[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]
COMBATING THE OPIOID CRISIS: HELPING
COMMUNITIES BALANCE ENFORCEMENT AND
PATIENT SAFETY
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FIFTEENTH CONGRESS
SECOND SESSION
__________
FEBRUARY 28, 2018
__________
Serial No. 115-103
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
30-411 WASHINGTON : 2019
-----------------------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Publishing Office,
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center,
U.S. Government Publishing Office. Phone 202-512-1800, or 866-512-1800 (toll-free).
E-mail, [email protected].
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
----------
Page
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 1
Prepared statement........................................... 3
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 4
Prepared statement........................................... 5
Hon. Doris O. Matsui, a Representative in Congress from the State
of California, prepared statement.............................. 6
Hon. Greg Walden, a Representative in Congress from the State of
Oregon, 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........................................... 12
Witnesses
Susan A. Gibson, Deputy Assistant Attorney, Diversion Control
Division, Drug Enforcement Administration...................... 13
Prepared statement........................................... 16
Answers to submitted questions............................... 246
Frank L. Fowler, Chief of Police, Syracuse Police Department..... 62
Prepared statement........................................... 64
Patrick M. Beardsley, Ph.D., Professor, Department of
Pharmacology and Toxicology, Virginia Commonwealth University.. 67
Prepared statement........................................... 69
John Mulder, M.D., FAAHPM, HMDC, Director, Trillium Institute.... 80
Prepared statement........................................... 81
Ponni Subbiah, M.D., Chief Medical Officer, Indivior PLC......... 89
Prepared statement........................................... 91
David Y. Kan, M.D., President, California Society of Addiction
Medicine....................................................... 95
Prepared statement........................................... 97
Answers to submitted questions............................... 254
Richard J. Nance, LCSW, Director, Utah County Department of Drug
and Alcohol Prevention and Treatment........................... 109
Prepared statement........................................... 111
Thomas J. Cosgrove, Partner, Covington and Burling LLP........... 136
Prepared statement........................................... 138
Answers to submitted questions \1\........................... 259
Andrew Kolodny, M.D., Codirector, Opioid Policy Research,
Brandeis University............................................ 141
Prepared statement........................................... 143
Answers to submitted questions............................... 261
Richard N. Logan, Jr., Pharm.D., Owner, L&S Pharmacy............. 145
Prepared statement........................................... 147
Submitted Material
Statement of Dr. Halberstadt, of the University of California,
San Diego, submitted by Mr. Green.............................. 178
Statement of the College on Problems of Drug Dependence,
submitted by Mr. Green......................................... 180
Statement of Hon. Brad Schneider, a Representative in Congress
from the State of Illinois, submitted by Mr. Green............. 182
Statement of a public health group, submitted by Mr. Green....... 184
Statement of the American Society of Addiction Medicine,
submitted by Mr. Green......................................... 186
Statement of the Center for Lawful Access and Abuse Deterrence,
submitted by Mr. Green......................................... 188
Statement of Catalent, submitted by Mr. Green.................... 189
Statement of the Pharma & Biopharma Outsourcing Association,
submitted by Mr. Green......................................... 191
Statement of the College on Problems of Drug Dependence,
submitted by Mr. Green......................................... 194
Report from the Center for Budget and Policy Priorities,
submitted by Mr. Green......................................... 196
Article entitled, ``The Opioid Epidemic: A Crisis Years in the
Making,'' The New York Times, October 26, 2017, submitted by
Mr. Lujan...................................................... 204
Article entitled, ``Inside the Story of America's 19th-Century
Opiate Addiction,'' Smithsonian, January 4, 2018, submitted by
Mr. Lujan...................................................... 213
Questions for the record from Representative David Kustoff,
submitted by Mr. Burgess....................................... 216
Statement of Prime Therapeutics, submitted by Mr. Burgess........ 218
Statement of the National Association of Chain Drug Stores,
submitted by Mr. Burgess....................................... 220
Statement of the University of Texas Health Science Center,
submitted by Mr. Burgess....................................... 226
Statement of Catherine M. Davis, Ph.D., Hopkins Bayview Medical
Center, submitted by Mr. Burgess............................... 227
Statement of CVS Health, submitted by Mr. Burgess................ 229
Statement of Braeburn, submitted by Mr. Burgess.................. 231
Statement of the American Hospital Association, submitted by Mr.
Burgess........................................................ 232
Statement of the Drug Policy Alliance, submitted by Mr. Burgess.. 238
Statement of Andrew C. Kruegel of Columbia University, submitted
by Mr. Burgess................................................. 240
Statement of Hon. Mark DeSaulnier, a Representative in Congress
from the State of California, submitted by Mr. Carter.......... 245
----------
\1\ The committee did not receive a response to Mr. Cosgrove's
submitted questions for the record by the time of printing.
COMBATING THE OPIOID CRISIS: HELPING COMMUNITIES BALANCE ENFORCEMENT
AND PATIENT SAFETY
----------
WEDNESDAY, FEBRUARY 28, 2018
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 1:04 p.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, Long, Bucshon, Brooks,
Mullin, Hudson, Carter, Walden (ex officio), Green, Matsui,
Castor, Sarbanes, Lujan, Schrader, Degette, and Pallone (ex
officio).
Also Present: Representative Walberg.
Staff Present: Jennifer Barblan, Chief Counsel, O&I; Mike
Bloomquist, Staff Director; Adam Buckalew, Professional Staff
Member, Health; Daniel Butler, Staff Assistant; Kelly Collins,
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, O&I, DCCP; Jay Gulshen, Legislative
Associate, Health; Zach Hunter, Director of Communications; Ed
Kim, Policy Coordinator, Health; Mark Ratner, Policy
Coordinator; Kristen Shatynski, Professional Staff Member,
Health; Jennifer Sherman, Press Secretary; Austin Stonebraker,
Press Assistant; Hamlin Wade, Special Advisor, External
Affairs; Waverly Gordon, Minority Health Counsel; Tiffany
Guarascio, Minority Deputy Staff Director and Chief Health
Advisor; Jourdan Lewis, Minority Staff Assistant; Samantha
Satchell, Minority Policy Analyst; Andrew Souvall, Minority
Director of Communications, Outreach, and Member Services; and
Kimberlee Trzeciak, Minority Senior Health Policy Advisor.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. The Subcommittee on Health will now come to
order. I will recognize myself for 5 minutes for the purpose of
an opening statement.
On the average, 115 Americans die every single day from an
overdose of an opiate. Our nation remains in the grip of a
frightening epidemic. The latest report from the Centers for
Disease Control and Prevention list West Virginia, Ohio, New
Hampshire, Pennsylvania, and Kentucky, as the five States
hardest hit, but we all know the crisis has ravaged every one
of our States. The statistics are heartbreaking. Five people
every hour on the hour die from an opioid overdose. It has been
said before; it bears repeating: Now more than ever we must
come together and strengthen our commitment to fight this. It
requires an all-hands-on-deck approach. Today's hearing is the
first of three legislative hearings on combating this crisis.
This hearing is the product of the Member Day the Health
Subcommittee held last October where over 50 Members of
Congress, bipartisan Members of Congress, both on and off the
Energy and Commerce Committee, came to us and shared with us
their personal stories of how the epidemic has devastated their
communities, and they also offered potential legislative
solutions. Since then, our teams have been hard at work
examining these policies and engaging the relevant
stakeholders.
There are two panels of witnesses before our subcommittee
today. First, I do want to welcome Susan Gibson, the Deputy
Assistant Attorney in the Diversion Control Division at the
Drug Enforcement Administration. Ms. Gibson, we look forward to
hearing your thoughts and the progress the DEA has made to stem
the flow of opiates through our neighborhood, and how these
legislative proposals would strengthen the agency's efforts in
what is now a public health emergency in our country. On the
next panel, we will hear from a cross section of stakeholders
representing local law enforcement, physicians, pharmacists,
hospice, on one hand, and to the anti-opioid researchers,
manufacturers, and policy groups on the other. We will look
forward to learning their insights on one or more of the bills
being considered today and anticipate a robust debate on the
merits of these policies, as the title of our hearing
indicates. We are seeking help from the communities to balance
enforcement and patient safety.
Today, we will focus our attention specifically on the
Controlled Substances Act. Over the last several months, the
committee has come to realize that some areas of this law
require an update or clarification. For example, synthetic
opioids, like fentanyl, have flooded the United States cities
and towns and pushed drug overdose deaths to levels never
previously seen. H.R. 2851, the Stop the Importation and
Trafficking of Synthetic Analogues Act, offered by
Representative John Katko, will better equip law enforcement to
get illicit synthetic drugs off of our streets while
modernizing scheduling guidelines for these drugs.
Another issue of critical importance is the growing risk of
the misuse and diversion of controlled substances.
Representatives Tim Walberg and Debbie Dingell introduced
legislation, H.R. 5041, the Safe Disposal of Unused Medication
Act, that would reduce the number of unused controlled
substances at risk of diversion or misuse by allowing hospice
workers to safely dispose of these drugs in patients' homes.
Another bill currently in discussion form, authored by
Representatives Ryan Costello and Rick Nolan, will improve
dispensing of implantable and injectable therapies that were
developed to make misuse and diversion more difficult.
We will examine two telemedicine bills that will improve
access for patients. The Special Registration for Telemedicine
Clarification Act, written by Representatives Buddy Carter and
Cheri Bustos, would clarify telemedicine waivers, and direct
the Attorney General to issue regulations for healthcare
providers to prescribe controlled substances through
telemedicine in legitimate emergency situations. The Improving
Access to Remote Behavioral Health Treatment Act, written by
Representative Gregg Harper and Doris Matsui, would expand
access for patients in rural and underserved areas to their
closest community mental health or addiction treatment centers
by allowing these facilities to be obtain a DEA registration
and qualify for the telemedicine exception under the Ryan
Haight Act.
Lastly, the subcommittee will consider two provider
education bills, the first bill, H.R. 4275, the Empowering
Pharmacists in the Fight Against Opioid Abuse, authored by
Representatives Mark DeSaulnier and Buddy Carter, would help
pharmacists detect fraudulent prescriptions through new
education materials. Another bill aims to improve doctors'
understanding of pain management and treatment guidelines and
best practices, among other things, by mandating 12 hours of
continuous medical education on the subject every 3 years. This
policy contained in H.R. 2063, the Opioid Preventing Abuse
through Continuing Education Act, authorized by Representative
Brad Schneider, does concern me because it seems to suggest
that doctors are primarily at fault for this epidemic, but as
we consider solutions critical to blunting this crisis, we must
strike a careful balance prior to casting blame.
As I said earlier, an important aspect of today's hearing
is to think through the debate that all of these policies have
before us. I believe what we accomplish here today will set the
tone for the next two hearings in this subcommittee.
With that, again, I want to welcome our witnesses, and
thank you for being here. And I will recognize Mr. Green of
Texas 5 minutes for an opening statement, please.
[The prepared statement of Mr. Burgess follows:]
Prepared statement of Hon. Michael C. Burgess
Our nation remains in the unrelenting grip of the opioid
epidemic. While the latest report from the Centers for Disease
Control and Prevention lists West Virginia, Ohio, New
Hampshire, Pennsylvania, and Kentucky as the five States
hardest hit, all of us know this crisis has ravaged other
States, too. The statistics are heartbreaking: on average 115
Americans die every day from an opioid overdose--that is nearly
5 people per hour. I said it before and will say it again. Now
more than ever, we must come together and strengthen our
commitment to fight this scourge--it requires an all-hands-on-
deck approach.
Today's hearing is the first of three legislative hearings
on combating the opioid crisis. It is the product 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 while also
offering potential legislative solutions. Since then, our teams
have been hard at work examining these policies and engaging
the relevant stakeholders.
There are two panels of witnesses before our subcommittee
today. First, I would like to welcome Susan Gibson, Deputy
Assistant Attorney in the Diversion Control Division at the
Drug Enforcement Administration (DEA). Ms. Gibson, we look
forward to hearing your thoughts on the progress DEA has made
to stem the flow of opioids through our neighborhoods and how
these legislative proposals would strengthen the agency's
efforts in what is now a public health emergency for the
country. On the next panel, we will hear from a cross-section
of stakeholders representing local law enforcement, physicians,
pharmacists, and hospices on one hand to anti-opioid
researchers, manufacturers, and policy groups on the other. We
also look forward to learning their insights on one or more of
the bills being considered today and anticipate a robust debate
on the merits of these policies that, as the title of our
hearing indicates, seek help communities balance enforcement
and patient safety.
Today, we will focus our attention specifically on the
Controlled Substance Act. Over the last several months, the
committee came to realize that some areas of this law required
an update or clarification. For example, synthetic opioids,
like fentanyl, has flooded U.S. cities and towns and pushed
drug overdose deaths to levels never seen before. H.R. 2851,
the Stop the Importation and Trafficking of Synthetic Analogues
(SITSA) Act, authored by Rep. John Katko, will better equip law
enforcement to get illicit synthetic drugs off our streets
while modernizing scheduling guidelines for these drugs.
Another issue of critical importance is the growing risk of
misuse and diversion of controlled substances. Reps. Tim
Walberg and Debbie Dingell introduced legislation, H.R. 5041,
the Safe Disposal of Unused Medication Act, that would reduce
the number of unused controlled substances at risk of diversion
or misuse by allowing hospice workers to safely dispose these
drugs in patients' homes. Another bill, currently in discussion
draft form, authored by Reps. Ryan Costello and Rick Nolan,
will improve dispensing of implantable and injectable therapies
that were developed to make misuse and diversion more
difficult.
Next, we will examine two telemedicine bills that will
improve access for patients. The Special Registration for
Telemedicine Clarification Act, written by Reps. Buddy Carter
and Cheri Bustos, would clarify telemedicine waivers and direct
the Attorney General to issue regulations for health care
providers to prescribe controlled substances through
telemedicine in legitimate emergency situations. The Improving
Access to Remote Behavioral Health Treatment Act, written by
Rep. Gregg Harper and Doris Matsui, would expand access for
patients in rural and underserved areas to their closest
community mental health or addiction treatment centers by
allowing these facilities to obtain a DEA registration and
qualify for the telemedicine exception under the Ryan Haight
Act.
Lastly, the subcommittee will discuss two provider
education bills. The first bill, H.R. 4275, the Empowering
Pharmacists in the Fight Against Opioid Abuse Act, authored by
Reps. Mark DeSaulnier and Buddy Carter, would help pharmacists
detect fraudulent prescriptions through new educational
materials. Another bill aims to improve doctors' understanding
of pain management treatment guidelines and best practices,
among other things, by mandating 12 hours of continuous medical
education on these subjects every three years. This policy
contained in H.R. 2063, the Opioid Preventing Abuse through
Continuing Education (PACE) Act, authored by Rep. Brad
Schneider, concerns me greatly because it seems to suggest that
doctors are primarily at fault for the opioid epidemic. As we
consider solutions critical to blunting this crisis, we must
strike a careful balance before casting blame.
As I said earlier, an important aspect of today's hearing
is to think through and debate the policies within these pieces
of legislation. I believe what we accomplish here will set the
tone for the next two hearings in our subcommittee.
With that, I again want to welcome our witnesses and thank
you for being here. I look forward to your testimony.
OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Green. Thank you, Mr. Chairman.
I want to thank you for the work on addressing the opioid
epidemic that has impacted countless families and communities
in our country. And as you said, according to the National
Institute of Health, 115 Americans die every day after
overdosing on opioids.
The misuse and addiction that opioids, including
prescription pain relievers, heroin, synthetic opioids, such as
fentanyl, is a serious national crisis that affects public
health as well as our social and economic welfare. The patterns
of lives ruined and lost due to the opioid epidemic must be
reversed. The opioid epidemic is complex and multifaceted, as
you said. However, there are no simple or quick solutions.
Ending the crisis will require better coordination of care,
community involvement, and finding solutions, and more
consistent use of improved pain control options. A
comprehensive response to this crisis must address the limited
resources currently available, the societal ills that fuel
addiction, and the stigma attached to drug use.
In recent years, Congress has expanded in this space. The
Affordable Care Act expanded healthcare coverage to 20 million
non-elderly Americans, giving access to the medical and
behavioral attention opioid victims need to overcome their
addiction. Any honest efforts to address the opioid epidemic
must include measures to stabilize and strengthen the
exchanges, make coverage accessible for Americans who currently
do not have health coverage, including the 3 million Americans
who lost their health insurance in 2017.
Last Congress, I was proud to support the passage of the
21st Century Cures Act and Comprehensive Addiction and Recovery
Act, CARA. CARA authorized several grant programs to help
prevent overdose, expand access to treatment, and help
individuals recover. Unfortunately, some of the grants created
under CARA have yet to receive funding through the
appropriations process. I hope our committee will work with our
colleagues on the Appropriations Committee to secure these
necessary funds.
Speaking with local stakeholders at home about the opioid
crisis, I can share that more Federal assistance is needed to
properly combat this epidemic. The committee needs to seriously
consider authorizing the necessary resources, and our State and
local partners need to help Americans struggling with opioid
addiction and recovery.
I look forward to hearing from our witnesses today, and
continuing our committee's examination at this nationwide
problem in the weeks and months to come.
Now, I would like to yield a minute and a half to my friend
and colleague, Congresswoman Matsui, from California.
[The prepared statement of Mr. Green follows:]
Prepared statement of Hon. Gene Green
Thank you, Mr. Chairman. I want to thank you for your work
on addressing the opioid epidemic that has impacted countless
families and communities in our country.
According to the National Institutes of Health, 115
Americans die every day after overdosing on opioids. The misuse
and addiction to opioids, including prescription pain
relievers, heroin, and synthetic opioids, such as fentanyl, is
a serious national crisis that affects public health, as well
as our social and economic welfare.
The pattern of lives ruined and lost due to the opioids
epidemic must be reversed. The opioids epidemic is complex and
multifaceted, however. There are no simple and quick fixes.
Ending this crisis will require better coordination of
care, community involvement in finding solutions, and more
consistent use of improved pain-control options. A
comprehensive response to this crisis must address the limited
resources currently available, the societal ills that fuel
addiction and the stigma attached to drug abuse.
In recent years, Congress has acted in this space. The
Affordable Care Act expanded health care coverage to 20 million
non-elderly Americans, giving access to the medical and
behavioral attention opioid victims need to overcome addiction.
Any honest effort by Congress to address the opioids
epidemic must include measures to stabilize and strengthen the
exchanges, and make coverage accessible for Americans who
currently do not have health coverage, including the three
million Americans who lost their health insurance in 2017.
Last Congress, I was proud to support the passage of the
21st Century Cures Act and the Comprehensive Addiction and
Recovery Act (CARA). CARA authorized several grant programs to
help prevent overdose, expand access to treatment, and help
individuals recover. Unfortunately, some of the grants created
under CARA have yet to receive funding through the
appropriations process. I hope our committee will work with our
colleagues on the Appropriations Committee and secure these
necessary funds.
Speaking with local stakeholders at home about the opioids
crisis, I can share that more federal assistance is needed to
properly combat this epidemic. Our committee needs to seriously
consider authorizing the necessary resources that our State and
local partners need to help Americans struggling with opioids
addiction and recovery.
I look forward to hearing from our witnesses today and
continuing our committee's examination of this nationwide
problem in the weeks and months ahead.
Now, I would like to yield one-and-a-half minutes to my
friend and colleague, Congresswoman Matsui of California.
Ms. Matsui. Thank you very much.
Thank you for yielding.
Mr. Chairman, I appreciate very much this hearing. As we
continue this discussion, I look forward to working together in
a bipartisan manner to effectively confront issues of access
and affordability for addiction treatment.
I am encouraged by the steps taken today, but want to
emphasize that this is just the beginning of what must be an
iterative and comprehensive approach to combating the opioid
crisis.
We can all acknowledge that, while controlled substances
should be carefully regulated, they also play a vital role in
the effective addiction treatment. Accessing treatment
continues to be a major hurdle in many communities. Today, we
are examining a discussion draft that I am working on with my
colleagues on the committee, Representative Gregg Harper, that
looks at ways that we can use telehealth to increase access to
substance use treatment.
We are also examining a bill authored by my colleague
Representative Brad Schneider that requires providers to
prescribe opioids for pain to undergo training on pain
management. These are targeted strategies, among many that we
must consider. It will also be imperative that we support
Medicaid funding, which has already played a crucial role in
reducing the treatment gap.
I look forward to continuing discussions here. This
conversation must be paired with the significant resources to
help patients and families who are suffering.
Thank you, and I yield back to the ranking member.
[The prepared statement of Mrs. Matsui follows:]
Prepared statement of Hon. Doris O. Matsui
Thank you for yielding. Mr. Chairman, as we continue this
discussion, I hope we can work together in a bipartisan manner
to effectively confront issues of access and affordability for
addiction treatment.
I'm encouraged by the steps being taken today, but want to
emphasize that this is just the beginning of what must be an
iterative and comprehensive approach to combatting the opioid
crisis.
We can all acknowledge that. while Controlled Substances
should be carefully regulated, they also play a vital role in
effective addiction treatment.
Accessing treatment continues to be a major hurdle in many
communities. Today we're examining a discussion draft that I am
working on with my colleague on the Committee, Rep. Gregg
Harper, that looks at ways we can use telehealth to increase
access to substance use treatment.
We are also examining a bill authored by my colleague, Rep.
Brad Schneider that would require providers that prescribe
opioids for pain to undergo training on pain management.
These are targeted strategies among many that we must
consider. It will also be imperative that we support Medicaid
funding. and the ACA. both of which have already played a
crucial role in reducing the treatment gap. I look forward to
continued discussions here. This conversation must be paired
with significant resources to help patients and families who
are suffering.
Thank you, I yield back.
Mr. Green. Thank you.
Mr. Chairman, I have a number of statements that I would
like to ask unanimous consent to place into the record.
Documents: H.R. 2851, a letter from Dr. Halberstadt, of UC San
Diego; a letter from College on Problems of Drug Dependence;
H.R. 2063, a statement on support of the bill from
Representative Brad Schneider; for Ensuring Patient Access to
Substance Use Disorder Treatment Act, a Public Health Group
letter regarding support for the Senate companion; a letter
from ASAM and CLAAD, expressing the support for the Senate
companion for Tableting and Encapsulating Machine Regulation
Act; a letter from Catalent and PBOA. Plus I have a Center for
Budget and Policy Priorities that was just released today on
the Medicaid expansion drastically increased coverage for
people with opioid use disorders. The latest data from the
Federal Agency on Healthcare Research and Quality highlight the
importance of the Affordable Care Act, the Medicaid expansion,
and increasing insurance among people with opioid use
disorders. Our analysis of these data will offer a
comprehensive picture of opioid-related hospitalization around
the country, finds that the share of hospitalization in which
patients were uninsured failed dramatically in States that
expanded Medicaid from 13.4 percent in 2013, the year before
the expansion, to 2.9 percent 2 years later. This steep decline
indicates that many uninsured people are coping with OUDs have
gained covered through the Medicaid expansion.
And I ask unanimous consent to place this in the record.
Mr. Burgess. OK. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Green. Thank you. I yield back my time.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman.
The chair recognizes the gentleman from Oregon, the
chairman of the full committee, Mr. Walden, for 5 minutes for
an opening statement.
OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Mr. Walden. I thank the chairman for his leadership on this
and many other healthcare-related issues, and I want to welcome
our witnesses, and we look forward to your testimony.
No community is immune from the opioid epidemic. It is
ripping apart the very fabric of our neighborhoods, from Oregon
to Ohio, from one coast to the other, from Connecticut to
California. Our friends and our neighbors are experiencing this
epic tragedy neighborhood after neighborhood, one that is
claiming the lives of more than 100 Americans each and every
single day.
Working together, we can and we must continue to help.
Congress must learn from the past. The Comprehensive Addiction
and Recovery Act, or CARA, was an important milestone in
helping States. The breakthrough 21st Century Cures Act struck
a fair balance of speeding up the availability of innovative
new drugs while maintaining patient safety, and it is already
delivering. Those two, in fact, put more money into the opioid
epidemic effort than Congress has ever put forward, and then we
doubled down with a budget agreement that was just passed and
signed into law by President Trump.
Lawmakers must acknowledge the present. In 2016, opioid
overdose deaths from both prescription and illicit drugs were
five times higher than 1999. And as public officials
representing our communities, we must plan for the future, and
that is why we are here today, to work toward our shared goal
of combating the opioid crisis.
Each statistic is disturbing in and of itself. Even more
tragic, every number has a name, a name like Mike. At a
roundtable that I held in southern Oregon a year or two ago, a
man named Mike simply showed up, sat in the chair next to the
wall. Didn't know who he was. And when we were done going
around the room, he wanted to talk about his situation.
You see, Mike's son was injured in a high school sporting
accident, and he became addicted to the prescription
painkillers provided by his doctor to aid in his recovery.
Eventually, Mike's son made the all-too-familiar transition to
the cheaper opioid source: heroin. And to this day, Mike's son
still struggles with his addiction that all began with opioid
prescriptions.
Mike then went on to talk about his sister, who also
suffered from addiction. She was a nurse. He commented that she
found herself with easier access to pills as a nurse, and when
coworkers and others caught on, she moved and continued to
procure pills elsewhere. Sadly, Mike's sister died as a result
of her addiction. So Mike came to the meeting, a roundtable of
law enforcement and medical professionals, to share his story
about what he had faced, what he had lost, and what he was
coping with.
His, tragically, is not a unique story; it is the story
that is ripping apart families all across our country. So we
have to act. And, as people know, this committee has had a very
aggressive, ongoing, diligent, deep investigation through the
Oversight and Investigations Committee on how we got to this
place in this country, and we will hold people responsible from
one end to the other.
The second track, however, is about the legislative
initiatives we can all wrap ourselves around in a bipartisan
way and move forward to get illicit synthetic drugs off the
streets. To safely dispose of unused controlled substances, to
improve patient access to substance use disorder treatments and
remote services, to help providers and pharmacists to better
prevent addiction, these are among just a few of the bills
today. And this is but one of three upcoming hearings on this
subject, with legislation we hope to be able to move to the
floor routinely and regularly between now and Memorial Day.
So it is important to acknowledge that this legislative
hearing is the appropriate venue to ask tough questions and to
make constructive suggestions on how we can improve these
bills. That is what the hearing is all about. Many of these are
discussion drafts because they are admittedly in need of
discussion.
