[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]
FEDERAL EFFORTS TO COMBAT THE OPIOID CRISIS: A STATUS UPDATE ON CARA
AND OTHER INITIATIVES
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FIFTEENTH CONGRESS
FIRST SESSION
__________
OCTOBER 25, 2017
__________
Serial No. 115-68
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
_________
U.S. GOVERNMENT PUBLISHING OFFICE
32-978 PDF WASHINGTON : 2018
COMMITTEE ON ENERGY AND COMMERCE
GREG WALDEN, Oregon
Chairman
JOE BARTON, Texas FRANK PALLONE, Jr., New Jersey
Vice Chairman Ranking Member
FRED UPTON, Michigan BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois ANNA G. ESHOO, California
MICHAEL C. BURGESS, Texas ELIOT L. ENGEL, New York
MARSHA BLACKBURN, Tennessee GENE GREEN, Texas
STEVE SCALISE, Louisiana DIANA DeGETTE, Colorado
ROBERT E. LATTA, Ohio MICHAEL F. DOYLE, Pennsylvania
CATHY McMORRIS RODGERS, Washington JANICE D. SCHAKOWSKY, Illinois
GREGG HARPER, Mississippi G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey DORIS O. MATSUI, California
BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida
PETE OLSON, Texas JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia JERRY McNERNEY, California
ADAM KINZINGER, Illinois PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida PAUL TONKO, New York
BILL JOHNSON, Ohio YVETTE D. CLARKE, New York
BILLY LONG, Missouri DAVID LOEBSACK, Iowa
LARRY BUCSHON, Indiana KURT SCHRADER, Oregon
BILL FLORES, Texas JOSEPH P. KENNEDY, III,
SUSAN W. BROOKS, Indiana Massachusetts
MARKWAYNE MULLIN, Oklahoma TONY CARDENAS, California
RICHARD HUDSON, North Carolina RAUL RUIZ, California
CHRIS COLLINS, New York SCOTT H. PETERS, California
KEVIN CRAMER, North Dakota DEBBIE DINGELL, Michigan
TIM WALBERG, Michigan
MIMI WALTERS, California
RYAN A. COSTELLO, Pennsylvania
EARL L. ``BUDDY'' CARTER, Georgia
JEFF DUNCAN, South Carolina
C O N T E N T S
----------
Page
Hon. Greg Walden, a Representative in Congress from the State of
Oregon, opening statement...................................... 2
Prepared statement........................................... 3
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 4
Prepared statement........................................... 6
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, prepared statement............................. 120
Hon. Steve Scalise, a Representative in Congress from the State
of Louisiana, prepared statement............................... 120
Witnesses
Scott Gottlieb, M.D., Commissioner, Food and Drug Administration,
Department of Health and Human Services........................ 8
Answers to submitted questions............................... 172
Elinore McCance-Katz, M.D., Assistant Secretary for Mental Health
and Substance Use, Substance Abuse and Mental Health Services
Administration, Department of Health and Human Services........ 10
Answers to submitted questions............................... 191
Anne Schuchat, M.D., Principal Deputy Director, Centers for
Disease Control and Prevention, Department of Health and Human
Services....................................................... 12
Answers to submitted questions............................... 228
Nora Volkow, M.D., Director, National Institute on Drug Abuse,
National Institutes of Health, Department of Health and Human
Services....................................................... 14
Prepared joint statement \1\................................. 16
Answers to submitted questions............................... 256
Neil D. Doherty, Deputy Assistant Administrator, Office of
Diversion Control Operations, Diversion Control Division, Drug
Enforcement Administration, Department of Justice.............. 31
Prepared statement........................................... 33
Answers to submitted questions............................... 272
Submitted Material
Statement of the American Physical Therapy Association, October
25, 2017, submitted by Mr. Shimkus............................. 122
Letter of October 24, 2017, from Mrs. Blackburn to Eric Hargan,
Acting Secretary, Department of Health and Human Services, and
Robert Patterson, Acting Administrator, Drug Enforcement
Administration, submitted by Mrs. Blackburn.................... 126
Statement of the American Hospital Association, October 25, 2017,
submitted by Mr. Tonko......................................... 127
Statement of the Protecting Access to Pain Relief Coalition,
October 25, 2017, submitted by Mr. Tonko....................... 131
Letter of October 25, 2017, from Kelly Clark, President, American
Society of Addiction Medicine, to Mr. Walden and Mr. Pallone,
submitted by Mr. Tonko......................................... 135
Statement of Ronald M. Hendrickson, Executive Director,
International Chiropractors Association, October 25, 2017,
submitted by Mr. Carter........................................ 138
Statement of Mike Durant, President, Peace Officers Research
Association of California, submitted by Mrs. Walters........... 142
----------
\1\ Dr. Gottlieb, Dr. McCance-Katz, Dr. Schuchat, and Dr. Volkow
submitted a joint written statement.
Statement of the American Medical Association, October 25, 2017,
submitted by Mr. Burgess....................................... 148
Letter of October 18, 2017, from Robert Twillman, Executive
Director, Academy of Integrative Pain Management, to Hon. Orrin
G. Hatch, a United States Senator from Utah, submitted by Mr.
Burgess........................................................ 153
Statement of the American Dental Association, October 25, 2017,
submitted by Mr. Burgess....................................... 155
Statement of the American Pharmacists Association, et al.,
October 25, 2017, submitted by Mr. Burgess..................... 159
Statement of J. Paul Molloy, Chief Executive Officer, Oxford
House, Inc., October 25, 2017, submitted by Mr. Burgess........ 161
Statement of America's Health Insurance Plans, October 25, 2017,
submitted by Mr. Burgess....................................... 164
FEDERAL EFFORTS TO COMBAT THE OPIOID CRISIS: A STATUS UPDATE ON CARA
AND OTHER INITIATIVES
----------
WEDNESDAY, OCTOBER 25, 2017
House of Representatives,
Committee on Energy and Commerce,
Washington, DC.
The committee met, pursuant to call, at 10:00 a.m., in Room
2123, Rayburn House Office Building, Hon. Greg Walden (chairman
of the committee) presiding.
Members present: Representatives Walden, Barton, Upton,
Shimkus, Burgess, Blackburn, Latta, McMorris Rodgers, Harper,
Lance, Guthrie, Olson, McKinley, Kinzinger, Griffith,
Bilirakis, Johnson, Bucshon, Flores, Brooks, Mullin, Hudson,
Collins, Cramer, Walberg, Walters, Costello, Carter, Duncan,
Pallone, Eshoo, Engel, Green, DeGette, Doyle, Schakowsky,
Butterfield, Matsui, Castor, Sarbanes, McNerney, Welch, Lujan,
Tonko, Loebsack, Schrader, Kennedy, Cardenas, Ruiz, Peters, and
Dingell.
Staff present: Jennifer Barblan, Chief Counsel, Oversight
and Investigations; Ray Baum, Staff Director; Mike Bloomquist,
Deputy Staff Director; Adam Buckalew, Professional Staff
Member, Health; Karen Christian, General Counsel; Kelly
Collins, Staff Assistant; Zack Dareshori, Staff Assistant;
Jordan Davis, Director of Policy and External Affairs; Paul
Edattel, Chief Counsel, Health; Adam Fromm, Director of
Outreach and Coalitions; Caleb Graff, Professional Staff
Member, Health; Jay Gulshen, Legislative Clerk, Health;
Brittany Havens, Professional Staff Member, Oversight and
Investigations; Zach Hunter, Communications Director; Peter
Kielty, Deputy General Counsel; Alex Miller, Video Production
Aide and Press Assistant; Christopher Santini, Counsel,
Oversight and Investigations; Kristen Shatynski, Professional
Staff Member, Health; Jennifer Sherman, Press Secretary; Alan
Slobodin, Chief Investigative Counsel, Oversight and
Investigations; Danielle Steele, Counsel; Christina Calce,
Minority Counsel; Jeff Carroll, Minority Staff Director;
Waverly Gordon, Minority Counsel, Health; Tiffany Guarascio,
Minority Deputy Staff Director and Chief Health Advisor; Chris
Knauer, Minority Oversight Staff Director; Jourdan Lewis,
Minority Staff Assistant; Miles Lichtman, Minority Policy
Analyst; Jessica Martinez, Minority Outreach and Member
Services Coordinator; Kevin McAloon, Minority Professional
Staff Member; Tim Robinson, Minority Chief Counsel; Samantha
Satchell, Minority Policy Analyst; Andrew Souvall, Minority
Director of Communications, Member Services, and Outreach; and
Kimberlee Trzeciak, Minority Senior Health Policy Advisor.
Mr. Walden. If our members and guests would take their
seats, it is 10 o'clock. We want to get started on time. I want
to thank our witnesses for being here. Before I start, I
especially want to thank the head of the FDA, Dr. Gottlieb. I
think we are going to have to give you an office, you have been
here so much this week, the third or fourth time, and we really
appreciate your cooperation with our committee and your
assistance in this and many other matters.
OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
OK, I will call to order the Energy and Commerce Committee.
This is, I think, our first full committee on a matter and I
think it points to the concerns we have about this issue as a
committee and as a country.
Each day, more than a thousand people are treated in
emergency rooms for misusing prescription opioids. Each day, 91
Americans die from an opioid overdose. In last year alone,
opioid overdoses have claimed the lives of more Americans than
the entire Vietnam War. In my home State of Oregon, more people
died last year from drug overdoses than from car accidents.
We hear these statistics over and over again at roundtables
throughout my district, most recently in Grants Pass in
Southern Oregon and Bend in Central Oregon. I have heard the
stories of Oregonians, put names and faces to these data
points. Addiction and overdoses are happening at alarming rates
in every community in our Nation. Just scan the headlines on
any given day and you will hear about a life destroyed by
addiction or about a raid that seized obscene quantities of
prescription painkillers or illicit drugs.
The United States is in the midst of a crisis that has
become a national emergency. The number of individuals dying
from opioid overdoses has reached epidemic proportions and even
more individuals with substance use disorders have become
estranged from their families, they are unable to work, or
living as shells of their former selves because of their
addiction. It is truly heartbreaking.
To respond to this growing epidemic, the Energy and
Commerce Committee has held countless conversations and
numerous hearings with experts and stakeholders, law
enforcement, individuals in recovery, and family members of
opioid abuse victims in order to improve the prevention and
treatment of this terrible addiction.
From the earliest hearings before our Oversight and
Investigation Subcommittee to legislative solutions tested in
our Health Subcommittee, our multiyear, multi-Congress findings
have led to bills that are now law, namely the Comprehensive
Addiction and Recovery Act known as CARA, and the 21st Century
Cures Act.
This year, this committee has initiated multiple bipartisan
investigations into allegations of pill dumping in West
Virginia and patient brokering schemes elsewhere in the
country. We have held hearings on the growing threat of
fentanyl, innovative ideas in the States, we have heard
directly from more than 50 members of Congress both on and off
this committee just 2 weeks ago, but more work needs to be done
and we must redouble our efforts to combat the growing crisis.
The primary purpose of this hearing is to hear from the
Federal agencies charged with implementing the provisions of
CARA and the 21st Century Cures Act and we appreciate you all
being here, but it also allows this committee to have an
important conversation with the DEA, first, to discuss recent
news reports that suggested a bipartisan bill that passed
through this committee and signed into law by President Obama
has negatively impacted the DEA's ability to combat the opioid
crisis. Second, we are looking for some long overdue answers to
basic questions and requests for data that this committee has
made to the DEA related to our ongoing investigation into
alleged pill dumping in the State of West Virginia.
I am going to be very blunt. My patience is wearing thin.
Our requests for data from DEA are met with delay, excuses and,
frankly, inadequate response. People are dying, lives and
families are ruined. It is time for DEA to get to this
committee the information we need and to do it quickly. No more
dodges, no more delays. We look forward to finally hearing
directly from DEA on these matters. In addition to the DEA, we
will be hearing testimony from officials at the Food and Drug
Administration, the Substance Abuse and Mental Health Services
Administration, the Centers for Disease Control and Prevention,
and the National Institute on Drug Abuse at the National
Institutes of Health.
It is our hope that today's testimony will allow us all to
learn more about the Government's shared efforts to address
this crisis, allowing us the opportunity to drill deeper to
learn about what is working and what is not working. It is our
job to always do that oversight and fix problems. We will also
have an opportunity to discuss how we can better prevent lawful
prescription use from spiraling into abuse and, more
importantly, we will discuss what more we can do to reduce
overdoses and save lives.
To the witnesses before us today, consider this another
call to action. We need your help as we pursue both our
investigative and our legislative work. It is imperative we
confront this problem from every side and it is crucial that
everyone remembers we are on the same team. This crisis
requires an all-hands-on-deck response.
We all want to end this scourge but we must be willing to
work together. From the most basic requests for data to
crafting and implementing laws, the lines of communication must
be open. If there are changes we need to make in the law,
please tell us. We have a duty to our constituents and the
American people to combat the epidemic from all angles.
Everyone has a stake in this fight.
[The prepared statement of Mr. Walden follows:]
Prepared statement of Hon. Greg Walden
Each day, more than 1,000 people are treated in emergency
departments for misusing prescription opioids.
Each day, 91 Americans die from an opioid overdose.
In last year alone, opioid overdoses have claimed the lives
of more Americans than the entire Vietnam War.
In my home State of Oregon, more people died last year from
drug overdoses than from car accidents. We hear these
statistics over and over again. At roundtables throughout my
district--most recently in Grants Pass, in southern Oregon, and
Bend, in central Oregon--I've heard the stories of Oregonians
who put names and faces to these data points.
Addiction and overdoses are happening at alarming rates in
every single community. Scan the headlines on any given day and
you'll hear about a life destroyed by addiction or about a raid
that seized obscene quantities of prescription painkillers or
illicit drugs.
The United States is in the midst of a crisis that has
become a national emergency. The number of individuals dying
from opioid overdoses has reached epidemic proportions. And
even more individuals with substance use disorders have become
estranged from their families, unable to work, or living as
shells of their former selves because of their addiction. It's
heartbreaking.
To respond to this growing epidemic, the Energy and
Commerce Committee has held countless conversations and
numerous hearings with experts, stakeholders, law enforcement,
individuals in recovery, and family members of opioid abuse
victims in order to improve the prevention and treatment of
addiction.
From the earliest hearings before our Oversight and
Investigations Subcommittee to legislative solutions tested in
our Health Subcommittee, our multiyear, multi-Congress findings
have led to bills that are now law--namely the Comprehensive
Addiction and Recovery Act (CARA) and the 21st Century Cures
Act.
This year, this committee has initiated multiple,
bipartisan investigations into allegations of pill dumping in
West Virginia and patient brokering schemes. We have held
hearings on the growing threat of fentanyl, innovative ideas in
the States, and heard directly from more than 50 members--both
on and off this committee--just two weeks ago. But more work
needs to be done and we must redouble our efforts to combat the
growing crisis.
The primary purpose of this hearing is to hear from the
Federal agencies charged with implementing the provisions of
CARA and the 21st Century Cures Act.
But it also allows this committee to have an important
conversation with the DEA.
First, to discuss recent news reports that suggested a
bipartisan bill passed through this committee and signed into
law by President Obama has negatively impacted DEA's ability to
combat the opioid crisis.
Second, we are also looking for some long overdue answers
to basic questions and requests for data that this committee
has made to the DEA related to our ongoing investigation into
alleged pill dumping in the State of West Virginia.
I'm going to be very blunt: My patience is wearing thin.
Our requests for data from the DEA are met with delay, excuses
and, frankly, inadequate response. People are dying. Lives and
families are ruined.
It is time for DEA to get this committee the information we
need, and to do it quickly. No more dodges. No more delays. We
look forward to finally hearing directly from DEA on these
matters.
In addition to the DEA, we will be hearing testimony from
officials at the Food and Drug Administration, the Substance
Abuse and Mental Health Services Administration, the Centers
for Disease Control and Prevention, and the National Institute
on Drug Abuse at the National Institutes of Health.
It is our hope that today's testimony will allow us all to
learn more about the Federal Government's shared efforts to
address this crisis, allowing us the opportunity to drill
deeper to learn about what's working and what's not working.
We'll also have an opportunity to discuss how we can better
prevent lawful prescription use from spiraling into abuse; and
most importantly, we will discuss what more we can do to reduce
overdoses and save lives.
To the witnesses before us today--consider this another
call to action. We need your help as we pursue both our
investigative work and our legislative work. It is imperative
we confront this problem from every side. And it is crucial
that everyone remembers we are on the same team.
This crisis requires an ``all hands on deck'' effort.
We all want to end this scourge. But we must be willing to
work together. From the most basic requests for data to
crafting and implementing laws, the lines of communication need
to be open. If there are changes we need to make in the law,
tell us. We have a duty to our constituents and the American
people to combat the epidemic from all angles--everyone has a
stake in this fight.
Mr. Walden. And with that, I yield back the balance of my
time and I recognize my friend from New Jersey, the ranking
member of the committee, Mr. Pallone, for an opening statement.
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Mr. Chairman, for calling today's
hearing. It provides the opportunity to hear from several
agencies within the Department of Health and Human Services as
well as the Drug Enforcement Administration about the opioid
abuse epidemic and the status of Federal efforts to combat the
crisis, including the implementation of CARA and 21st Century
Cures.
While I am pleased to hear from the witnesses before us
today, I am disappointed that you did not invite the Centers
for Medicare and Medicaid Services or CMS. Most people access
substance abuse treatment through their health insurance
coverage and it is a fundamental link and one without the other
leaves the millions of people of all ages that struggle with
this addiction out in the cold.
Between Medicare, Medicaid, CHIP, and the ACA marketplace,
it is well over a third of the population receives health
insurance through the programs that CMS oversees. Medicaid
alone is the single largest payor for behavioral health
services in the U.S. Put simply, a full and appropriate review
of this issue requires the presence of CMS.
Unfortunately, we all are too familiar with the tragic
consequences of the opioid crisis. Ninety one Americans lose
their lives to opioid overdose every day and millions more are
battling this chronic and potentially deadly health condition.
No community is immune. I know that like me each member here
today has heard far too many tragic stories about lives cut
short, families torn apart, and people left with few places to
turn as they struggle to find treatment.
In New Jersey, more than 1,900 people died from opioids
last year. The crisis has taken such a toll in my community
that we are hearing cries for help from some unlikely places.
Earlier this year, Peter Kulbacki, the owner of the Brunswick
Memorial Funeral Home in East Brunswick, New Jersey, published
a blog on the funeral home's Web site expressing his
frustration with the monthly calls he receives telling him that
someone has passed away from an opioid overdose.
I would like to share a brief excerpt from his blog because
I think it helps capture the true toll of this epidemic on
families, and I quote, I am witness to the parents left with
inexplicable grief. I am witness to the spouses left to carry
the emotional and economic burden of raising a family alone. I
am witness to the children who are left wondering why, and
experiences like this reinforce the need for Federal action to
address this crisis.
