tribal communities.
While this epidemic is impacting many communities throughout
America, it has disproportionately impacted tribes and has
further strained the limited public health and healthcare
resources that are available to the tribes. American Indians
and Alaskan natives had the highest rate of drug overdose
deaths every year from 2008 through 2015. A 519 percent
increase in drug overdose deaths from 1999 to 2015 is also one
of our statistics.
These demonstrate the critical need for more comprehensive
interventions in tribal communities to improve prevention and
treatment measures. The epidemic is so bad that several tribes
throughout the country have declared a state of emergency to
tackle the crisis. Historical and intergenerational trauma
including trauma across the life span, lack of funding at the
Indian Health Service, and a failure by states to include
tribes in state level prevention and public health programs all
contribute to this crisis.
In Minnesota, pregnant American Indian women were 8.7 times
more likely to be diagnosed with maternal opioid dependency and
American Indian infants were 7.4 times more likely to be born
with neonatal abstinence syndrome, meaning that the
repercussions of the trauma and this crisis are
intergenerational.
But the lack of funding for the Indian health system
overall is one of the greatest systemic contributors to this
crisis. Deferral of needed care due to lack of funding,
physician workforce shortages at IHS, has created greater
dependence on opioids. Limited funding means denial of needed
care nearly 80,000 times in 2016 alone. Instead of being
referred for surgeries or simpler treatments, patients are
offered and simply placed on prescription opioid medications to
address their pain as they wait for treatment and sometimes
they wait for years.
Policy solutions should focus on allowing tribes access to
long-term, sustained resources improving data and disease
surveillance, and traditional healing approaches. What would we
like Congress to do? Well, number one, allow tribes access to
the state targeted response to opioid epidemic grants. National
Indian Health Board supports the provisions of H.R. 5140 that
address this.
We also request that the legislation include a ten percent
set-aside for tribes. Direct funding of tribes reinforces the
tribal sovereignty and the government-to-government
relationship between the federal government and the tribes. It
also will ensure that tribal communities are directing the
programming so it can be most effective.
Number two, establish tribally-specific funding streams
such as behavioral health program for Indians modeled after the
Special Diabetes Program for Indians. That is outlined in H.R.
3704, the Native Health Access Improvement Act.
Number three, ensure parity between states and tribes in
any opioid related legislation advanced by this Congress. This
means specifically including tribes as eligible entities and
requiring tribal consultation information, data sharing, and
funding set-asides at the state level.
Number four, ensure that cultural and traditional healing
practices are able to be utilized with Federal resources that
includes Medicaid funding. Tribal communities have been healing
our own people for thousands of years and these practices are
highly effective in the communities where they are used. And
five, establish trauma-informed interventions in coordination
with tribes to reduce the burden of substance use disorders
including those involving opioids.
And we just learned that tribes received a $50 million set-
aside in the fiscal year 2018 omnibus for the state opioid
response grant and 5 million was set aside for tribal
medication assisted treatments. This is very important to us.
We know that members of this committee were activists in
getting this effort to happen and we say a big thank you, chi-
miigwech, and this is an excellent start.
Health information technology and data also represents a
serious challenge when it comes to the opioid crisis. I
understand that my time is expired and I want to be respectful
of the other witnesses, so the rest of my remarks appear in our
written testimony. Thank you, Chairman.
[The prepared statement of Ms. Bohlen follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you for your testimony. Without
objection, your full remarks will be made a part of the record.
Ms. Horan, you are recognized for 5 minutes.
STATEMENT OF ALEXIS HORAN
Ms. Horan. Thank you. Chairman Burgess, Ranking Member
Green, and subcommittee members, my name is Alexis Horan, Vice
President of Government Relations for CleanSlate Addiction
Treatment Centers. CleanSlate is grateful for the opportunity
to testify on H.R. 3692, the Addiction Treatment Access
Improvement Act, and H.R. 5102, the Substance Use Disorder
Workforce Loan Repayment Act, two bills that will expand access
to high quality treatment and promote the growth of a stable,
high quality, substance use disorder workforce capable of
meeting the growing demand for evidence-based treatment for
opioid use disorder.
CleanSlate is an office-based opioid treatment program.
That means we help patients overcome their addictions using
pharmacotherapies including buprenorphine and naltrexone, more
commonly known as Suboxone and Vivitrol, in combination with
supportive counseling and clinical and social care coordination
services. Our treatment centers are physician practices staffed
by a combination of physicians, nurse practitioners, physician
assistants, care coordinators, and support staff each of whom
play a critical role in delivering pharmacotherapy-based
treatment for opioid and alcohol use disorders.
CleanSlate operates 41 centers across eight states,
including Massachusetts, Indiana, Pennsylvania, Texas, Florida,
Arizona, Wisconsin, and Connecticut, with 8,000 patients
currently under our active care. Since our inception in 2009,
we have treated nearly 28,000 patients which we believe gives
us a keen understanding of the role medical treatment for
opioid addiction can play in ending the opioid epidemic.
We plan to open our first centers in Ohio and Kentucky this
spring. Our decision to open a new center sets in motion an
intensive recruiting, contracting, and community outreach
effort. Sadly, there is no shortage of demand for our treatment
services, but providing treatment to meet demand is
increasingly difficult primarily due to the challenges we face
in finding willing, experienced prescribers with sufficient
buprenorphine waiver slots to support our program.
Fully 20 percent of CleanSlate prescribers are at or near
their prescription limits. Despite our own internal workforce
building efforts and the addition of advanced practice
clinicians to the pool of eligible prescribers, we are not
always able to fully meet the demand for treatment in the
communities we serve. The Comprehensive Addiction and Recovery
Act of 2016 took important steps toward helping close this
treatment gap. However, demand for opioid use disorder
treatment continues to grow while the workforce does not grow
commensurately.
To give a sense of the dynamic we face, in 2017 CleanSlate
hired and trained 85 providers for medication assisted
treatment through our internal program, 58 of the 85 providers
did not have their prescribing waiver before they came to
CleanSlate. Even with these additions we constantly face
capacity challenges. H.R. 3692, the Addiction Treatment Access
Improvement Act, and H.R. 5102, the Substance Use Disorder
Workforce Loan Repayment Act, will meaningfully close key parts
of the treatment gap that exist in our country and we
appreciate that these measures are under active consideration
by the committee today.
Broadening the pool of eligible prescribers and their
capacity for highly qualified providers to treat larger panels
of patients, simply stated, would enable CleanSlate clinicians
and others around the country to treat more patients
immediately. Allow me to share the experiences of some of our
centers to illustrate this point.