So I look forward to the feedback from our witnesses and
our members. In the coming weeks, we will continue this hard
work, and we will continue the legislature hearings, and we
will get our job done. People like Mike and Mike's son and his
sister's family are depending on us, and we have a big job to
do here.
So I thank the members who have been so active in
participating. Together, we are going to get this job done, and
we need your help. So I would like to thank our two panels of
witnesses for being here today, and I look forward to your
feedback on these important issues.
I would also like to thank my colleagues for staying in
town to have this vital discussion. When others went home to
their districts, these Members said, ``This matters,'' and they
stayed. So combating the opioid crisis requires an all-hands-
on-deck approach, and I appreciate everyone's shared commitment
to that effort today and in the weeks and months ahead.
With that, Mr. Chairman, I appear to have run out of time,
and I will stop.
[The prepared statement of Mr. Walden follows:]
Prepared statement of Hon. Greg Walden
No community is immune to the opioid epidemic. It's ripping
apart the very fabric of our neighborhoods. From Oregon to
Ohio. From Connecticut to California. Our friends and our
families are experiencing an epic tragedy--one that's claiming
the lives of more than 100 Americans each and every single day.
Working together, we can help.
Congress must learn from the past. The Comprehensive
Addiction and Recovery Act, or CARA, was an important milestone
in helping States. The breakthrough 21st Century Cures Act--
striking a fair balance of speeding up the availability
innovative treatments and safeguarding necessary public health
protections--is already delivering.
Lawmakers must acknowledge the present. In 2016, opioid
overdose deaths--from both prescription and illicit drugs--were
five times higher than in 1999. And as public officials
representing our communities, we must plan for the future. This
is why we're here today--to work towards our shared goal of
combating the opioid crisis.
Each statistic is disturbing. Even more tragic, every
number has a name. Like Mike.
At a roundtable I held in Oregon, a man named `Mike' showed
up. Literally, he just showed up. Mike didn't know anyone in
the room. He'd heard of our meeting to discuss opioid abuse on
the news and wanted to share his story.
Mike's son was injured in a school sporting accident, and
he became addicted to the prescription painkillers provided by
his doctor to aid in his recovery. Eventually, Mike's son made
the all-too-familiar transition to a cheaper opioid source:
heroin. To this day, Mike's son still struggles with his
addiction that began with opioid abuse.
Mike went on to speak about his sister who also suffered
from addiction. A nurse, Mike commented that she found herself
with easier access to the pills. When coworkers and others
caught on, she moved and continued to procure pills elsewhere.
Sadly, Mike's sister died as a result of her addiction.
Mike came to the meeting--a roundtable I held with law
enforcement and medical professionals--in hopes that sharing
his stories could help ensure it doesn't happen to other
families.
Mike, and the countless other folks who have fallen victim
to this crisis, is the reason we're here today.
Today marks our first of three legislative hearings this
Congress. We'll focus on equipping law enforcement with the
necessary tools to fight the opioid epidemic with careful
attention to not compromising important public health
protections.
Getting illicit synthetic drugs off the streets, safely
disposing of unused controlled substances, improving patient
access to substance use disorder treatments and remote
services, and helping providers and pharmacists better prevent
addiction are among the handful of bills we'll review today.
It's important to acknowledge that this legislative hearing
is the appropriate venue to ask tough questions and make
constructive suggestions on how to improve these bills. Many of
these bills are discussion drafts because they are admittedly
in need of discussion. I look forward to feedback from each of
our witnesses as well as both the Democratic and Republican
members of this subcommittee.
In the coming weeks, this subcommittee will continue its
hard work with legislative hearings related to public health
and prevention efforts, as well as issues pertaining to
insurance coverage. This is just the beginning and represents
only a fraction of the ideas members from across the country
have formulated to overcome this epidemic.
I'd like to thank our two panels of witnesses for being
here today, and I look forward to your feedback on these
important issues. I'd also like to thank my colleagues for
staying in town to have this vital discussion. Combating the
opioid crisis requires all-hands-on-deck, and I appreciate
everyone's shared commitment in this effort.
Mr. Burgess. Do you yield to the gentlelady from Tennessee?
Mr. Walden. I would be happy to yield to the gentlelady
from Tennessee.
Mrs. Blackburn. Thank you, Mr. Chairman.
And I appreciate so much the hearing and our panels for
being here today to work with us on this issue. Tennessee has
seen a 10-percent increase in opioid deaths in 2015 and 2016.
And while we have worked for years on this issue, first
correspondence going back to 2012, on how we deal with this
epidemic, we are pleased to have this--Representative Katko's
bill, SITSA.
We are interested in your perspective on that. Dealing with
the synthetics is going to be important. Looking at the
scheduling of this, we know it needs to be a focus, because
much of the increase in the deaths deals with the synthetics
and the analogues. And thank you for being here. Thanks for the
perspective that you bring. And, as the chairman said, we have
got three hearings that are going to be on bills going forward.
We want to do our part at the Federal level to work with our
State and local responsibilities so that they have the ability
to address this crisis.
I yield back.
Mr. Burgess. The chair thanks the gentlelady.
The gentlelady yields back.
The chair recognizes the gentleman from New Jersey, Mr.
Pallone, the ranking member of the full committee, 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 is the first in a series of hearings meant to address
the opioid and substance abuse crisis that is ravaging
communities across the country. In my home State of New Jersey,
more than 2,200 people died from opioids in 2016 alone, but
obviously, this is a national crisis that is devastating
families every day, and, simply put, a lot more needs to be
done.
Now I must say that I am utterly confused as to why the
Republican leadership has chosen to hold this hearing on a day
when Congress is not in session, because these are serious
issues that deserve serious consideration. I know Chairman
Walden was thanking those who didn't go home and stayed, but,
frankly, no Member, in my opinion, should have to choose
between staying in Washington when we are not voting or going
home. And I think it is unfair to all the witnesses who have
flown here today and will likely end up with less engagement by
the time the panel ends.
I get the feeling that the Republican leadership is just
checking the box instead of giving members, staff, and
stakeholders the time to carefully consider the important
issues like the opioid crisis.
But last Congress, we took bipartisan action to pass CARA
and 21st Century Cures, both of which provided initial
investments and steps to address this crisis. These laws are
expanding access to treatments and providing recovery support
services, financial resources to help States take action to
prevent the misuse and abuse of opioids, and support the
reduction of controlled substances in circulation. And I look
forward to working to build on those efforts from both CARA and
21st Century Cures.
The legislative proposals we are examining today strive to
address a number of discreet policy problems under the
Controlled Substances Act that healthcare practitioners and law
enforcement officials face in combating the opioid and
substance abuse crisis. For example, we are considering
legislation from Congressman Walberg and Dingell that would
empower hospice employees to dispose of unneeded controlled
substances after a patient has passed away.
Another proposal from Congressmen Costello and Nolan would
allow pharmacies to dispense implantable and injectable
controlled substances directly to a practitioner, reducing the
ability for misuse or diversion. And we are also considering
legislation from Congressman Schneider, who I note is here,
that would require mandatory prescriber education as a
condition of DEA licensure. This would ensure that all
providers who treat patients for pain with opiates have
training on the best practices for prescribing opioids, early
detection of opioid addiction, and treatment and management of
opioid dependent patients.
I know that Chairman Burgess--I don't know if he was being
very critical--seemed to suggest that he didn't like the fact
that many of us consider doctors a part of the problem. I think
doctors are part of the problem. Now, that doesn't mean to say
that they are intentionally trying to overprescribe or do
anything bad.
But my experience, Chairman Burgess, is that oftentimes
doctors feel that they have to prescribe things and address
pain problems. That comes from their education, that that is
sort of their obligation. And so I think a lot of times we do
get doctors overprescribing, not because they are intentionally
trying to do anything abusive or criminal, but just because
they have learned in medical school that they need to do this,
they need to take care of pain if people are in pain.
So I do think that we need more education. I think that
many of the older doctors are not necessarily aware of the
dangers of overprescribing. So I am not trying to be difficult
with you, but I do think that is something that needs to be
addressed and that Congressman Schneider's bill does address
effectively.
We also will discuss how we can employ telemedicine in
treating those suffering from substance abuse and mental health
disorders, including individual practitioners and community
mental health centers and addiction treatment facilities. While
this policy holds the potential to expand treatment options for
those suffering, we must carefully consider how we can
safeguard against further abuse or misuse of controlled
substances.
And, finally, we will consider two proposals that I
continue to have strong concerns about. One is H.R. 2851, which
attempts to address the problem of illicit synthetic analogues.
And the second is the discussion draft that would propose
scheduling tableting and encapsulating machine-like controlled
substances.
I recognize the importance of addressing illicit synthetics
drugs and illegal importation, but both of these proposals
would give the Attorney General broad and unprecedented new
authority, including criminal penalties, as a way to deter
traffickers that fuel our opioid crisis.
I just want to say, Mr. Chairman, I do look forward to
hearing more from DEA and our witnesses today on these issues,
and I hope to work with all of us on a bipartisan basis to
address these concerns. Thank you.
[The prepared statement of Mr. Pallone follows:]
Prepared statement of Hon. Frank Pallone, Jr.
Today is the first in a series of hearings meant to address
the opioid and substance abuse crisis that is ravaging
communities across the country. In my home State of New Jersey,
more than 2,200 people died from opioids in 2016 alone. This is
a national crisis that is devastating families every day.
Simply put, a lot more must be done.
That is why I am utterly confused as to why the Republican
leadership has chosen to hold this hearing on a day when
Congress is not in session. These are serious issues that
deserve serious consideration. I know Chairman Walden was
thanking those who didn't go home and stayed, but frankly in my
opinion no Member should have to choose to stay in Washington
when we are not voting or go home. It is also completely unfair
to all the witnesses who have flown here and will likely end up
with less engagement by the time their panel ends. I get the
feeling that the Republican leadership is just checking the box
instead of giving members, staff and stakeholders the time to
consider important issues like the opioid crisis.
Last Congress, we took bipartisan action to pass CARA and
21st Century Cures, both of which provided initial investments
and steps to addressing this crisis. These laws are expanding
access to treatment and providing recovery support services,
financial resources to help States take action to prevent the
misuse and abuse of opioids, and support the reduction of
controlled substances in circulation. I look forward to working
to build on these efforts.
The legislative proposals we are examining today strive to
address a number of discrete policy problems under the
Controlled Substances Act that health care practitioners and
law enforcement officials face in combatting the opioid and
substance abuse crisis. For example, we are considering
legislation from Congressmen Walberg and Dingell that would
empower hospice employees to dispose of unneeded controlled
substances after a patient has passed away. Another proposal
from Congressmen Costello and Nolan would allow pharmacies to
dispense implantable and injectable controlled substances
directly to a practitioner reducing the ability for misuse or
diversion. We also are considering legislation from Congressman
Schneider that would require mandatory prescriber education as
a condition of DEA licensure. This would ensure that all
providers who treat patients for pain with opioids have
training on the best practices for prescribing opioids, early
detection of opioid addiction, and treatment and management of
opioid-dependent patients.
We will also discuss how we can employ telemedicine in
treating those suffering from substance use and mental health
disorders, including individual practitioners and community
mental health centers and addiction treatment facilities. While
this policy holds the potential to expand treatment options for
those suffering, we must carefully consider how we can
safeguard against further abuse or misuse of controlled
substances.
Finally we will consider two proposals that I continue to
have strong concerns about. The first is H.R. 2851, which
attempts to address the problem of illicit synthetic analogues.
The second is a discussion draft that would propose scheduling
tableting and encapsulating machines like controlled
substances. While I recognize the importance of addressing
illicit synthetic drugs and illegal importation of industrial
pill presses, both of these proposals would give the Attorney
General broad and unprecedented new authority, including
criminal penalties, as a way to deter traffickers that fuel our
opioid crisis.
I look forward to hearing more from DEA and our witnesses
today on these issues, and hope to work with my colleagues to
address these concerns so that we can all support legislation
that will help to address the opioid crisis.
Thank you, I yield back.
Mr. Burgess. The chair reluctantly thanks the gentleman.
The gentlemen yields back.
The chair now is pleased to--well, that will conclude
members' opening statements.
I would remind members, pursuant to committee rules, all
members' opening statements will be part of the record.
And we, again, want to thank our witnesses for being here
today and taking the time to testify before the subcommittee.
We do have two panels, and each witness will have the
opportunity to give an opening statement followed by rounds of
questions from members. Our first panel today, we are hearing
from Ms. Susan Gibson, the Deputy Assistant Attorney, Diversion
Control Division of the Drug Enforcement Administration.
We do appreciate you being here with us today, Ms. Gibson.
You are recognized for 5 minutes for an opening statement,
please.
STATEMENT OF SUSAN A. GIBSON, DEPUTY ASSISTANT ATTORNEY,
DIVERSION CONTROL DIVISION, DRUG ENFORCEMENT ADMINISTRATION
Ms. Gibson. Chairman Walden, Subcommittee Chairman Burgess,
Ranking Members Pallone and Green, and distinguished members of
the Health Subcommittee, thank you for holding this legislative
hearing today on several bills impacting the Controlled
Substances Act aimed at combating the opioid epidemic.
Let me say from the outset, the opioid crisis has been--and
will unfortunately continue to be--the top threat facing our
Nation. This epidemic includes not only prescription opioid
medications but also the proliferation of heroin, illicit
fentanyl, and fentanyl analogues.
Despite record numbers of overdose deaths, 64,000 in 2016
alone, we are making progress on the prescription drug front.
However, I fear that we are witnessing a fundamental shift
toward cheaper, easier to obtain illicit fentanyl produced in
foreign countries. This is where the opioid epidemic converges
with the synthetic drug threat.
Data has shown that the increase in opioid-related deaths
is largely attributed to illicit fentanyl. Synthetic opioids,
cannabinoids, stimulants are produced by rogue chemists who
create new drugs with unknown pharmacological effects in
humans. Because synthetic drugs are made in the lab, the profit
potential is enormous, and the ability to stay ahead of the law
only requires a small tweak in a molecular structure.
One kilogram of fentanyl purchased in China for roughly
$5,000 can generate up to $1.5 million in drug proceeds. All
the while, unsuspecting users of synthetics drugs are playing
Russian roulette every time they use these deadly substances.
The questionable legal status of these synthetics and their
ever-changing chemical composition makes it difficult for our
Federal, State, and local law enforcement counterparts to
intercept these deadly substances before they hit our streets.
This is not a U.S. problem. It is an international problem
that is growing in scope. According to the United Nations, more
than 100 countries have reported the presence of synthetic
drugs, and as of March 2017, approximately 750 substances have
been reported to the U.N.'s early warning advisory.
So what is the DEA doing about it? We are moving
aggressively to place temporary Schedule I controls on new and
emerging synthetic drugs. Since March 2011, DEA has utilized
this authority on 19 occasions to place 56 synthetic drugs in
Schedule I on an emergency basis, including 17 fentanyl
analogues. This process is unfortunately reactive and means
that we first observe the deadly consequences of synthetic drug
abuse before initiating control.
On February 6, 2018, DEA temporarily placed emergency
controls on the entire class of fentanyl-related substances in
an unprecedented effort to curb the disturbing trend in
fentanyl-related overdose death. Of course, we are continuing
to conduct criminal investigations. For example, last year, DEA
played a major role in helping take down AlphaBay, the largest
criminal marketplace on the internet and a key source of
illicit synthetics, including fentanyl, being shipped into the
United States.
Additionally, we have worked productively with China to try
and stem the flow of synthetics to our shores, resulting in the
scheduling of nearly 130 new psychoactive substances since
October 2015. Last month, domestic controls became effective in
China for two essential fentanyl precursors: NPP and ANPP.
Beyond the deadly synthetics threat, DEA is committed to
combating the epidemic through several different avenues,
including expansion, disposal, and treatment options, new pill
press regulations, and outreach to practitioners regarding the
prescription of opioids. The implementation of telemedicine
regulations pursuant to the Ryan Haight Act of 2008 to the
recent publishing of a final rule that help increase access to
opioid addiction treatment, DEA believes that this is important
to ensure access to opioid treatment options while mitigating
the risk of diversion.
In July 2017, DEA implemented a final rule pertaining to
domestic and international transactions involving tableting and
encapsulating machines. Overall, this rule will give DEA
greater visibility of transactions involving tableting and
encapsulating machines.
Finally, DEA recognizes the importance of opioid
prescription training for prescribers and has begun to ask
whether they have received training regarding prescribing or
dispensing of opioids. While this information is voluntary, it
will provide better data to show how many prescribers are
taking training.
Thank you for the committee's focus on the opioid crisis,
and I look forward to answering any questions you may have.
[The prepared statement of Ms. Gibson follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. We thank you for your testimony.
We will now move on to the portion of the hearing where
Members will be recognized to ask questions, and I am going to
begin the questioning by recognizing myself for 5 minutes for
questions.
On the proposed legislation offered by Mr. Katko on the
creating a new level of scheduling on the fentanyl analogues, I
guess, primarily, but I guess it could include other compounds
as well. Now, we are going to hear some testimony from our
stakeholders on the second panel about how that will perhaps
increase the bureaucratic load on people who are involved in
the research on these compounds.
Do you see the potential for any difficulty there or any
conflict there?
Ms. Gibson. Sir, I understand your concern for research,
and it is our concern, too. DEA supports research. We have
never denied a valid FDA research application, especially on
synthetic drugs. We welcome research on synthetic drugs. Right
now, we have 600 Schedule I researchers that are approved. We
have 420 that are approved regarding THC extract. And then we
have another 120 that are approved on an additional CBD
extract. So DEA is fully behind research.
Mr. Burgess. So, again, one of the observations that will
likely be made by a witness in the second panel is concerning
compounds that are put on a scheduling list, that once they get
on, it is almost impossible to get off. And I believe the point
is going to be made that the difference, the molecular
difference, between agonist and an antagonist can be quite
small. And if we restrict the access to molecules of a certain
class, that we may in fact be limiting the ability to research
drugs or compounds that would be helpful as antagonists.
Is that something that your agency is looking at or
concerned about?
Ms. Gibson. Sir, I understand your concern about the
analogues and the quick-changing nature of it, and I believe
with the bill that we are trying to pass here, it could be more
proactive in that arena. I think the biggest problem is exactly
what you said. We have a substance that we get; we identify it
as a problem. They change one atom on it, and then it is a
whole new substance. It is labeled differently, and it is
another problem to attack.
We do believe that fentanyl analogues belong in Schedule I.
We will look at every substance differently. And we work with
our counterparts at HHS and make sure all the scientific data
is there, and we make sure that we do it right as much as we
can. But we look forward to working with the committee about
any kind of concerns regarding that.
Mr. Burgess. And that is, of course, the whole purpose in
having the hearing, to explore some of these issues that are
brought up. You all will work closely with the Food and Drug
Administration as far as scheduling things in that class. Is
that correct?
Ms. Gibson. Sir, we work very closely with our counterparts
at HHS, FDA, and we rely on them and their expertise, yes.
Mr. Burgess. Let me just ask you a question. And you
mentioned it. Mr. Pallone mentioned it, as far as the
educational aspect. I am a physician, and I did receive
training on the use and potential misuse of opiates. It was
called medical school. I would just ask you, as far as the
agency is concerned, you see legislation being proposed where
you are going to be responsible for the oversight of an
educational activity that will be administered to the Nation's
physicians. I would just ask the question: Is the agency set up
to do that? Is the agency set up to handle that?
Ms. Gibson. Sir, I understand your concern for continuing
medical education, and we think it is paramount. We think it is
critical.
Mr. Burgess. Let me just--I do, too. And, historically,
that is an activity that has been regulated by the State. My
state requires me to receive a certain number of hours of
continuing education. Although I am not active and in practice,
I do keep my license active. So, yes, I am required to do those
things every year before that license can be renewed. So they
are set up, and that is part of the process.
Do you feel like your agency is ready to administer to the
continuing educational needs on this front the same as, say, a
State licensing agency is already doing?
Ms. Gibson. Sir, we definitely work closely with the States
regarding that, and that is a procedure that we would have to
look extremely close at, and we would have to work with the
committee to make sure that we would get that right. Again, we
do believe in continuing medical education. I don't think we
can dictate exactly what they take. It is----
Mr. Burgess. And therein is the problem. I will just pledge
to you that, yes, it is an issue that is important to me, and
we will work closely on that.
Ms. Gibson. I look forward to working with you.
Mr. Burgess. I will yield back my time.
I am pleased to recognize the ranking member of the
subcommittee, Mr. Green, 5 minutes for questions, please.
Mr. Green. Thank you, Mr. Chairman.
And welcome, Deputy Assistant Administrator Gibson. Thank
you for joining us today.
I want to focus my questions on the impact of scheduling
substances in Schedule I, which you mentioned in your
testimony, or under the proposed Schedule A that H.R. 2851
would have on research.
We hear from Dr. Beardsley in our second panel about the
difficulty associated with conducting research with Schedule I
substances. He noted in his written testimony that it can take
over a year to obtain a Schedule I registration. I heard from
others that requirements associated with Schedule I substances,
such as the storage and security requirements, can be very
costly. The time and resource burdens have, in some instances,
been a disincentive for young and promising researchers who
examine these substances for their therapeutic value.
My first question is, can you describe current requirements
DEA imposes on researchers who wish to study Schedule I drugs?
And I am particularly interested in whether you offer any
accommodations today for researchers.
Ms. Gibson. Sir, I appreciate your concerns for research,
and it is critical. We do have a strict process regarding
research as far as the application process. And the reason it
is strict and it has to be FDA approved is because we have to
prevent diversion. That is the bottom line. And we have to make
sure that everything that a researcher receives as product has
to be retained and secured.
But as far as research, if somebody brings a valid FDA
application to us, we will be approving it. In fact, if it is a
synthetic analogue research application, I will expedite it
because we need it done. We need it done.
Mr. Green. One concern I have heard from the registration
process today is confusing nature and how Federal and State
registrations interact. Some States require Federal
registration prior to application, yet the DEA advises a State
registration is needed prior to Federal application.
What guidance does DEA offer to researchers at States
regarding their registration process?
Ms. Gibson. Sir, I understand interaction with the States
and your concern how that could be different between State and
Federal. It is kind of shocking sometimes the difference
between the State and Federal Government on various issues.
However, when it comes to working in this arena, it is critical
for the Federal Government and the State government to work
together. And in order for the Federal Government to operate in
a State, we need their compliance, we need their understanding.
So we are more than happy to work with each State
individually and make sure that we come up with a proper
procedure, and we get it done right. Yes.
Mr. Green. Yes, it is confusing if the State requires
Federal and Federal also requires State, so I don't know if we
could do it simultaneously. That might be much easier for the
researchers. One of the bills before us today, H.R. 2851,
attempts to streamline the research registration process. We
heard from HHS, however, that this process could still
constitute a burden or barrier to research and could have a
negative impact on drug development.
Can you share what discussions, if any, DEA is having with
Health and Human Services regarding the registration process
for researchers, and how such process could be streamlined?
Ms. Gibson. Again, definitely research is a big concern for
us, too. We work closely with HHS regarding applications for
research. And, again, we do have 600 Schedule I researchers
already that are ready to go. Again, we believe the new
regulations could help streamline that process. So we look
forward to any kind of tool that the Congress could provide to
us to streamline that process, absolutely.
Mr. Green. Well, Congress doesn't always provide the
funding for a lot of agencies. We wish we were the
Appropriations Committee sometimes.
While I want to ensure that we are properly protecting
against abuse, misuse, and diversion of synthetic substances, I
also want to ensure that we are not unintentionally restricting
the ability of researchers and drug developers to discover new
and promising therapies.
Would you work with us on legislation to ensure that we do
not impede or inhibit or otherwise disincentivize research?
Ms. Gibson. Sir, I would absolutely love to work with you.
Mr. Green. Thank you.
And I yield back my time, Mr. Chairman.
Mr. Burgess. The gentleman yields back.
The chair thanks the gentleman. The chair recognizes the
gentleman from Oregon, the chairman of the full committee, Mr.
Walden, for 5 minutes for your questions, please.
Mr. Walden. Thank you, again, Dr. Burgess.
And to our witness, thank you for being here today. So, in
your testimony and in other people's comments this morning, we
have heard a lot of statistics, so I want to repeat a line from
your written comments that says, ``The sharpest increase in
drug overdose deaths in 2015 to 2016 was fueled by a surge in
overdoses involving fentanyl, fentanyl analogues, and synthetic
opioids.'' This was reported by the National Institute of Drug
Abuse or NIDA.
You go on to build a compelling case to give DEA additional
authority to get synthetics off of our streets. Under current
law, the DEA Administrator acting on behalf of the Attorney
General can temporarily schedule substances for a 2-year
period, with a possible 1-year extension to avoid imminent
hazard to public health.
And on February 6, 2018, this administrative tool was
utilized to place classwide Schedule I controls on fentanyl-
related substances.
My question is this: What additional tools would SITSA give
special agents to investigate and prosecute these substances
that they do not have today?
Ms. Gibson. Thank you, sir. I understand and I appreciate
your efforts to give us any kind of tools that we can to get
this job done because it is unprecedented, and it calls for
unprecedented measures to get this done.
Mr. Walden. Right.
Ms. Gibson. I do believe that the SITSA law outlines
sentencing, which makes it a lot easier to prosecute, even
though the prosecution sentencing guidelines are that of
Schedule III. But I think it streamlines the process, which
helps us tremendously. I think also, too, the false labeling I
truly support because they take a substance, they change the
atoms, and then they relabel it something, and it is a whole
new product. So----
Mr. Walden. What happens in your world, the enforcement
world, when that occurs?
Ms. Gibson. Well, right now, that we did the class of the
fentanyl, that helped us out tremendously. It was the first
time we ever did anything like that, and we are proud of that.
But it does make it very difficult. We have gone out to
convenience stores, banks. We have reached out to many people
regarding the purchasing of these synthetic fentanyls online,
the selling of them at the local shops--they got to know what
they are selling, and it is a difficult arena. And especially
my biggest concern is working with our counterparts because
they are on the front lines; they have to be armed with the
information they need to do their job.
And the dissemination of information, education to our
counterparts, that is critical. And I think DEA is doing a
pretty good job of that, as far as communicating with our task
forces out there. We have expanded our tactical division
squads, which I think can also provide a lot of expertise out
there. And I think that is the wave of the future as far as
tackling this subject.