I am happy that last year we were able to work together on
a bipartisan basis to pass CARA and 21st Century Cures. These
laws are expanding access to treatment and recovery support
services as well as advancing efforts to prevent the misuse and
abuse of opioids. For example, New Jersey is using the $13
million it received as part of the larger CURES law to expand
treatment and support services, invest in primary and secondary
prevention and training. Through CARA we also took steps to
reduce the amount of opioids in circulation by permitting for
the partial fill of controlled substance subscriptions and
supporting the expansion of drug disposal sites for unwanted
prescriptions.
These were positive steps in the right direction, but
committee Democrats have repeatedly stated that they were never
enough and, sadly, the growing epidemic proves that today.
These laws were a down payment on the types of efforts and
increased funding that Congress must support to respond and
eventually end this epidemic.
In addition to supporting positive bipartisan laws and
increase funding for substance abuse initiatives, Republicans
must end their pursuit of taking away health coverage for
millions of Americans. This is the very thing that ensures
people can actually access treatment. Republicans have spent
all year sabotaging the Affordable Care Act and attempting to
gut the Medicaid program by more than $800 billion.
This week, House Republicans including most on this
committee will support a budget that includes these cuts and
more. If successful, these actions by Republicans would have an
immediate and harsh impact on those struggling with addictions
and I will continue to fight these efforts.
Advancing efforts to respond to this crisis also means
Congress has a responsibility to figure out what went wrong,
how it went wrong, and how to make sure something like this
never happens again. That is why this committee is conducting a
bipartisan investigation into the role drug distributors may
have played in the ongoing opioid crisis and what systems
failed to protect communities.
The committee has sent a number of letters to several
distributors and DEA requesting information about drug
distribution practices including the amount of opioids shipped
into certain communities. Unfortunately, however, up to this
point we have had difficulty getting answers from DEA. In fact,
I asked a number of follow-up questions to DEA following a
committee hearing in March about opioid distribution in rural
West Virginia.
After 6 months, DEA just last night sent us the responses
to these questions. Of course there are also still many
questions in our letters to DEA that remain unanswered and DEA
has pledged its cooperation to work with the committee. So I
hope, moving forward, they can help us determine what systems
failed in West Virginia and what needs to be done to make sure
other communities are protected from such abusive practices.
So it is clear, Mr. Chairman, the Nation is in crisis and
Congress must do more to address the opioid epidemic. And I
thank you and yield back.
[The prepared statement of Mr. Pallone follows:]
Prepared statement of Hon. Frank Pallone, Jr.
Thank you, Mr. Chairman, for calling today's hearing. It
provides the opportunity to hear from several agencies within
the Department of Health and Human Services as well as the Drug
Enforcement Administration about the opioid abuse epidemic and
the status of Federal efforts to combat the crisis, including
the implementation of CARA and 21st Century Cures.
While I am pleased to hear from the witnesses before us
today, I am disappointed that you did not invite the Centers
for Medicare and Medicaid Services--CMS. Most people access
substance abuse treatment through their health insurance
coverage-it's a fundamental link and one without the other
leaves the millions of people of all ages that struggle with
this addiction out in the cold. Between Medicare, Medicaid,
CHIP and the ACA Marketplaces, well over a third of the
population receives health insurance through the programs that
CMS oversees. Medicaid alone is the single largest payer for
behavioral health services in the United States. Put simply, a
full and appropriate review of this issue requires the presence
of CMS.
Unfortunately we all are too familiar with the tragic
consequences of the opioid crisis. 91 Americans lose their
lives to opioid overdose each day and millions more are
battling this chronic and potentially deadly health condition.
No community is immune. I know that like me, each Member here
today has heard far too many tragic stories about lives cut
short, families torn apart, and people left with few places to
turn as they struggle to find treatment.
In New Jersey, more than 1,900 people died from opioids
last year. The crisis has taken such a toll in my community
that we are hearing cries for help from some unlikely places.
Earlier this year, Peter Kulbacki, the owner of Brunswick
Memorial Funeral Home in East Brunswick, New Jersey, published
a blog on the funeral home's Web site expressing his
frustration with the monthly calls he receives telling him that
someone has passed away from an opioid overdose. I would like
to share a brief excerpt from his blog because I think it helps
capture the true toll of this epidemic on families: ``I am
witness to the parents left with inexplicable grief. I am
witness to the spouses left to carry the emotional and economic
burden of raising a family alone. I am witness to the children
who are left wondering, 'why?'''
Experiences like this reinforce the need for Federal action
to address this crisis. I am happy that last year we were able
to work together on a bipartisan basis to pass CARA and 21st
Century Cures. These laws are expanding access to treatment and
recovery support services, as well as advancing efforts to
prevent the misuse and abuse of opioids. For example, New
Jersey is using the $13 million it received as part of the
larger Cures law to expand treatment and support services,
invest in primary and secondary prevention and training.
Through CARA, we also took steps to reduce the amount of
opioids in circulation by permitting for the partial fill of
controlled substance prescriptions and supporting the expansion
of drug disposal sites for unwanted prescriptions.
These were positive steps in the right direction, but
committee Democrats have repeatedly stated that they were never
enough. And sadly, the growing epidemic proves that today.
These laws were a down payment on the type of efforts and
increased funding that Congress must support to respond, and
eventually end, this epidemic.
In addition to supporting positive bipartisan laws and
increased funding for substance abuse initiatives, Republicans
must end their pursuit of taking away health coverage from
millions of Americans. This is the very thing that ensures
people can actually access treatment. Republicans have spent
all year sabotaging the Affordable Care Act and attempting to
gut the Medicaid program by more than $800 billion. This week,
House Republicans, including most on this committee, will
support a budget that includes these cuts and more. If
successful, these actions by Republicans would have an
immediate and harsh impact on those struggling with addiction.
I will continue to fight these efforts.
Advancing efforts to respond to this crisis also means
Congress has a responsibility to figure out what went wrong,
how it went wrong, and how to make sure something like this
never happens again. That is why this committee is conducting a
bipartisan investigation into the role drug distributors may
have played in the ongoing opioid crisis, and what systems
failed to protect communities.
The committee has sent a number of letters to several
distributors and DEA requesting information about drug
distribution practices, including the amount of opioids shipped
into certain communities. Unfortunately, however, up to this
point, we have had difficulty getting answers from DEA.
In fact, I asked a number of follow up questions to DEA
following a committee hearing in March about opioid
distribution in rural West Virginia. After six months, DEA just
last night sent us their responses to these questions. Of
course there are also still many questions in our letters to
DEA that remain unanswered. DEA has pledged its cooperation to
work with the committee, so I hope moving forward they can help
us determine what systems failed in West Virginia, and what
needs to be done to make sure other communities are protected
from such abusive practices.
It is clear, the Nation is in crisis and Congress must do
more to address the opioid epidemic. Thank you, I yield back.
Mr. Walden. The gentleman yields back. We now go to our
witnesses. Full committee hearing, only the chairman and the
ranking member give opening statements, just for our
committee's benefit. So now we go to our witnesses. We want to
thank you all for being here today and taking time to testify
before the committee. Each witness will have the opportunity to
give an opening statement followed by a round of questions from
members.
So today we will hear from Dr. Elinore McCance-Katz,
Assistant Secretary for Mental Health and Substance Abuse,
Substance Abuse and Mental Health Services Administration,
easily known as SAMHSA; Dr. Anne Schuchat, Principal Deputy
Director, Centers for Disease Control and Prevention at CDC;
Dr. Nora Volkow, who is the Director of National Institute on
Drug Abuse, NIDA, at National Institutes of Health, NIH; and
Dr. Scott Gottlieb, Commissioner of Food and Drug
Administration, FDA; and Mr. Neil Doherty, Deputy Assistant
Administrator, Office of Diversion Control, Drug Enforcement
Administration.
We appreciate you being here today and we look forward to
your testimony. We will start at this end of the table with the
gentleman who has been here at least one other time this week,
and maybe more.
Dr. Gottlieb, thank you for your work with our committee.
We greatly value your work there and at FDA, and we look
forward to hearing your testimony this morning on this matter,
sir.
STATEMENTS OF SCOTT GOTTLIEB, M.D., COMMISSIONER, FOOD AND DRUG
ADMINISTRATION; ELINORE MCCANCE-KATZ, M.D., ASSISTANT SECRETARY
FOR MENTAL HEALTH AND SUBSTANCE USE, SUBSTANCE ABUSE AND MENTAL
HEALTH SERVICES ADMINISTRATION; ANNE SCHUCHAT, M.D., PRINCIPAL
DEPUTY DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION;
NORA VOLKOW, M.D., DIRECTOR, NATIONAL INSTITUTE ON DRUG ABUSE,
NATIONAL INSTITUTES OF HEALTH; AND NEIL D. DOHERTY, DEPUTY
ASSISTANT ADMINISTRATOR, OFFICE OF DIVERSION CONTROL
OPERATIONS, DIVERSION CONTROL DIVISION, DRUG ENFORCEMENT
ADMINISTRATION
STATEMENT OF SCOTT GOTTLIEB
Dr. Gottlieb. Thank you, Chairman Walden, Ranking Member
Pallone. Thank you for the opportunity to testify today before
the committee. The epidemic of opioid addiction that is
devastating our Nation is the biggest crisis facing public
health officials, FDA included. As this crisis grew, many of us
didn't recognize the consequence of this threat. In the past we
missed opportunities to stem its spread, so we find ourselves
at a tragic crossroad.
We have a crisis of such massive proportion that the
actions we need to take are going to be hard. We will need to
touch clinical practice in ways that may make certain parties
uncomfortable. This may include steps such as restrictions on
prescribing or mandatory education on providers. Long ago we
ran out of straightforward options.
At FDA we are working across the full scope of our
regulatory obligations to impact this crisis. That means
updating and extending the risk management plans and
educational requirements that we impose on sponsors as a
condition of a product's approval. It means doubling our
efforts to promote the development of new, less addictive pain
remedies as well as opioids that are harder to manipulate and
abuse. It means updating our risk benefit framework to take
measure of the risks associated with misuse and abuse of
opioids and using this information to inform our decisions,
including recommending that products be withdrawn from the
market.
These steps and others are needed to prevent new addiction,
but given the scale of this epidemic with millions of Americans
already affected, prevention is not enough. We must also help
those who are suffering from addiction by expanding access to
lifesaving treatment. I would like to announce three new steps
today towards this goal.
First, FDA will issue guidance for product developers as a
way to promote the development of new addiction treatments. As
part of this guidance we will clearly lay out our interest in
the development and use of novel, nonabstinence-based endpoints
as part of product development. We also want to make it easier
to develop new products that address the full range of symptoms
of addiction such as craving.
Second, FDA will take steps to promote more widespread use
of existing, safe and effective, FDA-approved therapies to help
combat addiction. There are several FDA-approved treatments.
All of these treatments work in combination with counseling and
psychological support. Everyone who seeks treatment deserves
the opportunity to be offered all three options as a way to
allow patients and providers to select the treatment best
suited to the needs of each individual patient.
Unfortunately, far too few people who are addicted to
opioids are offered an adequate chance for treatment that uses
medications. In part, this is because insurance coverage for
treatment with medications is often inadequate. To tackle the
treatment gap, FDA plans to convene experts to discuss the
evidence of treatment benefits at the population level such as
studies that show communitywide reductions in overdose
following expansion of access to therapy.
There is a wealth of information supporting the use of
these medications. We are focusing on the data and the drug
labeling that can help drive broader appropriate prescribing,
so one concept that FDA is actively pursuing is the research
necessary to support a label indication for medication-assisted
treatment for everyone who presents with an overdose based on
data showing a reduction in death at a broader population
level. Such an effort would be a first for FDA. We believe that
granting such an indication can help promote more widespread
use of and coverage for these treatments.
A common question that arises with treatment is the proper
duration of medical therapy. Clinical evidence shows that
people may need treatment with medications for long periods of
time to achieve a sustained recovery. Some may even need a
lifetime of treatment. Recognizing this, FDA is revising the
labels of these medical products to reflect this fact.
Now I know all this may make some people uncomfortable.
That is why the third step I am announcing today is that FDA
will join efforts to break the stigma associated with
medications used for addiction treatment. This means taking a
more active role in speaking about the proper use of these
drugs. It is part of our existing public health mandate to
promote the appropriate use of medicine.
Misunderstanding around the profile of these products
enables stigma to attach to their use. This stigma serves to
keep many Americans who are seeking a life of sobriety from
reaching their goal. In this case, in the setting of a public
health crisis, we need to take a more active role in
challenging these conventions around medical therapy. This
stigma reflects a view some have that a patient is still
suffering from addiction even when they are in full recovery
just because they require medication to treat their illness.
This attitude reveals a flawed interpretation of science.
It stems from a key misunderstanding that many of us have about
the difference between a physical dependence and an addiction.
Because of the biology of the human body, everyone who uses
opioids for any length of time develops a physical dependence,
meaning there are withdrawal symptoms after the use stops. Even
a cancer patient requiring long-term treatment for the adequate
treatment of metastatic pain develops a physical dependence to
the opioid medication. That is very different than being
addicted.
Addiction requires the continued use of opioid despite the
harmful consequences. Addiction involves a psychological
craving above and beyond a physical dependence. Someone who
neglects his family, has trouble holding a job, or commits
crimes to obtain the opioids has an addiction. But someone who
is physically dependent on opioid as a result of the treatment
of pain but is not craving more or harming themselves or others
is not addicted.
The same principle applies to medications used to treat
opioid addiction. Someone who requires long-term treatment for
opioid addiction with medication including those that cause a
physical dependence is not addicted to those medications. Here
is the bottom line. We should not consider people who hold
jobs, re-engage with their families, and regain control over
their lives through treatment that uses medications to be
addicted.
Committee members, we need to embrace long-term treatment
with proven therapies to address this crisis. At FDA we will
step up our efforts to do our part to promote these goals. I
look forward to discussing these issues with the committee and
appreciate the opportunity to be hear today.
Mr. Walden. Dr. Gottlieb, thank you for your testimony and
your good work at FDA.
We will now go to Dr. Elinore McCance-Katz, assistant
secretary for Mental Health and Substance Use, Substance Abuse
and Mental Health Services Administration, SAMHSA.
Dr. McCance-Katz, thank you for being here today, please go
ahead with your opening statement.
STATEMENT OF ELINORE MCCANCE-KATZ
Dr. McCance-Katz. Thank you. Chairman Walden, Ranking
Member Pallone, and members of the House Energy and Commerce
Committee, thank you for inviting me to testify at this
important hearing. I am honored to testify today along with my
colleagues from the Department of Health and Human Services and
the Drug Enforcement Administration on Federal efforts to
combat the opioid crisis, a status update on CARA, and other
initiatives.
Over the past 15 years, communities across our Nation have
been devastated by increasing prescription and illicit opioid
abuse, addiction, and overdose. In 2016, over 11 million
Americans misused prescription opioids, nearly one million used
heroin, and 2.1 million had an opioid use disorder due to
prescription opioids or heroin. Most alarming are the continued
increases in overdose deaths, especially the rapid increase in
deaths involving illicitly made fentanyl and other highly
potent synthetic opioids since 2013.
The Trump administration is committed to bringing
everything the Federal Government has to bear on this health
crisis. HHS is implementing five specific strategies that are
guiding our response.
The comprehensive, evidence-based strategy aims to improve
access to treatment and recovery services to prevent the
health, social, and economic consequences associated with
opioid addiction and to enable individuals to achieve long-term
recovery; to target the availability and distribution of these
drugs and ensure the broad provision of overdose-reversing
drugs to save lives; to strengthen public health data reporting
and collection to improve the timeliness and specificity of
data and to inform a real-time public health response as the
epidemic evolves; to support cutting edge research that
advances our understanding of pain and addiction and leads to
the development of new treatments and identifies effective
public health interventions to reduce opioid related health
harms; and to advance the practice of pain management to enable
access to high quality, evidence-based pain care that reduces
the burden of pain for individuals, families, and society while
also reducing the inappropriate use of opioids and opioid-
related harms.
HHS appreciates Congress' dedication to this issue as
evidenced by passage of the 21st Century Cures Act and the
Comprehensive Addiction and Recovery Act. In my role as
Assistant Secretary for Mental Health and Substance Use at HHS,
I lead the Substance Abuse and Mental Health Services
Administration. I appreciate the opportunity to share with you
a portion of SAMHSA's portfolio of activities in alignment with
HHS's five strategies and how SAMHSA is implementing CARA and
the 21st Century Cures Act.
SAMHSA is administering the Opioid State Targeted Response
grants program created by the 21st Century Cures Act. By
providing $485 million to States in fiscal year 2017, this
program is increasing access to treatment, reducing unmet
treatment need, and reducing opioid overdose-related deaths
through the provision of prevention, treatment, and recovery
services. HHS is working to ensure the future funding
allocations and policies are as clinically sound and evidence-
based, effective, and efficient as they can be.
SAMHSA has several initiatives aimed at advancing the
utilization of medication-assisted treatment for opioid use
disorder. For example, in the past 4 years, more than 62,000
medical professionals have participated in online or in-person
SAMHSA-funded trainings on medication-assisted treatment for
opioid use disorders. SAMHSA regulates opioid treatment
programs and provides waivers to providers that prescribe
buprenorphine. Last year, SAMHSA published a final rule
allowing qualified physicians to obtain a waiver to treat up to
275 patients. SAMHSA has also implemented the CARA provision
that allows nurse practitioners and physician assistants to
prescribe buprenorphine.
SAMHSA has been actively implementing new initiatives to
address the opioid crisis made possible by CARA. In September,
SAMHSA awarded $4.6 million over 3 years in the Building
Communities of Recovery grant program created by CARA. Last
month, SAMHSA also awarded $9.8 million over 3 years for new
State Pilot Pregnant and Postpartum Women grants authorized by
the CARA act and $49 million over 5 years in new service grants
to help pregnant and postpartum women and their children.
SAMHSA has been a leader in efforts to reduce overdose
deaths by increasing the availability and use of naloxone to
reverse overdose. SAMHSA is currently providing grants to
prevent opioid overdose related deaths which are being used to
train first responders as well as to purchase and distribute
naloxone. In September, SAMHSA awarded additional grants
authorized by CARA including almost $46 million over 5 years to
grantees in 22 States to provide naloxone and related resources
to first responders and treatment providers. SAMHSA's National
Survey on Drug Use and Health provides key national and State-
level data and is a vital part of the surveillance effort
related to opioids.
Thank you again for the opportunity to share with you our
work to combat the opioid epidemic and I look forward to
answering any questions you may have.
Mr. Walden. Thank you very much. We appreciate your
testimony. We are going to stay on the healthcare side of this
and go to Dr. Anne Schuchat now, the principal deputy director,
Centers for Disease Control and Prevention, CDC.
Dr. Schuchat, thank you very much for being here and the
good work you do. Please go ahead with your statement. You
might pull the microphones a little closer. Thank you.
STATEMENT OF ANNE SCHUCHAT
Dr. Schuchat. Good morning, Chairman Walden, Ranking Member
Pallone, and members of the committee. CDC has vast experience
in defending Americans against epidemics and I appreciate the
opportunity to be here today to speak about the issues
surrounding the opioid crisis facing our Nation.