Our Anderson, Indiana treatment center currently employs
four prescribers who are authorized to prescribe MAT for a
combined total of 190 patients. Still, we have 60 patients on a
waiting list at Anderson. As a result, some patients are
driving over an hour away to another CleanSlate program in
Indianapolis to access treatment.
Alternately, our Scranton, Pennsylvania center has nine
prescribers who currently treat 570 patients with 100 treatment
slots still available. That may sound like a lot of capacity,
but in January 85 new patients joined that center and in
February 66 joined. At that rate, our capacity to treat more
people could and likely will be filled by the end of April.
H.R. 3692, the Addiction Treatment Access Improvement Act,
introduced by Representative Paul Tonko, addresses and
alleviates these challenges by allowing a larger pool of
advanced practice clinicians to prescribe MAT by making that
prescriptive authority permanent instead of sunsetting the
authority as it is under CARA, and by allowing highly
credentialed prescribers or those working in qualified practice
settings like CleanSlate to treat up to 100 patients at the
outset instead of just 30 as is under current law.
As stated before, prescription limitations are not the only
barrier to expanding access to treatment. There remains a
dearth of providers who are willing to work in this field due
in part to the complex medical, behavioral, and social needs of
patients with opioid use disorder as well as the stigma
associated with the patient population. These factors make
provider recruiting a challenge.
Retaining a high quality, compassionate workforce is also a
challenge. H.R. 502, the Substance Use Disorder Workforce Loan
Repayment Act, introduced by Representative Katherine Clark,
authorizes a robust loan repayment program for a wide range of
full-time substance use disorder professionals who provide
treatment in underserved areas. Not only will this legislation
incentivize newly minted providers to begin careers that
involve treating substance use disorders, the bill will also
help stabilize the workforce by meting out payments over 6
years which should counter attrition that is all too common in
this field.
CleanSlate strongly supports these important bills and
thanks Representatives Tonko and Clark for their thoughtful
contributions toward addressing an opioid epidemic that affects
us all. Together, H.R. 3692 and H.R. 5102 directly address
barriers that preclude providers from adequately providing
effective treatment for opioid and other addictions.
Thank you, Chairman Burgess, Ranking Member Green, and
members of the subcommittee once again for the opportunity to
speak in support of these bills and on behalf of my
organization and the addiction treatment field at large. The
hearings you are holding are tremendously important to
increasing awareness and building support for the policy
changes needed in our field and we look forward to assisting
you in any way. Thank you.
[The prepared statement of Ms. Horan follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. And we thank you for your testimony. We thank
all of you for your testimony this afternoon and thank you for
bearing with us through what has been a pretty long day. At
this time we will move into the question portion where members
are each recognized for 5 minutes for a series of questions.
And if he is ready, I will yield to the gentleman from
Virginia, Mr. Griffith, 5 minutes.
Dr. Bucshon, Mr. Griffith requests that I recognize you.
Mr. Bucshon. I would be happy to do that. Thanks, Mr.
Chairman.
Since you were the last one to talk, I think maybe I will
ask you a question. First, I have, it is a little opening kind
of statement, then I will ask the other members of the panel.
So, doctors do not prescribe insulin to a diabetic without
education, support, or routine follow-up care. That said,
prescribing buprenorphine without wraparound services, I would
argue, is substandard care. I am fully supportive of doing
everything we can to combat the opioid crisis ravaging the
country. That includes expanding access to medication assisted
treatment, Section 303 of CARA I helped author, for example.
However, it is important that we do so in a thoughtful way.
I was a heart surgeon before, so I am a medical person. A
health professional with no expertise in addiction medicine,
for example, can now prescribe ultimately buprenorphine to 275
patients. That is about 14 patients per day. These patients are
seen just once per month. Do you think that a provider seeing
14 patients a day is consistently able to provide the
comprehensive, therapeutic services that best fits the clinical
needs of his or her patients?
Ms. Horan. Well, thank you for that question. To the
training part, and I can only speak on behalf of CleanSlate and
how we train and educate our physicians, our physicians do come
from a wide range of backgrounds. Regardless of their
background, however, they are all put through about a 4-week
training program, internally with us, which includes a
combination of didactic and onsite learning and training.
In terms of the wraparound services we provide as an
organization, all of our clinicians are trained in supportive
counseling. We staff care coordinators at most of our centers
to make sure that the patient has at least access to, and not
just access to in terms of here is a business card, good luck
finding it in the community, but a warm connection to the
referrals that we have made. That is part of the community
outreach in terms of how we set up in a new community.
So our providers are, we believe, providing extensive
supportive counseling and then relying on the expertise that is
in the community to fill their primary care, dental care, OB-
GYN care, additional behavioral healthcare needs.
Mr. Bucshon. So I guess if you hired someone new and they
go through their training, would you think that they should be
able to see 14 patients a day, all month, right off the bat?
Because I think that is in your testimony and based on the
legislation is what you are implying that they should be able
to go right to the full amount right off the bat.
Ms. Horan. I do. We do, because we believe that we have
established programs that provide the administrative care
coordination and clinical support necessary to enable that
physician or that nurse practitioner or physician assistant to
really attend to the patient's addiction treatment needs.
Mr. Bucshon. Because I think, in CARA we were trying to
expand the scope of who can do this with a 3-year, with a
pilot, expanding the type of practitioner. But do you think we
should really lock in this big of an increase in the number of
patients, really, before we have seen a single piece of data
from HHS as was part of CARA to see if these practices are
successfully treating patients in adhering to the evidence-
based guidelines and ensuring that buprenorphine or methadone
or whatever, buprenorphine, which is one of the most diverted
medications, is not being further diverted? Because the whole
point was if we expanded this we wanted to get data to see if
that was successful.
Ms. Horan. Right, right. Again I am going to speak on
behalf of CleanSlate here and I will answer it in two parts.
One, we feel like we have some data that shows that our
treatment programs are successful. We worked with one of our
payers to look at our patient outcomes and we showed patients
who had been in treatment with us for 6 months had shown, as
compared to the treatment they had for 6 months prior, showed a
35 percent reduction in use of ERs, a 25 percent reduction in
any in-hospital stay, and reduced their conversion to Hepatitis
C by about 80 percent.
So we feel that at least again in our program, a program
that really wraps not just the patients around with services,
but the providers that work with them, the tools that they need
to do their job well, we believe that MAT can be successful. We
have worked now for almost a year with advanced practice
clinicians, thanks in part to the CARA bill, and they are
incredible additions to our team. There is no way we would be
able to meet the demand for treatment in the communities
without them and they work in collaboration with our physicians
in almost every scope of practice.