Mr. Walden. Congressman John Katko, who brought this issue
to our attention, is a prosecutor and won a national award from
the former U.S. attorney for his work going after narcotics and
organized crime in the narcotics world, and brought us this
measure. And we want to make sure that--because he has been on
the front lines there. He has prosecuted these cases, and he
says, they change one thing, and then there you are out there.
It just bollocks-es up the whole process to go shut down.
And he brought a woman to the State of the Union Address
whose 19-year-old son, if I recall the story correctly, smoked
something that he got at a head shop that I think had been
sprayed with a synthetic fentanyl, and I remember his mother
said--or her son said, ``What could be wrong with this? It is
natural,'' even though it was labeled ``not for human
consumption'' potpourri or something like that.
It is the wink and nod behind the curtain. They think they
are getting off on their liability when in fact they are
poisoning a generation. Her son died. So that is--in this
bill--one of the things we are trying to get at. Does this bill
get to that?
Ms. Gibson. It is a massive problem. And I think this bill
can help us get there. And, again, it is such a serious topic
right now because we have people out there, we have kids out
there, purchasing this stuff thinking it is a legal alternative
to the actual substance.
Mr. Walden. Exactly. And ``because it is natural,'' that
was the argument her son made.
Ms. Gibson. Absolutely.
We are facing cannibalism in certain States when they take
some of these substances. There has been a couple incidents in
Florida where the person took a cannabinoid or a cathinone and
actually started eating somebody. That is how serious of a
situation we have here.
Taking these synthetic drugs is similar to taking meth and
PCP at the same time. And the scientific term is excitable
delirium. So imagine that: meth and PCP at the same time. These
products are killing our kids out there. We have 750 substances
right now that we have identified. We took 56; aggressively, we
put them on the schedule. And out of that, what, I think my
math is 696 that are still out there that can kill our kids--
696 different substances----
Mr. Walden. Will this help get to that, or do we need more?
Ms. Gibson. It is going to streamline it. But we have to
look at the sentencing. We have to make sure that we are--these
people are peddling death. It is not a victimless crime when
you are dealing drugs.
Mr. Walden. That is right.
Ms. Gibson. And that is my biggest concern. I love to put
handcuffs on people that violate the CSA. And this law can help
us. And any other tool Congress can give us to tackle this
problem, I will take.
Mr. Walden. We want to be your partner in this effort. And
just to make clear, this is the first of three legislative
hearings we have announced. This one is focused more on the
enforcement effort. We fully understand we need to do more on
helping people who are addicted and treating--the treatment
piece, the mental health piece. This is going to be across the
whole spectrum. This begins the process to try and turn off the
access to these illicit drugs.
So thank you for your good work, and we look forward to an
ever-improving partnership between the administration and this
committee on this matter. And we are going to get this done.
So, with that, Mr. Chairman, I yield back.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman.
The chair recognizes the gentleman from New Jersey for 5
minutes for questions, please.
Mr. Pallone. Thank you, Mr. Chairman.
Ms. Gibson, in your testimony, you note that some
traffickers of fentanyl and fentanyl analogues have had
industrial pill presses shipped into the United States directly
from China and have been operating fentanyl pill press mills
domestically.
Now, DEA has also acknowledged that industrial pill press
machines are widely available on the open internet and that
some vendors mislabel the equipment or ship it disassembled so
as to evade regulatory oversight. And this is clearly one way
traffickers have been able to further increase the production
and availability of illicit fentanyl and other synthetic
opioids.
So my question is--I have several. Under current law,
importers and exporters are required to notify DEA of the
shipment of tableting and encapsulating machines. So how does
DEA ensure compliance with those requirements?
Ms. Gibson. Sir, I appreciate your concerns about those
machines, and I am happy that DEA did take that measure and get
up that regulation and get it in place. That requires any
importation of a tabulating and encapsulating machine 15 days
prior to it coming to the country.
Obviously, you are going to have the legal people out there
that abide by the laws, and they are going to be telling us
they are bringing it in. But we, as DEA, I have to worry about
the ones that aren't playing fair.
Mr. Pallone. The bad actors.
Ms. Gibson. Exactly. As an agent in New York City, I know
the criminals are very industrious. They are very creative;
that is their job. So they make their own kilo presses; I am
sure they can figure out a way to make their own pill presses.
And that is something else we can address in the sentencing
guidelines with SITSA. However, some organizations also
piecemeal it into the country, too. And then from different
sources, different shippers, they get one part of the machine,
and another part of the machine coming in separately. So that
is the problem.
But we are excited at least to see how the regulation works
and to see how many actually are coming into the country and go
from there. So it is really fairly new; it is July 2017 that we
started that.
Mr. Pallone. Do you think that DEA needs additional
authority over tableting and encapsulating machines?
Ms. Gibson. Sir, any kind of control regarding those
machines getting into the wrong hands, we would love a tool,
any kind of mechanism to prevent that from happening, yes. We
also have to understand that there are some people out there
that bring them in for legitimate business purposes, like
vitamins and different things like that.
So it is, again, a balance. And that is what I feel like,
since I took this position, you got to have that balance. And
making sure that people can do their job in the personal arena
and the business arena, that is important.
Mr. Pallone. Yes.
Ms. Gibson. But also to keep these machines out of the
hands of the people that don't need them is a problem.
Mr. Pallone. Well, let me go to the bill that we have, this
Tableting and Encapsulating Machine Regulation Act that we are
considering, that would define in statute tableting machine and
encapsulating machine. In addition, it would also propose a
schedule of such machines in a to-be-determined schedule.
Is there a precedent under the Controlled Substance Act for
scheduling machines or other devices?
Ms. Gibson. Sir, again, this is an unprecedented time. So I
can understand thinking outside the box. We never at DEA have
ever scheduled a machine. So that would be a new arena for us,
and that would be something that we would have to work closely
with you regarding.
Mr. Pallone. Let me just ask this because I know we are
going to run out of time. Can you describe for us the types of
requirements that tableting and encapsulating machine owners
would be subject to if they were placed into Schedule I? And
then I will ask also, what would be the penalties an owner
could potentially be subject to if they were not in compliance
with those requirements?
Ms. Gibson. Well, again, if you put a machine under a
schedule, they would have to obtain a DEA registration to
obtain that machine. So they would have to go through the DEA
registration process. Again, that is something we would have to
discuss with you further. We can definitely talk to our
counterparts at DOJ to see if they have any kind of
understanding of how we could go forward with a process like
that, but we would definitely have to talk to you more about
it.
Mr. Pallone. What about penalties? You don't want to
comment on what penalties an owner could potentially be subject
to if they are not in compliance?
Ms. Gibson. I think penalties could be addressed in SITSA
as far as sentencing, if you have a tableting machine or
encapsulating machine in your possession and you are not using
for it a legitimate purpose, I think that could be a sentencing
guideline that we could use, and that could be an option.
Mr. Pallone. Thank you, Mr. Chairman.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back.
The chair recognizes the gentleman from Michigan, Mr.
Upton, 5 minutes for questions, please.
Mr. Upton. Thank you, Mr. Chairman.
And I really appreciate your remarks and the full committee
chairman's as well. This is something that we need to deal
with, and I am glad to say that it is, for the most part, it
has been bipartisan from the get-go. We want to provide you all
the tools that you need. I dare say that every one of us knows
someone that it has impacted, and with the budget agreement
that we passed and the President signed--when we did
sequestration a number of years ago, no one ever heard of
opioids for the most the part in terms of where things are
today. No one would have thought that we would lose 65,000
people a year 8 to 10 years ago on this thing.
So I am glad to say that the budget agreement did increase
money versus what otherwise would have been a cut, and
specifically earmarked opioid abuse as one of the increases
that I know that the appropriators are going to come back with
us for before that March 23 deadline. And, of course, all of us
here on this committee supported 21st Century Cures, 51 to
nothing. And in that bill, we included a billion dollars for
opioids, and we know that that was only a 2-year bill, so it
expires. So that is one of the reasons this budget agreement is
so important where we focus on opioid abuse.
Last year, I met with a number of my law enforcement
officers undercover, and we talked--I met with a good number of
folks in southwest Michigan, but I wanted to spend some time
with my law enforcement folks to find out how easy is it to get
fentanyl and some of these other products like heroin and
others into west Michigan. They said it is real easy, because
it comes in oftentimes through the postal center. And Grand
Rapids is sort of the postal distribution center. They have one
postal inspector for all of west Michigan.
And it comes in in counterfeit labeling, and it changes.
They felt that they had good cooperation with FedEx and UPS,
but in fact, they know that it comes in there, too. And
particularly for the drug dealers, the folks that are getting
it, they can track it. They can find if it is delayed even 1
day, they are not going to be there to pick it up, go someplace
else. It is a huge enormous problem.
So I cosponsored a bill that would require the Postal
Service to provide package level detail, information for
packages imported from overseas to Customs and Border Patrol as
private carriers like UPS and FedEx are already required to do.
Because of that--and I applaud the President, he had a number
of us, on a bipartisan basis, down to the White House last
summer--I raised this issue with him and how we needed more
resources. And, frankly, when you think about trying to
identify some of these drugs coming in and we have seen cases
where just, you know, because of its potency, just any contact
at all can actually kill, whether it is dogs or people, so
there is an enormous problem.
Can you tell us how are you interacting with where--as we
know, when the President went to China a few months ago, I
signed a letter with a number of my colleagues to raise the
fentanyl issue to see what China can actually do to stop some
of this junk coming here.
But how is your frustration level with the law enforcement,
or with the shippers, and what can we do to help you there as
well?
Ms. Gibson. I understand your concern about tackling this
problem, and it is daunting. And that is one of the reasons why
I am proud of DEA, because we never give up. And drug work is
the most labor-intensive, frustrating entity that you can
encounter in law enforcement.
I know, when I was an agent in New York City, we routinely
worked with the postal inspectors. We have worked with
different shipping companies in various capacities, and we have
had a lot of success with them. Sometimes you strike out, but
you just got to keep on getting up to the plate and taking
another swing.
It is too important of a problem to just give up on. But we
definitely will take any kind of resources, any extra resources
that can be given to us. Specifically, if you have one major
concern, please let me know.
Mr. Upton. Let me ask you one quick question. Disposal of
pharmaceutical waste in the hospital requires strict adherence
to necessary protocols to avoid diversion of opioid waste,
primarily administrated doses that are medically necessary for
most surgical procedures from being improperly disposed of.
So to render those opioid nonretrievable and unusable
products for DEA regs at a much lower compliance burden than
what many providers currently experience, what are you doing to
help being able to dispose some of these that people may
voluntarily bring in that they can then rest assured they are
not going to be abused by someone later on?
Ms. Gibson. Sir, I understand your concern because I think
we have all been there where we had a loved one that passed and
we had all this medication that we didn't know what to do with
it. DEA prides itself on the National Take Back Initiative,
where we actually have one coming up April 28. Through the
beginning and the inception of that program, we have taken 9
million pounds of prescription drugs off the street--9 million
pounds. And, unfortunately, four out of five heroin users right
now start with taking the pills out of the medicine cabinet and
going ahead, using them, and developing a horrible habit.
So it is incumbent for us to get those pills. And we do a
lot with operation prevention. We get information out to
parents, students, teachers. Operation 360 right now. We are
working with communities to get the information out there. DEA
wears many hats, and I think a lot of times people think we are
just kicking in doors and arresting bad guys, but our Diversion
Control Unit, we tackle those problems as far as making sure we
get the information out there.
Mr. Upton. 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 questioning, please.
Ms. Matsui. Thank you, Mr. Chairman, and I want to thank
all the witnesses who are yet to testify yet for being here
today and also you, too. My priority here is to improve access
to care. And, as mentioned before, I am working on improving
access to remote behavioral health treatment. It is a
discussion draft, which is what it means: It is a discussion
draft. And we are still working on it, but I think it is
important to lay it out there so we can have a conversation as
to how we might improve it.
This is with Representative Harper. And both of us believe
that telemedicine has the potential to improve access,
especially in the midst of this opioid epidemic. However, I am
looking forward to hearing from stakeholders--all the
stakeholders--about how best to improve access via telemedicine
without creating new problems.
The last thing we want to do is to make it easier for
unscrupulous actors to prescribe controlled substances. And I
think you mentioned before that the bad actors are always the
ones who, I don't know, that is their job to figure out how to
mess up things, right?
Ms. Gibson. Yes.
Ms. Matsui. So we are going to have to try to figure out
what to do to prevent that. But I do though believe that many
people in our communities are receiving high-quality
comprehensive care in their local community behavioral health
clinics. And access to medication can be a part to treating
patients suffering from opioid use disorder and other mental
illnesses.
Ms. Gibson, according to DEA's interpretation of the Ryan
Haight Act, a hospital or clinic must first be licensed by the
State before registering with the DEA. Can you provide us with
some insight into the reasoning for DEA's narrow
interpretation?
Ms. Gibson. Ma'am, DEA agrees with any kind of efforts that
we can do to get somebody on the right path forward, and to get
them help. So I understand your concern, and I would love to
work with you.
It is incumbent that DEA works with the State government
regarding registrations. A lot of times, active investigations,
whether criminal or administrative in nature, we work hand-in-
hand with our State. So if there is a problem going forward
with having registrations, and if State is the problem, we can
figure that out and get you information that you need.
Ms. Matsui. So are there circumstances, then, under which
DEA could modify, work with this requirement to be more
inclusive at clinics that may be authorized by the State or
county but not licensed by the State?
Ms. Gibson. Again, this is where I have to put my DEA hat
on as though we were enforcement and regulation, because it is
so important to make sure that these clinics are abiding by
Federal and State laws.
Ms. Matsui. Right.
Ms. Gibson. So if a clinic wants to move forward with
obtaining registration for a narcotic treatment program and to
dispense MAT, medical assistance treatment, we would be more
than happy to work with them, because we want to make sure that
people have access to those types of treatment centers.
Ms. Matsui. Right. I am looking at it from a drug
enforcement perspective, and you are looking at certain
guardrails that must be put in place to assure appropriate
prescribing of controlled substances for a medication-assisted
treatment via telemedicine. That is the aspect of it here that
we are trying to address.
And it is a little bit different, but on the other hand, is
there a situation, I am trying to get to where we can narrow
this in a way, not so widely but not so narrowly as it is today
so that we might be able to have this remote telemedicine ways
of treatment in this crisis.
Ms. Gibson. Well, ma'am, as it stands right now,
telemedicine is authorized.
If we can get the patient to either a registered hospital
or clinic, with DEA, or a registered physician, physician
assistant, nurse practitioner, they use appropriate audio-
visual equipment, to their prescription and data-waived
physician, it can happen.
Ms. Matsui. The only problem, though, is that in a
situation, you would want the person to be in place and we are
looking at community clinics where that is not necessarily a
hospital or something that is licensed by the State. And that
would take away the efficiency of the telemedicine then. And we
are trying to get to that place where we can get the community
health clinics to be able to be participants in this with the
patient without having to move them somewhere, if you know what
I mean.
So anyway, it is something that we are trying to figure
out, Congressman Harper and I, to figure out how to get the
guardrails in place but have it flexible enough so we can do
this.
So thank you very much. We are going to be working with
you, I believe.
Ms. Gibson. Absolutely. I want to work with you and see how
we can figure that problem out.
Ms. Matsui. Thank you. I yield back.
Mr. Burgess. The chair thanks the gentlelady. The
gentlelady yields back. The chair recognizes the gentleman from
Illinois, Mr. Shimkus, 5 minutes for questions.
Mr. Shimkus. Thank you, Mr. Chairman. Thanks for being
here. I want to applaud my colleagues on both sides who--it is
easy for us to try to run home when we are not voting and they
are here working. And so hats off to both sides, because it is
such a national issue and a national concern. And we have got a
long way to go. This is a plethora of options and bills. There
is a lot of ideas out there, and a lot of them sponsored by my
colleagues on this committee and some outside the committee.
So I want to focus on this issue of FDA and DEA and this
pseudo, not a conflict, but the scheduling and the FDAs
approval for scientific safety and efficacy, and then the
listing. Where on this what we need to do is try to keep people
from taking the first dose and getting hooked, and that is a
whole set of problems, but then the other side is the
treatment. And some of this treatment has opioid-type events.
And so it is a total ban when you got to use that on the
treatment end, there is also a concern.
So I want to make sure the FDA's role in the scheduling
process is strong and solid. I think both sides talked highly
about the strength of FDA and its record, but it seems like
there is certain factors within the current eight-step process
to bring new drugs under the Controlled Substances Act such as
the state of the current scientific knowledge about the
substance or its risk to public health, are better suited for
the FDA and agency focused on scientific safety and efficacies
of drugs than the DEA, which enforces the criminal and civil
justice on controlled substances.
Does the DEA believe that in order to strike the balance
between addressing the risk posed by illicit use and allowing
the scientific research needed to develop new therapies that
the FDA should continue to have some role in the temporary and
permanent scheduling of controlled substances?
Ms. Gibson. Sir, I appreciate your concern about scheduling
substances and getting them out of the hands of our kids as
quickly as possible, too. It is critical to work with our
counterparts at FDA and HHS. I have the utmost respect for them
and I look forward to working with them in the future.
The only way we can tackle this problem is together. I came
from a task force in New York City comprised of DEA, NYPD, and
New York State Police, and the only way that we were as
successful as we were is because we worked together. So I
promise you that any kind of scientific data, anything that
FDA, HHS can bring to the table, I will be more than happy to
work with.
Mr. Shimkus. Yes, because the concern is to make sure that
you all make reasonable technical accommodations for research,
which is critical, and that FDA should continue to have some
role in the scheduling process. I appreciate your comments.
What we had hope was that you all, the DEA, would help provide
some technical comments to, in essence, the Katko bill, which
is the H.R. 2851, which I scribbled--I don't like to use
acronyms, so I try to scribble down, but then I can't read my
writing, so Stop the Importation and Trafficking----
Ms. Gibson. Synthetic Analogues----
Mr. Shimkus. Yes, you got it. So if you could provide us
some feedback on how we can address this concern about making
sure that the FDA can be involved in this process and what your
concerns will be as this bill--my guess would be this bill
would get a fair hearing and will move through the process. And
we would like to have your input on that.
Ms. Gibson. Again, sir, I understand all your concerns. And
especially being that I just came to this position, I have been
here a month-and-a-half.
Mr. Shimkus. Welcome. What a time.
Ms. Gibson. Thank you. But you know what, I think it is a
great time to be a part of it because it is such a massive
problems that it takes all hands on deck, and it takes
everybody to get on the same page and figure this out.
So I promise you, that is my motto. I need to work with
people. We need to bring people into this conversation. Because
I can talk about regulation all day long and making sure the
stuff stays out of the bad guys' hands, but I need to rely on
my scientific counterparts to understand everything going on.
Mr. Shimkus. We just don't want the two agencies to trip
over--we have the same objective. We just don't want the two
agencies to trip over each other. And so we need help
clarifying the language, that suits both sides, that would be
helpful.
And with that, I yield back. Mr. Chairman, thank you.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman. The chair recognizes the gentlelady from
Florida, Ms. Castor. 5 minutes for your questions, please.
Ms. Castor. Thank you, Mr. Chairman. Welcome, Ms. Gibson.
A U.S. District Court judge in Ohio, who is overseeing
hundreds of lawsuits that have now been consolidated into one,
these are lawsuits filed against opioid manufacturers and
distributors. The judge has directed DEA to release data about
the national distribution of opioids. The judge ordered the DEA
to inform him very soon that it will consent to releasing data
from the automation of reports and consolidated order systems,
ARCOS. ARCOS data, which drug companies must provide to the
government under the Controlled Substances Act shows
transactions made by opioid manufacturers and distributors.
The database shows how many pills were sold, where in the
U.S. they were sent, and what pharmacies bought them. The
database, as you know, is often used by agents conducting
criminal investigations into trafficking of prescription
opioids.
The judge proposed that the DEA give a list of drug
companies that manufacture and distribute 95 percent of the
opioids in each State broken down by each State for each year
between 2006 and 2014. The judge also would like the data to
include the total number of pills sold in every State each year
and how much market share each company enjoys.
Will the DEA comply with the judge's request?
Ms. Gibson. Ma'am, I understand what you are discussing
right now, because it has been a big part of my time since I
have been here in this position. I know personally, and I have
been part of the meetings, that we are working as much as we
can with the coalitions. We understand their goals. We have,
though, a right--well, not a right, but we have to protect
business proprietary information. We are working with them
right now to come up with the mechanism.
Ms. Castor. That is the business information of drug
manufacturers and distributors?
Ms. Gibson. Proprietary information, yes. And that is
statute. That is not something that I can chose to do. It is
statute.
Ms. Castor. But the DEA said you would provide a couple of
years of information. What is the difference?
Ms. Gibson. Ma'am, there are multiple lawsuits going on
right now, so I have to clarify actually which one, if you are
specifically talking about Ohio.
Ms. Castor. Yes.
Ms. Gibson. I know we have moved forward with several
States as far as giving them information. Some States we have
already. Some States we are still trying to work that out. So I
would have to get back with you regarding exactly Ohio.
Ms. Castor. I know the DEA will have to get back to the
Federal District Court judge.
Ms. Gibson. We have. We absolutely have.
Ms. Castor. --shortly.
Ms. Gibson. We absolutely have.
Ms. Castor. I would just encourage the DEA to be as
responsive as possible.
If there is a law that is preventing you from sharing
certain data, the Congress needs to understand that. And I know
there has been a lot of press reports about what has happened
with drug laws and things, but we need some honest brokers in
this business to help us combat it.
And you said you are committed to combating the epidemic.
And I would think DEA's full compliance with the District Court
judge's request for information would go a long way to doing
that.
Now, the Controlled Substances Act requires drug companies
to report the unusually large or suspicious orders, and if they
fail to do so, they are fined or they are suspended, or they
lose their registration. Then DEA has the ability, if they are
not complying, to issue orders to show cause or immediately
suspend them.
I am wondering, in this physical year, how many enforcement
actions have been taken by DEA, and can you characterize that?
Do you have those statistics in front of you?
Ms. Gibson. As far as enforcement action, we have taken
approximately 900 registrations per year in the past 7 years.
In the past 7 years, I believe we opened, what 10,000 cases,
about a couple thousand cases a year. So we are aggressively
going after people and we are opening up cases, and we are
using every tool that we have----
Ms. Castor. Could you provide those specific statistics to
the committee, up-to-date? Because looking on the website, the
data only goes through 2016, and it would be very helpful.
Also, there has been a lot of criticism about the DEA and
the revolving door between the DEA and drug companies and
manufacturers. What regulations are in place right now that--
just like Congress, we are prevented from lobbying for a couple
of years--what is in place right now, in ethics and government
that prevents an employee from the DEA leaving and going to
work for a drug manufacturer or a law firm that represents them
or a drug distributor right now currently in law or in agency
regulation?
Ms. Gibson. Ma'am, I wish I was close enough to retirement
to have to worry about something like that, but unfortunately
you are stuck with me for several years. I would have to get
back to you with specific information regarding that. We do
have an ethics committee and counsel back at DEA, and he can
provide exactly what you need regarding that.
Ms. Castor. Do you know of any restriction that is
currently operative at the agency?
Ms. Gibson. Again, I wish I had the opportunity to know.
That meant I was closer to retirement. But I----
Ms. Castor. Please get us that information.
Ms. Gibson. Absolutely.
Ms. Castor. Thank you very much. I yield back.
Mr. Burgess. The gentlelady yields back. The chair thanks
the gentlelady. The chair recognizes the gentleman from Ohio,
Mr. Latta for 5 minutes for your questions, please.
Mr. Latta. Thank you, Mr. Chairman, and thank you very much
for being with us today on this panel. Being from Ohio, we are,
unfortunately, right in the middle of this. We have seen some
sobering statistics that we had from overdose deaths. We go
back to 2015, we had 3,050 people lose their lives. In 2016,
that number went up by 1,000 to 4,050 people. And just in the
period ending from the physical year from the end of June of
2016 to 2017, that number went to 5,232. So we are seeing this
horrible increase in the State of Ohio. And also, a lot of this
is being caused because of fentanyl.
And when you look at in 2016, we saw about 58.2 percent of
all the overdose deaths because of something involving
fentanyl. So, our topic today is on the opioid crisis, but for
us in Ohio, we are going through an epidemic because of how bad
it is out there.
And if I could, because it is important for you, and I know
there is a little bit of discussion that you have had already
talking about drug take-back days and things like that. We have
participated in two within Lucas County with the sheriff. I was
absolutely astounded at how much came in that day. And then I
was with the Findlay Police Department, just south of there in
my district on another drug take-back day, and the amount of
drugs that were taken back that day.
So, there are things happening out there, and it is
important, but I am also working with legislation on getting
the information out for my communities. And it is the Info Act.
Because one of the things I have heard from my communities,
because I represent a lot of small areas. And the problem is
that they don't have the grant writers, they don't have the
information. They need to have some place they can go to get
the information, what is happening on the Federal side. And
also, just as importantly, where the money is to help. So, we
have been working on that because it is very, very important.
But let me ask you, because in your testimony, again, just
this data information back and forth, but in your testimony you
talk about the heroin-fentanyl task force which is the
intergovernmental working group, and you have a lot of law
enforcement, Homeland Security, investigative Postal, even
Defense and Intelligence Agency. Is it an oversight or is HHS
not part of that working group?
Ms. Gibson. Sir, which working group?
Mr. Latta. OK. This is the heroin-fentanyl task force that
you mentioned in your testimony. I see that HHS is not in that
group.
Ms. Gibson. Sir, I would have to get back with you exactly
what the role would be. But I know for a fact anything that
comes across my desk, I reach out for HHS immediately because
they provide the scientific expertise that I need to get this
job done. I have a lot of experts at DEA also, but we work
hand-in-hand with them. So even if it is not listed, we would
be more than happy to partner with anybody----
Mr. Latta. OK. Well, if you could just tell me if they are
in that working group, that would be important. Let me go on.
Because, again, when you are talking about fentanyl, and when
you are talking about the importation, especially from China,
and, again, I have had meetings with my 14 county sheriffs in
conference calls and meeting with them personally, and also
with my police chiefs across the districts.
One of the concerns out there, what is happening is, we are
seeing that fentanyl is now being laced with marijuana. And not
specifically in this case, but a young individual died in my
district recently from fentanyl about the size of three grains
of salt that took that person's life.
And what is DEA trying to do right now, trying to stop the
importation? I know a lot of it is coming across from there.