CDC's expertise as the Nation's public health and
prevention agency is essential in reversing the opioid overdose
epidemic. CDC is focused on preventing people from becoming
addicted in the first place. CDC has the unique role of leading
prevention by addressing opioid prescribing, tracking trends,
and driving community-based prevention activities.
America's opioid overdose epidemic affects people from
every community, and it is one of the few public health
problems that is getting worse instead of better. Drug
overdoses have dramatically increased, nearly tripling over the
last two decades. The opioid overdose crisis has led to a
number of other problems, including increases in babies born
withdrawing from narcotics and a drop in life expectancy for
the first time since the AIDS epidemic in 1993. But today's
overdose fatalities are just the tip of the iceberg.
For every one person who dies of an opioid overdose, over
60 more are already addicted to prescription opioids. Almost
400 misuse them, and nearly 3,000 have taken one. Using a
comprehensive approach as outlined in the HHS priorities, we
will work together to stop this epidemic.
CDC has been on the front lines since the beginning. Over a
decade ago, after hearing alarming news from medical examiners
about increases in overdose deaths and after an outbreak
investigation in North Carolina, CDC scientists made the
connection to prescription opioids. Today, we are working
closely with State health departments and providing guidance on
best practices so States can rapidly adapt as we learn what
works best in this evolving epidemic.
CDC now funds 45 States and Washington, DC, to advance
prevention in key areas at the community level including
improving prescription drug monitoring programs, improving
prescribing practices, and evaluating policies. In Kentucky,
prompts were added to the prescription drug monitoring program
to alert to high doses, which resulted in a 25 percent
reduction in opioid prescribing to youth. Illinois has expanded
efforts to integrate patient health information into their
prescription drug monitoring programs improving the
completeness of data available to prescribers and leading to
much greater PDMP use.
These are just a few examples of the great work being done.
These are the kind of improvements that can literally save
lives. CDC is also leading improvements to the public health
data we rely on to understand the crisis. We are now releasing
preliminary overdose death data and have improved reporting
significantly from a lag of 2 years down to a lag of 7 months.
As part of our funding to States, we are ramping up efforts
to get more reliable and timely data from emergency rooms,
medical examiners, and coroners through our enhanced
surveillance program. For the first time, we are tracking non-
fatal opioid overdoses so that we have a better understanding
of the changing epidemic so that States can respond
accordingly.
This is the value of nimble public health. States call on
CDC to provide on-the-ground assistance when they experience an
opioid-related crisis. We helped Massachusetts identify that a
surge in opioid deaths was caused by fentanyl and we assisted
Indiana to identify and contain an HIV and hepatitis C outbreak
related to injections of prescription opioids.
We truly appreciate the support we received from this
committee for our guideline for prescribing opioids for chronic
pain which we released last March 2016. Now we are focused on
making the guideline easy for clinicians to implement through
interactive trainings, mobile apps, and other ways. We are also
focusing on patients and their families. Just last month, CDC
released Rx Awareness, a communication campaign aimed to raise
awareness about the risk of prescription opioids. The campaign
features real-life stories like the one you described, accounts
of individuals living in recovery, and those who have lost
someone to an overdose.
CDC's unique approach to surveillance and prevention will
be key in reducing the opioid epidemic. We continue to be
committed to the comprehensive priorities outlined in the HHS
strategy and to saving the lives of those touched by this
epidemic. Thank you.
Mr. Walden. Thank you, Doctor. We appreciate your
testimony. Now we go to Dr. Nora Volkow, director, National
Institutes on Drug Abuse in the National Institutes of Health.
Doctor, thank you for being with us as well, please go
ahead with your opening statement.
STATEMENT OF NORA VOLKOW
Dr. Volkow. So good morning, everybody. Chairman Walden,
Ranking Member Pallone, and distinguished members of the
committee, I am extremely grateful for your support and
commitment to addressing the opioid crisis and for having me
here along with my colleagues to actually try to integrate our
efforts. You have already heard about the devastating scope of
the opioid epidemic. Today, I would like to discuss how science
is helping us address this crisis.
The story of a patient named Jeff illustrates the impact
research can make in the lives of those suffering from
addiction. Jeff developed a heroin use disorder after returning
from serving in the war in Afghanistan. He ended up homeless in
the streets of Seattle and eventually sought treatment. NIDA-
funded researchers at the VA in Seattle enrolled him a pilot
buprenorphine treatment program. Unlike traditional treatment
programs with long waiting lists, Jeff was started right away
on oral buprenorphine which immediately helped him stop using
heroin. The treatment helped Jeff recover. He has not used
heroin since for several months, he is no longer homeless, and
now has a regular job.
Unfortunately, Jeff's story is not typical. Most people who
suffer from an opioid addiction do not receive treatment and
when they do it is frequently not evidence-based. Jeff's story
illustrates how implementing research findings can
significantly improve treatment outcomes.
Addiction is a brain disease that is associated with
disruption of brain sequence that make it progressively more
difficult to stop using drugs even at the risk of losing one's
own life. When people suffering from addictions seek help, we
owe it to them and their families to provide the treatments
that research has proven most effective.
Thanks in part to NIDA support there are now three FDA-
approved medications for opioid use disorders: buprenorphine,
methadone, naltrexone. While significantly improving outcomes,
these medications are vastly underutilized and relapse rates
are still too high. Thus, more research is needed to develop
new treatments so we can reduce relapse rates in all patients.
NIDA has a successful record of partnering with industry to
develop new treatments. For example, NIDA and the FDA partner
with Lightlake and other pharma to develop a user-friendly
naloxone. Anyone can use this and it will deliver very rapidly,
very high concentrations of naloxone into the bloodstream which
is what you need in order to reverse an overdose. This product
which was done in partnership with pharmaceutical, as I
mentioned, was taken from concept into a product in basically 3
years. So we can do it.
In the face of this opioid crisis, NIH wants to expand on
these alliances and is working on establishing a public-private
partnership in collaboration with the FDA, academic research
centers, and the pharmaceutical industry that will focus on two
major goals: Goal number one, to develop effective non-
addictive pain medications to prevent Americans from developing
opioid use disorders while providing them relief from the pain
condition that they suffer.
The second goal is to expand medication options to treat
opioid addictions and to prevent and reverse overdoses. A
short-term focus will be the development of new formulations of
existing medications to facilitate compliance and the treatment
of hard-to-reach populations. Weekly and monthly depot
formulations of buprenorphine have already been submitted to
FDA approval. It would be a real gamechanger especially for
people who live in rural communities and face significant
logistical challenges accessing treatment. Other research is
building on our growing understanding of the neurobiology of
addiction to identify potential targets for treating it. This
includes not only medications, but also known pharmacological
therapies including vaccines.
In parallel and in collaboration with SAMHSA, we are
expanding services and implementation research to develop new
strategies for delivery of addiction treatment across
healthcare and criminal justice settings. An example is a story
that recently showed that initiating buprenorphine in the
emergency room to help ensure people will prevent them from
overdoses and effectively engage them in ongoing treatment.
We have an urgent crisis and as stated by the chairman, an
all-hands-on-deck approach is needed to solve it. NIH and NIDA
are fully committed to integrate our efforts with those from
other Federal agencies, industry, community organizations,
patients and their families, and Congress to solve it. Thanks
very much.
[The joint prepared statement of Dr. Gottlieb, Dr. McCance-
Katz, Dr. Schuchat, and Dr. Volkow follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Walden. Thank you, Doctor.
And now our final witness, Mr. Neil Doherty, deputy
assistant administrator, Office of Diversion Control, Drug
Enforcement Administration. We appreciate your being here as
well.
Mr. Doherty, please go ahead with your opening statement.
STATEMENT OF NEIL D. DOHERTY
Mr. Doherty. Chairman Walden, Ranking Member Pallone, and
distinguished members of the committee, thank you for holding
this hearing today to discuss the opioid epidemic and DEA's
response to this ongoing threat. For DEA, the opioid is the top
drug threat facing our Nation. This unprecedented epidemic
includes not only prescription opioids otherwise known as
controlled prescription drugs, or CPDs, but also the
proliferation of heroin and fentanyl trafficking, ultimately
leading to record levels of overdose deaths.
I believe that all of us at this table are collectively
making progress on CPDs, but I fear we are witnessing a
fundamental shift towards cheaper, easier to obtain heroin and
fentanyl. With illicitly produced fentanyl you have substances
up to 50 times more potent than heroin, sold as heroin, mixed
with heroin, and increasingly and often with a fatal result,
pressed into pill form by criminal networks as counterfeit
prescription painkillers. Of the estimated 64,000 Americans who
overdosed in 2016, 54 percent died of an opioid overdose. That
is one life taken every 15 minutes.
Mexican cartels are continuing to exploit the opioid use
epidemic and are continuing to produce and transport heroin
across the Southwest border. These cartels are aggressively
purchasing illicitly produced fentanyl from China, shipping it
into Mexico, mixing it with heroin and other substances,
pressing it into pill form, and shipping it into the U.S.
through established distribution networks.
What is the motivation behind the often deadly tactics
employed by the cartels regarding fentanyl? In a word, profit.
Fentanyl and associated analogues provide criminal
organizations with highly elevated margins for illicit revenue.
For example, one kilogram of fentanyl in China costs between 3
and $5,000, yet yields approximately 1.5 million on the streets
of the United States.
DEA stands with our interagency partners including those
represented here today to combat this epidemic across all
fronts. For DEA and our Federal, State, and local partners to
be successful in dealing with this threat we need a balanced,
whole-of-Government approach, one that attacks supply and also
works to reduce demand. We need to continue to lean forward and
use all available tools to identify, infiltrate, indict,
capture, and convict all members of these organizations,
foreign and domestic. With 221 domestic offices, 21 field
divisions, and 92 foreign offices in 70 countries, DEA is well
positioned to engage in this fight.
Foreign-based fentanyl manufacturers and domestic
distributors often operate with impunity as they exploit
loopholes in the analogue provisions of the Controlled
Substance Act and capitalize on the lengthy, resource-intensive
process to temporarily or permanently control these dangerous
substances. Every day, criminal chemists in foreign countries
are altering the molecular structure of different fentanyl
analogues keeping the same dangerous pharmacological properties
as the substances that are already controlled.
Despite these challenges there is good news. Our
partnership with our counterparts in China has resulted in the
scheduling of 128 new pyschoactive substances since October
2015 including numerous fentanyl and fentanyl analogues. In
addition, you probably heard last week that two Chinese
nationals were indicted as part of an investigation conducted
by DEA and other agencies and these individuals were designated
as CPOTs, Consolidated Priority Organization Targets, the
designation reserved for the most prolific drug traffickers in
the world.
Our investigators remain relentless in their pursuit to
dismantle these organizations and bring those responsible to
justice. DEA along with our global network of enforcement
partners will go after these types of criminals wherever they
operate. The DEA will continue to address these threats by
investigating and bringing to justice not those suffering from
opioid use disorders, but those who are exploiting human
frailty for profit.
DEA will use all criminal and regulatory tools available to
identify, target, disrupt, and dismantle organizations and
individuals responsible for the diversion and illicit
distribution of pharmaceutical controlled substances in
violation of the CSA. We will also work to reduce demand with
our community outreach and prevention efforts throughout the
country.
One example of such efforts is the DEA 360 Strategy which
brings together three distinct pillars of law enforcement aimed
at addressing the opioid, heroin, and violent crime crisis:
traditional enforcement, diversion control, and community
outreach. Now in its second year, this strategy has been
deployed to some of the hardest hit communities in the Nation.
The brave men and women of the DEA remain committed to
doing everything they can to address this threat. One pill is
enough; one life is worth it. Every pill that we stop from
hitting the street through diversion or counterfeiting
potentially stops it from getting into the hands of a young
American and saves them from opioid dependency, heroin use, and
possibly a fatal overdose.
Thank you for the opportunity to appear before you today
and I look forward to answering any questions you may have.
[The prepared statement of Mr. Doherty follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Walden. Mr. Doherty, thank you. We certainly appreciate
the work that your agents and you all do in this cause and they
have dangerous work and it is important work and we do
appreciate what they do.
I do want to start with you, however, with a simple
question that this committee has been asking the DEA for
months. Which companies supplied the pharmacy in Kermit, West
Virginia that received nine million opioid pills in 2 years,
and the pharmacy in Oceana, West Virginia that received 600
times as many oxycodone pills as another pharmacy just eight
blocks away between 2005 and 2016? Can you give us the names of
those companies?
Mr. Doherty. Thank you for that question, Chairman.
Currently, we are reviewing the request from the committee and
I do not have that data with me today. I apologize.
Mr. Walden. So we have asked for this information in a
meeting. We have asked for this information in an email. We
have asked this information in a letter and we have asked this
information now in a hearing. If you needed to get this
information for enforcement action, I suspect and hope you
would get it very quickly, right, within hours or days?
The bipartisan letter this committee sent to your agency
earlier this month asked the DEA to produce data and documents
answering this question and others that we asked by this
Friday. Is the DEA going to give us this information and
documents that we have requested by Friday?
Mr. Doherty. Sir, thank you for the follow-up. To your
point, sir, the DEA, we realize the importance of all the
requests from the committee and we treat them as such in light
of the opioid epidemic. With respect to the questions, for the
record, we did turn those over last night, sir.
Mr. Walden. Questions from April, I think, right?
Mr. Doherty. Yes, sir. And in terms of a May 8th letter, we
have been providing the answers on a rolling basis as to not
delay an overall lengthy response. Those have been provided to
the committee on a rolling basis and we continue to work on the
few outstanding questions. And to your point, sir, the most
recent letter, we are in receipt of that and we are preparing a
response.
Mr. Walden. So I hope you can appreciate our frustration on
this side. We have been trying to get to the bottom of this
pill dumping issue.
Can we please silence our phones?
We have been trying to get to the pill dumping issue in
West Virginia for a very long time. To me, this is a pretty
basic question, who are the suppliers? Just yesterday, we
finally received answers to the questions as you mentioned that
we asked for back in April. We still don't have all the answers
to the bipartisan letter we sent in May.
Some of the responses the DEA provided, frankly, are not
adequate. For example, in the May letter we asked the DEA to
produce documents about delayed or blocked enforcement actions.
Do you know how many documents your agency has produced? The
answer is zero. The agency responded and this is a direct
quote, DEA is unaware of documents related to the delayed or
blocked enforcement actions and suspension orders, close quote.
We obtained from another source a whole bunch of documents
that look pretty responsive to our request, and yet from the
agency we are told you are unaware of documents related to
delayed or blocked enforcement actions and suspension orders.
This is a problem. Enough is enough. Will you on behalf of the
DEA commit today to producing the documents and information we
have requested and soon, or do I simply need to issue a
subpoena because we are done waiting?
Mr. Doherty. Sir, we appreciate your concern and absolutely
we are treating it with the utmost importance as it should be
treated. There is no reason for the extended delay of the
questions for the record which is now in the possession of the
committee. We will make every effort to expedite every request
that is outstanding to the committee.
Mr. Walden. I mean just for members' awareness on both
sides of the aisle, the committee received yesterday a set of
documents from an anonymous source. Bipartisan committee staff
are now reviewing these documents.
Mr. Doherty, I have one more question before I move on.
Have you or anyone at the DEA that you are aware of received
any instructions or directives to erase emails or otherwise
destroy documents on this matter or any others?
Mr. Doherty. No, sir. I am not aware of that nor have I
been involved in any conversation relative to that matter.
Mr. Walden. Dr. McCance-Katz, let me move to you. Given
SAMHSA's central role in much of the Federal Government's
efforts to combat the opioid epidemic, it is imperative that
you and your staff have all of the tools necessary to perform
these duties. Are there currently any obstacles or barriers
hindering you and your staff's ability to respond effectively
to this crisis and, if so, what can Congress do to help?
Dr. McCance-Katz. Thank you, Chairman Walden. We have--we
are very grateful, actually, for the legislation that has
recently been passed by Congress in the 21st Century Cures Act
and in CARA that adds to the armamentarium that SAMHSA had
available to it to work with States and communities on issues
related to mental disorders and substance use disorders, and so
at this point we are in the process of implementing the laws
and are looking to have feedback to then determine whether we
need more than what we have.
We have, as you know, through the Cures Act made $500
million, each of 2 years, available to the States. We are
working with the States to develop their plans for evidence-
based interventions and treatments in their communities and we
are following up with them to determine outcomes. We collect
data as required by law and as we get that data we will be
looking at it to determine if more is needed.
Mr. Walden. Thank you very much.
Ms. DeGette. Mr. Chairman?
Mr. Walden. For what purpose does the gentlelady from
Colorado----
Ms. DeGette. I have a unanimous consent request.
Mr. Walden [continuing]. Seek recognition? Proceed with
your request.
Ms. DeGette. Mr. Chairman, I would ask unanimous consent to
place two letters into the record. One is the May 8th, 2017,
letter that you referred to, which the DEA gave incomplete
responses in particular documents to that was signed by you,
Mr. Pallone, Mr. Murphy, me, and Mr. McKinley. And then I would
also ask unanimous consent to put the October 13, 2017, letter
in the record. That is the one that was signed by you and Mr.
Pallone and Mr. McKinley and me, which you referred to, under
which we have received none of the documents that are
referenced in that letter.
And I just think it would be really useful to this hearing
if the witnesses and the public would know that we have been
trying to get these documents out of the DEA for quite some
number of months now.
Mr. Walden. Without objection, those letters will be
entered into the record.
And I would encourage our colleagues and others to avail
themselves of those letters. I think they ask pretty specific
questions that shouldn't be this difficult to get answers to.
Now I would turn to Mr. Pallone from New Jersey for 5
minutes for questions.
Mr. Pallone. Thank you, Mr. Chairman. And let me just
reiterate again representing the Democrats in support of what
Chairman Walden has been saying that we have sent these
bipartisan letters to DEA requesting specific information, but
we have had a very difficult problem in getting any answers. So
I guess I just wanted to start out, Mr. Doherty, by getting a
commitment that you will provide the committee with timely
information and answers to our questions as we move forward
because I totally agree with everything that the chairman has
said. I just--yes or no, please.
Mr. Doherty. Ranking Member Pallone, you have our
commitment that we will take every request from this committee
seriously. We will review it carefully and we will try to make
every effort whatsoever to respond in a timely, timely fashion.
Yes, sir.
Mr. Pallone. Thank you. Now I wanted to move to another
issue here. Coverage of the response to the epidemic often
focuses on expanding access to treatment and increasing the
availability of naloxone and, however, there are two elements
that must fit into a larger more comprehensive response.
Let me go to Dr. McCance-Katz. Could you briefly discuss
the importance of deploying a comprehensive response to this
epidemic spanning the entire spectrum from prevention to
recovery?