Mr. Bucshon. Yes. I would just say this, and some of my
personal views is sometimes the ends doesn't always justify the
means. I get that there are a lot of people out there on
waiting lists, but as a healthcare provider I think we also
want to be cautious. Your program is excellent, but there are
others out there that probably are not.
And so when we try to put public policy in place we want to
make sure, I do at least, we think about the patient at the end
of the day and across the country what is going to work. So I
would argue against immediately expanding to 275 without some
sort of a ramp-up and that is my personal view. I yield back,
Mr. Chairman.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back. The chair recognizes the gentleman from Texas, Mr.
Green, 5 minutes for your questions, please.
Mr. Green. Thank you, Mr. Chairman. I want to thank all our
panelists for joining us today, and I will start my questions
with Ms. Nickel.
Ms. Nickel, you note in your testimony that I have been
working with Congressmen Guthrie, Lujan, and Bucshon to
introduce the Comprehensive Opioid Recovery Centers Act. In
your testimony you highlighted that of the 21 million Americans
who need treatment for a substance use disorder like opioids,
only ten percent receive such treatment.
This almost begs the question, why aren't more Americans in
need receiving that treatment?
Ms. Hulsey Nickel. Our treatment system has a lot of gaps
that we need to fill and there are lots of silos and
fragmentation. And I believe the CORC Act will help us to fill
in some of those gaps and make sure that for example, going to
three different places to receive a medication if you have an
opioid use disorder can be very difficult and we need to make
sure we are streamlining how to have patient-centered care so
the right medication is identified and given to that patient
based on a doctor's advice and not just who you happen to find
near you or on a Google search or by calling someone off of a
commercial.
We need to make sure that this is led by health care and
have better provision of evidence-based service.
Mr. Green. What are the most common barriers to receiving
that treatment?
Ms. Hulsey Nickel. I think we have some pair issues with
finding coverage and how do you pay for this. We have a lot of
navigation problems that when this hits your family you usually
are thinking about like how do I Google someplace and empty out
my savings account, rather than how do I go find the right
physician or a counselor to help me build a treatment plan for
myself or for my loved one?
So I think the externalization from health care of removing
this out of our healthcare system is one of the biggest
barriers to making sure that we get the treatments to all the
patients that need it.
Mr. Green. One of the unique requirements of our
legislation is the need for treatment centers to have trained
personnel responsible for outreach to the key community
stakeholders such as institutions of higher education and the
criminal justice system. Can you speak to the importance of
this community integration as part of the treatment and
recovery?
Ms. Hulsey Nickel. Absolutely. Addiction is an illness that
begins mostly in adolescence or young adulthood. Ninety percent
of those that have a substance use disorder it began in those
ages. So that component with higher education or even earlier,
very important to make sure that you are initiating treatment
and intervening early. Right now this is the only disease that
we wait for it to worsen before we treat it. Can you imagine
like waiting for an amputation before you would treat diabetes?
So when you have those community outreach functions out of
your legislation and make sure that we are getting the help
that we need into the places where you can intervene earlier
and have better outcomes for that patient.
Mr. Green. OK. Through your work with the Addiction Policy
Forum do you have experience with treatment that have included
outreach to these key community stakeholders? If so, can you
share how community outreach has and has not improved the
treatment outcomes?
Ms. Hulsey Nickel. I think any opportunity you have for
community outreach is going to improve your outcomes and your
access to care. We need to vastly expand that type of service
and coordination. We need to go into younger ages and also
figure out new ways to get into families and communities so
that they know how to ask for help and where to go for
evidence-based care.
High schools, through employers and through the workplace,
through colleges, through our churches, it doesn't really
matter how they come in the door, but you need to make sure
that they find the right help so they don't get taken advantage
of directed to nonevidence-based care that is going to have
poor outcomes.
Mr. Green. In your work with your family members, people
who unfortunately have lost their battle with addiction as a
result of the opioid overdose, how common is it their loved
ones completed treatment without being offered a range of
treatment options and the necessary support services?
Ms. Hulsey Nickel. Unfortunately, of all of our families a
very large majority could not find evidence-based care. They
were denied care. They were offered very short periods of
treatment, 14 days or 21 days, instead of the long-term
wraparound care that they are needed. As I mentioned, trouble
accessing medications to treat addiction, not providing MAT for
someone who has an opioid use disorder, you are going to have a
very, very difficult time having a positive outcome. So this is
common in the stories we hear over and over again of not having
that quality care.
Mr. Green. OK. Well, Ms. Hulsey Nickel, thank you. Last
month, the CDC published troubling new data showing that
between July 2016 and September 2017 opioid overdoses visits to
emergency room departments increased by 30 percent. In
addition, opioid overdoses are increasing among men and women
of all ages from all parts of the country. This data highlights
the increasing severity of the opioid epidemic and the critical
role emergency departments must play in response to this.
And I will yield back what little time, I don't have any
time left.
Mr. Burgess. No, you don't. The gentleman's time is
expired. The chair recognizes the gentleman from Oklahoma, 5
minutes for your questions, please.
Mr. Mullin. Thank you, Mr. Chairman, and thank you once
again for your continued effort on holding these hearings. It
means a lot to me and so many other families. Thank you to the
panel for being here too and sticking with us. It has been a
long day and so I do appreciate it.
Stacy, thank you for working with us on the IHS Task Force,
coming in and talking to the staff, just Monday, and educating
us and working with us trying to figure out how we can help
better serve Indian country as a whole, and as you said in your
testimony that it is disproportionately high of accidental
overdoses inside of Indian country.
I represent the great State of Oklahoma. I am Cherokee
myself and, I have the highest Native American population of
any district and so this hits home really tough. And part of
what we are trying to do is make sure that it is not
overlooked.
Tribes are unique because we are considered sovereign
nations and so by getting funding to Indian country is vitally
important because most health care for Native Americans are
done within the IHS system. That was the Federal Government
obligation through the treaties to which they were signed. And
I understand most people don't understand that but it is where
I grew up my whole life. I am still living in Indian country. I
still live at the same place I was raised and my family was
raised. We are generational there.
I have got a question for you though. What are the benefits
to direct funding the tribes throughout this program?
Ms. Bohlen. Thank you, Congressman.
Mr. Mullin. No, thank you.
Ms. Bohlen. Well, first of all, directly funding the tribes
upholds the Federal Government trust responsibility and as you
so eloquently expressed the promises that were made in the
treaties to the tribes. The trust relationship that is
established through the Constitution, Federal law, and so
forth, is a relationship between the Federal Government and the
tribes.