You brought up the fact it is $3,000-$4,000 and how much you
can get on the street level, out there on the street with it
over $1 million. But what is the active role DEA right now is
taking on stopping the fentanyl from coming into the country,
especially from China or if it is being sent to Mexico or into
Canada and somehow getting brought back in the United States.
But what exactly are we doing at DEA?
Ms. Gibson. Sir, I appreciate your question, because I am
really proud to be sitting here saying that our DEA Beijing
country office works closely with the Chinese Government.
China has been a very good friend to us. And the fact that
they have put I think 138 new psychoactive substances. They
regulated them over in China for us, and they are not even a
problem over there. And statistics have shown if they regulate
a substance over there, it has a direct impact on law
enforcement encounters. It dramatically declines.
So DEA, we are very present in a lot of foreign countries
that I am very proud of, and I think our job starts thousands
and thousands of miles away from the United States borders, and
I think that is just one example of it. And we are really
appreciative for anything that the Chinese government can do
regarding regulating those substances.
Mr. Latta. Mr. Chairman, my time has expired.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman.
The chair recognizes the gentleman from Maryland, Mr.
Sarbanes, 5 minutes for your questions, please.
Mr. Sarbanes. Thank you, Mr. Chairman. Thank you, Ms.
Gibson, for being here. I appreciate it.
I was looking at the website of the Diversion Control
Division and some frequently asked questions on there. And I
was focusing on a part of it that talks about how while DEA
doesn't directly regulate the marketing of control substances,
it is in keeping with your mandate to ensure appropriate
safeguards against diversion, and you do have concerns when
marketing and advertising tactics appear to create increased
possibility for diversion or misuse.
And if you see such tactics leading to oversupply or
minimizing risk of abuse, you make every effort to work with
pharmaceutical companies and the FDA to find appropriate
solutions to these problems.
And I am really curious about the history of OxyContin and
the extent to which the Diversion Control Division had its wits
about it when it came to the marketing practices of Purdue
Pharmaceuticals and anybody else who was using unscrupulous
marketing techniques and what kind of lens that the vision that
you head up brought to that and continues to bring to that
since it is something that appears to fall within the mission
of the agency.
Ms. Gibson. Sir, I appreciate your concern.
The bottom line is the prescriber. One of our goals for
2018 is to have conferences regarding prescribers. Our goal is
to get as much information out there to prevent a physician
falling for those ads, and to make sure that opioid
prescription is done correctly.
Just recently over our website we added the link to the CDC
opioid prescription guidelines. So right now when it comes----
Mr. Sarbanes. So let me just interrupt. So your focus is on
the prescriber but let's say you see a pattern of prescribers
being bombarded with marketing tactics, false and misleading
information, broad campaigns to stretch the facts on what a
particular drug can and cannot do, the harm it may present, and
so forth. Presumably, if you see a pattern of that among the
prescribers that you are focused on, you would say you are, in
effect, trying to protect from some of those marketing tactics,
you then turn your attention, at least in part or in concert
with other agencies that have jurisdiction, to the source of
the marketing and bring some attention to that.
So that is what I am interested in right now. What is that
kind of focus? What are the questions you bring to those doing
the marketing? What is the inquiry, and investigation, and
pressure you bring to bear so that these marketing practices
aren't bombarding these physicians, or pulling them in to a
large disinformation enterprise?
Ms. Gibson. Sir, I appreciate your question because I have
to say, that is something that I have not encountered and or
really addressed since I have been here. So that would be a
learning curve for me, too. I would definitely want to sit down
with you and get you information regarding that because that is
information, too, the marketing tactics I think would have to
go a few years back for what your scenario is that you are
giving to me. And I would love to find out myself exactly what
we do.
Mr. Sarbanes. Well, I hope you get interested and it does
seem to fall squarely within the mission to pay attention to
these marketing practices. And there is a lot of history to
look at with how OxyContin was marketed, how Purdue managed to
overcome well-founded concerns and anxieties in the medical
community about the addictive nature of that particular
medication.
And the reason to study the history of it is because from
what I can tell, those kinds of marketing practices continue in
force. They may have, you know, altered them slightly to
respond to pressure in the public and from some agencies, but I
think the practices continue and we need you all to cooperate
with any agency that has relevant jurisdiction on this to make
sure we shut those kind of practices, marketing practices down
to protect people out there in the country. So I hope you will
bring attention to it.
Thank you. And I yield back.
Mr. Burgess. The gentleman yields back. The Chair thanks
the gentleman. The Chair recognizes the gentleman from Indiana,
Dr.Bucshon. 5 minutes for your question, please.
Mr. Bucshon. Thank you, Mr. Chairman.
I was a practicing cardiothoracic surgeon for 15 years
prior to coming to Congress. I have known about this opioid
situation for probably 25, 20-25 years. This is not a new
problem, but it kind of reached the tipping point, and it has
gotten dramatically worse, but the tipping point where it is
become a public health issue, specifically.
And a little background from a physician perspective. Back
in the 1990s there was a big push to control pain, both chronic
and acute pain. And that came really from everywhere. It came
from accrediting agencies for hospitals, it came from inpatient
advocacy groups, it came from nursing groups, doctor groups.
The little smiley face, frowny face on the patient's chart.
Your pain from 1-to-10 type of thing.
And so what happened is--and I am going to be quick here
because I have a question--what happened is that we somewhat as
a society started to create a culture of, in my view, of
prescribing opioid-type pain medicine, probably in many cases,
inappropriately when there were non-opioid alternatives that
could have been used for both chronic and acute pain.
And then it started to get linked to payment, where patient
satisfaction scores, hospitals, and others were worried about
getting their payment cut because of patient satisfaction
scores. And that included the ``fifth vital sign,'' which was
pain.
That is not a defense of practitioners, but it also is the
truth. And I think our society has created a culture that it is
going to take a while to turn the Titanic, right? We are not
turning the speedboat here. We are going to have to change our
medical culture to fix some of that.
So a couple questions: What percentage, approximately, do
you think of heroin being abused in the United States comes
across the southern border of the United States?
Ms. Gibson. I don't know if I can give you a specific
number, but I would think a fair majority of it would be
coming----
Mr. Bucshon. The majority comes across there. So, we have
some, not only in areas where we have the international
shipping, that is a huge issue, but my parents stayed down in
the Brownsville area for 20 years over the summer. And almost
weekly they would catch a semi-load full of either cocaine or
heroin, or something, right? And that is the ones they caught.
So, I think we do have an issue down there.
So in Indiana served the 8th district. It is very rural.
And this is going to change, we are going to change to a
different direction here a little bit. And we have a problem
with access to medication assisted treatment and I support the
use of telemedicine.
In your testimony, you mentioned that there is confusion
over whether a doctor is authorized to treat opioid-use
disorder using MAT, medication assisted treatment, can perform
the services via telemedicine, and the DEA is in drafting
process to implement regulations regarding special registration
for telemedicine.
Do you have a timeline of when you expect to promulgate
these types of regulations?
Ms. Gibson. Sir, I understand your concern about the
special registration. Upon my arrival here, I met with my
drafting unit, and I realize that that has been pending a
while, and it has been put on our unified agenda. And we are
going to make it a priority right now. But I really think it is
important for me to get out to 1.7 million registrants that it
can be done.
Mr. Bucshon. Yes.
Ms. Gibson. In certain circumstances it can be done. So the
special registration has nothing to do with telemedicine being
done now.
Mr. Bucshon. Right. Yes, just do your best to tell
everybody what the rules are. I think that is the bottom line,
right?
With that, Mr. Chairman, I yield back.
Mr. Burgess. The gentleman yields back. The Chair thanks
the gentleman. The Chair recognizes the gentlelady from
Colorado for 5 minutes for your questions, please.
Ms. DeGette. Thank you so much, Mr. Chairman. Before I ask
my questions, I just want to take a moment of personal
privilege and thank my wonderful healthcare staffer, Polly
Webster, whose last day is today, as a matter of fact. Polly
was instrumental in helping--Fred Upton is sitting here, and he
will tell you, she was instrumental in getting 21st Century
Cures over the finish line. And we are going to really miss
her. So thanks for all your good work, Polly. I appreciate it.
I also want to just make an observation, Mr. Chairman,
which is I am hoping, I know there was some disappointment that
a lot of the members left, but we had a very good showing on
both sides of the aisle today for this hearing. And when the
hearing was originally scheduled, it was scheduled for a day
when we thought we would be having votes. But having said that,
and listening to Ms. Gibson's testimony here, unfortunately, I
am going to have to miss the second panel because I am going to
have to go home--but I think there are so many issues around
this opioid issue, and certainly the scheduling of fentanyl and
other compounds is one issue. Some of the other members have
raised other issues. I believe that you are intending to have a
whole series of these hearings. And I think that it really will
be worth it.
Some of you know, everybody on the committee knows, I am
the ranking Democrat on the Oversight Subcommittee. And over
the last few years, we have had a number of hearings on the
Oversight Subcommittee around the opioid issue, so if there is
anything we can do to assist this committee, we could have some
joint hearings, or whatever.
Someone said it has reached a tipping point, and it really
has in every community in this country. And we need to take
aggressive action. Ms. Gibson, when I hear you talking about
the struggles with telemedicine and how are we listing these
substances and so on, it is just really clear there are a lot
of facets to this and a lot of things that can be tightened up.
So consider us to be your partners in this.
I did want to ask you about something that hasn't really
been discussed today. As tempting as it is to go very deep into
the issue of synthetic opioids, I want to ask you about drug
take-back programs. As you know there is a lot of unused
prescription drugs lying around in homes. And so Congress
passed the Secure and Responsible Drug Disposal Act in 2010.
What that says is it allows DEA registered entities like
pharmacies and hospitals to collect prescription drugs for
disposal.
Now in Colorado, my home State, the Consortium For
Prescription Drug Abuse Prevention has piloted a number of
successful drug take-back programs that have helped remove
these unused opioids. But unfortunately, as I understand it,
the Colorado Consortium is the exception not the rule.
Last October, the GAO released a report that said
nationally just 3 percent of DEA-registered facilities are
operating take-back programs. So I am wondering, Ms. Gibson, if
you know what the primary challenges that DEA registered
facilities face when they are trying to operate this program?
Is there something that you can do or we can help you do to
make this program more robust?
Ms. Gibson. Ma'am, I appreciate your endeavors to expand
upon this process because it is so critical getting this stuff
off the streets for our kids. I know what keeps me going during
the day is thinking about diversion and making sure that
anything that is taken from our citizens out there, get it out
of the hands of the kids to take is paramount to me. But I have
to make sure that it goes to the right person and that it is
not being diverted from that person and it goes to an entity
where it is secured and it is not going to be stolen. So there
is a lot of----
Ms. DeGette. Well, you are totally right, but those are
called DEA-registered facilities, and they are supposed to be
implementing this program. But only 3 percent of them are. I am
not talking about getting people who aren't registered to do
it. I am talking about people who are OK to do it, to do it. Do
you know if DEA has programs to bolster up these facilities
doing the take-back programs?
Ms. Gibson. I am going to have to look at that. I know we
have one coming up in April. And if I can address that and take
that back to my counterparts----
Ms. DeGette. That would be great, because if----
Ms. Gibson. Right.
Ms. DeGette. We are all committed to it.
Ms. Gibson. Yes.
Ms. DeGette. We just need to make it happen.
Ms. Gibson. Thank you.
Ms. DeGette. We have to make that happen.
Ms. Gibson. All right.
Mr. Burgess. The gentlelady yields back. The chair thanks
the gentlelady. The chair recognizes the gentleman from
Missouri, Mr. Long. 5 minutes for your questions, please.
Mr. Long. Thank you, Mr. Chairman. And Ms. Gibson, you
mentioned in your testimony that the drug control process under
the Controlled Substances Act is reactive, and that it requires
an extensive interagency collection and evaluation of data and
an arduous and time-consuming process. Is this current process
satisfactory?
Ms. Gibson. Sir, I appreciate your question. And I have to
say, and I am just not saying this, since my time at Diversion
Control Division, I am so impressed with the people that work
there, primarily because we were able to do the class of
fentanyls within 2 months. It may not sound quick to some
people, but to get that done and get those substances scheduled
in 2 months, a whole class, I think that was pretty darn good.
So you know, SITSA can help streamline that process a little
bit, but I think we are also doing our job just because of the
diligent efforts of the people in Diversion.
Mr. Long. So even though it is an arduous and time-
consuming process, according to your testimony, they are doing
it quick?
Ms. Gibson. We got it done in 2 months, and that is because
people, they went above and beyond.
Mr. Long. You also mentioned the difficulty of preventing
the distribution and abuse of controlled substances analogue,
designer drug, and you state the Analogue Act is cumbersome and
resource-intensive. Can you discuss what is and is not working
with the current structure?
Ms. Gibson. There is a process. And a lot of times the
process takes a little bit longer than what we want. Look, I
have 696 substances that I wish tomorrow I could put on a
schedule and get them dealt with and get them regulated. But
there is a process. And I have to adhere to that process. And,
again, it is up to the valiant people that work for me that do
their job above and beyond and get the process done.
Mr. Long. Well, speaking of the process, what can we do to
make it less cumbersome, or can we, so the DEA can use its
resources more effectively? If you had your druthers, what
would you rather them do?
Ms. Gibson. If I had my what?
Mr. Long. If you had your druthers. If you would rather do
something, what would you rather them do?
Ms. Gibson. If I had a choice, what I could do to make
this----
Mr. Long. That is English, yes. Choice, yes.
Ms. Gibson. OK. Sorry, I am a simple girl from
Pennsylvania. Again, I think that is one of the neat things,
that I come from an enforcement background. I was an agent in
New York City for 20 years, and now I have this hat to put on
under Diversion. And it is exciting because now I get to ask
those questions, and in a perfect world, what can I do, what
can I make better. And I ask that question a lot.
And so I am still formulating exactly what I can do to
think outside the box, but I know one thing I am definitely
believing in is getting information out there. I just recently
visited a methadone clinic. It was Dr.Hoffman's methadone
clinic here in D.C., PDARC, and I learned a lot of invaluable
tools from that and dissemination of information to get people
help, to get local law enforcement, help to tackle dealing with
this issue.
So, yes, sir, I can get back with you. Give me a month and
maybe I can have a lot more ideas. I have ideas brewing. I just
got to make sure that I take them into the right arena and move
forward with them. But I promise you, I am thinking outside the
box as much as I can.
Mr. Long. OK. Thank you. And thanks for being here. And
Diana had my other question there, so we got that answered when
she was asking her questions. So now that I have introduced
your druthers to the committee, I yield back.
Ms. Gibson. Thank you.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back. The chair recognizes the gentleman from New
Mexico, Mr. Lujan for 5 minutes for questions, please.
Mr. Lujan. Thank you, Mr. Chairman. Ms. Gibson, thank you
so much for joining us today. According to the CDC, in 2013
providers wrote almost 250 million opioid prescriptions in the
U.S. Enough for every American adult to have their own bottle
of pills.
Can you briefly explain how the high volume of opioids
prescribed in the U.S. contributes to the misuse of
prescription drugs?
Ms. Gibson. Sir, I appreciate your question. And from what
I am experiencing and what I am learning here, regarding
prescription of pills, we have a lot of doctors out there that
do God's work. They do the right thing. But we have some people
out there that have overprescribed. And it is incumbent upon
DEA to make sure that we get the education out there and maybe
provide guidance and correct some behavior, and go after the
people that are stockpiling currency at their house because
they are writing too many prescriptions, and they are doing
nefarious things. And that is actually happening. So that is my
concern, are those doctors. And I want to make sure I get the
education out there to streamline prescriptions.
Mr. Lujan. And so I think what you are referring to, Ms.
Gibson, is that the DEA recently started asking if new or
renewal of registrants for a DEA license have received training
on safety prescribing, prescription drugs.
Can you explain why the DEA took the action, and how the
DEA will utilize data on prescriber opioid training?
Ms. Gibson. We did it on a voluntary basis right now, so
any registrant that renews the registration or its initial
application for registration, they voluntarily check a box to
let us know that they received CME, continuing medical
education. Again, we have a great website. I have got 1.7
million registrants. And the best way of me communicating with
them is through that website so, and that is what I am
intending to do.
Mr. Lujan. So in the future, will the DEA increase
supplement prescriber training on the dangers of opioid and
safe prescribing practices for opioid medications?
Ms. Gibson. Absolutely, sir.
Mr. Lujan. I appreciate your testimony in that space, Ms.
Gibson. One thing I wanted to, I think, just bring up to the
committee: Ms. Gibson, how long has this opioid crisis been
affecting America?
Ms. Gibson. Sir, way too long.
Mr. Lujan. Do you know when it started?
Ms. Gibson. According to another physician that was here,
he has been a physician for 25 years, and he saw it. So I think
prescribing of opioids have happened well before we actually
recognized it as an epidemic.
Mr. Lujan. Would it surprise you if I said that the opioid
epidemic has been affecting America since before we were a
country?
Ms. Gibson. It wouldn't surprise me because I believe that
methadone was actually a World War II development, if I
remember correctly.
Mr. Lujan. Well, let's go back to the 1800s, at the very
least. So as we talk about the 19th century. The reason I bring
this up--and I am going to ask an article be submitted into the
record----
[The information appears at the conclusion of the hearing.]
Mr. Lujan. Is just so that we don't lose sight that this
problem is at least a couple hundred years old, if not over 300
years old, from where we are today, and what I hope that we
realize is that while we are talking now about pills, that some
of these drugs and strains that have hit the streets, these
were developed by companies to deal with opioid addiction. They
say, you are addicted to an opioid, so we are going to come up
with another opioid to treat that opioid addiction, and we are
going to warn about this one to treat that one.
And so the reason I ask that question, and I see some
giggling in the audience, which alarms me, this is a serious
epidemic, I think earlier someone said this was maybe 8 to 10
years old. People have been getting killed in all parts of
America for too long. And I know that in my district, we have
had problems in this space that whether they are prescription
drugs or heroin, as we have seen grow across the America.
I am real interested in going after all parts of the
problem that we see. I think earlier you said that you never
give up, ``we never give up at the DEA.'' Are there current
investigations pending with companies that were recently fined
to see if they have corrected their behavior about distributing
large amounts of pills in our communities?
Ms. Gibson. Yes, sir.
Mr. Lujan. I believe that Mr. McKinley joined our chairman
and our ranking member of this committee to inquire about some
of these questions to these manufacturers and distributors, and
it is something that we need to get to the bottom of, and that
we look forward to working with you.
And with that, Mr. Chairman, I would like to submit two
articles into the record, one titled, The Opioid Epidemic, a
Crisis Years in the Making, from the New York Times, October
26th, 2017, and from Smithsonian.com, inside the story of
America's 19th Century opioid addiction.
Mr. Burgess. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Lujan. Thank you, Mr. Chairman.
Mr. Burgess. The gentleman's time is expired. The gentleman
yields back. The chair recognizes the lady from Indiana, Mrs.
Brooks. 5 minutes for questions, please.
Mrs. Brooks. Thank you, Mr. Chairman, and thank you so
much, Ms. Gibson, for being here.
I have worked with the DEA. I was U.S. attorney in the
southern district of Indiana from 2001 to 2007, worked very,
very closely with the DEA during that time. Not only
prosecuting large drug trafficking organizations and know the
incredible dedication that agents have, but also worked with
Diversion at that time, because we did a very significant case
involving significant diversion of OxyContin by a physician.
And so I know that DEA has been involved in the
prescription, then-heroin problem for a long time, to my
colleagues on both sides of the aisle. But what I think has
changed over time is that we now know, because of the
incredible epidemic, I think in large part fueled by far too
many people being on opioids as a prescription initially, and I
think the research has shown that, that about 80 percent or so,
started with prescription drugs, moved to heroin, moved to
fentanyl, and that is where our overdose deaths are.
But I think we do have a lot of prescribers, not just
physicians but nurse practitioners, dentists, podiatrists, lots
of others that maybe have not had sufficient medical education
or continuing medical education.
And so in the spirit, in some ways, of Representative
Schneider's bill, I have been working on a bill as well, but in
a bit different format, because you mentioned there has to be
that interaction, DEA--and I was looking at your Diversion
website--between the States and the Federal Government on
regulation and on licensing.
Can you please talk with us about how DEA, DEA for anyone
to be a prescriber, they have to get what is called the magical
DEA number. Is that correct?
Ms. Gibson. Yes, ma'am.
Mrs. Brooks. And that is what it is called, isn't it?
Ms. Gibson. Yes, the DEA registration number.
Mrs. Brooks. The DEA registration number. And am I missing
categories of prescribers, besides physicians? We all know
physicians. But who is eligible to get a DEA number?
Ms. Gibson. As far as prescribers?
Mrs. Brooks. Yes.
Ms. Gibson. Well, right now anyone that dispenses, that can
write a prescription, needs a DEA number. Since I have been
there at Diversion, I have definitely been made aware of data-
waived prescribers, and that is for drug treatment.
Mrs. Brooks. And how long have you been there, in
Diversion? I know you have been an agent in the field for a
long time.
Ms. Gibson. A month and a half, ma'am.
Mrs. Brooks. OK. Well, welcome.
Ms. Gibson. Thank you.
Mrs. Brooks [continuing]. To leading the effort, because I
really do believe you are and need to be the person leading the
effort for DEA because we have to do a lot of things
differently than what we have been doing.
What we have been doing isn't working. We haven't turned
the corner yet. We are not just at the tipping point. We are
beyond the tipping point. We are losing far too many people. I
attended a funeral of a family friend in December, far too many
funerals last year. And we have not changed it.
And yet, I know that our prescribers do not want to be a
part of the problem, but I think we need more education. And I
think in Indiana, our State medical association, as well as a
number of the groups we have talked to are willing and want to
be a part of the problem and get more education. And in fact,
have done it in Indiana. Some States do. Some States don't.
And what I am asking is whether or not what we are working
on is 3 hours of continuing medical education over the period
which is every 3 years, is that correct? Do you know?
Ms. Gibson. According to your bill, I think it was 3 hours
every 3 years.
Mrs. Brooks. Correct. And that the States would then have
jurisdiction over determining what is the appropriate training.
And how do you feel about that? That the State medical
associations and the State medical licensing boards would be
the ones that would be in charge of working, of course, and
looking for the best practices of training from HHS?
Ms. Gibson. Ma'am, we rely on our State counterparts. We
need them. Hands down, we need them.
Mrs. Brooks. Well, in fact a prescriber can't get a DEA
license unless they show they have a valid medical----
Ms. Gibson. Yes.
Mrs. Brooks [continuing]. Or a valid license----
Ms. Gibson. Yes.
Mrs. Brooks [continuing]. In the State, is that correct.
Ms. Gibson. Yes. And oftentimes we work with the States
regarding, if a State can easily take away a registration, then
if they don't have that State registration, we are able to
revoke their Federal registration.
Mrs. Brooks. Is there enough coordination between all 50
States and DEA, or are there some problem States? I won't ask
you to name them.
Ms. Gibson. I have to say, again, I am proud of Diversion
investigators because they're imbedded in these communities,
and they all work closely with their States regarding those
issues. So I haven't heard of any issues, but obviously, if
there are, I will make sure that they are addressed.
Mrs. Brooks. I have a number of other questions but will
submit in writing. Thank you so much for your efforts.
Ms. Gibson. Thank you.
Mr. Burgess. The chair thanks the gentlelady.
Mrs. Brooks. I yield back.
Mr. Burgess. The gentlelady yields back. The chair
recognizes the gentleman from North Carolina, Mr. Hudson. 5
minutes for questions, please.
Mr. Hudson. Thank you, Mr. Chairman. Ms. Gibson, thank you
for being here today.
As you know, the opioid epidemic is arguably one of the
worst public health crises we have ever faced in this country.
In North Carolina, we have 4 of the top 25 worst cities for
abuse in the country, including Fayetteville, North Carolina,
in my district. I don't believe there is one silver-bullet
solution, but I have homed in one area that I do believe we can
make a big difference, and that is the proper disposal of
opioids.
As I examined disposal, I have found that almost every one
I talked to back home, a light bulb goes off when we start
talking about it, and they say, I have a bottle of pills in my
medicine cabinet. I talked to one woman who for 5 years moved
her bottle of opioids with her as she moved from apartment to
apartment.
And just a few statistics to provide: There are as many as
200 million opioids prescriptions written each year. As many as
92 percent of patients don't complete that. In other words,
have pills left over. Less than 10 percent of those folks
properly dispose of them. So we are talking about a huge
amount. And according to the National Institutes of Drug Abuse,
70 percent of heroin addictions start by a product found in a
home medicine cabinet.
I went on the DEA website last night, and the
recommendations for disposal of unused medications, including
DEA take-back programs--which I participated in--flush them
down the toilet, mix them up with something undesirable, such
as kitty litter or coffee grounds or dirt in a resealable bag
and throw them in the trash. These are recommendations updated
as of October 25 of 2017.
Given all the statistics I have just listed and the scope
of the opioid epidemic we are facing, do you think these
recommendations are effective? Just yes or no.
Ms. Gibson. Yes.
Mr. Hudson. OK. And then would you agree that we might,
though, need to explore some new ways to help patients dispose
of unused prescription drugs, in particular opioids?
Ms. Gibson. Absolutely.
Mr. Hudson. Great. Would you be willing to work with me on
some solutions we have been working on and taking a look at to
try to bring more options for consumers?
Ms. Gibson. Absolutely.
Mr. Hudson. Great. Well, I appreciate your testimony and
your time here today, and look forward to working with you on
this.
Ms. Gibson. Thank you.
Mr. Hudson. OK. And with that, Mr. Chairman, I will yield
back.
Mr. Burgess. The Chair thanks the gentleman. The gentleman
yields back. The Chair recognizes the gentleman from Virginia,
Mr. Griffith, for 5 minutes for questions, please.
Mr. Griffith. Thank you, Mr. Chairman. I appreciate it very
much. I appreciate you being here with us today.
So I have heard a lot of comments from my colleagues on
both sides of the aisle about concerns about doing research
with different--and I don't know what the right word is--but
when you change the formula a little bit on fentanyl, and they
are concerned about, we don't want this stuff on the street,
but what about research because it may be helpful, the drug
might, if you change it a little bit, it might actually have
some positive impacts. And you responded that you have 600
folks working on THC and cannabidiol.