Dr. McCance-Katz. Yes, Ranking Member Pallone. What I can
say is that there are issues that we need to address in terms
of prevention, prevention in terms of working with children and
families around education, prevention that is targeted to
individuals at risk for opioid overdose that includes making
available the antidote naloxone widely available. It also
includes providing training to first responders and to family
members and to getting to physicians and other prescribers to
help them understand who is at risk given medications they may
be receiving in the course of treatment, and co-prescribing
naloxone when needed.
In addition, when people develop opioid use disorders they
also may be at high risk for overdose. They are at risk for
overdose death and they also need access to the naloxone
antidote. We address this in a number of ways. We do that
through our treatment programs that provide medication-assisted
treatment for opioid use disorder. And by the way that is a
great way for demand reduction. We need to increase access to
treatment so that people have less demand for illicit opioid
use.
Mr. Pallone. Let me just--I am just running out of time.
Dr. McCance-Katz. Oh, sorry.
Mr. Pallone. Look, let me just say this. I know you
mentioned CARA, you mentioned the grants that had been
available with the 21st Century Cures bill, and obviously as I
have said, you know, I consider these down payments. I still
think we need a lot more funding for some of these things that
you are mentioning and that you know, we shouldn't just see
those as down payments.
I know, tomorrow, the President is having an event at the
White House and he is going to talk about establishing a
national emergency, but I really think that we have to talk
about more funding for some of these things. Not just the
grants that are already out there, which are great, don't get
me wrong, but there just needs to be a lot more.
Let me just get to the second question, and this is my only
other question but I will ask it to you as well as to Dr.
Volkow. As previously mentioned, treatment must be part of our
comprehensive respond efforts. Could you discuss how limiting
access or creating barriers to treatment could hinder our
ability to respond to the crisis? I will ask you and then I
will ask Dr. Volkow the same question.
Dr. McCance-Katz. Individuals who have opiate addiction,
which means they are physically dependent on opioid as well as
have the behavioral dysfunction associated with addiction, are
at risk for overdose and death and cannot live productive
lives. If they cannot get access to evidence-based treatment,
which includes medication-assisted treatment and psychosocial
interventions, then that places them at greater risk and it is,
I will just say it is very near impossible to recover without
getting assistance in the form of these evidence-based
interventions.
And by evidence-based interventions I do mean medication
and psychosocial services and one of the problems that we see
is that too often people do not get all of the components of
treatment that they need to recover.
Mr. Pallone. Dr. Volkow, did you want to add to that?
Dr. Volkow. Yes. No, I agree with Dr. McCance. And there
are three, I would add three things. One of them has to do with
the notion of how do you get access to medication-assisted
treatment? One of them is stigma, the other one is lack of
sufficient treatment programs to be able to deliver it, and the
third one is actually the lack of reimbursement for these
treatments.
And I think that there are unique opportunities to change
these and in particular, for example, one of the aspects that
we are very much invested in partnership with SAMHSA is
engaging the healthcare system in the expansion of the
treatment of individuals with substance use disorders. And also
I think an opportunity is to actually create policy to ensure
that individuals are offered, as was mentioned earlier by Dr.
Gottlieb, the opportunity of having access of to any one of the
three medications and that they will be reimbursed for them and
there will be no place of limitations on that time that these
medications are actually prescribed.
Mr. Pallone. I thank you.
And Mr. Chairman, just let me say again that my concern
continues to be that if the effort continues on the Republican
side to repeal or sabotage the ACA or cut back on Medicaid,
that this type of treatment will be even more difficult for
people to access. But thank you, Mr. Chairman.
Mr. Walden. The Chair now recognizes the vice chair of the
full committee, Mr. Barton, for 5 minutes.
Mr. Barton. Thank you, Mr. Chairman.
I wasn't aware until I listened to your questions the
difficulty the committee has had in receiving answers to
questions on a bipartisan basis, so I am going to direct what
would normally be my question period and opening statement to
Mr. Doherty.
We represent the people of the United States. When you get
a letter or your agency gets a letter from this committee that
is signed by the chairman and the ranking member and maybe the
subcommittee chairman, you are supposed to answer it. You are
not supposed to dodge it. Now, I am a former subcommittee
chairman of this committee and I am a former full committee
chairman of this committee. I have issued subpoenas with the
support of the minority to members of an administration of my
own political party. I have had confrontations with cabinet
secretaries, with directors of agencies that were appointed by
Presidents of my own political party.
It is absolutely unacceptable to listen with a straight
face to your answers to our chairman. Now if I were you I would
go back, get the answers in plain English as quickly as
possible. If you don't--and I know you are just the spear
carrier, you are not the decision maker; it is your agency--I
am going to recommend to the chairman that we bring the wrath
of this committee down on DEA. It is inexcusable when people
are dying every day from opioid overdoses that we have got
apparently a 3-month, 4-month running dodge from the Trump
administration.
Now our chairman is much more polite than I am, you know,
but you look up the definition of subpoena, the Constitution of
the United States and the American people, and get the answers.
Can you say yes sir to that? I don't want a dodge answer, I
want a yes or no answer. Are you going to go back and tell
whoever is running the show to get the answers our committee
chairman on a bipartisan basis wants, yes or no?
Mr. Doherty. Yes, sir.
Mr. Barton. Thank you. We will follow up on that.
Now I want to go to Dr. Gottlieb. What percentage of the
opioid crisis is prescription drugs versus illegal drugs?
Which----
Dr. Gottlieb. I will defer to my colleague from SAMHSA for
the current data. It has shifted a lot.
Dr. McCance-Katz. So if we look at the most recent NSDUH
data from 2016 there are about 11.5 million opioid misusers in
the country, about 948,000 are heroin users. So that----
Mr. Barton. So it is kind of 10 to 1?
Dr. McCance-Katz. Yes, sir.
Mr. Barton. OK. On the legal prescriptions should we on
this committee consider criminalizing the prescription, the
prescribing of legal opioid prescriptions if it is considered
excessive? Should that become a Federal criminal act?
Dr. Gottlieb. I don't know who the question is directed, I
mean that would fall within the context of the Controlled
Substances Act. We don't have jurisdiction over the
criminalization of prescribing in that context.
Mr. Barton. Well, we know we have a problem on the illegal
side and we have been dealing or not dealing with it
successfully for a number of years. But this excessive use of
legal prescription drugs, at some point in time the finger
points to the doctor that is prescribing the drug and that is
currently not an illegal act. Should we make that an illegal
act? When Chairman Walden says some pharmacy in West Virginia
gets 11 million pills or 9 million pills, somebody is
prescribing those excessively. Should that be a criminal act,
Federal criminal act?
Dr. McCance-Katz. So if I could, if there is excessive
prescribing and there is harm to a patient or death of a
patient that does become a criminal act. If it is found to be
excessive and negligent it can be charged as a criminal act.
There have been many prescribers who have been prosecuted under
current law. The difficulty becomes people who are not dying or
having those kinds of adverse events that really get to public
attention and so that excessive prescribing that puts you at
risk for addiction.
Mr. Barton. My time is expired. I know on an individual
basis it is difficult to determine what is excessive
prescription----
Dr. McCance-Katz. Yes.
Mr. Barton [continuing]. You know, in terms of the patient.
But the prescriber, if you have a prescriber who is routinely
prescribing a hundred times opioid prescriptions to the average
doctor in the area that is somebody I believe we ought to look
at. With that, Mr. Chairman, I yield back.
Mr. Walden. I think Dr. Schuchat wanted to----
Dr. Schuchat. I just wanted to say that quite a lot of the
overprescribing is not at that very extreme level, but we are
really just at the beginning of getting clinicians to do better
prescribing. It is only a year and a half since the CDC
guidelines on prescribing for chronic pain and in places that
are implementing them we are seeing pretty rapid changes in
prescribing. So I think we need to do a lot with prescribing
that was sort of within the range of practice.
Mr. Walden. All right, thank you. We will now go to my
friend from California, the gentlelady Ms. Eshoo, for 5 minutes
for questions.
Ms. Eshoo. Thank you, Mr. Chairman. Thank you to all of the
witnesses. I read your testimony very carefully last night and
I am left with the following observations. We have passed laws
to address the opioid crisis in our country and those two laws
have been mentioned. We have all of the respective agencies
before us working on it. We have a raft of statistics that are
the horrible of horribles in terms of what this is doing to the
country, how many people are addicted, how it is ravaging
families, communities, et cetera, et cetera.
How much of the crisis is due to opioids being prescribed
legally? I know that CDC handed this out and I think it tells
part of the story. For every one prescription or illicit opioid
overdose death in 2015, there were--and then it goes through
all of these numbers. But what I am trying to figure out is,
are we a nation that is just almost hopelessly addicted to
heroin--and just say that out loud. How much is due what is
legally prescribed for pain management, whatever, and versus
how much is due to illegal use?
And I ask that question because I think we need to direct
what we are doing. If we are going to put in place new laws or
see how the laws are already working we need to know this. So
who can answer that question just very briefly?
Dr. Schuchat. Yes. This is not an either/or situation.
Ms. Eshoo. I am not presenting it that way.
Dr. Schuchat. But to say that----
Ms. Eshoo. But I want to understand it better.
Dr. Schuchat. Sure.
Ms. Eshoo. I mean is it tilted towards just prescriptions
that are written?
Dr. Schuchat. We got into this issue with the prescribing.
Ms. Eshoo. Pardon me?
Dr. Schuchat. We got into this issue with prescribing of
opiates. We prescribe three times higher levels.
Ms. Eshoo. No, I understand that. I want to know what the--
--
Dr. Schuchat. And most people----
Ms. Eshoo [continuing]. Where the dividing line is. Is it
10 percent prescription drugs and 90 percent people that love
heroin?
Dr. Schuchat. Over the last 2 years we had a spike in
illicit drug-related overdose deaths.
Ms. Eshoo. But can you tell me what the numbers are?
Dr. Schuchat. And that was----
Ms. Eshoo. Does anyone know?
Dr. Schuchat. Yes. Well, we had 65,000 deaths in 2016.
Ms. Eshoo. I know about the deaths.
Dr. Schuchat. About 49,000 of them were----
Ms. Eshoo. I want to know what is bringing it about,
though----
Dr. Schuchat [continuing]. Related to----
Ms. Eshoo [continuing]. In terms of usage.
Dr. Schuchat. Yes. The increase in 2016 was fentanyl
illicit laced with heroin. So the increase is the illicit
drugs, but most of the people who are using illicit drugs
became addicted through prescribing, through prescription
opioids. That was their initial addictive product.
Ms. Eshoo. Have the agencies come together to examine, set
down the, you know, CARA and the 21st Century Act and what was
contained in them kind of as an overlay on this whole issue on
opioids and made any kind of determination as to the early
effectiveness of these laws; do we know? We don't know.
Dr. Volkow. No. We don't know, but we know that----
Ms. Eshoo. We don't know because it is too early?
Dr. Volkow. It is too early.
Ms. Eshoo. It is too early to know. In the area of
treatment how much in terms of Federal health insurance
programs contain the money for this for treatment overall, does
anyone know? Well, maybe someone can respond later in writing.
It would be good to know, because if we are busy cutting and
undermining that then it upends the underlying purpose of this
hearing. I mean we can talk and talk and talk. We know we have
a tremendous problem. People are dying daily. But if we are
undermining the treatment at the same time, I think we need to
have that documented.
Mr. Doherty, how many--you testified that your agency is
doing everything you can possibly do, overwhelming commitment,
et cetera, et cetera. I believe you or I would like to believe
you. How many opioid-related cases have actually been
successfully adjudicated and how many open, active cases are
there coming out of your agency and its work doubling down on
the opioid crisis in our country?
Mr. Doherty. Ma'am, historically, in the----
Ms. Eshoo. No, I don't want to know historically. I want to
know up to date.
Mr. Doherty. Well, ma'am, during the last year there have
been approximately 2,000 arrests made with respect to diversion
control cases and that would represent approximately 1,600
cases that were initiated. Those represent sweeping enforcement
actions such as a weeklong action that took place this past
July in partnerships with HHS and the FBI, the National Health
Care Fraud Takedown initiative.
This was the first year the DEA was a full partner, 120 of
the 412----
Ms. Eshoo. Does it include the companies that you haven't
identified yet?
Mr. Doherty. I am sorry, ma'am?
Ms. Eshoo. Does it include the companies that you have not
identified yet?
Mr. Doherty. That did not include companies. These were 120
individuals prescribing opioids of which 115 of the 412 were
medical professionals.
Ms. Eshoo. I am way over my time. Thank you, Mr. Chairman.
Mr. Walden. Thank you. We now go to the gentleman from
Illinois, Mr. Shimkus, for 5 minutes on questions.
Mr. Shimkus. Thank you, Mr. Chairman. Thanks for the
hearing. Thank you all for being here.
I am going to shift some of the tone. Just a couple days
ago I tweaked my back. I was in pain. When we went through this
process last Congress, I was visited by a lot of patient groups
who were just concerned that the pendulum would shift. And we
use the term ``chronic pain,'' you know, people who have it
forever, and I want to make sure that we don't lose them in
this debate, people who wouldn't be able to get out of bed
without some assistance.
So I do have a statement for the record, Mr. Chairman, I
would ask unanimous consent, from the American Physical Therapy
Association addressing this.
Mr. Walden. Without objection.
[The information appears at the conclusion of the hearing.]
Mr. Shimkus. Because then it goes into my first question
for Dr. McCance-Katz. In your question-and-answer and some of
your comments, you talked about all of the components of
treatment, which as I am getting more educated in this process
it seems to me that we are not always considering all of the
components, or maybe physicians, they may get stovepiped into
one delivery system. And every patient is different, every pain
issue, and that is kind of where the physical therapists are
saying, hey, this should be part of some treatment.
So can you for the sake of all of us kind of talk about the
difference between naltrexone, Suboxone, and methadone, just
briefly?
Dr. McCance-Katz. I will try. Yes, so naltrexone is an
opioid antagonist. What that means is that it will block the
effects of an opiate. So if somebody is opiate-addicted and
they are withdrawn from those opioids and then started on
naltrexone and then they use an opioid again they will not get
the effect that they were expecting, so it will block them from
getting high. So that is the value of naltrexone.
It is often seen as a medication that gives a person a
chance to get back to counseling because they may relapse while
they are in their regular using environments----
Mr. Shimkus. OK, just pushing you--Suboxone.
Dr. McCance-Katz. I am sorry? Oh, you want me to go on.
Mr. Shimkus. Just pushing you.
Dr. McCance-Katz. OK, here you go. Suboxone is what we call
an opioid partial agonist, and what that means is that it has
lower abuse liability and has less potency in terms of euphoric
effects----
Mr. Shimkus. OK, methadone.
Dr. McCance-Katz [continuing]. Than does methadone which is
what we call a full agonist and it is a medication that is only
available for the treatment of opioid use disorder through
federally regulated opioid treatment programs which my agency
regulates.
Mr. Shimkus. OK, let me go to Dr. Schuchat. How does CDC
inform evidence-based best practices? So if you are using these
three different things how do you collect that data?
Dr. Schuchat. CDC is working to evaluate the medication-
assisted treatment and counseling efforts that SAMHSA has right
now, so we actually have a study in the field with these
different modalities, look at outcomes----
Mr. Shimkus. So then the information can get out and
people----
Dr. Schuchat. Right, so that we can share----
Mr. Shimkus [continuing]. Can make better determinations.
OK, let me go to Mr. Doherty. This will be a friendly
question. Category II or III what is the difference?
Mr. Doherty. Schedule?
Mr. Shimkus. Schedule, yes, Schedule II or III on the drug
listing.
Mr. Doherty. Yes, sir. So with respect to Schedule II, for
instance, those are controlled prescription pain medications in
the oxycodone, hydrocodone family and we certainly, they go in
a range from III, IV, and so on.
Mr. Shimkus. So what is the difference between a II and a
III?
Mr. Doherty. The difference is, sir, is that it is more
strictly controlled within DEA on the schedule.
Mr. Shimkus. Why?
Mr. Doherty. Based on the scientific dependency of it too.
Mr. Shimkus. OK, dependency, what else?
Mr. Doherty. Danger for abuse.
Mr. Shimkus. Danger for abuse.
OK, let me go to Dr. Gottlieb, FDA black box labeling. It
is my understanding there is no communication based upon
Schedule and what might be labeled. Now you see where my whole
thrust of these questions is more information, more different
practices, and then that would also go to labeling. If DEA says
Schedule III is less addictive, shouldn't that maybe be listed
on the label?
Dr. Gottlieb. I could certainly take it back to the agency.
There is labeling language that reflects some of the qualities
of the drugs that relate to their abuse potential currently.
Mr. Shimkus. Do you agree that there may or, I mean I would
hope that we would talk together and that our agencies would
communicate that. That might give the practitioners a little
more information.
Mr. Chairman, my time is expired. I yield back.
Mr. Walden. I thank the gentleman's comments. It is
interesting in Oregon, I think through the Oregon Health Plan,
they actually often give the antidote naloxone with the
prescription for opioids, which the people in the roundtables I
have been in sends a real signal of seriousness about what
people are being given to take, the opiates, because here is
the antidote because it may kill you. And they tell me that
gets the attention of those receiving the prescription.
With that we will turn to the gentleman from New York, Mr.
Engel, for 5 minutes for questions.
Mr. Engel. Thank you, Mr. Chairman and Mr. Pallone, for
convening today's hearing.
This epidemic has touched so many people in each of our
districts in so many ways, so I would like to talk about the
specific challenges in my district facing Westchester County in
New York and the Bronx in New York City. I represent a large
portion of Westchester where opioid-related deaths shot up more
than 200 percent between 2010 and 2015, but that changed in
2016 when the rate of opioid-related deaths in Westchester fell
nearly 30 percent and evidence suggests this was thanks to the
overdose reversal drug naloxone. Naloxone. That is why I didn't
go to medical school, law school was easier.
Between 2015 and 2016, Westchester EMS workers and law
enforcement began using this medication much more frequently
following State and local efforts to make it more accessible
and ensure first responders know how to use it, so I believe
this shows what is possible when we afford communities the
resources they need. So Congress must continue to invest the
necessary funds to respond to the opioid epidemic and support
proven public health approaches spanning the entire spectrum
from prevention all the way to recovery.
I am so encouraged to see a devastating trend reversed in
Westchester, but this battle obviously is far from over.
Naloxone is certainly a lifesaver but it could also be a
gamechanger, and if we can connect people with treatment after
they have overdosed we might even save more lives.
So Dr. McCance-Katz, how are we doing as a country with
respect to connecting Americans with treatment after they have
overdosed and how can Congress help us do even better?
Dr. McCance-Katz. Yes. Thank you for that question.
And so we have, SAMHSA has a number of programs that are
demonstration programs across the country that address issues
around the need for naloxone as an antidote. Treatment in EDs
and what we are doing in the models that we are working with
include bringing peers, people with lived experience of opiate
addiction into the emergency departments so that they can talk
with people who have experienced an overdose and provide them
some guidance and help and support to get them to treatment.
And we are in the process of having these programs under--they
are ongoing right now and we will be evaluating those programs.