When funding for programs is sent to the states with the
hope or maybe even the intention that the state will share that
funding with the tribes, there is no legal obligation and there
is no accountability whatsoever on whether any of that money
will reach the tribes and that is largely because the trust
responsibility cannot be delegated to the states.
Mr. Mullin. Right.
Ms. Bohlen. It has to be honored at the federal level. So
the benefits are tremendous. If I may, Special Diabetes Program
for Indians, it is not a large investment from the government
to the tribes, but it is a public health program that is taking
the best of Western medicine and the best of tribal traditional
practices and implementing a preventive treatment program that
is probably, after immunizations, the most successful public
health program in the country. The tribes know how to do this.
Mr. Mullin. Right. And I want to elaborate just a second on
what you said it is not their obligation. It is not the State's
obligation. The treaty was made with the Federal Government and
it is not a handout. It is payment from land that was taken
from the tribes for years and years ago and that obligation and
that payment still stays in place.
And for tribes to be able to ask the State for it, the
State does look at it as it is not our obligation and which it
is not, it is not any fault to the State. Oklahoma deals with
this in a very unique way. I have 19 different tribes just in
my district and we have a unique relationship with the States.
But we do have to realize that through the grant programs they
need to be available to the Indian country also.
So, one more question for you. Can you discuss the
technical challenges that we have that is hampering Indian
country with getting the data and the information that they
need?
Ms. Bohlen. Yes, I can talk about that briefly. The health
IT system in Indian country, it does not have great
interoperability among the various electronic health records
and so forth, that the tribes who are self-governing may choose
to use an application that is different from what the Indian
Health Service uses which is the RPMS system. And RPMS system
is very cumbersome in terms of trying to extract data and
trying to make the picture that you actually want to make out
of the disparate ways that data is collected.
There needs to be an investment in Indian country to
advance electronic medical records. The agency, I believe,
States it would require $3 billion over 10 years to bring that
system into par with what the rest of America is experiencing.
Mr. Mullin. Thank you so much. My time is out. Thank you,
Stacy, again for working with us. Thank you, Chairman. I yield
back.
Mr. Burgess. The chair thanks the gentleman. The chair
recognizes the gentleman from Maryland, Mr. Sarbanes, 5 minutes
for your questions, please.
Mr. Sarbanes. Thank you very much, Mr. Chairman. I want to
thank the panel for very compelling testimony. I wanted to
focus particularly on H.R. 5102 which has been mentioned. This
is a bill that I am very proud to be cosponsoring with Mr.
Guthrie on this committee, but the prime sponsors are Katherine
Clark of Massachusetts and Congressman Hal Rogers who have
really taken the lead on this issue of trying to respond to
shortages in the workforce.
And it has been touched on by Ms. Horan, but I wanted to
again go over some of the statistics and information we have
that call upon us to have an aggressive and, I think, creative
response to the provider shortage. We know that there are
workforce shortages for all of the various substance use
disorder healthcare professional categories across the United
States. According to SAMHSA in 2012, in addition, the turnover
rates in the addiction services workforce ranged from 18.5
percent to over 50 percent. And in a recent survey, nearly half
of the clinical directors and agencies that specialize in
providing a substance use disorder treatment acknowledge real
difficulty in trying to fill these open positions and then keep
them filled, dealing with the lack of qualified applicants on
the one hand and the inability to keep folks in place on the
other hand.
In Maryland, where we are certainly facing as every State
in the country is a severe crisis in terms of substance use
disorder and the effects of the opioid addiction epidemic, I
have been hearing this as well. Recently I met with the head of
Baltimore Medical System, which is one of our federally
qualified health centers in Maryland, and she told me about her
own difficulty in finding and keeping healthcare professionals
that specialize in this arena.
So the bill that has been introduced by Congresswoman Clark
and Congressman Rogers and is being cosponsored in this
committee by Mr. Guthrie and myself, we create a pretty
creative loan repayment program for substance use disorder
treatment providers. Participants in this program could receive
up to $250,000 in loan forgiveness if they agree to work as a
substance use disorder treatment professional in an area that
is most in need of their services. So that could be a mental
health professional shortage area or in a county or
municipality that has overdose death rates above the national
average. That would be one qualifying category.
Participants can work in a wide range of facilities, which
is important. Community health centers, I alluded to that.
Hospitals, recovery programs, correctional facilities, et
cetera, wherever the need exists in a significant way. And it
will be available to a broad range of direct care providers
including physicians, registered nurses, social workers, other
behavioral health providers.
So we are hoping that this will allow us to attract new
providers into this very, very important field and it has
received strong endorsements from the American Society of
Addiction Medicine, the National Council for Behavioral Health,
the Addiction Policy Forum, and so forth. So again I am very
proud to be part of this.
I did want to ask you, Ms. Horan, just to speak, if you
could, with a little more detail to what you have seen and
gathered by way of data and otherwise about this shortage in
these particular areas of practice and what it would mean to
have this kind of an incentive program in place to address it.
Ms. Horan. Sure. Thank you for the opportunity. Again I am
going to speak from CleanSlate's perspective on this because I
think it is a slice of, I think, reality that might reflect
what other programs like ours are facing.
Recruitment is an ongoing challenge. There are not a lot of
highly trained physicians or advanced practice clinicians with
a lot of addiction medicine background or addiction psychiatry
background. Many of those that are out there are working in the
field already. So we are always looking for new, compassionate,
committed talent to try and help us both grow our programs
across the country, but just try and keep the programs that we
have running.
As you mentioned, turnover is very high for various reasons
in the field. And turnover, while it might be a bear for us in
terms of, the administrative side of it, the biggest problem is
the danger to patient continuity of care. And so any effort,
particularly this one, I think, will really help us bring, and
probably newer, younger talent to the field, the folks that are
really carrying the highest debt burden at this point and that
is a good thing.
I think these are probably folks who are graduating within
the last couple of years who may have had a little bit more of
the addiction and pain education in medical school, we hope,
but also who might not have some of the biases about addiction
treatment that exist in other parts of the treatment. So
certainly for us it is just another wonderful tool that we have
in our toolbox to try and recruit the best, just so that we can
provide our patients with the best care. Thank you.
Mr. Sarbanes. Well, thank you for your testimony. I yield
back. And hopefully we will get this through and help will be
on the way. Thank you. I yield back.
Mr. Burgess. The chair thanks the gentleman. The chair
recognizes the gentleman from Georgia, 5 minutes for your
questions, please.