My concern is, and I think probably where this concern has
come from other folks is, is that this has been a long standing
complaint with the DEA on substances that are either
unscheduled or Schedule I, such as marijuana. You mentioned THC
and cannabidiol. Virginia had the first medical marijuana law
in the United States passed in 1979 by former Congressman Rick
Boucher when he was in the State Senate, and member of the
House of Delegates, the late Chip Woodrum.
And from 1979 to 1998, there wasn't a whole lot going on,
because in 1998, somebody tried to take that law off the books.
That is when I got involved in this issue. And what we heard at
that time in Virginia was, yes, they say they are doing
research at the DEA, but we have a hard time getting approval.
And I note with some interest that in our next panel, we
have a witness, Dr.Beardsley, who in his written testimony,
tells us that in one instance, it took over 4 months to get
cannabidiol added to my Schedule I registration. And this drug
has no abuse potential and no street value, so I think it is
pretty much accurate.
So I want to work with you to get the language right. I
don't want this stuff on the street. But I also want to make
sure that we don't have a repeat of the past, and then once it
gets put into a Schedule I or Schedule A, as the Katko bill
would have it do, that we not just immediately take all those
substances off the table for research. Because if we don't
continue to look at all the possibilities for all kinds of
treatments, we may not know what we are missing, and we may
have some value in that.
Will you agree to work with me on that and others to get
this language right so that we can do the research while trying
to give you the power to get the nasty stuff off of the streets
that we don't want our kids using, but knowing that sometimes a
little poison can be a medicine?
Ms. Gibson. Sir, I appreciate your concern about research,
and it is my concern, too. And I will be more than happy to
work with you regarding research. If we can streamline the
process, if we can get the right people to do----
Mr. Griffith. What I want is not just the research. I want
your folks and your legal team to help our legal team come up
with language that allows us to do both. To make it improper to
have it on the streets, but still to allow our research
universities and our folks and our doctors and our medical
community who are doing research, to look for those miracle
cures, even if one of those may have some component that is a
fentanyl derivative.
Ms. Gibson. Sir, I will be more than happy to work with
you.
Mr. Griffith. On getting that language down?
Ms. Gibson. Yes, sir.
Mr. Griffith. Excellent. Thank you.
Also, Mr. Beardsley's written testimony mentions a policy
change made a few years ago that now requires a researcher to
have a separate control substance registrations for each
building that they conduct research in.
So he goes through a system, and he says, I used to have
one person who could be in charge of it, now I have to have 20
people. And some of those people have to have four different
registrations because they work in four different buildings.
And he is at MCV, Medical College in Virginia, VCUs medical
school. And it is in downtown Richmond, and they do stuff in
lots of different buildings, four for research, apparently.
I am just wondering why that policy change was made and if
we couldn't change it back?
Ms. Gibson. Sir, again----
Mr. Griffith. You have been here a month-and-a-half and you
don't know the answer to that one. Can you research that and
get it for me?
Ms. Gibson. But I want to find the answer for you.
Mr. Griffith. Yes, ma'am.
Ms. Gibson. I am sitting here and I want to find the answer
for you. And I definitely want to work with you regarding this,
because I believe research is very important.
Mr. Griffith. Yes. And I understand that. That is a
reasonable answer in light of the fact you have been there 6
weeks.
Have you all released any updated regulations or guidance
to pharmacists or other healthcare professionals and/or
patients regarding the implementation of Section 702 of CARA,
which allows prescribers and patients to request a partial fill
of Schedule II control substances. And if yes, where can that
information be found. And if not, why?
Ms. Gibson. Sir, I believe that is still in my regulations
department, still being drafted. And we are trying to get that
language right, but is it definitely part of the CARA bill, and
we are definitely working on it.
Mr. Griffith. Well, and I would hope that, and I appreciate
that you all worked hard to get the fentanyls rescheduled or
scheduled in 2 months, but this would cut down on supply out
there on the street and would really appreciate if your
department that handles that could get that done expeditiously.
With that, I have to yield back because my time is up and I
thank you much.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back. The chair recognizes the gentleman from Georgia,
Mr. Carter, 5 minutes for questions, please.
Mr. Carter. Thank you, Mr. Chairman. Thank you, Ms. Gibson,
for being here. I appreciate it very much. We talked earlier
today, you had a question from another member about a bill that
I am cosponsoring along with one of my Democratic colleagues,
the Special Registration For Telemedicine Clarification Act of
2018.
And you mentioned that it is available now that through
telemedicine you can get a waiver in order to write a
prescription for an opioid for pain medication without seeing
the patient but seeing them through telehealth. Is that right?
Ms. Gibson. It is not a special waiver, from what I
understand. Telemedicine under the Ryan Haight Act----
Mr. Carter. Right.
Ms. Gibson [continuing]. Has been outlined as far as there
are certain situations that you can follow and you can engage
in telemedicine.
Mr. Carter. But the Ryan Haight Act limits that.
Nevertheless, the intent of this bill that we are cosponsoring,
Representative Bustos and myself, is to allow or to direct the
agency to come up with and to promulgate the rules so that we
can do this, so that it can happen. Because this is extremely
important, particularly in rural areas where telemedicine is
vital, and particularly for patients who need that pain
medication who may not have access to a professional at that
time.
Ms. Gibson. I agree that telemedicine is definitely needed.
But, again, when I put my regulatory hat on and my main concern
is diversion.
Mr. Carter. I understand. Do you feel like this is
something that you can do? Because what we say in this
legislation is to direct the agency to come up to DEA to
promulgate the rules within 30 days of the passage of the law.
Ms. Gibson. I understand.
Mr. Carter. OK. Well, I just want to make sure. And
certainly, we are concerned about the fraudulent use of it as
well. So another bill that I am cosponsoring, again, along with
one of my Democrat colleagues Representative Mark DeSaulnier,
is Empowering Pharmacists in the Fight Against Opioid Abuse
Act. And that, of course, is for the DEA to help pharmacists to
identify fraudulent prescriptions. And that is something that
is very important. For your information, currently I am the
only pharmacist serving in Congress. I practiced for over 30
years. And I have to tell you that this is something we do need
help with, and we welcome this help. We want to have the
ability to identify fraudulent prescriptions.
However, you have to keep in mind that we are not law
enforcement officers. The only thing worse, I think, for myself
as a practicing pharmacist, the only thing worse than
dispensing medication that would be opioids, in particular,
that would be for abuse and for diversion, would have been to
deny a prescription to a person who truly needed it. That is
very difficult.
I don't want to have to profile. It is unfair for you to
expect me to have a patient come in and for me to make a
decision by looking at that patient and saying that they don't
look like they need this, that I am supposed to keep them from
having it. That is simply not right. And something that I am
not trained in. So I hope you will keep that in mind during the
time that you are looking at it.
Another thing I wanted to touch on was what we did in CARA,
the Comprehensive Addiction Recovery Act, to allow 3
prescriptions for a 30-day supply to be written. One of the
things that has been suggested, and it was just mentioned, was
the fact that possibly allowing physicians to have a refill on
a prescription, in a smaller amount.
All of us in pharmacy have experienced getting a
prescription for simply a dental procedure for 30 oxycodone.
And that is something we hate to see.
So I hope that the Department will look at possibly
allowing for a smaller quantity with perhaps just one refill
that has to be filled within a certain time period. That is
something that I had hope you will look at as well.
Mr. Carter. One of the things that concerns me is--look,
there are rogue practitioners in every profession, every
profession, including the medical profession, and
practitioners. And one of the things that concerns me is that I
have never had a doctor who said: I didn't know opioids were
addictive.
Physicians are smart people. They are intelligent people.
They have gone through intensive training. They understand it.
They do need to have continuing education with it.
But it does concern me, and it concerns me how long it
takes for the DEA to respond to some of these rogue doctors.
Sometime I hope you will look at that.
The last think I wanted to touch on is, when I was a member
of the Georgia State legislature, every year, we have a
dangerous drug act, and we include drugs into the Schedule I
classifications in our State. I did that on numerous occasions.
It is very difficult. It is going to be very difficult with you
with the synthetic drugs. I know how they get around it.
I just want to ask you. After it becomes a Schedule I drug,
a state can't overrule you and say that that could be legal,
can they? You know where I am going.
Ms. Gibson. I know where you are going.
Mr. Carter. OK. Yes or no.
Ms. Gibson. And if Federal law identifies a substance to be
Schedule I, it is Schedule I.
Mr. Carter. Can I ask you one question?
Ms. Gibson. Yes, sir.
Mr. Carter. What is marijuana?
Ms. Gibson. Schedule I.
Mr. Carter. Thank you very much.
Mr. Chairman, I yield.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back.
The chair recognizes the gentleman from Kentucky, Mr.
Guthrie, the vice chairman of the subcommittee. You are
recognized for 5 minutes for questions.
Mr. Guthrie. Thank you for being here today. In your
testimony, you mentioned AlphaBay, a criminal marketplace
website operated for over 2 years. I understand it took a lot
of national and even international resources to take them down.
Can you please tell me if there is now a timely process in
place should another AlphaBay surface again?
Ms. Gibson. Sir, I appreciate your questioning because
these cases are difficult. These cases are labor intensive to
include diversion cases. Going after physicians, it is
incumbent that we use every tool in our toolbox to go after
them, to include working with our state. So, yes, they are
labor intensive, but we get it done, and that is why I am proud
of the DEA, because no matter what the task is in front of us,
we figure it out, how to do it, and we get it done.
Mr. Guthrie. I understand that, and I agree. But if there
is something unique like website--this new website that came on
board, you went through a 2-year process, and you did, there
had to be lessons learned, to say, well, this is something that
we could have done differently, done better that would have
sped up the process again or sped up the process, and hopefully
that is more adopted into plans?
Ms. Gibson. Sir, I am a fairly aggressive human being, and
I believe that we learn from anything that we do, and we make
it better. And that being said, anything that we can improve
upon to get these bad actors out there in handcuffs, I am all
for. Anybody who violates the CSA intentionally, they will be
in handcuffs, if it is up to me.
If it is a distributor and if I have a criminal case that I
can make against them, they will be in handcuffs, I promise
you.
Mr. Guthrie. Thank you, I appreciate that. And also,
yesterday, Attorney General Sessions announced the formation of
the new Prescription Interdiction & Litigation Task Force at
DOJ. I was very pleased to hear about this. And can you please
speak to the DEA's role in this task force and how the DOJ task
force will work with the DEA Special Operations Division on
heroin/fentanyl task force.
Ms. Gibson. Sir, I appreciate your question, and that is a
new endeavor. And we are working with our counterparts at the
Department of Justice right now to understand our role. So I
would have to get back with you regarding your answer.
Mr. Guthrie. OK. Thank you.
Also, I know several people, Ms. DeGette and Mr. Hudson and
others, have mentioned the National Drug Take Back Initiative.
I think several of us have asked about that. It has been
effective, but we can do more. I know that Mr. Walberg, who is
probably going to go in a couple of minutes, has a bill
addressing unused opioid disposal for hospice. I won't get into
his area, but I know he is going to talk about that.
But would you just kind of speak to safe disposal and what
options do we have, and what you would like to see Congress do
in that respect?
Ms. Gibson. Sir, I appreciate that concern because it is a
concern of mine, because once we can get these drugs off the
street in the prescription pill form, we have to make sure that
they are not diverted again. So that requires guidelines. That
requires policy. And we would be more than happy to work with
any entity out there to come up with a game plan so that when
we get those pills off the street and we can get them into a
safe location and they remain in custody to be disposed of,
that is our ultimate goal.
Mr. Guthrie. OK. Thank you. And that finishes my questions.
I yield back a minute 26.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman. I think we have accommodated all the members of
the subcommittee, and I am now pleased to recognize Mr.
Walberg, who is a member of the full committee, 5 minutes for
your questions.
Mr. Walberg. I thank the chairman for your hospitality and
allowing me to sit with this panel today.
And, Ms. Gibson, thank you for the work that you do, and
thank you for being here.
In Mr. Mulder's testimony to come, it expresses support for
H.R. 5041, a bill that I have sponsored along with a couple of
other members of our committee. He expressed the support of it
being expanded to authorize hospice personnel to dispose of
unused medication when a living patient undergoes a medication
change. Would the DEA have concerns with that proposal?
Ms. Gibson. Sir, we definitely want to work with you and
the committee to make sure that we get the language right and
we get the process right, because we want to make sure that we
get those drugs into the hands of an entity that can secure
them and prevent them from being diverted.
Mr. Walberg. Well, I think that would be the concern of the
hospice personnel as well at this point, plus making sure that
there isn't a temptation by leaving those in the medicine
cabinets or--we look forward to working on that.
Would the DEA be supportive of language being included in
the bill to add additional reporting requirements? For example,
a notation on the patient's record that state the date the
medication was destroyed, the dosage, and who destroyed the
medication, could that alleviate concerns?
Ms. Gibson. That is definitely language that we can talk
about and add. Absolutely, it would be a mechanism that would
we could use.
Mr. Walberg. Thank you. I won't wear out my welcome. Those
were two questions I had. I yield back.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back. I believe that has accommodated everyone who had
questions.
Mr. Green, do you have a followup?
Mr. Green. No.
Mr. Burgess. Neither do I. We are going to take the
briefest of recesses while we transition the panel.
Ms. Gibson, I want to thank you for your participation
today. I expect we will have an opportunity to talk about all
of these things in more detail as your tenure in the agency
increases. So thank you for being here today.
Ms. Gibson. I look forward to it. Thank you.
[Recess.]
Mr. Burgess. I think we have almost successfully
transitioned. We still have a couple of vacant chairs. There we
go. Well, I think we have transitioned to our second panel
today, and we want to thank our witnesses for being here and
taking the time to testify before the subcommittee.
Once again, each witness will have the opportunity to give
an opening statement, and that will be followed by rounds of
questions from members. So, today, this afternoon, in the
second panel, we are going to hear from Mr. Frank Fowler, Chief
of Police, Syracuse Police Department; Dr. Patrick Beardsley,
Professor, Department of Pharmacology and Toxicology, Virginia
Commonwealth University; Dr. John Mulder--I have got you out of
order--Dr. Mulder, John Mulder, Director, Trillium Institute;
Dr. Ponni Subbiah, Chief Medical Officer, Indivior; Dr. David
Kan, President, California Society of Addiction Medicine;
Richard Nance, Director, Utah County Department of Drug and
Alcohol Prevention and Treatment; Thomas Cosgrove, Partner,
Covington and Burling, LLP; Dr. Andrew Kolodny, Codirector,
Opioid Policy Research, Brandeis University; and Richard Logan,
owner of L&S Pharmacy.
We appreciate each of you being here today and, again, are
grateful for your forbearance in what has been a long
afternoon. Chief Fowler, you are recognized for 5 minutes to
give a summary of your opening statement.
And, chief, make sure your microphone is on.
STATEMENTS OF FRANK L. FOWLER, CHIEF OF POLICE, SYRACUSE POLICE
DEPARTMENT; PATRICK M. BEARDSLEY, PH.D., PROFESSOR, DEPARTMENT
OF PHARMACOLOGY AND TOXICOLOGY, VIRGINIA COMMONWEALTH
UNIVERSITY; JOHN MULDER, M.D., FAAHPM, HMDC, DIRECTOR, TRILLIUM
INSTITUTE; PONNI SUBBIAH, M.D., CHIEF MEDICAL OFFICER, INDIVIOR
PLC; DAVID Y. KAN, M.D., PRESIDENT, CALIFORNIA SOCIETY OF
ADDICTION MEDICINE; RICHARD J. NANCE, LCSW, DIRECTOR, UTAH
COUNTY DEPARTMENT OF DRUG AND ALCOHOL PREVENTION AND TREATMENT;
THOMAS J. COSGROVE, PARTNER, COVINGTON AND BURLING LLP; ANDREW
KOLODNY, M.D., CODIRECTOR, OPIOID POLICY RESEARCH, BRANDEIS
UNIVERSITY; AND RICHARD N. LOGAN, JR., PHARM.D., OWNER, L&S
PHARMACY.
STATEMENT OF FRANK L. FOWLER
Chief Fowler. Thank you. Thank you, Chairman Burgess,
Ranking Member Green, and the distinguished members of the
Committee on Energy and Commerce. I am here today to make an
effort to paint a picture of a community that has been ravaged
by synthetic drug abuse. Beginning in 2013, the Syracuse Police
Department responded to an increase in the use and subsequent
overdose of synthetic marijuana known as Spike. The Syracuse
Police Department implemented various means of tracking the
problem in addition to our law enforcement efforts.
In 2015, the Syracuse Police Department saw its largest
number of overdoses from the use of synthetic marijuana, the
largest number of overall cause for services related to overall
overdoses and persons down, and also made the largest number of
arrests related to this substance. While the department took
steps to get these drugs off the streets, new chemical
formations of Spike were beginning to be put into circulation.
In addition to all of the Syracuse Police Department's
efforts, the only thing that we could charge a person with was
a local law violation, issuing them an appearance ticket and
releasing them. This is just one example of the dangerous
synthetic compounds that are flooding our streets. Toxic
synthetic drugs are designed to mimic drugs like marijuana,
LSD, cocaine, ecstasy, and other hard drugs. They could be more
potent than the real thing, and oftentimes are more deadly.
In addition, these drugs are not simply affecting the
users, my officers and other first responders are put in harm's
way simply by coming in contact with these often lethal
substances.
As a local law enforcement official, we need H.R. 2851, the
SITSA Act, which was introduced by Congressman Katko. This bill
takes a big step towards eradicating these harmful substances
and protecting our community. SITSA will give my officers the
tools they need to target synthetic substance and the criminals
who distribute and traffic them.
Under this bill, a drug such as Spike could be temporarily
or permanently added to the new schedule under the Controlled
Substances Act in as little as 30 days after the chemical
compound has been identified. The abusers of these synthetic
drugs are not simply confined to my jurisdiction. Colleagues of
mine from across the country are dealing with the same issues
and have expressed a need for a solution. H.R. 2851 is that
solution.
I urge this committee to pass this bill and to give us the
tools we need to combat this deadly epidemic. Thank you again
for this opportunity and I welcome your questions.
[The prepared statement of Chief Fowler follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you, Chief Fowler.
Dr. Beardsley, you are recognized for 5 minutes, please.
STATEMENT OF PATRICK M. BEARDSLEY, PH.D.
Mr. Beardsley. I am Dr. Patrick Beardsley, a professor of
pharmacology and toxicology at the Virginia Commonwealth
University. In addition to my faculty appointment, I am a
member of the Expert Committee on Drug Dependence for the World
Health Organization, a committee that is the first step for
processing drugs for their international control.
Thank you for the opportunity to be here today to discuss
SITSA, H.R. 2851. We are all dedicated to finding paths to take
us away from our present opioid crisis. I believe one path will
be through research. There is a perpetual need to strike a
balance between regulatory control of drugs to ensure public
safely and the necessity for researchers to have access to
controlled drugs to further science.
The Controlled Substances Act, the CSA, explicitly
recognizes both those needs, and I am personally sympathetic to
both needs. As a researcher of the drugs of abuse, however, I
have concerns that SITSA upsets that balance. I would like to
take the next few minutes of your time to identify my concerns.
It is my opinion that the Attorney General has already been
able to effectively regulate all synthetic opioids that are
known to be a current problem via the present CSA. Effective
February 6 of this month, the DEA issued a scheduling order
that included all fentanyl-related substances that are not
currently scheduled to be included in Schedule I.
Fentanyls constitute the greatest portion of all synthetic
opioids abused. A few non-fentanyl synthetic opioids that have
been identified as abused have previously been scheduled.
Because most, if not all, currently abused synthetic opioids
are currently scheduled under the CSA, it is unclear of the
introduction of Schedule A by SITSA to help address the current
problems with abused synthetic opioids.
Considering 13 fentanyls are exclusively identified in
SITSA to be included in Schedule A, it is likely all will
eventually be transferred. How public health would be enhanced
transferring these compounds from Schedule I to Schedule A
conditions is also unclear. The addition of another category of
drugs by SITSA to the CSA is problematic. In so doing, it adds
another level of costly bureaucracy to researchers who work
with drugs of abuse.
Registrants with only a Schedule II to V registration will
have to obtain a Schedule A registration. All registrants,
whether they hold a Schedule I or a Schedule A registration,
will have to submit protocols to the Attorney General for his
approval to justify the use of each drug in Schedule A.
Functionally, this arrangement is very similar to how research
with Schedule I drugs are now handled. It can take a year or
longer to obtain a Schedule I registration, and it can require
many months to have a new drug added to one's existing Schedule
I registration. With similar delays that are now impeding
research with Schedule I drugs transferred to Schedule A drugs,
SITSA will provide nothing to the research that will has hasten
our understanding of synthetic opioids through science and will
likely only impede that progress. This problem is compounded by
an absence of a mechanism in SITSA for removing a drug from
Schedule A once it is scheduled.
Under SITSA, the Attorney General has the power to place a
compound in Schedule A based upon a drug structure. And in the
absence of additional scientific information, commonly provided
by HHS and NIDA, the National Institute of Drug Abuse, this can
result in misclassifications of drugs and missed opportunities
for discovering medications we need to confront the opioid
crisis with.
Determining scheduling driven by chemical structure can be
misleading. For example, the chemical structures of morphine
and naloxone are very similar, yet one is highly abused and the
other is an antagonist that is an antidote to the effects of
the other. Adding a compound just based upon structural
similarity to an abused compound may inadvertently ban an
antidote to the abused compound.
In addition to my concerns regarding SITSA, I do have
suggestions that would make conducting research with synthetic
opioids and controlled substances in general more efficient,
far less costly, and bring much relief from the bureaucratic
burden of conducting research with them. My statement time
doesn't permit me to enumerate them, but my suggestions can be
found in my written statement, and I would be happy to discuss
them later, if asked.
I have tried to identify a few concerns I have with SITSA
as a researcher, and I welcome any questions you may have.
Thank you.
[The prepared statement of Mr. Beardsley follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you, Dr. Beardsley.
Dr. Mulder, you are recognized for 5 minutes, please.
STATEMENT OF JOHN MULDER, M.D., FAAHPM, HMDC
Dr. Mulder. Thank you, Chairman Burgess and members of the
committee. We appreciate the opportunity to just share a few
moments with you this afternoon. I am John Mulder. I am a
physician who has been practicing in the field of hospice and
palliative medicine for over 30 years and have cared for a lot
of folks, thousands over that period of time.
I am here in support of House bill 5041 and appreciate
Representative Walberg, as well as Representative Dingell and
Representative Hudson, for crafting and advancing this bill. It
is pretty straightforward. This bill would allow licensed
hospice personnel to destroy medication in the home that is
left over after a patient dies, or in cases where someone is
still living, but the medication has been changed, leaving
excess medication in the house. It would allow for them to
properly dispose of that.
Every year in America, we care for between 1 \1/2\ and 2
million hospice patients, which means that those are the
numbers of patients that are dying. And I would submit that
virtually everyone has medication left over. We can't predict
when someone is going to die. Therefore, we prescribe
medications, typically in small amounts, but they die, and
medications are left over.
So the mathematical extrapolation is pretty
straightforward. We end up with tens of millions of doses of
controlled substances that are left in the homes of our hospice
patients every year. And at this point in time, our hospice
personnel are not legally allowed to handle that. They can make
recommendations, but as we have already heard in earlier
testimony, the availability of take-back programs, the process
of using the mail-in envelopes and other processes that are in
place legally are sometimes onerous, and families typically
don't take advantage of that. That just leaves too many
medications left on the shelf and ultimately potentially to be
sometimes innocently, but sometimes nefariously, abused by
family members or diverted.
So, when we are talking about a quick and easy way to get
rid of millions of doses of controlled substances off the
streets--potentially off the streets--this is a very simple,
and I would note, bipartisan effort that has--that to me makes
an awful lot of sense. And that is it. That is it.
The only thing I would add is--just the one thing I have
noticed in a lot of legislation, both Federal as well as State,
is that in the effort to push forward legislation, a lot of
times the role of hospice in the care of the patients and the
unique and special plight of hospice patients is sometimes
overlooked, and sometimes the legislative burdens and barriers
could have the potential of introducing preventable suffering
for our hospice patients.
So I would just ask that the committee and members be
mindful of the unique nature of hospice concerns and to take
advantage of the resources of the National Association of Home
Care and Hospice as a resource for additional input. I as well
am available to answer any questions or concerns that someone
might have about this issue.
[The prepared statement of Dr. Mulder follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you, Dr. Mulder. We appreciate your
testimony.
Dr. Subbiah, you are recognized for 5 minutes, please.
STATEMENT OF PONNI SUBBIAH, M.D.
Dr. Subbiah. Good afternoon. I am Dr. Ponni Subbiah. I am a
neurologist and chief medical officer at Indivior, global
specialty pharmaceutical company with a core focus on addiction
medicine. We have a 20-year commitment to the vision that all
patients have access to evidence-based treatments. We developed
the first buprenorphine-based medication for treatment of
opioid dependence in the U.S.
Today, we have a portfolio of treatments for opioid
addiction, as well as a pipeline of product candidates to
address unmet patient needs for this and other disorders,
including alcohol use disorder and schizophrenia. To address
the opioid epidemic, it is important to understand the patient
journey. It is complex and often misunderstood.
Addiction is a brain disease and not a moral failure.
However, social stigma, prejudice, and misconceptions about
addiction coupled with feelings of guilt and shame often
prevent people from seeking help. Even when people want help,
cravings and withdrawal symptoms can be so intense that there
is generally only a small window of time when a person can
emotionally and physically pursue treatment.
The healthcare system, however, does not always encourage
treatment during that window due to structural barriers to
care. This is one reason that many of those who need help go
untreated. Any patient in need of treatment for opioid use
disorder should have access to the medication-assisted
treatment prescribed by their healthcare professional.
Indivior's focus on patient needs to drive decisions
inspired the R&D team to develop Sublocade, which received FDA
approval on November 30 of last year. Sublocade is the first
once-monthly Schedule III buprenorphine extended release
injection for subcutaneous use. In the face of this growing
addiction crisis, FDA granted the product fast-track approval
and priority review designation.
Now, it is indicated for the treatment of moderate to
severe opioid use disorder in patients as part of a complete
treatment plan that includes counseling and psychosocial
support. Sublocade uses the Atrigel delivery system, which
allows for once-monthly dosing and is intended to be
administered only by healthcare providers. Sublocade will be
distributed through a restricted distribution system, which is
part of a risk evaluation and mitigation strategy program. The
goal of this program is to mitigate serious harm or death that
could be result from intravenous administration, self-
administration, by the patient.