I will tell you though I am from Rhode Island. I come to
Federal service having been a practicing physician, a
psychiatrist in Rhode Island, and was involved with the opioid
epidemic in Rhode Island. And one of the things that we
observed in Rhode Island was that a lot of times when people
are reversed they are not comfortable, that sometimes they will
experience opiate withdrawal when they are given naloxone and
they are not ready. They are not ready to commit to treatment
at that time.
And so what we started doing was getting consent from
people so that our peers could follow up with them in
communities. And we think this is going to be a key piece of
connecting people to treatment and we will be expanding those
kinds of models at SAMHSA.
Mr. Engel. Well, thank you. And let me say the other part
of my district is the Bronx. We are not seeing, unfortunately,
the same signs of hope there. More New Yorkers die of overdoses
in the Bronx than in any other city borough last year. Eighty-
five percent of those deaths involved opioids.
And despite the proximity and attached to each other,
Westchester and the Bronx have many differences. On average,
communities in the Bronx have fewer resources, the uninsured
rate is higher, and communities are more diverse. So the
disparity that we are seeing and the trajectory of these
counties' opioid epidemics is also an economic disparity and a
racial disparity. So the consequences of this disparity are
really heartbreaking. Your ZIP Code should not determine your
health or what you get to make you better. We need to do
better.
So on the basis of that statement, let me ask Dr. Schuchat
and Dr. McCance-Katz again, how can Congress address these
disparities and ensure that every person regardless of sex,
race, location, or income has the same ability to get
treatment?
Dr. McCance-Katz. I will just say SAMHSA has an Office for
Behavioral Health Equity. We are very involved in monitoring
those kinds of issues and we work very hard to provide guidance
to States and communities on culturally appropriate, culturally
sensitive interventions, and we will be continuing that work.
Mr. Engel. Dr. Schuchat?
Dr. Schuchat. Yes. And one of the things CDC was able to do
with the increased funding this past year was strengthen the
syndromic surveillance goal from 12 States to 32. And what that
has allowed is better data on where the problems are, hotspots
or inequities can be followed up and so you can get more
resources. Even the naloxone distribution can be targeted to
where the overdoses are highest and expanding services into
those areas.
I know in the New York area, in New York City area that has
been done, trying to figure out where the need is and get the
clinical services closer to those hotspots.
Mr. Engel. Thank you both. Thank you, Mr. Chairman.
Mr. Walden. Thank you, Mr. Engel. We will now go to the
chairman of the Subcommittee on Health, the doctor from Texas,
Dr. Burgess.
Mr. Burgess. Thank you, Mr. Chairman, and thanks for
holding this hearing. First off, I am going to ask unanimous
consent to my opening statement being made part of the record.
Mr. Walden. Without objection.
[The information appears at the conclusion of the hearing.]
Mr. Burgess. And I will point out that your attention to
this issue has been important. At the subcommittee level as you
know we heard from over 50 members, not just from on the
committee but throughout the Congress, 50 members. We held a
Members' Day on problems that people were having with opiate
abuse back in their districts and we did hear that it literally
touches every part of the country.
I am going to ask questions of the doctors on the panel. I
have been on this committee long enough to remember when we had
a hearing on the underprescribing of pain medicine in 2005, so
just for those of you who are still in practice, what is a
doctor to do? You have a patient that has a condition that is
painful and you want to alleviate that suffering. How do you
now approach that? Are you not going to use an opiate where you
might have otherwise thought it was appropriate?
Dr. Gottlieb, you referenced that it is going to cause us
to think in some uncomfortable ways because we have run out of
reasonable options. So starting with you I would just like to
go down the panel and hear from you.
Dr. Gottlieb. Thank you for the question, Congressman.
There is a role for these medications in medical practice and
there is patients who have acute pain conditions where these
medications can be effective. There are some patients with
chronic conditions like metastatic cancer pain that are going
to require long-term treatment with opioids. But I do think
that there was a generation of physicians trained, and I think
it was my generation of physicians trained, to make more
indiscriminate use of these drugs than we should have.
I remember when I was practicing in the hospital as a
resident, and that is not too long ago, every patient had a
standing order for Percocet. Every 6 hours a patient had a
standing order for two tabs of Percocet that could be
prescribed at the nurse's discretion, almost every patient.
That wasn't good medical practice we now know. That sensitized
a lot of patients who were hospitalized for 5 or 6 days to
round-the-clock, immediate-release formulations of opioids, and
some of those patients left the hospital addicted.
So I think we need to rethink how we use these drugs and I
think we are in the process of doing that. But that is going to
also require to reeducate a generation of physicians and that
is what we are doing.
Mr. Burgess. Since you brought up your residency I will
bring up mine. My generation of doctors was able to put a
refill on a prescription that we sent home with the patient and
somewhere along the line that ended. Now I realize those are
State laws, but the inability to refill a prescription, and
really this is for any of you, the inability to refill a
prescription without going back and seeing the doctor and
having that face-to-face encounter, I mean it seems to me that
human behavior might dictate that a doctor would--I don't want
to get calls for a refill on a pain medicine so I will write it
for twice the amount that I used to write it for. Does that
happen?
Dr. Gottlieb. Look, I will defer to my colleagues who have
more substantive data on these issues. But when we look at the
epidemiology we see too many 30-day prescriptions being written
for indications for which, you know, the proper course would be
a 4- or 5-day prescription. You have dental procedures, minor
surgical procedures, so we do see that happening.
And to the extent that we believe that addiction correlates
with exposure, and one of the keys to solving the new addiction
crisis is to reduce overall exposure to opioid drugs, you would
want to encourage approaches that make it easier if not try to
create more direct incentives to prescribe shorter duration
uses. That includes packaging. It includes proper education.
These are things we are looking at doing.
Mr. Burgess. Sure. I am going to have to jump ahead so I am
going to ask all of you to respond to that question in writing
to me if you would, because I do need to ask Mr. Doherty a
question on--you used a term that I was not familiar with, the
CPOT; is that right?
Mr. Doherty. That is correct, sir.
Mr. Burgess. And that stood for?
Mr. Doherty. CPOT stands for Consolidated Priority
Organization Target, and it is a Department of Justice term
designated for our most prolific trafficking organizations in
the world.
Mr. Burgess. And what legal tools do you have? When you
arrest a CPOT and bring a successful prosecution what are you
charging them with, just the drug laws or are you able to
charge them with injury to a person or murder?
Mr. Doherty. Well, with respect to your question, sir, and
thank you, the CPOT designation is typically affiliated with
organizations, mainly international organizations, our large
target list in China, our target list in Mexico. So to point
out the press release last week of the two Chinese nationals
that I mentioned in my opening statement----
Mr. Burgess. Right.
Mr. Doherty [continuing]. These individuals are prolific in
nature shipping massive amounts of fentanyl to our country.
Mr. Burgess. So if you are successful in prosecuting them,
what statute are they prosecuted under?
Mr. Doherty. Sir, they would be prosecuted under a variety
of violations, importation.
Mr. Burgess. So how long do they go away for?
Mr. Doherty. Sir, I can't comment on that particular case.
Mr. Burgess. But in general what would the sentencing
guidelines be?
Mr. Doherty. Generally speaking, if we were to go after a
CPOT and either arrest him in the United States or have him
extradited, potentially, hypothetically he could stand RICO
charges. He could stand murder charges. He could stand money
laundering charges. He could stand wire fraud charges. So
really----
Mr. Burgess. Is it theoretically possible to bring murder
charges against someone in that situation?
Mr. Doherty. If we can definitely prove, and again I
realize this is a hypothetical situation.
Mr. Burgess. Sure.
Mr. Doherty. If we can definitively prove that either he
was directly involved, he or she was directly involved in
murder or supplied fentanyl to individuals in this country that
overdosed and died, we would definitely, unequivocally, bring
murder charges, death resulting charges on these individuals.
Mr. Burgess. And I would make that widely known and
dispersed. Thank you, Mr. Chairman. Thank you, sir.
Mr. Walden. Thank you, Mr. Chairman. And one of those
folks, an Oregonian overdosed related to that case where the
indictments came down, so it is personal to our State. We will
go now to the gentleman from Texas, Mr. Green, for 5 minutes.
Mr. Green. Thank you, Mr. Chairman and our ranking member,
for this really important hearing today. The 21st Century Cures
Act contained a billion dollars to fight the opioid epidemic.
This is substantial but certainly not enough to win the fight.
Dr. Schuchat, can you talk about how this funding is being
used on the ground?
Dr. Schuchat. Well, the 21st Century Cures Act didn't
actually provide funding to the CDC, so I probably want to let
my colleagues talk about that. The committee in last year's
2017 appropriation did give, separately give CDC a $50 million
increase which has been incredibly helpful in our reaching out
to more States to speed up the timing of the quality data that
helps them know what they are doing and to increase the
consumer awareness with the communication effort.
But I should probably let my colleagues talk about the
funding.
Mr. Green. Whichever has the information, I was wondering
what the outreach was. You know, it is relatively soon for even
though the bill was passed, but what are we seeing changed now
because of that?
Dr. McCance-Katz. Yes. So SAMHSA is responsible for the
State Targeted Response. This is the 500 million a year for
each of 2 years. The first year was allocated to the States. We
have been working with the States on developing their plans
based on their assessments of their communities and their needs
related to prevention, treatment, and recovery services.
We review those. We make sure that evidence-based practices
are being used and then the States will procure the services
that they need to implement those plans and we are at that
point right now, sir.
Mr. Green. OK. I would hope you would continue because, you
know, we want to see where this--and you are learning I guess
from different States on what works and what doesn't.
Dr. McCance-Katz. Yes. And we would be happy to provide
additional information as time goes on to this committee.
Mr. Green. OK, thank you.
Dr. Volkow, I understand that NIH is partnering public and
private stakeholders to accelerate the research in the non-
opioid, non-addictive therapies. I also understand that Dr.
Gottlieb has taken proactive steps to provide information and
to reshape the provider behaviors as it relates to prescribing
practices for opioid.
This panel would be the experts who are actively engaged in
fighting the public health battle, so I want to ask you what I
believe is a key question on the strategy going forward. How do
we elevate the value and utilization of alternatives of the
opioids across the healthcare system? Some alternatives do
exist today and are we hearing more are in the development?
But given the rampant rate of prescribing and use of
opioids how do we change that part of the problem? And that was
any----
Dr. Volkow. Yes. No, and I think that the point has to do
with how do you change the practice of clinicians that have
been overrelying on the utilization of opiate medications for a
variety of reasons to treat severe pain and become actually to
treat not so severe pain.
So one of the big challenges is how do you implement the
CDC guidelines, number one. And number two, among one of the
challenges is to ensure that physicians will be reimbursed for
actually following the guidelines. Because what they recommend
is a multi-pronged approach for the management of pain,
integrated response that is much more expensive than what it
would cost to give you an opioid prescription.
So as we are discussing the notion of changing and
educating and training physicians on the use of prescription
opioids and management of pain, we need to change the structure
of reimbursement so that the doctors can do the right thing for
their patients and get reimbursed for it.
Dr. Gottlieb. I will just, I can pick up just to add that
we do see innovations in the pipeline that could provide
alternatives to opioids and provide opioids that are harder to
manipulate in ways that could help defeat abuse. We see
technologies that where the opioid-like drugs but are biased at
the mu-opioid receptor in ways that might not have the same
addictive potential. We see second and third generation abuse
deterrent formulations that are potentially much harder to
abuse, things like prodrugs in development. So there are very
interesting, very promising technologies available that could
potentially treat chronic and acute pain in ways that don't
lead to the same addiction.
And I would also offer that there is a lot of medical
device alternatives. We have approved about 200 different
medical devices that have components that treat pain, about ten
of those are very novel devices. And so we see a lot of
opportunity looking across the continuum of medical devices as
well to help address painful syndromes locally rather than
systemically.
So there is a lot of opportunity and we have fast tracked
some of these products. These products would be also eligible
for the breakthrough therapy designation that this committee
made available to the agency.
Mr. Green. Thank you, Mr. Chairman.
Mr. Burgess [presiding]. The gentleman's time has expired.
The gentleman yields back. The Chair recognizes the gentlelady
from Tennessee, 5 minutes for questions, please.
Mrs. Blackburn. Thank you, Mr. Chairman. We appreciate that
all of you are here. As you have heard from everybody, this is
work we have been working on for years and trying to figure out
how to best get a handle on this issue and end this epidemic
and it is so important that we hear from you.
What I want to start with, and this is to each of you on
this panel, are there any existing statutes that prevent your
agency, your respective agencies, from effectively responding
to the opioid crisis?
Dr. Gottlieb. Well, Congresswoman, we would be delighted to
work with the committee to look across the range of our
different authorities and what more we can be doing. The one
that I would just point out in response to your question is
where we are trying to take some new steps to think about how
we step up our oversight in the international mail facilities
to target synthetic drugs coming in through the mail. And in
this regard we have worked very closely with Customs and Border
Patrol, the commissioner there has been a very good colleague
to FDA.
But there is the potential that we might want to take a
look at some point at some of the seizure authority we have----
Mrs. Blackburn. OK.
Dr. Gottlieb [continuing]. To perhaps make it more
efficient to operate inside those IMFs.
Mrs. Blackburn. OK, anyone else have any existing statute
that is an impediment?
Mr. Doherty. Ma'am, from DEA's standpoint, and I will
address what was recently reported in the media, one of our
administrative tools, an immediate suspension order recently
came under report in the media.
We would be happy to work with Congress and we look forward
to working with Congress with Department of Justice oversight
to ensure that from an enforcement, criminal enforcement
perspective, a civil sanction perspective, and an
administrative perspective, which are all tools that we use to
prevent the diversion of illicit pharmaceuticals, we would be
more than happy to work, as I said, with Congress with
Department of Justice oversight to ensure that we have the most
updated and applicable tools moving forward to attack the
opioid crisis.
Mrs. Blackburn. OK, anyone else?
Dr. Volkow. Well, I think that on following my DEA
colleague, I think one of the issues that becomes very
important on the aspect of research is our ability to work with
substances that are being abused, illicit substances that are
very, very dangerous. And that is important because if we don't
understand it from microbiological properties we cannot
actually develop treatments. And one of the aspects on it is
that because they are Schedule I substances then it can become
very, very difficult to actually do research on them.
So being able to generate the category that allows us to
protect the public from these substances what allows us to do
that research would facilitate our ability to respond to this.
Mrs. Blackburn. OK. That is great. And if any of you would
like to submit something to us in writing that would be
helpful.
And Dr. McCance-Katz, you mentioned and I will just ask you
to submit this in writing, you talked about implementation of
21st Century Cures. If you will give us your timeline for where
you are on that because, and you can just give it to us in
writing.
Dr. McCance-Katz. I will.
Mrs. Blackburn. We are all interested in that because that
is getting the money out to our States and that is an
imperative for us.
Mr. Doherty, I am coming back to you on the Ensuring
Patient Access and Effective Drug Enforcement Act. It required,
it required the DEA and HHS to submit a report to Congress
identifying current issues with diversion efforts including
information on whether coordination between the industry and
law enforcement has helped. And that report was due to us in
April, so it is now 6 months late.
I sent a letter over this week asking about this report, so
why don't you--and Mr. Chairman, I would like to submit for the
record the letter that was sent over requesting the delayed
report.
Mr. Burgess. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mrs. Blackburn. And what I would like to hear from you is,
what is the status of that report? You have heard the
frustration with this panel for not getting information we need
from the DEA, so we are adding this to the list. Where is the
report? What is the status of it, when should we receive it?
Mr. Doherty. Congresswoman, thank you for that question.
And with respect to the report that you mentioned, DEA has
engaged with Health and Human Services on that report and it is
my----
Mrs. Blackburn. Engaging isn't getting a report to us that
is now 6 months late. So when do we get the report?
Mr. Doherty. It is my understanding, ma'am, that HHS has
the lead on this report that you reference.
Mrs. Blackburn. Have you all submitted your needed
information to HHS to write this report?
Mr. Doherty. I believe we have and we have been actively
working on our part of the report with them.
Mrs. Blackburn. OK, thank you, yield back.
Mr. Burgess. The Chair thanks the gentlelady. The
gentlelady yields back. The Chair recognizes the gentlelady
from Colorado, Ms. DeGette, for 5 minutes for questions,
please.
Ms. DeGette. Thank you, Mr. Chairman.
Mr. Chairman, we have been talking today about 21st Century
Cures and the billion dollars that Fred Upton and I were
pleased to put into that bill for State funding to develop
opioid prevention programs. Just for the record, in Colorado we
have a program called the Consortium for Prescription Drug
Abuse Prevention. They are already taking this money from Cures
and they are already doing work to reduce overdose deaths. It
is really important that we do this on a State-by-State level
because the States have different needs, and I would hope that
we would work as a committee to extend that funding out past
2018 because it expires in 2018.
Mr. Doherty, I just want to follow up--I am over here. I
want to follow up on a couple of the chairman's questions and
others. We have been talking to you about that May and that
October letter that we sent to the DEA asking for responses and
documents. Were you aware that the chairman and several other
members also met with the Acting Director of the DEA in July,
on July 28th of this year? Were you aware of that meeting?
Mr. Doherty. Yes, ma'am.
Ms. DeGette. And were you aware that at that meeting we
also asked him to provide that documentation and those answers,
and he said he would?
Mr. Doherty. Ma'am, I am generally aware of the meeting. I
am not sure what was discussed at the meeting.
Ms. DeGette. OK. Well, I will tell you that is what
happened. Now I also want to ask you, as the chairman said, we
have been investigating reports of shipments of large amounts
of opioids to Kermit, West Virginia. Can you tell us today
which distributor, or distributors, supplies those large
amounts of opioids to the pharmacies in Kermit, West Virginia?
Mr. Doherty. Ma'am, as I said before, I don't have that
information with me.
Ms. DeGette. When can we expect to get that information
from you?
Mr. Doherty. And we will expedite that information and
after the hearing.
Ms. DeGette. One week, one month, one year--when can we
expect to get it?
Mr. Doherty. Ma'am, I would not be able to put a timetable
on that.
Ms. DeGette. You are not going to tell me.
Mr. Doherty. I will----
Ms. DeGette. Chairman, I think that subpoenas may be really
considered in this point.
Let me ask you another question. On the October 13th letter
which I put into the record a little while ago, the committee
using DEA's collected ARCOS data looked at the amount of
hydrocodone and oxycodone that went into the various regions of
West Virginia and they show that from 2000 to 2010 there were
dramatic increases in the distribution of opioids to the
regions examined by the committee. Would you agree that some of
these trends are troubling?
Mr. Doherty. Yes, ma'am. I would.
Ms. DeGette. OK. And has the DEA conducted its on analysis
of its ARCOS data regarding the trends in West Virginia and
does the DEA know which distributors were responsible for this?
Mr. Doherty. Ma'am, the DEA has upgraded our office----
Ms. DeGette. I think yes or no will work. Do you know who
did this?
Mr. Doherty. Ma'am, with respect to the shipments, the
ARCOS data provides information and we are currently unable to
determine definitively----
Ms. DeGette. So you don't know.