Mr. Carter. Thank you, Mr. Chairman, and thank all of you
for being here. I have described the opioid epidemic in our
country as being twofold. First of all, we have that part that
is somewhat tangible that we can somewhat put our arms around,
that is, how do you control these numerous prescriptions that
are being written, limiting the number of prescriptions,
limiting the pills, those things are somewhat tangible.
But then we talk about all those millions of people who are
addicted now and how do you deal with that? That is a whole
different subject, if you will, and a whole different
situation. That is why I am so glad to see all of you here and
I appreciate it very well, very much.
And, Dr. Rosenberg, I want to start with you, because as
the only pharmacist currently serving in Congress I find it
fascinating that--I feel like there is a big void that exists
right now in medicine. And I have preached this to the
pharmaceutical manufacturers that we have opioids and once you
get past opioids we really don't have anything else to
prescribe.
You have ibuprofen and tramadol and then you go to opioids
and there is a big gap there. And I have been on the
pharmaceutical manufacturers. We need to fill in that gap. And
over my career I have witnessed miracles come out of research
and development, but I still haven't seen them fill in that
gap. That is why I am so interested in your program. And I want
to tell you that until this hearing I was not familiar with it,
but I commit to you that I am going to study it. I do think
there is value in this. There are alternatives that can be used
that we need to use as opposed to just putting people on the
opioids.
I can remember practicing my pharmacy across from a dental
clinic and they would always give them three prescriptions--
ibuprofen, the pain pill, and the antibiotic. And they would
come in and say oh, I don't need the antibiotic, I just need
the pain pill. Yes, right. Well, we finally passed a self-
imposed rule, you had to get the antibiotic if you are going to
get the pain pill.
But, really, I am going to study more, so I want to
acknowledge you. Now, I want to go to Ms. Nickel.
I found your testimony to be fascinating and I want you to
know how much I appreciate what you are doing. I had the
opportunity along with Chairman Burgess and Mr. Green to attend
a conference a couple of weeks ago and we heard from a retired
sheriff from West Virginia who told the story about a young
man, a boy who was always late for school and who was in a
family of opioid addicts.
And instead of the police officer just simply turning him
into juvenile detention he decided to mentor him and when he
was mentoring him he had a birthday. And he asked him, he said,
what do you want for your birthday? And he said I want a clock.
And the policeman said why would an 8-year-old want a clock?
And he said, because I don't want to be late. I want to be on
time. He didn't even have a clock.
And that is why I find your story so fascinating. How do
you break that cycle? What was different? What broke it for
you? How can we mentor people? We know particularly us in
Congress that, you know, it is just cyclical and the
generations it is hard to break those cycles like that.
Ms. Hulsey Nickel. Thank you. You know, when I get asked
this question I sort of come back to it is all about science.
We need to use evidence-based and science programs and
interventions for kids that are impacted by this epidemic, kids
like me, and we need to find them early and we need to give
them the services right away.
And I love that you mentioned mentoring because that was
one of the key components for me as well. The mental health
department in our county assigned me a big sister when I was 11
years old and it was the first person I had ever met that had
gone to college and was professional and a mentor and a real
guide for me. But I also had mandated mental health. There were
loving family members that I was put with in kinship care,
living with my grandma, my grandparents. And we know to
identify children that are impacted. And there is trauma. There
is adverse child events.
Mr. Carter. Right.
Ms. Hulsey Nickel. You are susceptible to lots of things.
So we need to identify all these kids early and then get them
the services that they need.
Mr. Carter. I am sure probably many of you read the book,
Hillbilly Elegy, and, you know, J.D. Vance and that story, what
a fascinating story. And it is just what you are saying, same
scenario.
Mr. Hampton, I also found your testimony to be fascinating.
Thank you for being here and thank you for what you are doing.
I wanted to ask you, and I really want to ask all of you, what
works? That is something I am struggling with because so many
of my colleagues think all we have got to do is throw money at
it and we know it has got to be more than that. What programs
work?
Mr. Hampton. Thank you for that question, Congressman. It
is a matter of throwing money at things, but I think it is a
matter of throwing money at the right things, first of all.
Mr. Carter. OK, fair enough.
Mr. Hampton. So the Surgeon General's 2016 report, and then
I will go into my own personal experience, said that after year
1 people like myself we are considered in remission after year
1 of recovery. After 5 years we have an 85 percent chance at
maintaining long-term recovery. So the question becomes why are
we not supporting people beyond that in that first critical
first year, but also up to those 5 years? For me----
Mr. Carter. Because this is a lifelong challenge.
Mr. Hampton. It is a lifelong challenge. For me, I had been
through treatment multiple times, detox multiple times. I will
say treatment works. Treatment saved my life. But my 18 friends
who have died in the last 2 years all had been through
treatment, all had been through detox. Where we, I believe the
system is failing is we are not spending enough time and money
on recovery and recovery support services and we are
constantly, you know, we are bunching up treatment with
recovery. Treatment is not recovery. Recovery happens when you
leave treatment.
Mr. Carter. I am way over my time but I have to ask and I
am going to ask, do programs with a spiritual component work
better than others?
Mr. Hampton. Congressman, there are multiple pathways to
recovery. Personally, me, I am a member of a 12-step fellowship
and that is what works for me, but I have seen programs for all
sorts of different people, faith-based, folks who are agnostic.
It works and there are many different ways that people do this.
Mr. Carter. That is the big challenge for us that we find.
We want to fund the programs that work, but it is just a
struggle.
Mr. Hampton. I will add to that, every year SAMHSA--I went
this year in September, they release all the numbers. We know,
the Federal Government knows how many people are addicted to
heroin, how many people are using cocaine, all the different
drugs, the age groups, State by State data. There are 23
million people that are living in long-term recovery in the
United States and I don't believe that the Federal Government
has spent time studying us and how we achieved it. So maybe
that would be a good first step.
Mr. Carter. Again I want to thank all of you for being here
and I yield back, Mr. Chairman.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman. The chair would inquire of the gentleman of
Oregon, do you wish to--pass on questions.
So the chair will recognize the gentleman from Virginia, 5
minutes for your questions, please.
Mr. Griffith. Thank you very much, Mr. Chairman. And I
appreciate all of you being here. As I think one of the
previous members said, it has been a long day for you all. We
know that and we appreciate you being here.
Ms. Nickel, I am going to address most of my questioning to
you. I represent 22 counties, mostly rural, and seven
independent small cities. The biggest one is about 25,000. The
smallest of my cities is 3,500. We are all in an area that is
underserved for drug abuse and mental health so we have
problems there.
So that is where I am coming from when I ask these
questions because we don't have enough treatment centers. In
fact, in a huge number of my counties they just don't have
anywhere to go. And I had some folks who are recovering and
trying to do what they can, but there is no long-term treatment
there. So that is where my questions are coming from and keep
that in mind, if you would, with the answers to them.