All healthcare settings and pharmacies that order and
dispense Sublocade must be certified and establish procedures
to verify that the medication is dispensed directly to a
healthcare provider for administration by a healthcare provider
only. As every patient's journey toward recovery is different,
access to all evidence-based treatment options is critical.
Sublocade represents one such option.
Government policies impacting these treatments must adapt
to ensure patients to have access to new innovative medical
technologies. Historically, buprenorphine treatments have been
daily oral medication, and the Controlled Substances Act allows
for dispensing this medication directly to patients. However,
Sublocade, as required by our FDA approved REMS can only be
administered directly by the healthcare provider and cannot be
dispensed directly to the patient.
In recent years, the distribution of injectable products
have evolved from a transitional buy and bill system where
physician practices purchase drugs directly from a distributor
to one that allows specialty pharmacies to ship a patient's
prescription directly to administering provider. For example,
current long-acting injectable treatments used for
schizophrenia utilized both these distribution methods to
ensure optimal patient access to these medications.
Current law, however, is ambiguous and could impede patient
access to new treatment innovations. We agree with
Representatives Costello and Nolan that the law needs to be
clarified so that these next-generation buprenorphine products
can be accessed directly by healthcare providers through a
specialty pharmacy restricted delivery system, as well as a
traditional buy-and-bill system.
We support the proposed legislation to remove ambiguity in
the current law to ensure that patients of opioid use disorder
and their providers have the same level of access to these
innovative treatments as they do to other injectable products.
This technical clarification will ensure the safest
distribution channels for these new medical technologies.
Thank you again for the opportunity to address the
committee. Together, we can transform addiction from a human
crisis to a recognized treatable disease. Thank you.
[The prepared statement of Dr. Subbiah follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you for your testimony.
Dr. Kan, you are recognized for 5 minutes, please.
STATEMENT OF DAVID Y. KAN, M.D.
Dr. Kan. Chairman Burgess and Ranking Member Green, thank
you for inviting me to participate in this hearing. Thank you
to the subcommittee for your leadership in addressing our
country's opioid epidemic.
My name is Dr. David Kan, and I am the president of the
California Society of Addiction Medicine, a chapter of the
American Society of Addiction Medicine, also known as ASAM.
This testimony is offered on behalf of ASAM. Established in
1954, ASAM is a national medical specialty society of more than
5,000 physicians and allied health professionals whose mission
is to increase access to high-quality addiction treatment. I am
board certified in addiction medicine and psychiatry. I served
10 years in Federal service at a VA methadone program within
the San Francisco VA Medical Center as medical director. I am
the current medical director at Bright Heart Health, which
provides telemedicine services in 21 states across the United
States.
My testimony today will focus on three facts. Number one,
addiction involving opioid use is effectively treated with a
combination of medications and psychosocial interventions. And
ASAM has published guidelines that detail best practices for
the use of these medications.
Number two, there are significant barriers to accessing
medications for addiction involving opioid use and a nationwide
treatment gap.
Number three, changes to the Controlled Substances Act to
facilitate the use of telemedicine and new medication
formulations can expand access to medications for addiction
involving opioid use to close the gap. There are currently
three medications--methadone, naltrexone, and buprenorphine--
that are FDA approved and have substantial evidence for their
effectiveness treating addiction involving opioid use.
Given the bills being considered today, I will focus my
remarks on the safely and effectiveness of buprenorphine.
Compared to full opioid agonists like methadone, buprenorphine
is much safer with significantly lowered overdose deaths and
adverse events. The direct healthcare savings per treated
opioid dependent patient per year exceed $20,000. ASAM has
published clear standards of care for clinicians treating
patients with addiction, as well as prescribing guidelines.
Despite the strong evidence used for the use of
buprenorphine, very few eligible patients are offered
medications to help treat their disease. Studies have shown
that 80 percent of patients with opioid addiction don't receive
any treatment, and the majority of States don't have enough
treatment providers to provide the capacity to meet the need.
Other access barriers include transportation difficulties,
limited hours of operation, and few prescribers who accept
Medicaid or Medicare, often making access to treatment next to
impossible. Making smart and targeted changes to the Controlled
Substances Act to facilitate treatment of buprenorphine and for
addiction involving opioid use via telemedicine and the use of
new buprenorphine formulations are steps this Congress should
take to expand addiction treatment access.
Telemedicine provides significant opportunities to reach
more patients. The Ryan Haight Act limits the expansion of
treatment with buprenorphine for addiction involving opioid use
via telemedicine by generally requiring an in-person medical
evaluation or the presence of the patient in a DEA-registered
hospital or clinic.
Consistent with ASAM's standards of care and national
practice guidelines, ASAM recommends that the requirement for
an in-person physical exam by the prescribing clinician be
revised to allow for a physical exam to be conducted by another
appropriately licensed healthcare professional and documented
in the patient's medical record.
Additionally, ASAM recommends limiting this exception to
the in-person physical exam requirement only to those
physicians who hold additional certification or who practice in
a qualified practice setting per the definitions in the 2016
SAMHSA rule that raised the dated 2016 prescribing limit. These
changes would increase access while ensuring high-quality care
from competent healthcare providers and safety for the patients
to reduce diversion.
Secondly, ASAM encourages Congress to amend the Controlled
Substances Act to allow for specialty pharmacies to deliver new
injectable and implantable buprenorphine formulations directly
to the administering clinician's practice rather than relying
on the buy-and-bill method for obtaining and being reimbursed
for the medications. Such a change is not a new pathway for
medication delivery; it would allow for these controlled
substances to be delivered as many noncontrolled substances are
already. It is a technical, commonsense fix that will expand
treatment access while potentially reducing buprenorphine
diversion. And ASAM urges this subcommittee to advance the bill
to approve it.
Thank you again for the opportunity to present here today.
I look toward to your questions.
[The prepared statement of Dr. Kan follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you, Dr. Kan.
Mr. Nance, you are recognized for 5 minutes, please, for an
opening statement.
STATEMENT OF RICHARD J. NANCE
Mr. Nance. Thank you, Chairman Burgess, Ranking Member
Green, and members of the committee, I appreciate the
opportunity to testify on an issue that is impacting community-
based addiction and mental health centers across the country.
Thanks to Representatives Carter, Bustos, Harper, and
Matsui for their leadership on the two discussion draft bills
focused on the Ryan Haight Act. We appreciate your work.
I am honored to be here today on behalf of the National
Council for Behavioral Health, a national group that represents
2,900 member centers who serve more than 8 million adults and
children living with behavioral health disorders in the United
States. Since 1998, I have served as the director of Utah
County's Department of Drug and Alcohol Prevention and
Treatment. I am a member of the National Council. I am also a
licensed clinical social worker in the State of Utah. My
department provides a comprehensive range of drug and alcohol
prevention and treatment services, including medication-
assisted treatment for opioid addiction and abuse.
Over 40 percent of the people I have in treatment at my
agency right now are there for an opiate issue, and over 30
percent of them are receiving medication-assisted treatment.
That is nearly 400 out of 850 clients I have in treatment
today.
I am here to discuss an issue that limits community
addiction and mental health centers' ability to provide
patients access to treatment using telemedicine. Medically
appropriate treatment for behavioral health conditions
sometimes involves controlled substances. Unfortunately, today,
thousands of centers across the country are unable to utilize
telemedicine that results in a prescription for a controlled
substance due to the DEA's narrow interpretation of the Ryan
Haight Act.
In my remarks, I will explain why this is and why the
Matsui-Harper bill provides the relief we need in order to be
able to serve patients more effectively. Let me state upfront
first, though, the National Council appreciates and affirms the
importance of the Ryan Haight Act. As recent reports have
shown, even with the act in place, it is still far too easy to
go online and buy controlled substances without a valid
prescription.
In November of 2016, two junior high students in Park City,
Utah, ordered a drug called U47700, a synthetic opiate
analogue, sometimes referred to as Pink, took the drug and
overdosed and died. These studies underscore the importance of
the DEA's vigilance over the online ecosystem and the rogue
actors that claim to be doing telemedicine and operating an
online pharmacy but, instead, are functionally pill mills.
Our goal is to allow licensed, DEA-regulated, community
addiction and mental health centers staffed by regulated and
licensed professionals to be able to comply with the Ryan
Haight Act in order to improve patients' access to care. So
what we are asking is that you regulate us. I don't know too
many people who would come in here and ask you to regulate us.
Here is how the situation plays out in Utah and illustrates
the problem around the country. The act allows for a
prescription of controlled substance without a prior in-person
examination in limited circumstances, known as telemedicine
exceptions. The most common way telemedicine is allowed is when
the patient is located in a DEA-registered hospital or medical
clinic and is being treated by a DEA-registered provider
located offsite. The problem is DEA has interpreted the
hospital and clinic exception so narrowly that it often does
not apply to community-based addiction and mental health
centers.
For an example, one patient at one of the Utah's community
addiction and mental health centers is in crisis. I am giving
you an example here. The patient may need addiction treatment
involving medication-assisted treatment with a controlled
substance like Suboxone. The center is staffed with the social
workers, nurses, counselors, and other licensed mental health
professionals, sometimes including physicians. Due to shortages
of providers in parts of Utah, the center where our patient is
located rarely has a DEA-registered doctor onsite. But the
center does have the ability to connect the patient to a DEA-
registered addictionologist using telemedicine technology. The
problem is my center is licensed by the Utah Department of
Human Services as a drug and alcohol treatment agency, not
licensed as a hospital or medical clinic by the Utah Department
of Health, as the DEA requires.
As such, my licensed center is unable to register with the
DEA and the hospital or clinic telemedicine exception in the
Ryan Haight Act doesn't apply. Accordingly, we can't provide
the needed care to patients using telemedicine. Instead, we
must wait for a DEA-registered doctor to go on the road to do
an in-person physical examination before the patient gets a
prescription for Suboxone or another controlled substance to
treat their opioid addiction. This is just one illustration of
the problem.
As discussed in my written statement, there are many other
examples of how the DEA's narrow interpretation of hospital or
clinic is keeping legitimate centers from treating patients
utilizing telemedicine when controlled substances are needed.
The Harper-Matsui bill aims to remedy this.
Finally, although the opioid epidemic is the subject of
today's hearing, it is critical that the DEA allow centers to
use telemedicine to treat other mental health conditions, too.
This is discussed also further in my written statements.
Thank you very much. I appreciate the opportunity to be
here, and I am also willing to take questions.
[The prepared statement of Mr. Nance follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you, Mr. Nance.
Mr. Cosgrove, you are recognized for 5 minutes, please.
STATEMENT OF THOMAS J. COSGROVE
Mr. Cosgrove. Thank you, Chairman Burgess, Ranking Member
Green, and members of the subcommittee, for the opportunity to
testify today. My name is Tom Cosgrove. And until last year, I
was an official at the Food and Drug Administration responsible
for current good manufacturing practice enforcement and
compliance within the Center for Drug Evaluation and Research,
or CDER.
In that role, I was responsible for ensuring manufacturing
quality and compliance for the thousands of drug manufacturing
facilities around the world that make medicines distributed in
the United States. Since December of 2017, I have been a
partner at the law firm of Covington & Burling here in
Washington. Covington represents a number of clients in the
food, drug, and cosmetics industries that use tableting and
encapsulating machines. The subject of the draft bill under
consideration, which is the Tableting and Encapsulating Machine
Regulation Act of 2018, but the views expressed today here are
my own.
I share Congress' and the public's concern about the opioid
abuse epidemic and am encouraged to see so much action in
Congress and society at large aimed at ending the crisis. In my
role at FDA, I was aware of the acute problem of the
importation of illicit opioids, opioid analogues, and synthetic
drugs from overseas from international mail facilities. This
appears to be a different issue, however, than the use and
regulation of tableting and encapsulating machines in the
United States.
Virtually all manufacturers of solid oral drugs in the
United States use tableting or encapsulating machines in some
form, at least as those terms are defined under the draft bill.
This includes prescription, nonprescription, and many animal
drugs covering everything from innovative new drugs to OTC
products that people use daily. In addition, dietary supplement
manufacturers commonly use tableting and encapsulating machines
as part of their manufacturing processes.
One need only walk down the health and wellness aisle of
the local supermarket to get a sense of the ubiquity of
products manufactured using tableting and encapsulating
machines. Furthermore, tableting machines are often used in the
manufacture of candy, cosmetics, and certain household products
such as cleaning agents.
Were the draft bill to be enacted as now written, lawful
domestic manufacturers using tableting and encapsulating
machines to produce legally marketed, noncontrolled products,
including nondrug products, they would be subject to the CSA's
strict requirements for controlled substances.
A straightforward reading of the draft bill at hand would
appear to require manufacturers to register with the DEA and
with state authorities in each location that they hold or
operate a machine. Manufacturers apparently would need to store
tableting and encapsulating machines in secured areas, such as
the ones used to safeguard controlled substances themselves.
This includes things like electronically-monitored safes, steel
cages, or vaults that meet certain specifications.
Manufacturers hoping to dispose or replace malfunctioning
machines could need to transfer machines to companies
specifically registered by DEA to render those machines
nonretrievable. In addition, manufacturers might need to comply
with additional recordkeeping and paperwork requirements each
time they move a machine. Such requirements, if enacted, could
cause domestic manufacturers to incur direct costs of machine
registration, recordkeeping, security, and disposal, and
indirect costs from training, education, and audits to ensure
compliance.
We live in a time also where there is enormous pressure on
drug manufacturers to move their operations overseas for cost
reasons. In fact, one of FDA's main challenges today is keeping
up with the pace and explosion of drugs being manufactured
overseas in places like India and China.
Ironically, the draft bill would burden most of the
companies that have nothing to do with opioids or other
controlled substances because these companies would need to
establish CSA compliance systems from scratch. Furthermore,
Congress has already amended the CSA to give DEA special
authority to regulate tableting and encapsulating machines.
In 1988, Congress passed the Chemical Diversion and
Trafficking Act, or the CDTA. That act is described in the
written testimony of Ms. Gibson, who testified earlier today,
and I won't recap that here.
If Congress decides that enhanced regulation of tableting
and encapsulating machines is needed. I would encourage a more
tailored approach that builds on existing authorities. First, I
would want to better understand why DEA's existing CDTA
authorities are not sufficient. One potential further approach
would be to consider amending the CDTA, such that companies
would also register equipment with DEA beyond only reporting
transactions. This could be tethered with an appropriately
crafted exemption for firms regulated by FDA. This way, DEA
could develop a more robust database of tableting and
encapsulating machines so that perhaps thousands of companies
around the United States would not suddenly be regulated as if
they were holding controlled substances.
If Congress decides to move forward on this or any similar
proposal, I would be happy to serve as a resource in
deliberations going forward. Thank you for the opportunity to
testify today. I would be happy to take any questions.
[The prepared statement of Mr. Cosgrove follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you, Mr. Cosgrove.
Dr. Kolodny, you are recognized for 5 minutes, please.
STATEMENT OF ANDREW KOLODNY, M.D.
Dr. Kolodny. Thank you, Chairman Burgess, Ranking Member
Green, and members of the Health Subcommittee, for the
opportunity to testify today. And my name is Dr. Andrew
Kolodny, and I am the Codirector of Opioid Policy Research at
Brandeis University. I am also the Director of Physicians for
Responsible Opioid Prescribing. My testimony today is on behalf
of PROP, Physicians for Responsible Opioid Prescribing.
As you all think about solutions to the opioid crisis, I
think it is very important to frame the problem and to frame it
the right way. I believe that the correct way to frame the
opioid crisis is as an epidemic of opioid addiction. Not
everyone who dies of an opioid overdose was suffering from
opioid addiction, but the studies tell us that the vast
majority of the people dying are opioid addicted.
If we frame the problem the right way, as an epidemic of
opioid addiction, the strategies, the big picture strategies,
for bringing it under control become much more clearer. We
really have to accomplish two things. We have to prevent more
people from becoming opioid addicted, and we have to see that
the people who are addicted are accessing effective treatment.
When I say ``epidemic,'' I am not exaggerating. From 1997
to 2011, there was a 900-percent increase in the number of
people suffering from opioid addiction, and it is that increase
in the number of Americans with opioid addiction that explains
why we are experiencing record high levels of overdose deaths,
why we are seeing a soaring increase in infants born opioid
dependent, outbreaks of injection-related infectious diseases,
and a flood of heroin and fentanyl into our communities.
To bring the epidemic under control, we have to prevent new
cases of the disease. That primarily is going to be through
cautious prescribing. And I am going to focus the remainder of
my statement on H.R. 2063, a bill to mandate prescriber
education.
Although I do not support the bill in its current form, I
am strongly in favor of mandatory education for DEA registrants
who intend to prescribe more than a 3-day supply of opioid
analgesics. And I commend Representative Schneider and his
cosponsors for introducing this legislation. The need for this
law becomes clear when we look at the cause of our opioid
addiction epidemic. And the CDC has been perfectly clear about
why we are experiencing this epidemic.
What the CDC has shown us--and we have got a slide up here.
If you look at the slide, the green line at the top represents
opioid consumption or prescribing in the United States. The red
line represents deaths involving prescription opioids, and the
blue line represents addiction involving prescription opioids.
The CDC has really been saying that, as that green line went
up, addiction and overdose deaths went up right along with it.
As the prescribing increased, it has led to the epidemic that
we have got today.
The reason that that green line began to go up so rapidly,
the reason the medical community began prescribing so
aggressively is because we doctors were responding to a
brilliant multifaceted marketing campaign that changed the
culture of opioid prescribing in the United States. Starting in
the nineties, we began hearing that patients were suffering
because we were too stingy with opioids. We began hearing that
we should stop worrying about addiction, that even with long-
term use, the risk of addiction was much less than 1 percent.
We began hearing that opioids were safe and effective for
conditions like low back pain, where the leading experts tell
us they are neither safe nor effective. We would have been less
gullible if we had just heard these messages directly from drug
companies. But as we heard earlier, these messages came to the
medical community from every different direction. In
particular, we were hearing these messages from professional
societies.
The American Academy of Pain Medicine and the American Pain
Society in 1997 put out a consensus statement calling for much
greater use of opioids and claiming that the risk of addiction
had been overblown, even that the risk of overdose deaths had
been overblown.
My greatest concern with H.R. 2063 is that it relies on
these organizations and other professional groups with industry
ties to provide the government-mandated prescriber education.
One of the most important lessons from the crisis is the need
for strict firewalls between pharmaceutical company marketing
and medical education. Had marketing not been so cleverly
disguised as education, we might not have an opioid addiction
epidemic today.
If we learn from our past mistakes, we will not rely on the
same industry-funded professional societies that got us into
this mess to provide the education we need to get out of it. It
may be hard for you to believe that, in the midst of our opioid
addiction epidemic, that doctors are still overprescribing, but
we are. The United States continues to prescribe more opioids
than any other country on Earth.
Millions of dollars were spent misinforming the American
medical community about opioids, but very little has been done
to correct the record. That is why prescriber education must be
made mandatory, and that is why the content for the education
must be developed and administered by individuals and
organizations who do not accept payments from pharmaceutical
companies. Thank you.
[The prepared statement of Dr. Kolodny follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you.
Mr. Logan, you are recognized for 5 minutes, please.
STATEMENT OF RICHARD N. LOGAN, JR.
Mr. Logan. Chairman Burgess, Ranking Member Green, members
of the subcommittee, thank you for holding this hearing on the
opioid crisis. I am Dr. Richard Logan. I have been a community
practice pharmacist since 1975 and currently own two pharmacies
in southeastern Missouri. Oddly enough, in addition to my
duties as a community practice pharmacist, I have spent the
last 25 years as a Missouri certified police officer and am a
recently retired prescription drug diversion investigator for
the Mississippi County, Missouri, Sheriff's Department.
I am here today on behalf of the National Community
Pharmacists Association to present some of my experiences and
viewpoints focusing on viable solutions to prevent drug abuse
and diversion while maintaining legitimate access of patients
to needed medication.
NCPA represents America's community pharmacists, including
owners of more than 22,000 independent community pharmacies
just like mine. Our job as healthcare professionals is to help
patients safely navigate medication-related treatment across
multiple disease states. We are focused on positive outcomes
and safe medication usage.
Yet, as pharmacists, we struggle to meet these goals in the
midst of an opioid epidemic that kills hundreds of people daily
and over 200,000 Americans since 1999. My flagship pharmacy is
in Missouri. It is the first pharmacy across the Mississippi
River on I-57 and Highway 60 from Illinois, Tennessee, and
Kentucky. My State has no adequate functioning PDMP and, as
such, is a magnet for those who would abuse prescription
opioids.
It is not unusual for travelers to drive hundreds of miles
from eastern Kentucky, Ohio, or other areas distant to me to
visit a pill mill in Georgia or Florida and end up at my
prescription counter with prescriptions for narcotics, lots of
narcotics. Common sense tells me that somewhere between
Kentucky, Florida, and Missouri, those folks have passed a
pharmacy, but they end up at mine.
I once investigated a traveler who had driven U.S. Highway
60 across just southern Missouri, had seen eight physicians and
visited 18 pharmacies in search of opioids. I served on many
search warrant teams, made many arrests, some at my own
prescription counter, had lots of convictions, dodged bullets
in the line of duty, spent nearly 25 years fighting drug abuse,
was responsible for putting together a bicounty prescription
drug task force that led to many arrests, and still I feel like
I have done nothing to stem the tide. It is just that
overwhelming.
All the while, as a practicing pharmacist, I go to bat for
my legitimate patients who need opioid therapy so they can lead
a productive life and not be denied therapy or declined therapy
due to the stigma attached to opioid abuse. As the final
checkpoint in the system of checks and balances, pharmacists
play a vital role in ensuring all medications, including
controlled substances, are appropriate for their patients.
Pharmacists are often the last professional an opioid
patient sees and the first professional to realize that a
patient is slipping into an abusive pattern. Pharmacists must
monitor their patients and work in collaboration with other
healthcare providers, understand the risks and benefits of
opioid therapy, and keep the best interest of the patient at
the center of all decisions.
There are promising policies that Congress or the
administration could move forward that would have a positive
impact on mitigating or preventing abuse. One such policy is
included in H.R. 4275, the Empowering Pharmacists in the Fight
Against Opioid Abuse Act, to provide for the development and
dissemination of programs and materials for training
pharmacists, healthcare providers, and patients on indicators
that a prescription is fraudulent, forged, or otherwise
indicative of abuse or diversion. This is not only a
commonsense policy; it is one that fits in well with the DEA
360 strategy to engage all of those involved with opioid
treatment.
NCPA supports such efforts to bring greater diversity and
education to other healthcare providers and patients regarding
a pharmacist declining to fill a controlled substance. NCPA
offers itself as a resource, if necessary. Thank you.
[The prepared statement of Mr. Logan follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Burgess. Thank you, Mr. Logan.
And thanks to all of our witnesses for your testimony. It
has certainly been insightful.
At this time, I would like to yield to the gentleman from
Oregon, the chairman of the full committee, for your questions.
Mr. Walden. Thanks, again, Mr. Chairman, for your
leadership on this issue and your subcommittee's good work.
And to all our witnesses, thank you for your testimony, it
is very, very helpful in our work.
I want to ask Chief Fowler, you provided a crime analysis
report as part of your written testimony. The primary focus of
the report is overdoses related to Spike or synthetic
marijuana. Have you seen other synthetic drugs on the streets
in your community? What has been the impact of these
substances? And is synthetic marijuana the worst analogue drug
on the streets of Syracuse, or do you have data that fentanyl
and other opioids are worst?
Chief Fowler. So, currently, Spike, the one that I spoke
about, is the one that we are having the most problem with. But
fentanyl is certainly a tremendous problem, and it ranks
second.
Mr. Walden. Which is the most deadly?
Chief Fowler. Fentanyl is indeed the most deadly. We see
the most deaths associated with overdoses with fentanyl.
Mr. Walden. What is the practical effect with Spike? What
happens when you come on a scene?
Chief Fowler. It is marketed as a synthetic marijuana, but
it has a hallucinogenic effect. And what we see is people in
what I could best term as psychosis. They are acting out in a
very bizarre fashion, oftentimes violent, incoherent. And then
they exhibit a number of medical issues in which they have to
be addressed at the local hospital.
Mr. Walden. Such as?
Chief Fowler. Rapid breathing. Some even pass right out
after they have exhausted themselves from running around and
acting in a very bizarre way. Sweating profusely. And I am not
a medical expert----
Mr. Walden. Right.
Chief Fowler. I would imagine that everything that a
company--a person's heart rate rising, their blood pressure
rising, I would imagine that that has some type of medical
effects on a person, but I am not a medical expert, so I can't
tell you what those are. But the bizarre behavior and the
violent behavior, that is something that I can really identify
with.
Mr. Walden. What is the youngest age that you have seen
either----
Chief Fowler. Quite young.
Mr. Walden. What is that?
Chief Fowler. When this first came on the scene, what we
discovered was that it was sitting right on the shelf in the
local convenience stores.
Mr. Walden. Now, wait a minute. It was what?
Chief Fowler. When it first came on the scene, it was
sitting right on the shelf of local convenience stores in these
very colorful packages, and I personally overheard a couple of
high school students talking about why it is that they would
choose to use Spike over marijuana; it is because they happen
to be on probation, and if they were to have to give a
urinalysis test, that this substance would not appear. And so
they were using this to get away with a probation violation.
So our young people started to use this substance, and they
were experiencing the same things that everyone else was, these
episodes of psychosis there in the schools, on the streets. So
we see all ages.
Mr. Walden. So the legislation Mr. Katko brought to our
attention and worked hard on is very focused on the fentanyl
analogues?
Mr. Nance. Sure.
Mr. Walden. In your police department's experience, what
other synthetic drugs do you think we should be addressing
comprehensively by class? What else should we be looking at
here?
Chief Fowler. Well, I think that all of the synthetic drugs
that we can identify, we need to take a look at them because
what is happening is, is that they are all appearing on our
streets. The minute that we bring one substance under control,
a different or another substance will pop up. And we have a
simultaneous problem with Spike and fentanyl right now.
Mr. Walden. And so, broadly speaking, do you feel like your
department has the tools you need when your team comes across
illicit synthetic drugs? The goal here is we want to get this
right when we put this legislation together. So what are we
missing here that would be helpful in your efforts?