Mr. Doherty. It is my understanding currently that we have
information relative to companies involved and we are reviewing
that data to determine what we can legally----
Ms. DeGette. And I assume we will get that answer too,
correct?
Mr. Doherty. Yes, ma'am.
Ms. DeGette. OK.
Dr. Volkow, I wanted to ask you a question about the
naloxone. You had a really snappy spray of the naloxone that
you used, but I think you can probably tell us that most of the
people who are distributing naloxone cannot afford that; isn't
that accurate?
Dr. Volkow. Thanks for the question because I think it is
very important.
Ms. DeGette. OK.
Dr. Volkow. We can have very fancy scientific tools that
are so expensive that nobody can afford it.
Ms. DeGette. Right.
Dr. Volkow. This thing costs $37.50.
Ms. DeGette. Well, unfortunately, I--what is the
manufacturer of that?
Dr. Volkow. This is Opiant, and it is in partnership with
the Adapt Pharma.
Ms. DeGette. OK. So the Adapt price in 2016 according to
the New England Journal of Medicine was $150. And in fact, in
the August recess this year, I went over to the Harm Reduction
Center in Denver. I actually got trained how to use naloxone,
and they gave me some naloxone that they give out to people.
They told me they can't afford to use that. And what they gave
me was this little vial of chemicals and they gave me a syringe
and another little vial--which I actually learned how to inject
somebody--and the reason they use that is because that one
costs only $39.50.
And so my point to you and the point I want to make to the
chairman: We are going to have to do some more investigation in
this committee. This is where it intersects with the increase
in prescription drug prices. Because the auto injector was $690
and now it is $4,500, the one that you have got there it is
$150. Even the one I have here, between I think 2014 and 2016
has gone up to 39.60.
So it is great to have naloxone for people, but if you
don't have something that is easy to administer because the
prices are just going up, then it is not going to be usable.
Dr. Volkow. And I completely resonate with you we want to
do things that are affordable. But I want to comment on the
notion that this implementing the syringe does not deliver
naloxone at sufficiently high concentrations because it is very
diluted. So we not only have to give something that is
affordable, but we need to give something that is effective.
Ms. DeGette. You are totally right. I agree, thank you.
Thanks, Mr. Chairman.
Mr. Burgess. The Chair thanks the gentlelady. The
gentlelady yields back. The Chair recognizes the gentleman from
Ohio, Mr. Latta, 5 minutes for questions, please.
Mr. Latta. Well, thank you very much, Mr. Chairman. And
thank you very much to our panel today. We really appreciate
you being here and this is a very, very important hearing that
we are having today. Ohio, in 2015, we lost 3,050 people
because of opioid overdoses and last year that total went up to
4,050. And our county coroners are now predicting that
unfortunately we are on a pace to exceed the 2016 numbers.
And I have my second opioid forum and that was held last
week and, you know, when you are talking about these statistics
of 3,050 or 4,050 people losing their lives, you know, those
are the statistics but you put a face with them. And I talked
with a parent who had lost a child because of opioid overdose
and it is, you know, it is heartbreaking. And so I am very
happy that you are here today because this is a very important
subject and we are in an epidemic across this country.
And Dr. McCance-Katz, if I can start with you, CARA
provided significant funding for States to expand substance use
disorder treatment through grants administered by SAMHSA. In
addition, CARA required that grantees submit data that will be
posted online and easily searchable. Can you provide us with a
status update of those requirements?
Dr. McCance-Katz. Yes. So SAMHSA has awarded grants under
the CARA initiative, the legislative requirements. Some of
those we call this our MAT-PDOA program which is focused on
medication-assisted treatment specifically for prescription
opioids and heroin users. And so we are collecting data and
that data will be available at the end of the program and it
will be available to individuals to easily analyze, yes.
Mr. Latta. Let me follow up too. And what accountability
measures is SAMHSA requiring to make sure of States to make
sure that that grant money is being wisely spent out there?
Dr. McCance-Katz. Yes. Thank you for that question. What is
required is that they submit to SAMHSA their plans for their
States and what practices they intend to use. We review those.
We provide guidance to them. And in the terms and conditions of
grant award they are required to use evidence-based practices
going forward and so we will be working very closely with them.
Now that requires that we provide them technical assistance
and so that they can make determinations of what evidence-based
practices are best for their communities, every State being
different of course. And we are developing a new program of
enhanced technical assistance where we will help States to get
experts from the various fields that provide care in substance
use disorder treatment--psychiatrists, addiction medicine
specialists, advanced practice nurse practitioners, physician
assistants, social workers, peers--that will be available to
States to help them as they think through their needs and put
evidence-based practices in place.
Mr. Latta. Well, thank you. And when we had the forum last
week in my district one of the things that came up, and this
will pretty much be a yes or no answer for all of the panel
that is here today, part of the issue is for a lot of the folks
out there is a lack of reliable information and data that is
available out there and it is difficult for many of especially
smaller communities to find funding streams and access
information on how effective Government programs have been to
combat opiate abuse. I am working on a bill right now that
would create a publicly accessible electronic database to help
mitigate these problems.
And I would just like to ask each of you real quickly if
yes or no would you all be, as we are working on this
legislation to collaborate with me to make sure we can get this
information out there to the public, because again it is a
very, very difficult thing for the smaller communities, smaller
agencies to do. So if I could just go right down the line, if I
could ask for your cooperation on that.
Dr. Gottlieb. Yes, sir, Congressman.
Dr. McCance-Katz. Yes, happy to do that.
Mr. Doherty. Yes, sir. We would be happy to work on that.
Dr. Schuchat. Absolutely.
Dr. Volkow. We would be delighted.
Mr. Latta. Well, thank you very much. And maybe if I can
just follow up with the remaining time that I have with FDA.
You know, when we were talking and you mentioning, Doctor,
about that you know what we have with the epidemic we have in
the United States, but looking around the world, do other
countries have the same situation that we have with this opioid
epidemic?
Dr. Gottlieb. I would defer to my colleague from SAMHSA,
but my experience with the data is no, Congressman, and
prescribing in other countries isn't as rampant as it is here
in the United States.
Mr. Latta. So you are saying it is on the prescribing side
because of where we have gone.
Maybe I could, Mr. Chairman, I am a little bit over my time
but----
Dr. Gottlieb. Certainly that started on the prescribing
side. We still have, I think it is a fair assessment we still
have too many prescriptions being written particularly for the
IR formulations of these drugs, 190 million prescriptions a
year represents 90 percent of all the prescriptions that are
written for opioids. But increasingly, it is shifting to a
problem of illicit drugs and low-cost alternatives which are
the heroins and the synthetic fentanyls.
Mr. Latta. Well, thank you very much, Mr. Chairman. My time
is expired.
Mr. Burgess. The gentleman is correct, his time has
expired. The Chair recognizes the gentleman from Pennsylvania,
Mr. Doyle, 5 minutes for questions, please.
Mr. Doyle. Thank you, Mr. Chairman.
Based on CDC data in 2015, over 4,200 individuals age 15 to
24 died of drug-related overdose deaths. This is an increase of
almost 200 percent since 2000 when the number was less than
1,500. So we know that children, adolescents, and young adults
are part of this epidemic. Not just because they are losing
parents and being sent to foster care, but because they are
using drugs, getting addicted, and dying. The Children's
Hospital of Pittsburgh has screened more than 31,000 children
in the first 3 months of their new program rollout and has
already found 60 children to be at high risk for or at levels
of substance abuse.
So my question for the panelists, and I would start with
Dr. McCance-Katz, what resources are being directed across the
agency to the prevention and treatment of substance use
disorder in children and adolescents?
Dr. McCance-Katz. We have a number of initiatives that
address substance abuse and substance abuse prevention in
children and adolescence and I will just start with pregnant
women who are opioid-dependent and we have programs to assist
them with treatment. We also make technical assistance
available to providers so that they can provide the best care
to women and their infants who may be born physically dependent
on opioids and need treatment. We also have a program that has
just recently started that will address issues and what we call
transitional age youth.
And so the age group that you are speaking of and this
would be 18-to-25-year-olds is a difficult group to treat.
Traditionally, they are more difficult to engage in treatment.
We don't have a lot of information as we do in older, in adults
as to what works best for them. And so we are bringing experts
into SAMHSA to give us information about how to work best with
this age group and to provide that guidance then to States and
communities.
In addition, we are also putting together a workgroup that
will look at the effects of opioids on the developing fetus,
and so what kinds of issues could be expected in terms of
development of children who have been opioid-exposed in utero.
That is an ongoing project.
I might though ask my colleague Dr. Volkow to mention some
of the initiatives and research they are doing, some excellent
research at NIH on these issues as well.
Dr. Volkow. I want to highlight only one because I think
that the issue of preventing the drug use among teenagers and
young individuals is one of the most impactful things that we
can do. So one of our main initiatives in partnership with
other institutes is that a story that will be prospectively
following 10,000 children as they transition into adulthood and
periodically assessing them for their brain development in
order to understand how exposure to drugs actually influences
the development and architecture of the brain.
And that is very important, because if we understand it
then that we can tailor intervention to try to reverse them, to
reverse them and provide resilience for those that may have
vulnerabilities. So this is one of our top priorities, to
actually protect that adolescent from getting exposed to drug
and if they get exposed how do we actually restructure it into
one intervention that will provide them with resilience.
Mr. Doyle. Yes.
Dr. Schuchat. Maybe I could just say some of the CDC
initiatives really do target that age group. In terms of
improved prescribing, we know that a lot of people who become
addicted's first prescriptions were for, you know, youth
sports-related problems for instance. Our consumer-facing
communication campaign really targets the families of
survivors, the parents who have lost a child.
And then the last thing I would mention is a technical
package that CDC released about efforts that can intervene
against the problem of youth suicide which has an overlap with
the opioid issue.
Mr. Doyle. Thank you. I would just like to, you know, I
appreciate all these answers, but I would just like to add that
it seems a lot of what is being discussed also needs to be tied
into children having health insurance and access to care.
And in my State in Pennsylvania, over 1.2 million kids rely
on Medicaid and CHIP for their health care and as we all know,
we have spent a lot of time this year talking about huge cuts
to Medicaid and this body, unfortunately, has yet to come to an
agreement on how to fund CHIP. So I guess it really begs the
question how much do all of these programs matter if children
don't have basic health insurance.
Mr. Chairman, with that I see my time is expired, and I
will yield back.
Mr. Burgess. The gentleman yields back. The Chair thanks
the gentleman. The Chair recognizes the gentleman from
Kentucky, the vice chairman of the Health Subcommittee, 5
minutes for questions.
Mr. Guthrie. Thank you, Mr. Chairman. Thank you for
yielding. I appreciate everybody being here, this is important.
Kentucky, like a lot of States, has had its share of
tragedies through the heroin and opioid overdoses. Our State
legislators, our Governor, and everybody is working very hard,
our physicians, trying to move forward, and our Drug Task Force
folks, I mean it is all-out effort and it is still a very, very
serious problem as that is why we are here today.
Dr. McCance-Katz, I wanted to ask you a question. A
behavioral health provider in my district reported that it is
not uncommon--not uncommon, I guess that means it is a little
less than common, but not uncommon--for some of the managed
care organizations to request up to 70 pages of authorizing
paperwork from their board-certified addiction specialists to
treat one patient with medication-assisted treatment. This
provider stated that it can require 2 to 3 hours of staff time
to submit the requested paperwork to treat one patient.
In your testimony you mentioned the Medication Assisted
Treatment for Prescription Drug and Opioid Addiction grants
within SAMHSA. Would you please elaborate on this program and
inform me of what SAMHSA is currently doing to evaluate and
ensure patients receive timely treatment and quality providers
are able to deliver care to their patients?
Dr. McCance-Katz. So SAMHSA has a number of initiatives to
bring people to medical attention early on. We have a program
that has been in place for a number of years. Not the program
that you are speaking of, but it is called our SBIRT program
which is Screening, Brief Intervention, and Referral to
Treatment. This is a paradigm that involves training primary
care providers on how to screen for hazardous substance use or
use that has evolved into a use disorder and get people to
appropriate treatment. So we do a lot of work in that area.
In addition, we have our what I said was our MAT-PDOA,
Medication Assisted Treatment program that is funded through
the CARA act and this is a program that allows States to
develop programs that focus on medication-assisted treatment to
getting that to their community. States can do this in any
number of ways.
In fact, before I had this position I had one of those MAT-
PDOA grants in Rhode Island and what we did was we put together
what we called a center of excellence for the treatment of
opioid use disorder to stabilize people coming into treatment
for serious opioid addiction and then to transfer them to
community providers who were willing to take on this care. They
previously were not willing to do that because, because they
were concerned that they didn't have the skill set needed to
deal with all of the aspects that addiction brings to care.
And so every State will do this differently, but those are
the types of programs and there are different iterations. We
call them sort of hub and spoke models where you have--well, I
will stop there.
Mr. Guthrie. OK, thanks. Well, I think we agree that
patients have to receive timely treatment.
Dr. McCance-Katz. Yes.
Mr. Guthrie. And at the facility in my district they found
that in 1-year follow up the majority of patients on
medication-assisted treatment are still actively involved in
the treatment, and these individuals are less likely to be
incarcerated and to relapse, and to be employed. So, you know,
it is important.
One more question for you then. One of the recommendations
of the interim report of the President's opioid commission was
to repeal the prohibition of Medicaid paying for services for
some patients in an institution for mental diseases or IMD
exclusion as we all refer to it here. I have heard from many
that we should dial back this limitation in certain instances,
if not entirely, particularly in the midst of a national opioid
epidemic where only a small percentage of individuals who need
treatment are getting it.
Do you support some kind of repeal of the IMD exclusion and
if so what should it look like?
Dr. McCance-Katz. What I would say is that this is an issue
for the President and Congress to deal with, and at HHS we
would be happy to implement whatever you decide on in that
area.
Mr. Guthrie. OK. One of the issues that when we deal with
this repeal of the IMD exclusion has been the subject of a lot
of debate for a couple years, and the greatest barrier that is
preventing is the cost to the Federal Government. In 2016, CBO
estimated a 40-to-60-billion-a-year cost over 10 years. What do
you think Congress and CMS and SAMHSA or the States could do to
try to counter this major cost increase?
Dr. McCance-Katz. Again, this is not an area that the
administration has a position on that I can provide to you
today, but certainly we would be happy to work with you on
those kinds of issues. But I will say one thing. Not everything
with addiction needs to be in an inpatient setting and in fact
most people can be treated very effectively on an outpatient
basis with medication-assisted treatment, psychosocial
supports, and community supports.
Mr. Guthrie. OK, thank you very much. I appreciate those
answers and I appreciate your position. And my time is expired
and I yield back. Thanks.
Mr. Burgess. The Chair thanks the gentleman. The gentleman
yields back.
The Chair recognizes the gentlelady from California, Ms.
Matsui, 5 minutes for questions, please.
Ms. Matsui. Thank you, Mr. Chairman, and I want to thank
the witnesses for being here today.
We all know the opioid epidemic affects us all and
certainly no community is immune to this disorder. This
committee has done important work to begin addressing the
epidemic but I must reiterate the point that we can't talk
about this crisis without acknowledging the importance of
protecting Medicaid. Addiction is a medical condition and
requires treatment. And for many, that treatment is made
available through the Medicaid program, which the ACA expanded
to millions more adults in need. Taking away those critical
services will certainly take us backwards.
The Prevention and Public Health Fund created by the ACA to
make targeted investments in prevention programs in our
Nation's public health infrastructure now funds 12 percent of
CDC's annual budget. If the Prevention Fund were to be
repealed, States would lose billions of dollars to spend on
programs in communities, including programs to address the
opioid crisis.
Dr. Schuchat, can you discuss the work that CDC has done on
public health research and infrastructure relating to the
opioid epidemic?
Dr. Schuchat. CDC is really focused on strengthening
prevention by improving prescribing implementation of our
treatment guidelines for chronic pain, the use of opioids and
chronic pain with efforts to find out how can we best implement
them, making it easy for clinicians, doctors, pharmacists,
nurse practitioners to prescribe carefully.
We are also focused on evaluating the medication-assisted
treatment that we hear about to understand what works best for
different circumstances and evaluating the naloxone
distribution program that SAMHSA has as well.
Lastly, we are focused on this consumer-facing campaign,
evaluating its impact as we try to scale it up. Right now, we
have been able to fund four States to launch the campaign and
22 of the States that receive funding from CDC will be using
their funds to mount it but we really hope that that will be
able to go nationwide and reach the public.
Ms. Matsui. Well would that be affected if CDC funding were
cut by 12 percent across the board?
Dr. Schuchat. No. Every dollar that goes for prevention is
lifesaving and cost-saving. And so we will work with Congress
with the resources that we get to do the most good.
Ms. Matsui. OK, in order to truly address the opioid
crisis, we will need to build up our behavioral health system
so that everyone has access to prevention and treatment in
their communities. That is the goal of the Excellence in Mental
Health Demonstration Project that my colleague, Representative
Lance and I worked to create and that is now being administered
by SAMHSA in eight States.
Dr. McCance-Katz, can you give us an update on the
implementation of Certified Community Behavior Health Clinics?
Dr. McCance-Katz. Yes, I can. So those funds have been
released to the eight States, as you mentioned, that were
selected. These States are putting together what we call
Certified Community Behavioral Health Centers, which bring
together the elements of treatment, evidence-based treatment
for serious mental illness and for substance use disorders so
that an individual can get all of the care they need because we
know that co-occurring disorders are quite common in one place.
We think the model is quite nice. It is a model that is not
a standard fee for service model but it is a bundle payment
similar to what goes on in community health centers. We are
very hopeful that that is going to be a model that will yield
positive results and we hope can be sustained.
Ms. Matsui. Well, we hope so, too, absolutely.
Now, in addition to the short-term funding we provided in
21st Century Cures, we authorized additional funding for a
variety of programs intended to address the mental health and
substance use treatment system in a more long-term manner. For
example, we authorized additional funding for treatment and
recovery for homeless individuals, behavioral health
integration and community health centers, mental health
awareness training, and more.
Dr. McCance-Katz, can you provide an update on some of
these programs authorized or reauthorized in 21st Century
Cures?
Dr. McCance-Katz. So we are working with Federal partners
to address issues of behavioral health and primary care. We
have a strong alliance with HRSA. And as you know, HRSA just
released $200 million in new grant funding to integrate
substance abuse treatment into community health centers. SAMHSA
works with them on technical assistance to assure that
evidence-based practices are being used.
We also continue our homeless grant initiatives at SAMHSA
and we could get you the data if you would like to have it
but----
Ms. Matsui. That would be lovely.
Dr. McCance-Katz [continuing]. We see very positive results
in getting people stably housed.
Ms. Matsui. OK, thank you very much and I see my time has
expired. Thank you.
Mr. Walden. The Chair now recognizes the gentleman from New
Jersey, Mr. Lance, for 5 minutes.
Mr. Lance. Thank you, Mr. Chairman, and good afternoon to
the panel.
Congresswoman Matsui and I are a tag team on the
demonstration projects in the eight States and I am sure you
are shocked to learn that New Jersey and California are two of
the eight States.