So part of that is it is obviously important to build a
pipeline of qualified healthcare providers that have been
trained in substance use disorder treatment and pain management
education, and as I understand it, the TEACH Act will help
highlight curricula from centers of excellence and disseminate
these best practices widely. What types of healthcare workers
will the bill educate and how will the TEACH Act take into
consideration the smaller institutions that are educating
healthcare workers with limited resources, because if you are
just doing the big ones you are not going to reach all of my
counties.
Ms. Hulsey Nickel. Absolutely. Thank you so much for that,
Congressman. The TEACH Act will help to make sure that we get
the right curriculum and training to all different kinds of
healthcare providers, from specialty physicians, emergency
departments, primary care, pediatricians, nurse practitioners.
We need to move this to a chronic disease model, chronic care,
and make sure that we have qualified and trained healthcare
providers in all different types of settings, hospitals, in
your regular doctor's office or your pediatrician's office so
they can identify and assess and treat substance use disorders
more early.
This is particularly important for rural communities where
you are not going to find as much specialty treatment. Very
long distances, we are doing work on the ground in a few places
like Ohio in rural communities, very difficult to find
medication-assisted treatment, providers that can prescribe the
medicines that you need to treat opioid use disorder that can
do that long care follow up. And it also is true we need to
have long-term care plans--12 months, 3 years, 5 years--
depending on the severity of that substance use disorders, and
TEACH Act will give healthcare providers the tools that they
need to assess, identify, and make sure we build those
treatment plans.
Mr. Griffith. I appreciate that. Also, the Comprehensive
Opioid Recovery Centers Act will identify some of the best
centers in America providing care for addiction and recovery.
And from what I understand, these centers deliver the full
complement of addiction services. Congress will direct funding
to support those centers and they in turn will provide
documentation and data on their effectiveness, their models of
care, and their collaboration with their communities.
Is the goal of the bill to scale up and spread so that
there are more centers of excellence across the U.S. or is the
goal to lift all boats with the rising tide so that any
facility can improve even if they are not able to reach the
centers of excellence level? And obviously when you don't have
any you may need to start with something. Even if it doesn't
meet the gold standard, we would like to have something that
meets at least the silver standard.
But what do you think? Will the bill help with that?
Ms. Hulsey Nickel. I believe so. I think it could help
actually with both. I think creating these centers of
excellence so we can really advance what patient-centered care
looks like, to take down these silos to have better coordinated
care, and then the lessons learned from these centers to be
applied throughout our healthcare systems and to all of the
components that we need to treat this illness. So I think it
will actually have both effects.
We have a lot of rural communities that are struggling with
this illness and we need to have more evidence and more new
programs and protocols in place that we get to them quickly.
And I believe that the Comprehensive Opioid Recovery Centers
bill will help to do that.
Mr. Griffith. I appreciate that. And for those folks who
came in to see me, I hope this helps them know that we are
trying to find something and several of those folks as I said
were in recovery. Complement all, it is not easy.
I appreciate you, Mr. Hampton. But all those that we have
had testify over the last couple of days, there have been a
number of people that have had issues who are now in recovery
and I compliment you all. And look, we have to realize there is
a lot of talent out there that we are wasting if we don't use
those people who are in recovery. And I yield back.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back. Does the gentleman from Oregon seek recognition?
Mr. Schrader. Yes, just briefly, Mr. Chairman. I want to
thank the panelists for coming and sharing their stories. That
will help us craft hopefully a better solution at the end of
the day. I am in a listening mode right now and appreciate it
very much, but a colleague of mine I would like to yield to,
the Ranking Member Mr. Green, for some salient questions,
please.
Mr. Green. I want to thank my colleague for yielding to me.
I have got a question for you, Ms. Deal-Smith, but when I
was practicing law and dealt with clients through the mental
health process I saw so many times when people were--it was a
revolving door and a lot of things that we don't understand
that this is a lifelong illness.
And I would see these patients, or clients of mine on a
regular basis. I said, why weren't you, you left here, you had
medication, you were doing fine. And a number of them said,
well, I felt so good I didn't think I needed my medication. And
I said, do you have anybody in your household that has heart
trouble? I don't know if that is cured but you have to take the
medication.
And so, but this is a lifelong illness in some cases and we
need to recognize that. But sure, we would like a cure, but we
would like a cure for cancer too, but we are still trying to
manage it, so. But, Ms. Deal-Smith, how much of are you
comfortable sharing, can you tell us about the background and
history with substance use disorder?
Do you want to turn on your mike?
Ms. Deal-Smith. So my addiction started at an early age. I
was 12 years old when I had my first alcohol and it progressed
as the years went by and when I was like 28 years old I got
into trouble with my addiction. I got a DWI and I had to go to
residential treatment for 28 days. And in that treatment center
I was given the tools to learn about my addiction and how to
help myself get through hard times when they would be coming up
and when I got out of treatment I had a director where I worked
that helped me through the process because he was in recovery
himself.
So I had a lot of support in my recovery and that is what I
bring here is I am there for the people that are in recovery. I
help them get along. I take them to the hospitals, the
medications that are prescribed for them can they take this,
can they not take it, so I talk to the therapists and the
counselors, the substance abuse counselors and we find a good,
a better way to treat them.
And if it is an opioid that they are prescribed we have to
say, OK, is this good for them? The person is in recovery, no,
it is not good for them. Let's look for another alternative so
we can assist with getting them through this hard time. So that
is part of my job is to be there for the client when they need
you most and that is in early recovery.
Mr. Green. Congratulations. You were able to go from your
history to be a peer support specialist. What do you think is
the most important aspect of your job working with people in
recovery, because if it works we would like to see how it works
around the country, so.
Ms. Deal-Smith. It works because people like me who is in
recovery are there to help them guide through the hardest time
of their life to educate them and say, no you can't do this,
yes you can do this. I will help you. I will do this. They meet
me halfway and I meet them halfway. So I am able to be there
for them when they need me the most.
I have people that are taking care of them at night and
then they can call me when the clients, the relatives, need
help, need assistance. I am there for them. I am there all the
time.
Mr. Green. Thank you.
Thank you, Mr. Chairman. I yield back.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back.
Mr. Tonko, you are not on the subcommittee, but do you wish
to be recognized for questions?
Mr. Tonko. I do.
Mr. Burgess. You are recognized for 5 minutes.