Chief Fowler. Sure. Law enforcement is only as effective as
the laws that we enforce.
Mr. Walden. Right.
Chief Fowler. Let's take Spike, for example, because that
is what I have talked about the most. Right now, it is not
scheduled. And the only thing that we can do is give people an
appearance ticket for a local law violation for----
Mr. Walden. What does that mean, a local law enforcement
violation?
Chief Fowler. Well, we went to our local legislators and
had them enact a local ordinance to----
Mr. Walden. Against Spike?
Chief Fowler. Excuse me?
Mr. Walden. Against Spike.
Chief Fowler. Yes. To make the substance illegal. And that
is the charge that we utilize.
Mr. Walden. What is the penalty?
Chief Fowler. It is a violation, so----
Mr. Walden. Oh, it is a traffic ticket, in effect.
Chief Fowler. Basically, sir.
Mr. Walden. So it is not a deterrent, to speak of?
Chief Fowler. Not at all. Not at all.
Mr. Walden. Thank you.
And thanks again to the whole panel. You all have been most
helpful in our work, and we are going to continue down this
path, and we are going to get it right, and we are going to
pass new laws so you have the tools you need to stop this to
the best of your ability. But we need your input, so thank you
very much.
Chief Fowler. Thank you, sir.
Mr. Guthrie [presiding]. Thank you. The chairman yields
back. And the chair will recognize Ms. Castor from Florida for
5 minutes.
Ms. Castor. Thank you very much, Mr. Chairman. And thank
you to all the witnesses for being here this afternoon.
Dr. Kan, in your testimony, you talk about the significant
barriers to access for folks who are suffering from opioid
addiction. And you call it, you say we have a significant
addiction treatment gap in America. You cite the journal of the
American Medical Association, a report in 2015 that says 80
percent of Americans with opioid addiction do not receive
treatment.
And a lot of you here have recommended some ways to tackle
the problem. It seems like it is so piecemeal, though. These
recommendations are good, to do a little more in telemedicine
and buprenorphine formulations and distribution, but this is a
public health crisis. And what I am hearing at home from
parents and others, there is just no capacity out there. There
is just no, even in the Affordable Care Act now, we have new
requirements that insurance cover essential health benefits,
including mental health.
Under Medicaid, yes, you have some treatment options, but
it is just not happening on the ground. So what else can you
recommend to us to help improve the long-term treatment that so
many Americans are going to need to tackle their addiction?
Dr. Kan. Thank you for that question. I think telemedicine
is one piece of the entire puzzle. There is a much broader
puzzle when it comes to reducing stigma around the illness,
that is part of the effect in this telemedicine, in that people
don't have to walk into a clinic and be publicly identified as
being treated.
In addition to that, we need to expand access to all forms
of treatment, both different formulations and different avenues
in which people can get that type of treatment. If I think
about opioid use disorder as a physician, about 80 percent of
the side effects is predicted by medications alone. Meaning
that with medications, you can effectively reduce the risk for
accidental overdose, and counseling is significant. It is
incredibly important in changing people's lives, but we need to
create expanded access. We need to keep people alive.
This is a position that has been considered the American
Society of Addiction Medicine, and it is certainly a position
that ASAM has taken in that we need to reach out to patients
that we do not see. I don't worry about the patient that is in
my practice. I don't worry about the patient that I am treating
because they are in front of me, and I can monitor them and
give them appropriate treatment.
However, the person who leaves my practice or they
disappear from care, I worry about because I know they are not
receiving care.
Ms. Castor. So Mr. Nance, you are on the ground doing this.
What is it going to take for us, really, to make sure that the
folks who need long-term treatment, receive that long-term
treatment.
Mr. Nance. Well, Dr. Kan is right. The biggest problem we
face is capacity. You mentioned this yourself, that was the
beginning of your question. We have got the capacity in Utah to
treat less than 20 percent of the people that need drug and
alcohol treatment. So workforce is a huge factor. If we don't
have the staff to deliver the services, we can't provide the
treatment.
Effective evidence-based treatments are important as well.
And we strive very hard to identify those that we can afford,
implement them, train our staff to implement them to fidelity--
--
Ms. Castor. So you are recommending to offset, we need to
do more in workforce training for doctors, nurses, counselors?
Is that part of it?
Mr. Nance. Yes, we need to provide more primary behavioral
health staff, but other specialties that don't deal primarily
with drug and alcohol prevention and treatment services need
more training and education on how to identify and refer
someone to treatment and provide some of those treatments
themselves.
Ms. Castor. And Dr.Kolodny, you have cited some very stark
statistics that we are now-- what are your recommendations to
really tackle the barriers to access for--JAMA says 80 percent
of Americans with opioid addiction don't receive any treatment.
How do we get to that?
Dr. Kolodny. I very much appreciate that question. I think
the only way we are going to get there is with 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-licensed drug and alcohol
treatment programs don't offer buprenorphine. Many of them
don't even have enough physician time to be able to prescribe
buprenorphine. Among people who are getting it right now, even
people with good insurance often have to pay out of their own
pocket for the doctor's visit, their Medicaid or their
commercial insurance is only paying for the prescription.
If we really want to see deaths start to come down, it has
to be easier to get treatment than it is to get a bag of dope.
If someone who is opioid-addicted when they wake up in the
morning, they are going to need to use. Many people will have
something by the bedside because they are going to be feeling
very sick when they start to wake up. If they have got $20 in
their pocket and they know where they can go get heroin, even
if it has got fentanyl in it, that is what they are going to
do. And if finding a doctor is more expensive and more
difficult, we are not going to start to see overdose deaths
start to come down.
So we really have to build out a system that doesn't exist,
and I don't see any other way other than investing billions for
that system.
Ms. Castor. Thank you very much. I yield back my time.
Mr. Burgess [presiding]. The chair thanks the gentlelady.
The gentlelady yields back. The chair recognizes the gentleman
from Kentucky, Mr. Guthrie, 5 minutes for questions, please.
Mr. Guthrie. Thank you very much, Mr. Chairman. And thank
you all for being here. This is very informative.
And, Dr. Kan, I have a question for you. Thank you for your
insightful testimony. Knowing that you have firsthand
experience treating patients with opioid addiction, as well as
utilizing telemedicine builds your credibility both as a
practitioner and a witness.
My questions will be two. When using medication-assisted
treatment, how common is it for you to pair this medicine with
cognitive behavioral therapy? And is it important that any
changes to the Ryan Haight that increases access to medicated-
assisted treatment not be so tailored that the result
unintentionally cuts off behavioral therapy?
Dr. Kan. Thank you for those questions. So the answer to
your first question, how often do I combine treatment with
therapy, and you mention cognitive behavioral therapy, which is
a very specific type of therapy, but we use multi-modal
therapies that we pick because of the patient assessment, what
is it that they need? And within my practices, within the VA,
within my company, it is 100 percent. One hundred percent of
patients receive psychotherapeutic intervention.
The second question--I am sorry, I forgot the second
question at this point.
Mr. Guthrie. The second question, is it important that any
changes to Ryan Haight that increase access to medicated-
assisted treatment not be so tailored that the result
unintentionally cuts off behavioral therapy?
Dr. Kan. I think that the room for psychotherapeutic
intervention should always be available. And when we talk about
the qualified practice setting within the data--2016 amendment,
it does cover those things that the people have the capacity to
provide the therapy, if it is indicated.
Mr. Guthrie. Thank you. And I have a question for
Dr.Mulder. Thank you for your testimony and for the Michigan
Home Care Hospice Association support for the Safe Disposal of
Unused Medication Act.
In your testimony, you note that roughly 98 percent of
hospice care days are provided in a patient's residence. You go
on to explain that at a moderate-sized hospice care with 2,000
patients per year, approximately 1 million pills will be
prescribed per year.
So a series of questions: If 98 percent of these
prescriptions, roughly 1 million pills are going into homes,
isn't this statistic alone enough to validate the need for safe
disposal? Is it your belief that safe disposal would reduce the
likelihood of misuse or diversion? And are you able to give
some examples of safe disposal that hospice workers have used
in the past or currently use in States that allow this type
of----
Dr. Mulder. Yes. Yes. And I will give you some examples.
Mr. Guthrie. Perfect.
Dr. Mulder. So going back a few years, as I mentioned, I
have had the privilege of working in the hospice industry for
over 30 years. And so we have seen, it is very, very common in
past years, a nurse would come out, she would declare the
death, she would sit and work with the bereaved family. And
then with a witness, she would either crush and flush the
pills, or in case of liquid opioids, just put them down the
sink and turn the faucet on. That is what they did.
In later years, when they said, oh, maybe we shouldn't be
doing the flush thing, that they would, most of the nurses
would carry kitty litter in their trunk, and they would bring
in some of that. They would crush the pills and the liquid and
just mix them with kitty litter, take it back and dispose of it
back at the office. I suppose it ended up in a landfill
somewhere, but I don't really know.
But that is how they did it in the past. Since I had----
Mr. Burgess. Will the gentleman yield for 1 minute.
Mr. Guthrie. Yes, I will yield.
Mr. Burgess. We also have the EPA under our jurisdiction.
Be careful. They might be watching.
Dr. Mulder. I understand.
Mr. Burgess. I yield back.
Dr. Mulder. You didn't hear that from me.
But, again, that is in the past. That is in the past. And I
think some of the more recent strategies are simply because of
that.
They just didn't want opioids winding up in our water
supply and our landfills. And so, more recently when the laws
were amended and changed and introduced, that restricted the
personnel, who could really take back medications, that really
put the hands off. And I want to say that goes back to about
2013 or 2014, 2013 or 2014. I don't remember the exact dates of
the legislation, so that is how they did it in the past.
I don't know how they are doing it in States that they
currently allow that but now--and there has also been another
trend that we saw developing, where patients families would
say, oh, you can't touch that, that is mine now. He died, but I
inherit everything that was his. And so those are my pills, and
you may not touch them.
Mr. Guthrie. Well, thank you for your testimony. And it is
certainly an area, when you start looking at the volume, that
we have to address. And so I appreciate my friends from
Michigan for bringing this forward.
Dr. Mulder. Thank you.
Mr. Guthrie. And I yield back my time.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman. The chair recognizes the gentlelady from
California, Ms. Matsui, 5 minutes for questions.
Ms. Matsui. Thank you, Mr. Chairman. As I mentioned in my
question to DEA, the purpose of the discussion draft I am
working on with Representative Harper is to expand access to
treatment where it is not currently available. We are seeking
to do this within the current Ryan Haight telemedicine
prescribing framework.
Mr. Nance, you are familiar with the community behavior
health clinic system in Utah and see a need for additional
access to remote prescribing for the patients you serve. Can
you expand upon the need that you see for more access to
medication-assisted treatment and the challenges that clinics
and their patients face?
Mr. Nance. Sure. Here is a visual representation of one of
the challenges. This is a pretty good shot of the road from
Moab down to Blanding, Utah. From my office to Blanding is
about a 300-mile drive. There are about 4,000 people that live
in Blanding. If someone down there has an opioid addiction
problem and rural and frontier areas have a higher rate than
the rest of the country in general for opioid addiction
problems, their access to treatment is very, very limited.
So I kind of hang out with some farmers from time to time.
Ms. Matsui. OK.
Mr. Nance. And one of the funny things I have heard one of
them say was, the darn beavers can irrigate better than I can,
but the water has got to the end of the row. So we need to have
access to telehealth treatment so that if a client shows up in
the community behavioral health center in Blanding and needs
opioid addiction treatment, that that can be provided for them
through a physician that may be located in Provo or Salt Lake,
or some other place along the Wasatch front where the majority
of the population of the State lives.
If we can't do that, we are going to have a higher death
rate than we already do. We had 600 last year in the State of
Utah, 187 of those were heroin, and all the rest were
preparation opioids. So we need to be able to have qualified,
certified license addiction medicine professionals to be able
to provide services in those small outlying towns across the
country, not just in Utah.
Ms. Matsui. So you are dealing with putting doctors on the
road to do in-person exams, is that right?
Mr. Nance. Yes, I am sorry to interrupt you. If my
addictionologist was to drive to Blanding, it would take her 2
days away from the office to possibly see one patient, if that
patient showed up. People with opioid disorders typically are
sick and disorganized and cognitively impaired. They have a
difficult time keeping appointments. That would take the
ability away for her to see somewhere between 48 and 60
patients in my own office and would cost us close to $2,000 in
her time and travel time and overnight stay to be the able to
see that one patient.
Ms. Matsui. So you mentioned it is important for the
committee to allow telemedicine to be used for mental health
treatments as well, not just substance use disorder. Why is
that?
Mr. Nance. Same thing. In rural Utah, there aren't that
many psychiatrists to go around. Right now we have been doing
telehealth through Project Echo with the University of Utah as
kind of a platform to do that. The same thing happens in New
Mexico. And it is pretty easy for a child psychiatrist, for
instance, and there are even fewer of those than there are
addictionologists in the State, to be able to use telehealth
technology to evaluate a patient at that remote site.
But if they are going to write a prescription for a
controlled substance, like a benzodiazapine for an anxiety
disorder, or ADHD for attention deficit and hyperactivity
disorder, that face-to-face issue still exists under the Ryan
Haight Act.
Ms. Matsui. OK. Could I just address some concerns that
have been expressed?
Now, you expressed strong support for preventing fraudulent
remote prescribing. Obviously, they all do. There may be
concerns that opening a new pathway to registration for non-
DEA-registered clinics may lead to fraudulent prescribing. We
need to ensure that there are sufficient requirements on both
the clinic with a patient present and a doctor doing the
prescribing remotely. For clinics you represent, how are the
authorized, and what is the regulatory oversight they undergo?
Mr. Nance. That is a very good question, too. We are
licensed by the Utah State Department of Human Services. We
have a licensing inspection every year. We also get an
inspection from the Utah Medicaid program. We also get a
contract compliance audit from the Utah Department of Human
Services, and a peer-review visit. We get at least 3 or 4
oversight visits every year.
So our centers are licensed, our staff are licensed. And
what I am proposing we do is kind of an agency-to-agency
practice model. It is very similar to the Vermont hub and spoke
model. You may be familiar with that. If you are not, you ought
to look that up.
Ms. Matsui. OK.
Mr. Nance. It is on addictionpolicy.org, I believe,
website. And Vermont is kind of small. I think the furthest
distance between one side and another might be 100 to 150
miles. It is a lot further than states on the left.
Ms. Matsui. Well, I have a lot of questions, but I also
know we will be working on discussion drafts, so I will be
hopefully conferring with you and others on the committee. So
thank you very much for that.
Mr. Nance. And the National Council staff will be happy to
be a resource for you as well.
Ms. Matsui. Thank you.
Mr. Nance. It is just up on K street.
Mr. Burgess. The gentlelady yields back. The chair would
observe that Project Echo was a product of the Energy and
Commerce Committee.
The chair now recognizes Dr.Bucshon from Indiana, 5 minutes
for questions, please.
Mr. Bucshon. Thank you, Mr. Chairman. Dr.Kan, Section 303
of CARA, the Comprehensive Addiction Recovery Act was something
that meant to expand available treatment and give patients
information basically on what their treatment options are. It
also included requirements for individual treatment plans and
other things. How is SAMHSA doing with implementing, you know,
the new, some of the changes that were made in CARA?
Dr. Kan. I probably couldn't comment on how SAMHSA is
doing. I think Dr. McCants Kats could probably provide some of
that testimony, but my understanding, is that they are making
affirmative----
Mr. Bucshon. I have already asked her so.
Dr. Kan. OK. I would defer to her on the answer.
Mr. Bucshon. All right. OK. I didn't like her answer, but
that is OK.
Mr. Nance.
Mr. Nance. You want me to answer the same question?
Mr. Bucshon. Yes.
Mr. Nance. Well, this has been a great thing----
Mr. Bucshon. I mean, are you getting good guidance from
SAMHSA after CARA was----
Mr. Nance. Yes, what SAMHSA has done is transmitted the
guidance to the Utah State Department of Substance Abuse and
Mental Health.
We had several meetings back in the spring of 2017. The
funding was made available to us. We had to write applications
for that that complied with what the State guidance was.
Mr. Bucshon. Yes.
Mr. Nance. So it has been really helpful. I had 10 hours a
week of physician prescriber prior to the CARA Act and the 21st
Century Cures Act. Now I have her full time. The physician I
had on contract with before would not prescribe buprenorphine
for me. Now, I have a full-time physician that will prescribe
buprenorphine and that we can make available to other parts of
the State.
Mr. Bucshon. OK. Now, HHS would increase the therapy--the
number of people. Has that been implemented? I mean from 100 to
any practice to HHS----
Dr. Kan. Yes, that has. Both on an ongoing basis for people
who are qualified but also in emergent circumstances when
people reach 100 patient cap.
Mr. Bucshon. OK. That is good to hear. Doctor--yes go
ahead.
Dr. Subbiah. I would just add something to that. I think
the caps have been increased, but if you look at the physicians
or healthcare providers who have been waivered, not many of
them are prescribing up to capacity. Because it is not only
stigma of disease, we have to overcome also stigma of
treatment----
Mr. Bucshon. Understood.
Dr. Subbiah [continuing]. And taking care of these
patients.
Mr. Bucshon. Yes, I agree. In fact, this next question is
for you. For long-acting buprenorphine, are insurance companies
and CMS paying for this?
Dr. Subbiah. This product, Sublocade, just got approved at
the end of last year and it is going to be on the market in
March.
Mr. Bucshon. It got approved by FDA, right?
Dr. Subbiah. FDA.
Mr. Bucshon. Yes, that is different than CMS?
Dr. Subbiah. Yes. So it is not, right now, in the market
yet. It will be in the market starting in March.
Mr. Bucshon. Yes, I am just asking, did CMS give a coverage
decision on it?
Dr. Subbiah. Not yet.
Mr. Bucshon. Not yet. Because what we are finding in a lot
of areas in healthcare right now as we get FDA-approved
products, both drugs and devices, and then we get delayed
payment decisions from CMS, which is preventing access to
patients. So that is a big problem. If that is the case, I
would appreciate knowing about that because we try to have some
impact on that.
Dr. Kolodny, I was interested in your testimony talking
about continuing education for physicians. Is there anything
the Federal Government can do to encourage, maybe, what I would
call ground-level training, which is not after people who are
already out of medical school and practicing, but I have been
talking with the Association of American Medical Colleges, for
example, about implementing more training programs for
assessing pain and properly treating pain in medical schools,
and then certainly residency programs.
I mean, do you have any thoughts on that?
Dr. Kolodny. You know, I think the bigger problem are the
older doctors, not the docs coming out of training. Doctors who
are in their 20s and 30s, they have come of age during our
opioid addiction epidemic. Many have lost friends to opioid
overdoses. They are much less likely to fall for the nonsense
that you can prescribe long-term and a patient won't get
addicted.
The bigger problem are doctors my age and older----
Mr. Bucshon [continuing]. Who had it drilled into them for
15 years that we need to prescribe more and more.
Mr. Bucshon. Right. And I commented on that during the
testimony from the DEA. I am in that boat. I went into practice
in 1995. We all understood that.
Dr. Kan, last question real quick. The existing laws in-
person medical evaluation as well as allowable exemptions, you
explained in your testimony that the in-person evaluation
committee excepted if a patient is being treated by and
physically located in a DEA-registered hospital or clinic or a
patient is being treated by and in the physical presence of
another DEA-registered practitioner, does this narrow exception
cause geographic access problems--and you may have answered
this in part--particularly for patients in rural areas that
cannot physically get to a DEA-registered hospital or clinic or
a DEA-registered practitioner?
Dr. Kan. I am speaking on behalf of ASAM. So ASAM does not
have a position on this specific issue. I will say in my
practice, we lose 20 percent of our patients because we can't
get a physician to them between the time that they call and our
72 hours that we set out the goal to meet with them. And we
send the physicians to the patients. We don't require the
patients to travel to us.
Mr. Bucshon. Understood. Thank you. 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 questions, please.
Mr. Green. Thank you, Mr. Chairman.
Mr. Cosgrove, your testimony was basically not to make it
harder to import these pieces of equipment that make pills is
that correct?
Mr. Cosgove. Well, I don't think it is necessarily that. I
think my testimony really is focused on making sure that
legitimate users of tableting and encapsulating machines are
not suddenly stuck with the requirements of the CSA, the
Controlled Substances Act.
Mr. Green. OK.
Mr. Cosgrove. I think there can be ways for importation to
be monitored and blocked in appropriate circumstances, but what
we don't want is thousands of facilities around the country to
suddenly have controlled substances within their walls.
Mr. Green. Well, for example, I assume some company in the
United States actually produces these machines also?
Mr. Cosgrove. I believe that is correct. I think some of
them are also imported from Germany and other countries.
Mr. Green. OK. Dr.Beardsley, I want to thank you for
sharing your experience as a researcher because this is the
Health Subcommittee, and we are proud of our efforts to try and
plus up NIH funding.
You noted in your testimony, it will take over a year to
obtain a Schedule I registration. I heard from others that the
requirements associated with Schedule I substances such as
storage and security requirements can be cost prohibitive, in
some instances, be a disincentive for researchers to examine
these substances for their therapeutic value.
You note in your testimony the confusion in the application
process and delay in obtaining an approved registration
inhibits researchers, especially young researchers, from
commencing research with drugs of abuse and from dedicating
their careers to study.
To what extent does this confusion in the process and other
hurdles you mentioned, protocols, registration, costs,
obtaining institutional support, inhibit researchers and
institutions from taking up projects with Schedule I
substances?
Mr. Beardsley. Well, thank you for that question. There is
a huge hurdle in becoming a Schedule I registrant, for
instance. The application process entails submitting security
requirements, detailing how much drug you will be using in your
protocol. In my case, I work with laboratory animals. I have to
identify how many doses I will be giving each animal and what
routes of administration. I have to estimate the amount of drug
I will be administering to be approved with the protocol.
And just that point is particularly difficult to estimate
the amount of drug one needs to do research.
Mr. Green. Well, I only have 5 minutes.
Mr. Beardsley. Oh, I am sorry.
Mr. Green. We heard from HHS, however, that H.R. 2851
attempts to streamline the researcher registration process. But
we heard from HHS that there may still be, constitute a barrier
to research that may have negative impact on drug development.
Could you reiterate why you think this and what steps we
can to remove those hurdles, and clearly getting bumped between
Virginia and the DEA on which one registration you get first.
That seems pretty silly. We ought to be able to deal with that.
Mr. Beardsley. Right. First off, with SITSA, a drug can be
put into Schedule A only based upon structure. That is
problematic because there are many drugs that have similar
structures, some of which are drugs of abuse, some of which are
antidotes to those drugs of abuse.
So if a drug is scheduled, it is really a disincentive for
a researcher to begin conducting research with that drug. If
the drug is in the schedule for no other reasons than its
structure, we will never know whether it is a drug of abuse or
a breakthrough medication. So that is one instance in which
scheduling a drug just based on structure can be a disincentive
for conducting research with these drugs.
And for younger researchers to go through the hurdles of
obtaining the Schedule I registration, for instance, that is
yet another hurdle.
Mr. Green. Well, we don't want to do anything that would
eliminate the potential for research, because that is the other
thing that we want to do. But be that as it may, we will see
what we can do.
Dr. Kolodny, do you believe requiring 12 hours of
continuing education every 3 years is a practical requirement
for healthcare practitioners to prescribe opioids?
Dr. Kolodny. I do think that we should be mandating
prescriber education. I think that we should allow doctors who
don't intend to prescribe more than a 3-day supply of opioids
to opt out. If we had an opt out, then you are not making
people take training irrelevant to their practice. Many doctors
would opt out, because 3 days is more than enough. You would
reduce the number of doctors able to prescribe aggressively.
And for doctors who do major surgery or treat cancer, they
would take the training.
I think that is the way to go. I would like to point out
that for buprenorphine, a medicine much safer than drugs like
oxycodone, we have an 8-hour training requirement, and then we
limit the number of patients the doctor can treat. Whereas, for
the drugs that are causing addiction, causing overdose deaths,
we have no training requirement and we have no caps on the
number of patients that they can prescribe to.
Mr. Green. OK. Thank you. I yield back, Mr. Chairman.
Mr. Burgess. The chair thanks the gentleman. The gentleman
yields back. The chair recognizes the gentlelady from Indiana,
Mrs. Brooks, 5 minutes for questions, please.
Mrs. Brooks. Thank you, Mr. Chairman. Dr. Kolodny, I am
going to follow up. And I assume you heard from the last panel,
from DEA, that I, too, am working on a bill, but slightly
different. While fewer hours, it comes in part from the
President's Commission on Combating Drug Addiction Opioid
Crisis, and it was top recommendation that all prescribers
should be required to have some continuing medical education. I
know you agree with that.
Ours calls for 3 hours, but it is not just about preventing
the overdose, it is also about education on physicians and
other practitioners, learning how to detect of their own
patient base that they already have, not just the prevention of
the addiction, but also, how they can learn more about just
addiction writ large.
Do you believe that state licensing agencies are equipped
to produce and manage education programs of this type? Because
I know you are not in favor of other organizations producing
that training. What about state licensing or agencies, possibly
in conjunction with working with best practices from HHS?
Dr. Kolodny. It took a while for policymakers on a State
and Federal level to recognize that the opioid addiction
epidemic was being fueled by very aggressive prescribing, that
the medical community really needed to change course. And many
State legislators have responded by passing laws mandating
prescriber education on a State level. I don't believe those
systems are working.
The way they typically work is that every doctor in the
State who has a registration, whether or not they ever intend
to prescribe an opioid, has to take a course on pain treatment.
It is usually online. The content for these courses is awful.
In many cases, the courses are taught by the same doctors who
were teaching the courses that really got us into this mess.
I don't think that is the way to go. I think this should be
done on a Federal level linked to DEA registration with an opt-
out for doctors who don't want to prescribe more than 3 days,
let them opt out. But then they are not allowed to prescribe
more than 3 days. That would overnight shrink the pool of
doctors capable of prescribing aggressively. I like that you
are thinking about addiction and we really do want to teach
more than just how to prescribe these medicines. We need to
also be teaching people who prescribe addictive drugs about
addiction.
Mrs. Brooks. And I will probably be submitting for the
record, because I have a couple other questions for another
panelist about other model programs or ideas you might have on
the specific types of courses and so forth.