Now I am increasingly of the view that fee for services is
outdated and outmoded. To Dr. McCance-Katz, do we have analysis
yet on the bundled payment system for the eight States?
Dr. McCance-Katz. No, sir, we don't. We don't but we will
be following that very closely and happy to share when we get
it.
Mr. Lance. Do you have any indication when that might be
within the next year or ----
Dr. McCance-Katz. I think within a year, but this has--
really it has just started. And so I would say in a year, yes.
Mr. Lance. Thank you. And the Congresswoman and I are
working on expanding that program. I think we are both of the
belief that this is the wave of the future and, certainly, I
will continue to work with my colleagues in that area.
According to CMS, the Medicare population has among the
highest and fastest growing rates of diagnosed opiate use
disorder; if I understand it, currently six of every one
thousand beneficiaries. But CMS policy appears to be blocking
access for our Nation's senior citizens to receive treatment
for their substance use disorder with two primary treatment
modalities, buprenorphine and methadone.
I know this is not your agency, Dr. McCance-Katz, but in
what ways, in your judgment, could CMS work with SAMHSA and
other Federal partners to ensure that senior citizens utilizing
Medicare who need treatment can get the help they need?
Dr. McCance-Katz. Yes, so we do work collaboratively with
all of our sister agencies within HHS, CMS being one of them.
And SAMHSA has the ability to provide CMS any information on
the effectiveness of these treatments in all age groups and we
would advocate for that.
Mr. Lance. Thank you very much.
Mr. Doherty, my understanding is, as the legal prescription
drug supply is constrained the use of street heroin increases.
I suppose this is logical because addicts seek to get the
drugs, they, unfortunately, are addicted, and regardless of the
source or the medium.
Is there a direct statistical correlation between the
availability of prescription opioids and increased usage rates
of illegal heroin?
Mr. Doherty. Yes, sir. As you correctly point out and we
appreciate your question, the statistics show that 80 percent
of first initiate heroin users, so 80 percent of first-time
heroin users are now getting to that dark place through the use
of prescription opioid pain killers.
Mr. Lance. Eighty percent?
Mr. Doherty. Eighty percent of first-time heroin users.
Four out of five first-time heroin users are now using heroin
and turning to cheaper heroin. And with the advent of fentanyl
coming into our country in pill form, many times these
individuals are playing Russian roulette. They truly do not
know what they are getting and they truly are taking their own
lives in their hands. And DEA is committed to not only stopping
counterfeit prescription pill manufacturing but also elicit
importation of fentanyl, as I mentioned in my opening
statement.
Mr. Lance. Is there a way that we can use advanced data
metrics to predict where users will seek illegal heroin so that
we can direct interdiction resources to those places?
Mr. Doherty. Sir, we have many programs currently initiated
that normally use data analytics but also use investigative
resources across the spectrum to show where places will
eventually have heroin imported to.
So in other words, our DEA 360 Strategy has hit some of the
hardest communities in the country that have been plagued by
this disease and this opioid scourge.
Mr. Lance. Where would some of those places be in the
country, the hardest hit places?
Mr. Doherty. Dayton, Ohio; Albuquerque, New Mexico;
Manchester, New Hampshire. These are places that our DEA 360
Strategy has been deployed to. It is a three-prong strategy. We
use traditional enforcement, data analytics, diversion control,
and community outreach in bringing the communities back.
Mr. Lance. So you mentioned Dayton, for example. So these
are just average American cities with the same challenges that
the rest of the country has.
Mr. Doherty. Well, yes, sir. And certainly the opioid
epidemic is exasperated by the controlled prescription drugs
now getting people to the point where they have an opioid
disorder, switching to cheaper heroin and now really playing,
as I said Russian roulette with respect to content.
Mr. Lance. And my time has expired. I yield back.
Thank you, Mr. Chairman.
Mr. Walden. The Chair thanks the gentleman. The Chair
recognizes the gentleman from California, Mr. McNerney, for 5
minutes.
Mr. McNerney. Well, I thank the Chair and I thank the
witnesses.
Ms. McCance-Katz, how would limiting access to treatment
impact the opioid epidemic? So how is that going to affect it,
limiting treatment?
Dr. McCance-Katz. Well, if treatment were limited, people
would have more serious adverse events, deaths, inability to
function in society, all of the fallout of opioid addiction.
Mr. McNerney. What about limiting early intervention care?
Dr. McCance-Katz. I am sorry?
Mr. McNerney. Early intervention.
Dr. McCance-Katz. Early intervention.
Mr. McNerney. Same story, right?
Dr. McCance-Katz. Yes, sir.
Mr. McNerney. Well the Affordable Care Act and Medicaid
expansion have been crucial for treatment for those with opioid
use disorders and also for providing early intervention care. I
know this has been the case in my district, which includes
Stockton, California, a city where opioid overdoses up to six
times higher than the State average.
So I am very disappointed that instead of focusing on
finding solutions to address the opioid epidemic, Republicans
have been engaged in an nonstop effort to repeal Affordable
Care Act, which would have a devastating impact on people
struggling with opioid use disorders and would be catastrophic
for combating the opioid epidemic.
So, Ms. Volkow, your written testimony mentions the HHS 5-
Point Opioid Strategy. The fourth pillar of the strategy is to
support cutting-edge research that advances our understanding
of pain and addiction. What are some examples of recent
developments in this area of nonaddictive pain management that
resulted from your research?
Dr. Volkow. This is quite extensive. And as Dr. Gottlieb
was mentioning, in the area of pain, for example, one of our
partnerships has been to develop abuse deterrent formulations
of opioid medication so that the person cannot divert them and
abuse them and there are several drugs already approved by the
FDA.
We are also working with pharmaceuticals to develop non-
opioid based medications that are going to be effective in
addressing pain.
And in the field of opioid use disorder, for example, we
have partnered with pharmaceuticals to develop extended release
formulation such that the patient does not need to go to the
clinic on a daily basis to get their medication but can go
every week, every month, every 6 months and that improves
compliance. And as a result of compliance, they are also
protecting them from actually overdosing.
So these are some of the examples in terms of successful
partnerships that are developing treatments for those that need
them.
Mr. McNerney. So what are the ultimate goals of this
partnership, then?
Dr. Volkow. To accelerate and incentivize pharmaceutical
industry to get into these spaces. Pharmaceutical industry has
not been traditionally engaged in developing medications for
addictions. Addictions are too stigmatized. It was felt that
they wouldn't recover their investment. So we have to reach
them, by being a Federal agency to reach those products and
then present it to pharmaceuticals so that they can bring them
to the market.
In the pain space, also, there is a need of energizing
pharmaceuticals because they have been decreasing their
investment on medications for brain-related diseases, including
pain. So how do we create a partnership engaging also FDA to
ensure that they see an incentive to move forward and develop
pain treatments? Because right now, of course, they are making
already a lot of money from selling opioid medications. So it
is a little bit they are in competition with themselves. So how
do you incentivize them to go beyond that?
Mr. McNerney. So it sounds like we would have--Congress
would have a role in----
Dr. Volkow. Yes.
Mr. McNerney [continuing]. Developing those practices.
Dr. Volkow. And, indeed, there are ways in which Congress
can help develop, facilitate. I mean for example, in terms of
how do you make an incentive for a pharmaceutical to go into
the development of medications for addiction, could you not
treat them like you treat for example developmental vaccines?
So can you get them expansion of their paths? Can you give them
priority evaluation?
So the Institute of Medicine did an analysis on how
actually changes in policy could lead to incentivizing
pharmaceuticals to help us develop better treatments for opioid
addiction.
Mr. McNerney. Thank you.
Ms. Schuchat, do you think that high school sports are a
significant role in opioid addiction?
Dr. Schuchat. What I would say is I don't know. I think
that the principle issue is to change the culture in the
doctor's office or the nurse practitioner's office to help
people follow our recommendations about chronic pain. We say
think twice before starting an opioid. Start low. Go slow, if
you are increasing it. And follow-up regularly about whether
the goals of treatment are being met.
A lot of our history as docs over the past 15 years or so
has been to begin with opioids, where we really don't think
that is a good idea.
Mr. McNerney. Thank you.
Mr. Chairman, I yield back.
Mr. Walden. I thank the gentleman.
I now recognize the gentleman from Mississippi, Mr. Harper,
for 5 minutes.
Mr. Harper. Thank you, Mr. Chairman, and thanks to each of
you for being here on this very critical subject.
I mean the opioid epidemic is certainly destroying our
country and we see this every single day and how it is
impacting lives and families. You know you have seen families
that have been lost and destroyed because we haven't been able
to provide perhaps the resources, perhaps the right action to
take. And I know we have made great resources in making--great
strides in making those resources available. But one of the
biggest concerns that I have--and I will say this. I think this
may be some of the most important work that our committee is
going to do this year is to try to assist and provide some
guidance and those resources here.
But one of the biggest problems that we see on the ground
is how do you get those resources that we put out to the local
level, particularly predominantly this country is still rural
in most of our geography. So how do you get that to rural
America? How do we do that?
Because you know when you have, perhaps, a county with some
small cities or municipalities, law enforcement is stretched so
thin that these groups can operate with impunity on selling and
destroying those lives.
So that would be my question is, How do we get this down to
rural America? And I would like each of you to give me your
quick thoughts on that.
Dr. Gottlieb. I would defer to my colleague from SAMHSA on
that, Congressman, but I would echo the need to get the
treatments into those settings.
Dr. McCance-Katz. Yes, and so we have to use technologies
to reach rural communities and we have a couple of programs at
SAMHSA that address rural health directly. One of those is
telehealth. That is an evolving way of providing care so that
you can really extend the reach of a single practitioner who
may be a distance away from where they are providing care but
that is a model that we are very much working on at SAMHSA with
partners in various States and we are supporting efforts in
developing those models.
And the other way that we do this is through some of our
training programs. We have a lot of very effective training
programs that SAMHSA sponsors and one of them is something
called Project ECHO. What that is is a program where at a site
you will have experts that get together and will be able to do
conferencing, conference calls, video conferencing, and be able
to talk with clinicians in distant areas about problems that
they are having and how to provide care to patients.
Mr. Harper. You mentioned telehealth, which obviously is an
amazing item and certainly very important in my home State of
Mississippi because University of Mississippi Medical Center
has been one of leading proponents of that for almost 15 years
that have developed that in a great way.
But then we are talking about rural America. So yes, we
have telehealth but then we also have problems with broadband
access in those same rural areas that are stretched for
resources. So we have got to come up with a plan here that
actually will help not only in law enforcement and prosecution.
And while these things are here, usually you see these people
after they have entered into a problem and are looking for
treatment and help.
We want to stop this before it can happen and so that is
why I think we are in a great need there.
We are very limited on time. Dr. Schuchat, why don't you
give me your response?
Dr. Schuchat. Yes, just to say that CDC is funding 45
States and DC right now. And in many of those States, it is the
rural populations that are being harder hit with the opioid
epidemic. We just did a report on that in our Morbidity and
Mortality Weekly Report.
But we have injury control research centers, for instance
in West Virginia, that have been doing rural pilots of
distribution of naloxone, the Kentucky coalitions that are
really looking at what works in those rural communities that
have been hardest hit. I think we heard it before that every
State is different and there are different solutions but we
have really been trying to get resources out there to the front
line so that the solutions will make sense for the communities.
Mr. Harper. And you have had a rollout of communications
program, obviously, that I know you have discussed. Is that
having the right impact? Is that going to be something that
will help on that preventive end?
Dr. Schuchat. It is just beginning and the four States that
we have just launched it in were hard-hit States, including
Kentucky, New Mexico, Ohio, and Massachusetts. Those are areas
that high burden. We are hoping, though, that it will get
rolled out much more widely.
Mr. Harper. And we look forward to seeing the impact of
that.
With that, I yield back.
Mr. Walden. I thank the gentleman.
I now turn to the gentleman from Vermont, Mr. Welch, for 5
minutes.
Mr. Welch. Thank you very much. I am delighted to have you
here and I want to talk to Mr. Doherty from the DEA.
All of us on this panel were involved in hearings on the
Ensuring Patient Access and Effective Drug Enforcement Act and
it passed out of this committee unanimously. I was one of the
co-sponsors, along with Mrs. Blackburn and Mr. Costello. And
that was the subject of a commentary or a report by 60 Minutes
and the Washington Post, both respected journalistic
organizations.
And those of us who supported the bill, and that is all of
us here, were very concerned and we want to get to the bottom
of it. In fact, I have sent a letter to Mr. Walden, the
chairman, asking for a full investigation allowing the whistle
blower to come in, allowing the DEA to get in because bottom
line, we are on the same page. We want to do everything we can
to stem the tide of illegal opioids and we want to pass
legislation that by no means handcuffs the ability of your
organization to do its job.
But I have got a chart here because I want to ask a couple
of questions. The focus of that report had to do with the
falloff in the use of immediate suspension orders. And as I
understand it, that order was one where pretty much on any
suspicion that the DEA had, they could close down a
distributor. But if you look at the chart, the reduction went
from 65 immediate suspension orders in 2011 down to five. That
was a low point and that was in 2015, correct?
Mr. Doherty. Yes, sir.
Mr. Welch. And it went up to nine in 2016. So the law that
we supported was signed into law in 2016. So here is my
question. Unless the effect of the law occurred before the
passage of the law, the law that we passed was after there had
been already a decline in the use of that tool, one of many
tools by the DEA. Is that correct?
Mr. Doherty. That is absolutely correct, sir.
Mr. Welch. So is it fair to say, because I think that we
need some reassurance on this, that the law we passed, whatever
its issues and I want to get to those, was not responsible for
the preexisting decline in the use of that tool, the immediate
suspension order.
Mr. Doherty. Sir, to answer your question, the law that was
passed in April of last year, it is too early to tell what the
demonstrative impact of the----
Mr. Welch. No, wait. I am asking something else because I
want to get to that.
Mr. Doherty. Yes, sir.
Mr. Welch. But isn't it irrefutable that the demonstrable
impact on immediate suspension orders, that those started
declining before the law was in effect in 2016? You went from
65 to 5 before the law had passed.
Mr. Doherty. That is correct.
Mr. Welch. So the law, obviously, was not what caused the
decline in the use of that tool. You had many other tools and
were using them vigorously. Thank you. Correct?
Mr. Doherty. We have many tools. You are correct, sir, yes,
we are using----
Mr. Welch. Right but the immediate suspension--because this
is the heart of the question and we really have to know. We
have to know. All of us have to know. That law that we passed
occurred after immediate suspension orders had already declined
from 65 down to 5, right?
Mr. Doherty. That is correct.
Mr. Welch. And then after the law was passed, it went up to
nine.
Mr. Doherty. That is correct.
Mr. Welch. OK. So we all want to help. And do you have some
specific legislative recommendations for our committee that we
could take that would give additional authority within the
Constitution to assist you in getting your job done?
Mr. Doherty. Sir, thank you for that follow-up. And let me
say from the diversion control perspective, we use a variety of
tools. The tool you mentioned is an administrative action and
we certainly look forward to working with Congress with
Department of Justice oversight to ensure we have the most up-
to-date tools.
Mr. Welch. Look, you have got a very important job. We
support it. Do you have recommendations, including any specific
things you suggest we should do to amend the law we passed or
even repeal the law we passed?
Mr. Chairman, I bet I speak for every single member of this
committee. We want to know that information because we would
take that up immediately.
Mr. Doherty. Yes, sir, and DEA shares your concern. And
that matter is under coordination with the Department of
Justice as we speak.
Mr. Welch. All right. We need a date certain. I mean time
is marching on. This story shocked folks and rightly so because
everybody in America is just devastated by what is happening to
friends, to family, to loved ones. OK? So, we are ready to go.
And Mr. Chairman, I will leave it up to you but we are
having a hard time, at times, getting the responses back. And
now that this question is out there about a law where the
suggestion is we did harm, not good, I think all of us want to
correct that.
Mr. Walden. Correct.
Mr. Welch. I will leave it to you.
Mr. Walden. Yes, Mr. Welch. And on behalf of the committee,
my view has always been, when we pass a bill that is just the
starting place. By the way, that is why we are having the
hearing today is to look at is CARA working. Is 21st Century
Cures Working? You need to go back and do the oversight and see
what is working. And if something is not working, we need to
know so that we can fix it.
My question is, What led to the decline in use of what you
showed there on the graph? Was there an internal decision that
led to that? Are there people that are upset about it? I mean
because that clearly all happened, as you point out, the law
ever was passed, unanimously, by the way, House, Senate,
President Obama signed it.
So the question is, Why did the agencies stop using that
tool or dramatically reduce use of that tool? That is the heart
of the matter here. Who made those decisions? But when we can't
even get basic information about who is supplying a pharmacy or
two in West Virginia nine million pills in 2 years, it leads me
to believe we have much bigger issues at stake here we also
have to deal with.
So we look forward to working in partnership with you on
this, Mr. Welch.
I will now go to the gentleman from Texas, Mr. Olson for 5
minutes.
Mr. Olson. I thank the Chair and welcome to our witnesses.
Mr. Chairman, this may be the most important hearing this
committee has in the 115th Congress because we are dealing with
life and death. Life and death. I will bet someone in this room
knows someone who has been addicted to prescription opiates.
Some in this room may know someone who has died from the
addiction. Some in this room may know someone who is addicted
to illicit opiates. I guarantee you the people watching on C-
SPAN know these people and they are hurting.
My first question is for you, Mr. Doherty. You mentioned
that the opioid prescription crisis is now expanding to other
illicit drugs, mostly heroin. It is roaring back with a
vengeance with a new synthetic sidekick cousin, fentanyl. I
have been told a piece of fentanyl the size of a grain of salt
can be lethal to a human being. It is that dangerous.
The cartels, as you mentioned, are mixing up down there
with heroin with stuff coming from China. There is no quality
assurance. It is the cartels. That poison is coming to America.
And that means it is coming across the southern border, my own
State of Texas.
I talked to our Border Patrol yesterday about their
enforcement actions. They say right now they capture about 50
percent of the traffic coming across our border. They can do
better. They will do better with more resources and support
from Congress.
But the cartels, they are good at adapting. When I was in
the Navy, we were trying to get them down in Panama. And I
would see submarines. They would come up here, go across, come
up Northern Mexico, go across by San Diego, pop up at night.
You can't see them. They dig tunnels. They can get over.
So my question is, What is DEA doing to combat the opioid
crisis coming across the border working with CBP, probably some
of the Drug Task Forces, and also local authorities? What are
you doing right now to stop drugs from coming across, the
fentanyl mixed with illicit opiates?
Mr. Doherty. Congressman, thank you for that question. I
would point directly to our Special Operations Division, our
Fentanyl Heroin Task Force. It is a multi-agency task force
that collates, coordinates, and deconflicts information across
all of the United States and all over the world, quite frankly.
And we work closely with CBP and all of our Federal, State, and
local partners.