Mr. Tonko. Thank you, Mr. Chair and Ranker Green. I thank
you both for waiving me on to the subcommittee. I am grateful
that the committee has decided to focus its attention on this
life and death issue. It means a lot to the communities that I
represent in the capital region to see Congress working
together across the aisle to reduce the burden of this deadly
opioid epidemic.
In particular, I am pleased that we are considering two
bipartisan bills that I have had a hand in authoring, the
Addiction Treatment Access Improvement Act and the TEACH to
Combat Addiction Act. Combined, these bills would expand access
to medication assisted treatments for opioid use disorders and
help to prepare our next generation medical workforce to tackle
the disease of addiction.
So, Ms. Horan, thank you for your testimony in support of
the Addiction Treatment Access Improvement Act. In your written
remarks you discuss the importance of including nurse
practitioners and physician assistants as part of the addiction
workforce. Can you go into a bit more detail about how NPs and
PAs are integral to addiction care at CleanSlate and how
integrating other high skilled nursing professions might
enhance CleanSlate's ability to provide high quality substance
use treatment?
Ms. Horan. I would be happy to. Thank you for the question.
I think, first and foremost, they help us meet the demand in
the communities. As we have mentioned before we have talked
about workforce shortages, some of the limitations around
prescriptive authority, even if you can and are willing to do
it, and the nurse practitioners and physician's assistants have
been willing, wonderful, warm additions to our team.
I would say more than that they work alongside in strong
collaboration with our physicians to prescribe, rather to
provide a whole host of clinical services from physical exams
to the support of counseling to medication management. They are
part of the backbone of our clinical program. In terms of
adding additional highly trained, interested, invested
prescribers, we welcome them all. It is not easy to find folks
who are this eager and this willing to work in the space and if
they want to be part of the solution and join our team, we more
than welcome them.
Mr. Tonko. Thank you. And I would think struggling with
that illness, when you have the moment of clarity, treatment on
demand is essential.
Again, Ms. Horan, how do CleanSlate and other high quality
treatment centers work to minimize the risk of diversion of
medication assisted treatment and how would the Addiction
Treatment Access Improvement Act specifically encourage
expanded treatment capacity in high quality settings like
CleanSlate?
Ms. Horan. Again thank you for the question. So I am not
sure I talked much about our treatment model aside from who
staffs it. We are what we call a high touch model so the
patients that come to our centers are seen with a high level of
frequency. So the sicker you are, the more severe your illness
is, the more frequently you will be seen. That would be about
twice a week.
And then as you progress in your recovery, we are looking
for markers of recovery, a number of things that are telling us
that you are getting better, you will be seen once a week. Even
at your most stable you won't be seen less than once a month.
So that is important for a number of reasons. One, it is a way
to keep the patient and the provider accountable to the
patient's goals. Two, it brings them into the office with
enough frequency where and in each visit they are given urine
drug screens and other things. So we are testing for not just
the drugs of, you know, of misuse but to make sure that they
are taking the medication properly.
We also do more standard diversion control tactics. We do
random pill, or patient recalls where they have to come in and
bring their films and then we count films. And I think those
things all combined we feel pretty secure that our patients are
using the medications as prescribed.
Should a patient for some reason be found to have diverted
the medication for purposes other than why we prescribed it
that would be a cold stop for us. That would be a reason why we
would ask a patient to leave. Now having said that, it is not
in the interest of the patient or in the interest of the
community to not make sure that that patient is somewhere else.
Typically they will be referred up to methadone or somewhere
else in the community.
So I just want to make clear that they are not being exited
to nothing. And there will be instances when they can rejoin
depending on the circumstances but, generally speaking,
diversion, we take a pretty hard stance on that.
Mr. Tonko. Thank you. In your testimony you described
waiting lists to access treatment in your facility in Anderson,
Indiana. Unfortunately this is not an isolated phenomena as I
have spoken with individuals in my district who have had to
wait a year or more for a treatment slot. When an individual
who is struggling with addiction is faced with barriers to
treatment like waiting lists, what does that do for their
chances of recovery?
Ms. Horan. Well, first and foremost, The data shows that if
access to MAT is a relapse prevention tool it also greatly
increases, or reduces the chances that our patients will
overdose. So when patients come to our centers, we have talked
about readiness for change. Readiness for change means we want
to open the door and bring them in right away. To have to turn
a patient away means that we feel like we have put them at risk
for relapse or for overdose. Moreover, it is just demeaning and
demoralizing to finally be ready for change, to be ready to
enter treatment, and to not be able to access it when you are
ready for it.
We will do everything we can to ensure that that patient
even if they can't be seen in our center is at least seen in a
treatment program within the community or within, as in the
case of the Anderson patients can access the next closest
CleanSlate Center. But it is just, fundamentally it is a lost
opportunity that really shouldn't exist.
Mr. Tonko. Thank you, Mr. Chair. I yield back.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back. Does the gentleman from Texas have another
request?
Mr. Green. Mr. Chairman, I have a unanimous consent request
to place into the record a statement from Congressman Bill
Pascrell in support of H.R. 5197, the Alternative to Opioids in
the Emergency Department Act, and also a statement from
Congresswoman Katherine Clark and Congressman Hal Rogers in
support of H.R. 5102, the Substance Use Disorder Workforce Loan
Repayment Act of 2018. I ask unanimous consent to place those
in the record.
Mr. Burgess. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Burgess. The chair will recognize himself for 5 minutes
for questions.
Dr. Rosenberg, I was intrigued by your testimony and your
alternatives that you use in your emergency department. There
is an ancillary bill that is not directly related to what you
are doing, but it seems to me that it has some connection. Dr.
Gottlieb, yesterday, when he, the commissioner of the Food and
Drug Administration, was talking to us talked about the
difficulty of developing new treatments for pain and that the
datasets are sometimes vague and indecipherable. And you seem
to be doing though some work with what you described as
alternative pathways. Is that correct?
Dr. Rosenberg. That is correct.
Mr. Burgess. So the bill that, actually it is only in draft
form right now and it is one that is under development, but it
is to encourage the Food and Drug Administration to develop
draft guidance for alternative pain medicines and use and
breakthrough designation along that development pathway. Again
Dr. Gottlieb referenced how difficult that is in the research
and regulatory environment, but you seem to have found a way to
make that useful. Is that correct?
Dr. Rosenberg. That is correct, Mr. Chairman.
Mr. Burgess. What, if I may ask, if it is not proprietary,
what is it? You reference enzymes in your testimony.
Dr. Rosenberg. The principles behind the ALTO protocol is
to really increase the number of tools in the physician's
toolbox. As one of the congressmen suggested, there used to
only be Tylenol, Motrin, and opioids, and if I wanted to
guarantee the patient the best treatment we would give them
opioids. Obviously that was a bad decision.