Dr. Kan, my concern, and you have testified about the fact
that so few people receive treatment but yet many people have
medical professionals in their lives or they do see medical
professionals. Would you say it is uncommon for primary care
physicians or the physician that has prescribed the opioids to
detect and to diagnose an addiction?
Dr. Kan. I would say that it is quite common. Dr. Kolodny
made a comment earlier that I agreed with, that the change in
opioids is going to cost in the billions of dollars. But the
changes that we can have now is we need to educate the
prescribers on how to identify problematic use.
For example, we know that anywhere from 15 to 45 percent of
patients who are taking prescribed opioids for chronic pain
demonstrate aberrant behavior, meaning that they have a urine
drug screen that is negative for the opioid. They may have
something else in the drug screen or there is other problems.
I think that treating the opioid epidemic, one of the main
emphases that we see is that primary care needs to be taught
how to do it. I think of buprenorphine a lot like insulin. If
you look at the Type 2 diabetes disease model, it is almost a
perfect analogue for opioid use disorder. I think of opioid use
disorder with chronic exposure, whether for recreation or
medication, changes the brain. And for some patients they need
buprenorphine, just as some people who suffer from diabetes
need insulin.
And I would argue to you that insulin is far more dangerous
than buprenorphine.
Mrs. Brooks. Would you please share with me, though, aside
from continuing the medical education, which is what I have
been focused on in crafting a bill, what else can we do to
better equip physicians, primary care, who are not trained
addiction specialists as to what they should be doing?
Dr. Kan. I think what we need to equip them with is the
access to the specialist. The greatest difficulty that a
primary care provider sees, they don't know who to send the
person to, because the addiction specialist they referred them
to may be a cash practitioner or they may not have access to
treatment.
So we need to educate a workforce that once the primary
care provider identifies the person, then they can be sent to
the specialist. This is the Vermont hub and spoke model.
Because they have hubs that are specially trained clinics, and
when they stabilize, they go back to their primary care
provider. It is a model that has been used in the city and
county of San Francisco where I work part-time.
I already had my DEA x-waiver, but I was required to get it
because the model that they use is they have extensive
treatment and then goes back to the primary care provider once
somebody is stabilized. As they destabilize, go back to the
hub.
Mrs. Brooks. Thank you. My time is up. I yield back. Thank
you all for your work.
Mr. Burgess. The chair thanks the gentlelady. The
gentlelady yields back. The chair recognizes the gentleman from
Virginia, Mr. Griffith, 5 minutes for questions, please.
Mr. Griffith. Thank you very much, Mr. Chairman. Mr. Nance,
let me just say thank you for your testimony that you have
given thus far on telemedicine. It is a very important field
for us to get in and explore.
My district is in the east, but it is a very rural
district. And while we don't have the miles that you have,
sometimes getting around the mountain, particularly when the
weather is not the best or when people are having problems to
begin with, as you pointed out, can be a problem. And so I
agree with many of the things that you say and appreciate your
testimony here today on that. I appreciate everybody's
testimony today. It has been very informative.
Dr. Beardsley, if I might just briefly. You talk about
drugs and compounds may be structurally similar. And we heard
some comments earlier today about the long history of opioids,
and sometimes we treat one opioid with another opioid. And so I
am just kind of curious, the naloxone, are you absolutely
certain that that doesn't have an addictive problem down the
road? Do you think that works for us no matter what?
Mr. Beardsley. I am absolutely certain that naloxone does
not have addictive properties.
Mr. Griffith. Because it is the antidote, as you said
earlier.
Mr. Beardsley. It is an antagonist, right, to opioids that
are abused. That is an antidote, more or less it reverses their
effects.
Mr. Griffith. Yes. I appreciate it. That takes me to you,
Mr. Logan, if I might. One of your recommendations is to allow
pharmacists to prescribe naloxone.
Can you explain the differences you have seen in terms of
access to reversal drugs in the States that currently allow
this compared to those that do not. And how has increased
access improved patient treatment?
Mr. Logan. There is a long answer to that question.
Mr. Griffith. Can I get a shorter one?
Mr. Logan. You can.
Mr. Griffith. You can send a longer written one, if you
would like.
Mr. Logan. Naloxone is a life-saving drug. When it is used,
it is in a life or death situation. If it is not used there is
no treatment thereafter. In that instance, the more we
distribute the easier it is to get, whether provided by a
healthcare professional, an EMS, or a family member. It doesn't
matter. We have got to get it in the hands of the people who
need it. And as of now, if I am not mistaken, naloxone is
available through pharmacies in every State.
Mr. Griffith. OK. You referenced a Virginia program,
Virginia's Medicaid Addiction Recovering Treatment Services has
a new benefit for Medicaid patients which includes coverage for
SBRT (ph) provided by pharmacies. And I wrote that down. I am
bad with all those names, too. But could you explain how that
program works and specifically, how it has worked in Virginia
and what good that does?
Mr. Logan. I am going to defer to NCPA for that answer. I
can tell you about what is happening in Missouri.
Mr. Griffith. All right. Tell me what is happening in
Missouri.
Mr. Logan. Not much.
Mr. Griffith. OK. But it seems like what they are looking
for is giving the pharmacists the authority to--and they will
send me a written response--but giving the pharmacists the
authority to say, ``Hey, we think this person might have a
problem.'' And instead of having law enforcement swoop in, have
some education and try to get treatment for that individual
first. Is that your understanding of the program?
Mr. Logan. The whole goal of the program is to keep
addiction addiction and not make addiction criminal. We don't
want a person who is ill being treated in the legal system.
From both sides of my life, my pharmacy healthcare side and my
law enforcement side, we want those people properly assigned
and properly treated.
Mr. Griffith. Absolutely. And so do we. And I appreciate
you on that.
Dr. Beardsley, back to you. I know earlier you were
scratching your head a little bit. That is what us lawyers call
conditional relevancy. I was setting up his question but asking
you something. And you were like, why is he asking me that.
But now I am going to ask questions directly to you and
that is, you talked about how adding a new drug to your
existing Schedule I registration may take months. Now for the
folks back home who are watching this in the middle of the
night or right now, you have to get permission to do--you do
Schedule I registration, to do research on some of the more
dangerous drugs, or at least the ones that are on Schedule I,
isn't that correct?
Mr. Beardsley. That is correct.
Mr. Griffith. And so could you tell us how, so we can all
better understand, how taking months to get the Schedule I
registration for a researcher can gum up the process.
Mr. Beardsley. Well, it interrupts the research process if
you have to wait for months in order to get approved for using
a drug.
The initial process for even applying to have a Schedule I
drug added to your registration is lengthy for the researcher
himself. It takes several hours to prepare a protocol. And that
also has research costs in terms of downtime. In my case, I do
research in four laboratories--buildings are very close
together. And yet I have to have four Schedule I registrations,
four Schedule II to V registrations, and four commonwealth of
Virginia registrations to do that research. That all adds cost
and hampers research.
Mr. Griffith. Cost, time, and makes it harder to come up
with good results, isn't that correct?
Mr. Beardsley. Well, it ends up creating a bureaucratic
morass that can almost make research untenable.
Mr. Griffith. Well, I appreciate that. My time is up and I
appreciate all of you. And I yield back.
Mr. Burgess. The gentleman yields back. The chair thanks
the gentleman. The chair recognizes the gentleman from Georgia,
Mr. Carter, 5 minutes for questions, please.
Mr. Carter. Thank you, Mr. Chairman. Mr. Chairman, before I
start, I want to compliment you and staff. This is an
outstanding panel. Seriously, we got boots on the ground. So
often, with all due respect, we only have people from academia.
But this is truly boots on the ground. And I just can't tell
you, I am so impressed. I am sorry I had to leave a little
earlier to go meet with another group, but let me get started
because I have a lot I want to go through.
I am going to start with you, Dr. Kan. I want to ask you,
because telemedicine--I have got a bill that we are considering
with telemedicine--but specifically with the Ryan Haight Act,
it limits expanded access to buprenorphine. And I am just
wondering if you can speak to that, very quickly, about how we
could do away with that so that we could be able to prescribe
it, if we needed to, but because of this act, as I understand
it, we are not able to?
Dr. Kan. If we amend it to the recommendation that we can
rely on another provider, that would be extremely helpful. With
my company, we rely on emergency department physicians. We pair
with emergency departments to identify, get them started on
buprenorphine and quickly matriculate into care.
The short version of it is that the drug dealers are open
24/7.
Mr. Carter. Right.
Dr. Kan. We need to be ready to do the same.
Mr. Carter. Right. Mr. Nance, you mentioned this also in
your testimony, about the limitations that Ryan Haight Act is
causing us on that. Can you comment on that very quickly?
Mr. Nance. Can you ask me a more specific question?
Mr. Carter. Particularly, as I understand it, it limits the
expanded access to treatment with some of the drugs that we
need to be treating this opioid addiction with, like
buprenorphine.
Mr. Nance. Yes, the whole point of my testimony is that,
especially in rural and frontier areas----
Mr. Carter. Absolutely.
Mr. Nance [continuing]. You have very, very few licensed
providers who will actually be willing to provide
buprenorphine. My friend at the DEA in Utah says we have 503
licensed trained buprenorphine prescribers. Only 125 of them
are actually practicing and prescribing buprenorphine. But if
you go on the buprenorphine treatment binder on their website,
there are only about 70 listed.
Mr. Carter. Right.
Mr. Nance. So you have got a huge potential labor pool out
there but they are just reluctant to do it because they are not
familiar with----
Mr. Carter. But specifically with telemedicine, if we were
able to have the physician be able to prescribe it then, as I
understand it, and they can't because of the Ryan Haight Act.
Mr. Nance. Right. It is very, very difficult. You have to
have that first face-to-face. If we can get the community
behavioral health centers included as a kind of separate
definition inside the Ryan Haight Act, then we can open up a
lot of potential buprenorphine services to the patients in
those extreme----
Mr. Carter. OK. Let me move on. Mr. Logan, I wanted to ask
you. Did you all ever get the PDMP in Missouri?
Mr. Logan. I keep getting asked these questions with long
answers.
Mr. Carter. OK. I need you to make it real quick. Yes or
no.
Mr. Logan. We have an executive order signed that examines
prescriptions written and adjudicated through a third-party
insurance.
Mr. Carter. OK.
Mr. Logan. And prescribes blame to over-prescribers.
Mr. Carter. OK. For a long time 49 out of 50 States had it.
Missouri was the only one who didn't have it. And it needs to
go across State lines. As you pointed out earlier in your
testimony, you are right on the State line. And you are going
to get prescriptions as I did, in my pharmacy from many States.
So that is why it is so very important.
I wanted to mention just a couple of other things. Mr.
Cosgrove, you mentioned a number of companies, pharmaceutical
manufacturers are moving overseas. Is that because of our tax
laws? We changed that just recently, so I hope that we have
resolved that.
Mr. Cosgrove. Well, I am not an expert in tax law.
Mr. Carter. Right.
Mr. Cosgrove. I do know that the manufacturing costs
overseas for a number of reasons----
Mr. Carter. OK.
Mr. Cosgrove [continuing]. Are dramatically lower than----
Mr. Carter. Well, if it is because of manufacturing costs.
But if it is because of the tax problems, then we have resolved
that problem with the Tax Cuts and Jobs Act. So I want to make
sure we understand that.
Dr. Subbiah, you mentioned about the new drug that you had.
I just wanted to ask you very quickly. You haven't used
specialty pharmacies, only practitioners can be injected. Was
that mandated by the FDA or did the company decide that is the
way that you wanted to go? Because access is a big problem when
we are talking about these kinds of drugs, and obviously, that
is going to limit access there.
Dr. Subbiah. So this was in discussion with the FDA. It is
part of our risk evaluation mitigation strategy program.
Mr. Carter. OK.
Dr. Subbiah. Because a lot of doctors, some of them do not
want to do the buy-in bill, and so there had to be another way
in a restricted distribution system. So if a doctor in Utah
wanted to prescribe Sublocade, they can contact one of the
specialty pharmacists that we are working with.
Mr. Carter. Right.
Dr. Subbiah. And they will get a named patient for
prescription that will be sent to that doctor for use only in
that patient.
Mr. Carter. OK. And one last thing. Dr. Mulder, thank you.
I was a hospice consultant pharmacist for many years. And quite
often in Congress, we have the tendency to overreact and overdo
it. And you pointed out something that is very important. There
are people out there who truly need these drugs. We need to
make sure that they are going to be able to get them and have
access to them. So thank you for pointing that out.
Mr. Mulder. Amen.
Mr. Carter. Yes. Thank you, Mr. Chairman. I yield back.
Mr. Burgess. The gentleman yields back. The Chair thanks
the gentleman. And does the gentleman from Michigan wish to be
recognized for questions?
Mr. Walberg. Yes, Mr. Chairman.
Mr. Burgess. You are recognized for 5 minutes.
Mr. Walberg. Thank you. Thanks again for letting me sit in
this panel. And specifically, I would add to my colleagues'
comments--and compliments to you, Dr. Mulder. It is a tough
field that you are in. And it is a compassion field, and we
want to make sure that we do things right. But I am delighted
that you are also thinking along the lines of how do we carry
on our impact with end-of-life issues, with human beings in
need, but also make sure that what we use and use
appropriately, doesn't end up causing problems for others down
the road.
In our home State of Michigan, Mr. Mulder, we have seen
real challenges with diversion and misuse of leftover
medications that have contributed to the opioid crisis.
Hospices and hospice personnel could play a key role in helping
ensure these drugs are properly disposed of, but current DEA
regulations appear to pose an obstacle.
Could you please describe the current challenge that
hospice personnel face when an individual passes away and there
is remaining unused medication? How does the current law
specifically prevent hospice personnel from destroying this
unused medication to ensure that it is not diverted to another
purpose?
Dr. Mulder. Well, it somewhat has to do with the take-back
provisions in which, if they are going to receive these
medications, whether for the purpose of distributing them
somewhere else or to, of destroying them, it is a reverse
distributor process. And they have to be licensed by the DEA as
a reverse distributor to be able to take those medications in.
I think I am using the right terminology. The pharmacists can
correct me if I am not.
But when that came into effect then, they, by law, can't
take those medications. They really are not allowed to do
anything with that. And that is the primary limitation.
Mr. Walberg. Is that the same problem in an actual physical
hospice facility?
Mr. Mulder. No, it really isn't. And part of that has to do
with how those facilities are licensed. And that may vary from
State to State but that does not exist, for example, we have a,
our hospice operates in a facility. We do not have that same
restriction.
Mr. Walberg. OK. In your opinion, what type of licensing
should a hospice worker have to be able to destroy unused
medication? Is that something that needs to be further
clarified in my bill, H.R. 5041?
Mr. Mulder. Yes. Well, for sure, physicians, physician
assistants, nurse practitioners, and registered nurses, I would
put at the top of my list as those who already have licensure
and could, I think, very logically be certified to be able to
manage that process.
Mr. Walberg. So they have the background, they have the
training, they have the certification. If indeed they are
retired and volunteer services, would that carry over?
Mr. Mulder. I probably would not extend that to volunteers.
Volunteers, although they function in many capacities as a kind
of a surrogate employee at the hospice, the relationship is
different, the financial relationship is different, the
regulatory relationship is different. And I probably would be
reluctant to subscribe that particular task. That is my own
personal view, though, to a volunteer.
Mr. Walberg. OK. Well thank you. I appreciate the entire
panel and sitting in, but appreciate, Dr. Mulder, your points.
I yield back.
Mr. Burgess. The gentleman yields back. The Chair thanks
the gentleman. The Chair would observe that I had delayed my
questioning to allow other members to pose their questions and
then catch planes, or trains, or automobiles, whatever they
needed to do.
Dr. Mulder, I really was encouraged to hear you use the
term, we are going to miss some episodes of preventable
suffering. And it worries me, too.
Mr. Mulder. Thank you.
Mr. Burgess. One of my very first hearings in this
committee, and it was a long time ago, but it is why doctors
are not prescribing enough pain medicine to the point that some
others have made on this panel. I have seen the pendulum swing
both ways. And I do worry that we live in the land of
unintended consequences here in the United States House of
Representatives.
So it worries me that some of the things that we are
perhaps contemplating today are going to put more people into
the realm of preventable suffering that is not prevented, and I
worry about that. So thank you for what you do in bringing that
to our attention as well.
Mr. Mulder. Well, thank you for your comments and we will
be looking forward to the diligence of this committee to make
sure that doesn't happen.
Mr. Burgess. Yes, ever hopeful.
Mr. Logan, first off, I want you to know that in the
appropriations bill for Labor, Health and Human Services that
the House of Representatives passed in September--now, the
Senate has never taken any action, so it hasn't become law--but
the bill that we passed in September actually did carve up some
dollars for people who don't have a PDMD available so that it
would be available.
I am a big believer in PDMPs. I think they are useful. I
worry about burdening people with too many inputs that they
have to put in their electronic health record but at the same
time--or too many queries of a database, but still, this is one
that I think can be very useful.
But let me just ask you. You described a situation where
your pharmacy is, and you are on a big highway, that is the
crossroads of the Nation and people come from all over the
country with prescriptions they have received somewhere else
and then they present them to you. Did I understand that
correctly?
Mr. Logan. Yes, you did.
Mr. Burgess. And I got the impression, I may have been
overcalling it, but I got the impression that you felt that
sometimes--I don't want to infer anything. Do you feel that
sometimes the prescription perhaps is overly generous with the
amount of medication that is dispensed?
Mr. Logan. Any time I see multiple prescriptions for
multiple people in one vehicle in quantities of excess of 180
oxycodone, I think that is excessive, yes.
Mr. Burgess. So with your keen powers of observation, you
are able to deduce that that may be an overprescribing
situation?
Mr. Logan. Thank God it don't take no rocket scientist.
Mr. Burgess. And that is the point. Our representative from
the agency, from the DEA, I don't think is here any longer, but
I was under the impression every time I wrote a triplicate
prescription for a controlled substance that it goes into--
whether I had a PDMP or not--it goes into a database. Somebody
is monitoring that. Maybe someone at my State level, maybe
someone at the Federal level.
So it is not a surprise that these prescriptions are going
out the doors or the pills are going out the doors. I had this
very conversation with Secretary Azar 2 weeks ago when he was
here. CMS has a lot of data at its disposal. It knows who under
their care, in Medicare or Medicaid, is receiving an untoward
number of pills. And it also knows the pharmacies to which it
is reimbursing payment where an untoward number of pills are
going out. Is that not recently to assume?
Mr. Logan. An inordinate number of these prescriptions are
cash. There is no claim generated for them. So what you deal
with at a payor level is paid claims. PDEs we call them. If
there is no cash claim, if there is no PDMP, it never happened.
Mr. Burgess. Well, back to the point of the PDMP, why I
thought it was important to put the money forward on that. This
committee actually authorized a bill, it was called NASPER well
over 10 years ago, that was to provide that type of help. It
got tied up in the appropriations process, and although it was
authorized on several occasions, it was never funded. So I
tried to correct that last September so that it would be
funded.
But I guess the point I am getting at is it is not a
surprise that there are some people who are overprescribing,
and you can know who they are. You have brought up a point that
I had not actually considered, which was the cash transaction,
but still, the pharmacy has a record of the pills that they--
are you not required to account for every controlled substance
dose that comes through your shelves?
Mr. Logan. Absolutely. The pharmacist's duty of care is to
determine the legality of the prescription. Are all the numbers
on it? Is it filled out correctly? But also the legitimacy of
the prescription. Is there a valid prescriber-patient
relationship? Have there been diagnostic tests done to justify
what we are talking about? A lot of times, the pharmacist has
to go on gut feeling on the legitimacy. And the independent
pharmacist is in a unique position. We determine our own
destiny.
We can say yes, we will fill it. No, we won't. We are where
the buck stops. There are people who work for companies that
may not have the discretion to determine the legality and
legitimacy and go strictly on the legality of the prescription.
Mr. Burgess. And I guess the point I was getting at, at
some level, that data is available, because whether it be an
independent pharmacist or a chain pharmacy, all of those
dosages of those controlled substances have to be accounted for
somewhere.
Mr. Logan. In either controlled substance inventory
mandated by DEA or purchases through wholesalers.
Mr. Burgess. Correct. So it is knowable if a location is
receiving an unusual or an untoward amount of product, is
that----
Mr. Logan. Absolutely.
Mr. Burgess. And Dr. Kolodny, obviously you and I do see
things a little bit differently on some of the approaches, but
I will say this: I look at our doctors as our allies in this,
not our adversaries. I think if we treat our doctors as allies,
they will be our allies. If we treat them as adversaries, they
will be our adversaries.
We, I think, sometimes unnecessarily complicate the lives
of our physicians to the point where some of them will just
give up and we will have preventable pain that doesn't get
prevented or that doesn't get treated. So I just worry that
putting the onus on a practicing physician to do some mandatory
training, I don't know that that is going to solve the problem
when the problem is as big as what Dr. Logan describes at his
crossroads pharmacy. And yet, that data is known. Somebody
knows that those bills are going out the door, right?
Dr. Kolodny. Yes. And I think we do agree that doctors are
not to blame. I think that doctors were responding to brilliant
marketing. And that is why we are seeing litigation from
counties and States across the country and why the Department
of Justice and Attorney General Sessions announced yesterday
that the Federal Government is going to be helping out. There
is an understanding that the medical community has been
deceived about the risks and benefits of these drugs.
The pill mill doctors, we have to try and stop them because
they are killing a lot of people, but they are really not the
root of the problem. The bigger problem is the well-meaning
doctors and dentists who are inadvertently creating customers
for these doctors. We have to stop those doctors because they
kill people. But this epidemic will not end unless we prevent
more people from becoming opioid-addicted.
Mr. Burgess. And here is where we disagree. I practiced in
the 1980s and 1990s. I can rarely remember writing a
prescription for more than 12 doses of a controlled substance.
I had a surgical practice, and someone who was operated on was
going to need pain relief. I recognized that. It did seem like
in the old days we could allow for a refill on a prescription.
And that may be a State function in Texas, but it seems like
that went away at some point. And I don't know if that led to
the conclusion that people are going to write larger numbers of
pills so they don't get a telephone call on the weekend. I
don't know. I am inferring that. I have no data to back that
up.
But it just seems like the world changed somewhere between
the late 1990s and the end of the first decade of the 21st
century.
Dr. Kolodny. You are absolutely right. In fact we know
exactly what year the prescribing began to take off. It
happened in 1996. And it wasn't just OxyContin that starts to
take off in 1996. Hydrocodone, hydromorphone, morphine, the
fentanyl patch. Starting in 1996 is when the prescribing really
begins to explode.
In 2014, the fall 2014, we put Vicodin into a more
restrictive category where it couldn't be phoned in easily and
where you couldn't write refills. And that may have had an
influence on the quantity in a prescription, but the overall
impact of that change was a dramatic reduction in the number of
hydrocodone pills that were prescribed.
So I think the bigger part of the problem was starting in
1996, a multifaceted campaign that was very effective that told
doctors that we need to prescribe more. And many doctors are
still very badly misinformed. I think in an ideal world we
would not have to make doctors take a training course. We could
rely on doctors. But in this situation, doctors are not able to
accurately weigh the risks versus the benefit for the patient
in front of them.
Mr. Burgess. I disagree with that. That is our job. That is
what we do. That is what we were trained to do. So you and I
are going to fundamentally disagree on that. I will just
conclude with the observation, I have gone way over time, but
since I am the chairman, I can do that.
I don't know that any of the doctors who are writing those
prescriptions that Mr. Logan gets presented with at 2:00 or
3:00 in the morning, I don't know if--you may force them to
take a continuing education course, but I don't think it is
going to alter their behavior in the least.
And I also agree with you that some of the courses that are
available, I, in fact, took for my CME last August, I did an
online course on opiate use and proper prescribing. One thing I
have learned to do over the years is how to take a test. I
disagreed with the philosophic premise that was coming out of
this large medical school in the east, but I was able to answer
the questions the way they wanted and got what my goal was,
which was my continuing education hours.
You all have been very generous with your time today and I
do appreciate it.
Mr. Green, do you have a followup?
Mr. Green. Yes, Mr. Chairman. I am not going to ask for the
full 6 minutes that you took but I just want to ask, is
anybody----
Mr. Burgess. You see, I aggregated all of the extra time
that was taken on your side of the dais.
Mr. Green. Well, I just want to ask other witnesses, if you
have any short statements in response to the chair or any of
the stuff we did, because our efforts are to try a find a
solution, and the balance, what we can do. Because we know we
have an epidemic, but I have also seen overkill and that is
what some of the testimony is, but we also know we need to deal
with this issue. And does anybody have anything else for what
the Chair responded to?
Yes, Doctor.
Dr. Subbiah. I think the main thing you heard from all of
us is that it requires a multi-pronged approach. It is going to
require the treatment, it is going to require telemedicine. It
is going to require education. And I think all of those are
going to be very important. It is very encouraging today that
you did allow all of us to give those different perspectives.
So thank you.
Mr. Burgess. That is what a hearing is all about.
Mr. Green. Yes. One thing. I had a constituent in our
district who worked for many years in construction and he
needed an opioid. And one of the chain drug stores, Walgreens
that I work with all the time, because they help do
immunizations in my area. The independent pharmacist has the
right to decide that. And so I asked the regional director, I
said, well, could this fellow go to another Walgreens? He said
well, that pharmacist might decide not to. We ended up finding
his medication, probably not at the most reputable pharmacy
that we should have.
So there is an issue about people who really need it just
to survive because of their lifestyle or their work. As we get
older, we find out that where we fell down and we are 30 years,
when you are 65 you all of a sudden say, hey, that hurts. So,
but anyway, thank you, Mr. Chairman.
Mr. Burgess. The Chair will not refer to you as an enabler.
I do want to thank all our witnesses again for being here
today, and for the time you have invested. As you can see, this
is an important topic. And as the Chairman said we are going to
have multiple hearing on this.
I would like to submit statements from the following for
the record: Congressman David Kustoff, Prime Therapeutics,
National Association of Chain Drug Stores, the University of
Texas, Johns Hopkins University, CVS Health, Braeburn.
[The information appears at the conclusion of the hearing.]
Mr. Burgess. Pursuant to committee rules, I remind members
they have 10 business days to submit additional questions for
the record, and I ask the witnesses to submit those responses
within 10 business days upon receipt of said questions.
Without objection, the subcommittee is adjourned.
[Whereupon, at 5:12 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
[all]