The principles between ALTO and the development of the ALTO
protocols was really to search the world literature for
existing protocols that existed without the use of opioids. Let
me just give a quick example. Renal colic, if anybody had
kidney stones, is a tremendously painful condition. But there
have been treatment protocols and treatment successes in the
literature using IV lidocaine that we used to use commonly for
cardiac issues, now that works tremendously well for people
with renal colic. It does two things. One, it relieves the
pain. And we have to do more study on this, but it seems like
it passes the kidney stone more quickly.
So the real secret behind ALTO is finding existing
protocols, not going through an I or a B, not doing a lot of
studies, at least that is how we created it by taking the
protocols that are out there. We use medications like nitrous
oxide and do nerve blocks and lidocaine and use patches, but it
is a layering of different medications and protocols together
to get the maximum benefit for the patient.
Mr. Burgess. Well, I thank you for that. It is very
intriguing. Of course I am old enough to remember when we had
toradol and stadol as new medicines.
Dr. Rosenberg. Yes, indeed.
Mr. Burgess. We no longer have those in our toolbox.
Mr. Hampton, thank you for being here. Your testimony, very
compelling. We have heard and learned something around sober
homes or sober living homes and I assume you are from
California----
Mr. Hampton. That is correct.
Mr. Burgess [continuing]. Since your representative is
Representative Chu. Now there was recently some news from
California about, I think, new regulations at a state level
that they were applying to sober living homes. Do I recall that
correctly?
Mr. Hampton. Actually, yes, Congressman. I have been
working on that legislation also. Yes.
Mr. Burgess. And so I wasn't sure what it was, so I Googled
it and then what impressed me was the vast number of sober
living homes that are available. Sober living homes California,
and there is a lot of stuff that comes up on the little iPad.
And we have had some hearings in the Oversight Subcommittee and
I will say this as delicately as I can, but apparently all
sober living homes are not created equal. Is that fair to say?
Mr. Hampton. That is correct, yes.
Mr. Burgess. And I don't know whether it was you or someone
else who referenced that how you get to treatment may vary and
it could be through an advertisement on the television. We have
all seen the advertisements. I have wondered about the
advertisements. Pretty hard for a patient to discern what is
reasonable, what is not. They are in trouble, they know they
need help, here is someone offering help.
So take us through that a little bit how, from a patient's
perspective how do you navigate that?
Mr. Hampton. Currently, it is nearly impossible, I would
say, to be able to find an ethical, stable home without having
firsthand knowledge of the home or a referral from a trusted
family or friend. As you know, there is a lot of claims-based
marketing that is going on, false claims-based marketing that
is going on with treatment centers and with sober homes.
Luckily for me, my story happens that I, it is by sheer
luck that I sit here today and that I found my way into a
stable recovery residence. I had lived in Florida for some time
also. That is where I am from. So I had been through multiple
unscrupulous homes.
Families have a very hard time navigating the system.And I
think that there is a solution to, you referenced California so
the outcome of my friend Tyler dying was not just going to
Congresswoman Chu and looking at the federal level, but it was
going to our state senator as well and assembly members and
drawing up legislation.
When we came up with SB-1228 there was no standard. There
was no Federal standard. There were no best practices that the
Federal Government was publishing saying here is what a
recovery residence should look like. I believe that that is a
solution. It would have helped us with crafting the California
legislation and I do believe other states are looking for that
as well and part of that should be a ban on claims-based
marketing.
There Re a lot of good places that people could find and we
could draw them a road map, but unfortunately they don't have
the types of budgets that some of these unscrupulous operators
have because of the fraud they have committed and money that
they have made off of the others' backs.
Mr. Burgess. Well, perhaps you will be good enough to share
with the subcommittee some of the data that you have collected
over time and that is a much longer conversation, but we may
ask, if you would, to submit that in writing.
And I do recall during the previous Congress we worked on
the CURES for the 21st Century bill and the mental health title
in that and also the peer support that I think you described
seemed at some times to be almost as effective as the
medication assisted therapies. Is that a fair statement?
Mr. Hampton. Yes. IThat is a fair statement. I think that
again there are varying ways of recovery. I would say that peer
support, in my opinion, medication assisted treatment does not
work without the wraparound services as we have heard and the
peer support. We need more MAT.
I am a supporter of MAT in other but going back to the
housing issue, MAT is not welcome in, I would say, the super
majority of sober homes in the United States. There is a huge
disparity in terms of the services that someone on MAT can
receive. So that is something that the states, I believe, need
to deal with as well.
Mr. Burgess. Very well. Well, you have been a great panel.
And seeing there are no further members wishing to ask
questions, I again want to thank our witnesses for being here
today. I do want to submit statements from the following for
the record.
Regarding H.R. 5102: the American Medicine Foundation, the
Addiction Policy Forum, the American Academy of Addiction
Psychiatry, the American Association of Colleges of Osteopathic
Medicine, American Nurses Association, American Osteopathic
Association and the Massachusetts Osteopathic Society, the
American Society of Addiction Medicine, Association for
Behavioral Healthcare, the Coalition to Stop Opioid Overdose,
the International Certification & Reciprocity Consortium,
Legacy Community Health, National Board of Certified
Counselors, the National Council for Behavioral Health, the
United States Representatives Clark and Rogers.
Regarding the Mullin Amendment in the Nature of a
Substitute to H.R. 3545, a Partnership to Amend Part 2,
Confidentiality Coalition, Premier, America's Essential
Hospitals, Congressman Patrick Kennedy, National Governors
Association, President's Commission on Combating Drug Addiction
and the Opioid Crisis.
Articles from the following: The Journal of Accountable
Care, American Journal on Addictions, New England Journal of
Medicine, Journal of American Medicine, Ascension Michigan,
Bloomberg Health Data Management.
And further statements from the following: The American
Academy of Neurology, the American College of Obstetricians and
Gynecologists, the American Society of Addiction Medicine, the
Electronic Health Record Association, Keith Pardieck, National
Association of Chain Drugstores, National Coalition on Health
Care, Ohio State University, United South & Eastern Tribes
Sovereignty Protection Fund.
And I would also like to submit Congressman Patrick
Kennedy's statement for the record. He was unable to join us
yesterday due to weather, but had planned on it.
[The information appears at the conclusion of the hearing.]
Pursuant to committee rules, I remind members they have 10
business days to submit additional questions for the record. I
ask the witnesses to submit their responses within 10 business
days upon receipt of the questions. Without objection, the
subcommittee then stands adjourned.
[Whereupon, at 2:54 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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