However, as a command and control targeting center, our
SOD, Special Operations Division, is specifically designed to
look at cartel activity, and to target them at the appropriate
level, and then, obviously, bring those seizures to bear, and
follow up on leads within the domestic United States. We stand
with all of our Federal partners in combatting this and share
information on a routine basis.
I truly believe it is a whole of Government approach in
that DEA partnered with Federal, State, and local agencies. We
need to redouble all of our efforts. We can do better and we
should do better.
Mr. Olson. Another question. What is DEA doing to combat
online sales of fentanyl and new psychoactive substances via
the dark web, online sales, getting around the border?
Mr. Doherty. Thank you for the follow-up, Congressman. With
respect to online pharmaceutical sales, fentanyl sales, NPS,
new psychoactive substances, DEA has been very aggressive in
this area.
Just last month, there was a joint takedown of AlphaBay,
the world's largest dark net network for criminal activity,
however, selling fentanyl and other dangerous drugs. It was
estimated that this network earned approximately $1 billion
annually. It was a sweeping investigation with DEA, and the
FBI, and others. And we think that DEA, in partnership with
other Federal agencies, in concert with our State and local
agencies can make a difference with respect to dark net
trafficking and internet trafficking. And we will stand with
all of our partners in doing so.
Mr. Olson. Thank you. I am out of time. I want to conclude
by saying the fact that thousands of Americans have died with
these prescription drugs, illicit drugs is a collective failure
of American society. And Americans know that failure is not an
option. It never has been. It never will be. Let's get this
fixed ASAP.
I yield back.
Mr. Walden. The gentleman yields back. The Chair recognizes
Mr. Tonko for 5 minutes.
Mr. Tonko. Thank you, Mr. Chair. Thank you to our witnesses
for your work on this critical issue.
Something that keeps me up at night when thinking about
this epidemic is the so-called treatment gap, the idea that
when someone is struggling with the disease of addiction has
that moment of clarity and attempts to get help, that they will
be met with a closed door and a waiting list.
This idea is not simply theoretical. Last year I toured an
addiction clinic in my district, where I spoke to a person who
had waited over a year to get off of the waiting list to access
treatment. Nationwide, we know that only 20 percent of those
with opioid use disorder are engaged in any form of treatment.
These delays are deadly. Our Nation wouldn't tolerate a
diabetic having to wait one year to get insulin and we can't
tolerate this delay.
Now, this committee took some good first steps to address
this issue last Congress by passing legislation offered by Dr.
Bucshon and myself to expand buprenorphine prescribing
privileges to nurse practitioners and physician assistants, an
option that almost 4,000 NPs and PAs have utilized to date,
however, I believe we need to do more.
So Dr. McCance-Katz, would you agree that we currently lack
the treatment capacity that we need as a nation to take care of
everyone who is seeking help from this deadly disease without
delay?
Dr. McCance-Katz. I would agree with that.
Mr. Tonko. Thank you. And with the passage of CARA and the
new DATA 2000 regulations promulgated by SAMHSA IN 2016, NPs
and PAs are now able to treat patients with buprenorphine and
certain doctors are able to treat up to 275 patients at a time.
How has the healthcare work force responded to these new
authorities? And has SAMHSA heard any feedback from the
provider community about barriers that still exist which are
preventing additional providers from seeking a DATA 2000
waiver?
Dr. McCance-Katz. So we do have some data. What I can tell
you is we checked. As of yesterday, we have 3,656 physicians
who have asked for a waiver to prescribe to up to 275 patients.
We have had over 3,000 nurse practitioners get the DATA waiver.
And a little over 800 physician assistants get the waiver.
There are multiple reasons that people in the healthcare
professions don't get the waiver. There is still a lot of
stigma attached to the treatment. We don't do a lot of training
in medical and pre-graduate programs for advance practice
clinicians in the area of addiction medicine and so we need to
increase our workforce.
Mr. Tonko. I thank you for that.
I have heard from other advanced nursing professions, such
as certified nurse-midwives who are willing and able to provide
additional medication-assisted treatment capacity but are
prevented from doing so under current law. An expansion of DATA
2000 privileges to these professionals would, in particular,
help vulnerable populations like pregnant and postpartum women.
While this change would ultimately require new legislation to
implement, would you commit to working with Congress in helping
to examine the feasibility of including additional highly
trained medical professionals in the DATA 2000 waiver program?
Dr. McCance-Katz. Oh, yes, indeed.
Mr. Tonko. Thank you.
And shifting gears, quickly, I wanted to talk about another
population that is particularly vulnerable to opioid overdose
and that is individual reentering society after a stay in jail
or prison. I have read research that indicates that these
individuals are up to eight times more likely to die of an
overdose during their first 2 weeks post-release than at other
times.
Can anyone on the panel validate that number and provide
some context on why these individuals are at such high risk?
Dr. Volkow. This is correct. And one of the reasons why
they are at greater risk is once you actually have been away
from taking opioids, you lose your tolerance but the addiction
still persists unless you have actually attempted to treat it.
So if you don't treat it, the prisoner leaves jail or
prison and then they immediately relapse without the tolerance.
And that is why the risk of overdose is much higher. And that
is why we are proposing research that actually implementing the
medication-assisted treatment at the time of release from jail
or prison to protect them from overdosing.
Mr. Tonko. Thank you. Anyone else?
Dr. McCance-Katz. I would just add that SAMHSA has an
offender reentry program. That is one of the focuses of that
program. We are also working with the Bureau of Prisons on
identification of inmates with opioid use disorder and how to
address when they are about to leave.
Mr. Tonko. OK, might I just add -- I thank you for that. I
just want to add that I believe that Medicaid could play a key
role in improving outcomes during reentry and I hope to work
with our witnesses and my colleagues on this committee on
legislation I have introduced to explore this concept further.
In other words, providing Medicaid coverage 30 days before
release so that we can get these individuals under some sort of
structured program before they are released and at such high
risk of overdose.
With that, I yield back.
Mr. Walden. I thank the gentleman.
I will now turn to the gentleman from West Virginia, Mr.
McKinley, for 5 minutes for questions.
Mr. McKinley. Thank you, Mr. Chairman.
I tried to come up with questions that haven't been raised
so far with it and my first question primarily would be just
how much Federal resources are truly being allocated to this
issue. Do any of you have a grasp of how much money? I am
talking from NIH, CDC, DOJ, DEA. How much money are we putting
into this program nationally?
Dr. Volkow. Well, I can speak for NIH because it is
actually the agency that I am representing. And from the
perspective, for example, there are two components to it, one
of them addressing----
Mr. McKinley. Can you just give me an amount, an
approximate amount?
Dr. Volkow. For paying, we are putting $500 million on
opioid use disorders.
Mr. McKinley. Collectively. Collectively. We have a short
time. So collectively, are we talking $2 billion, $5 billion?
Dr. McCance-Katz. We have a little over $2 billion in our
block grants for substance abuse, prevention and treatment,
plus discretionary.
Mr. McKinley. But is there some way that one of you or
however can collectively come up with how much money is the
Federal allocating? Because Mr. Pallone suggested in his
testimony--in his comments we need to put more money into it. I
don't know how much money we are currently putting into it.
If I could move on to the second--so if someone could get
back to me, maybe from CDC.
Dr. Schuchat. We just have $125 million at CDC.
Mr. McKinley. Yes, OK, but collectively. Everybody, what
priority are we really setting on this issue?
Secondly, I would like to know how much money is coming to
West Virginia. We have been asking for over a year. We can't
get answers from any of you.
So here is a chart that shows it. We have opioid-related
deaths. We are the highest in the Nation at 41 per 100,000.
That is 20 percent higher than the number-two state and almost
40 percent higher than the number-three state. It is nearly
2\1/2\ times the national average. I don't understand why more
resources aren't flowing to help out a rural State like West
Virginia.
Let me give you an example, though, on the neonatal births
with opioid dependency. The national average is six per
thousand but in West Virginia it is 140, nearly 25 times worse
than the national average.
So when West Virginia applied for a grant from you all,
SAMHSA, they were denied. I would sure like to know why because
you all stood up, sat there and talked about how you are
dedicated to this issue and here we are with a desperate
situation, we are under water, and we put in a grant and we are
turned down.
We also were excluded under their first round of the CARA,
$180 million were supposed to be assured; $144 million was
distributed. West Virginia got zero in that first round.
This has got to stop, this idea coming from the Beltway,
you all sitting back here. We are on the front lines. And I
want to build back on what Harper was talking about in rural
America.
I just came from a county, Taylor County, 27,000 people,
125 arrests already this year. They have no resources from the
Federal Government for help on this. They have, for 5 years,
gotten not one dime to help out on the opioid problem they are
having in Taylor County with 27,000 people.
And then I went to another county, Preston County. Three
little towns, all collectively, between the three of them have
less than a thousand people. They don't have the resources to
have a teleconference. They don't have the resources to apply
for a grant, to seek money. They are getting zero. No money is
going to that rural county because they can't apply for it.
I would like to hear how we do this for rural America. Are
we telling them you have got to file for an application? We did
and we were denied by your group. What is the other group? Are
we telling this little counties or towns that have 200 or 300
people you have to get a grant writer to submit something for
you? They can't afford it. They don't know how to do it.
What is your suggestion? And get out of the Beltway and
come with me back into rural America to find out how this
physically works in a town of 200 people with an 84-year-old
mayor. How are they supposed to address it when they know--the
mayors talk--they know they are selling drugs in the Post
Office parking lot and they don't have a police officer in that
community to make an arrest? They physically see it every day,
drugs being sold there. How do we stop it?
I am sorry, did I miss something?
Dr. Schuchat. I can just say that CDC's funding the State
of West Virginia to work with all the counties. I am so sorry
that the people in the towns you have been reaching haven't
been getting support.
Mr. McKinley. Zero.
Dr. Schuchat. We need to do better. We are getting $2.6
million to the State of West Virginia to work statewide for----
Mr. McKinley. We have got the worst situation in the
country and we are saying file applications. Make an
application. They don't know how to make an application. They
don't have the resources to do it. There is no grant writer.
And then when we did, we were denied. Twenty-five times worse
than the national average, and we were denied on neonatal.
Someone has got to tell me what we did wrong or why we don't
deserve to have more treatment.
Dr. Volkow. And you deserve and I have actually gone to the
communities in West Virginia and Kentucky. I am going to Ohio.
I think that what we are trying to understand is the
infrastructure and create partnerships.
And also, interestingly, West Virginia learned from what
the communities have developed that actually have been
effective to help other communities with similar problems.
But you are absolutely right, the needs of rural America
are some that require special attention.
Mr. McKinley. Thank you. I yield back.
Mr. Walden. The gentleman's time has expired.
The Chair recognizes the gentlelady from Michigan, Mrs.
Dingle for 5 minutes.
Mrs. Dingell. Thank you, Mr. Chairman. I want to thank
all--I have no voice. I have no voice because I did 10 town
halls in the last district work period on opioid drug
addiction. And I thank all of you for your service.
It is a really complicated issue, which we can tell by all
the questions. And I put a human face on it. My father was a
drug addict from prescription drugs before anybody ever talked
about it or knew what it was. And my sister started young and
there is nothing that I didn't do. I know what it was like to
go look on the streets to see people selling the drugs, to have
her in and out of drug treatment centers, and ultimately she
lost the battle and died of a drug overdose.
I am married to a man, who is not going to be happy I am
saying this publicly, who this room is named after, who has a
legitimate pain need. And I have learned more about pain drugs
than I ever wanted to do and it is becoming an even more
serious problem with people with chronic disease.
And at these town hall meetings because I have said this is
a complicated issue and we have to make sure that the pendulum
doesn't go too far the other way, how do we make sure those who
need pain pills and the oncologists are coming out--I did a
town hall with Joe Kennedy last week and I have been hearing at
every town hall--and we have started community coalitions, and
we have got the law enforcement, and the police, and the
hospitals, and school teachers, and the kids all part of it.
And we have all got to be part of it.
But it is complicated and we all need to understand it is
complicated. But how do we work together to start to address
it?
So my first question, Dr. Gottlieb, I am going to address
it to you because you talked about it a little earlier. In
order to mitigate the opioid crisis, we have got to change the
paradigm.
The other point I will make before asking this question,
because there has been very little discussion about mental
illness today, and the fact of the matter is too many people
are self-medicating for anxiety and depression. And I will bet
that half the constituents in West Virginia don't have jobs.
They are turning to that for solace and now they can't get a
job. People don't understand that most of the jobs in this
country that are open are going unfilled because people are
failing those urine tests. We need to start to do some reality
but I want to make sure that people who have legitimate pain
needs are getting treated, too.
So what are we doing to change the paradigm for treating
pain and addiction in America? One way to do this is to advance
the understanding of the biology of pain and addiction in order
to enable the development of innovative treatments.
Dr. Gottlieb, how are you partnering with industry in order
to ensure that novel and safer treatments for pain and
addiction are being developed?
Dr. Gottlieb. Thank you, Congresswoman. I will just echo
your comments.
In economically and socially challenged environments where
the drugs are abundant and treatment is scarce, I think
widespread addiction only seems inevitable.
We announced a series of steps today that we are going to
take. Principle among them is trying to look at how we advance
the guidelines that we have in place to help innovators and
drug developers develop novel treatments for the treatment of
addiction. We want to advance the endpoints that we use in
those clinical trials to perhaps open up a full range of
potential treatments that can address aspects of addiction like
craving, and look at novel endpoints like perhaps reduction in
overdoses, or hospitalization.
But I will just close by saying that we also know that the
medical treatments, while highly effective, need to be
delivered in the context of psychosocial interventions and
services that help them be most effective. The evidence shows
us that these treatments are most effective when they are
delivered in the context of services and also deliver other
forms of treatment that address some of the psychosocial
aspects of addiction.
And I would just point to my colleague from SAMHSA, who was
a pioneer in developing these kinds of programs in Rhode Island
and really developed a model for how this can be done
successfully nationwide.
Mrs. Dingell. I would come back at though and we are
talking about the addiction that has happened. We need to be
developing new ways to treat pain and come up with alternatives
so we are using non-addictive pain medicine.
Dr. Gottlieb. So I appreciate the question. I might have
misunderstood it, Congresswoman.
Mrs. Dingell. Well, it is both but we need to be talking
about that.
Dr. Gottlieb. I fully agree with you and you know there are
products in development right now and products in the pipeline
that address aspects of pain through pathways that we think
might not have the same addictive potential as opioids. That,
obviously, needs to be demonstrated scientifically. We are
looking at abuse-deterrent formulations.
I would also just point out to the committee that if you
look at the clinical data on NSAID use in arthritic patients,
it went down sharply after we imposed some additional warnings
related to NSAID use. And I think we have to look at that in
the context of the current crisis because it seems intuitive
that some of those patients who might have been prescribed
NSAIDs now were prescribed immediate release formulations of
opioids instead.
And so I think we need to look at the risk benefit of all
these drugs in concert. We sought to do that with the blueprint
we advanced with respect to new educational requirements for
physicians for the first time asking physicians to be educated
not just on proper prescribing of opioids but proper
prescribing of opioids in the context of all of the available
therapy for treating pain.
Mrs. Dingell. Thank you.
Mr. Walden. I thank the gentlelady.
I will now go to the gentleman from Illinois, Mr.
Kinzinger, for 5 minutes.
Mr. Kinzinger. Thank you, Mr. Chairman. Again, all of you,
thank you for being here.
And I want to make it clear you know this is a tough
hearing I think but we know that you guys all want to solve
this problem. And you are working hard to do it whether it is
whatever agency. This is something that we wish would go away
but there is some difficulty in what we are dealing with.
You know one of the conundrums we have is the idea that
people, as was mentioned, have a legitimate need for pain
medicine. Some people find themselves addicted with that. Some
people don't. And then we very strictly regulate how that pain
medicine is put out. And in many cases they just transition to
heroin, then, because they can't get access to the drugs that
hooked them.
In fact in my district, law enforcement agencies say that
heroin is cheaper on the street than marijuana right now, which
is incredible. And that is why you see a lot of what you do.
I was just, about 3 or 4 weeks ago, I was leaving church
going to the gym. And I pulled into the parking lot and there
was a wrecked vehicle in the gym parking lot and somebody I
knew was standing outside of it. So I went over and there was a
guy, probably my age, slumped over in the car in an apparent
heroin overdose. So EMS came over, we called 911, and they
administered Narcan. And he came back and then proceeded to not
talk about what happened at all.
So I, in fact, as I think we all did, a lot of us did, in
the last district work period, we had these opioid roundtables
to hear from people what is going on. And I remember a funeral
director in LaSalle County saying that he buried his own son to
a heroin overdose and that it used to be 20 years ago they
would have one death a year related to ODing, and now it is one
a month. And he says every time he has to deal with a family
with something like this, it like reopens all his old wounds.
And so I hear all these stories. You know but I am hopeful.
There are groups like The Perfectly Flawed Foundation in
LaSalle, which is a recovery addict that started this to help
folks, or Safe Passage, which is a program in Dixon, Illinois
run by the police. So I know the communities are rising to the
challenge.
One of the concerns we have, though, is in rural areas like
my district, the access to treatment facilities. You know
usually if somebody wakes up from an overdose, or is pulled
out, or whatever, they have about maybe 30 minutes to an hour
where they want to recover. But then once that hour is up, the
addiction takes back over. And so when you have a massive delay
in being able to get people treatment, obviously in many cases
they choose, at the time they can finally get in they have
either gone back to drugs or the addiction has just taken back
over.
So I just want to kind of open it to the floor and just say
you know what are your agencies doing to kind of address the
unique challenges that are specific to rural communities. And I
know this question may have been asked already but if you guys
just want to take that over, we will start here.
Dr. Volkow. Yes, from the perspective of research, we are
actually funding researchers to develop new models of care that
actually can address the unique needs of rural communities. And
one of them is the spokes and hub, for example, where you can
have one physician with expertise actually linked with nurse
practitioners that deliver the care. The telehealth is another
approach that is actually quite widely utilized.
We are also evaluating models that will expand our ability
to provide with medication-assisted therapy, for example. In
Rhode Island, we are funding a project where the pharmacists
are actually not only dispensing the buprenorphine but actually
following it up. And that gives the visibility of touching a
much greater number of individuals. We are----
Mr. Kinzinger. Could you keep it brief because I want to
make sure everybody gets a chance here?
Dr. Volkow. So we are taking these, providing these
evidence-based treatments in communities and then we try to
transfer them, or translate them, into other communities. So we
are funding research on those in that model.
Mr. Kinzinger. OK, next?
Dr. Schuchat. Yes, I would just say that the State funding
that we give has a requirement that public health and public
safety work closely together. And what that really means is at
that local or town level you have the right people coming
together, like in that parking lot that you were talking about.
Mr. Kinzinger. Yes, sir?
Mr. Doherty. Sir, from a law enforcement perspective, DEA,
I would also say a 360 Strategy is effective in the rural
areas. We are leveraging our State, local, and district
partnerships with police departments. We have become adept,
more adept, in my opinion, at data analytics. We are putting
out threat assessments to all 21 of our field divisions to look
at every area of potential diversion of pharmaceutical
controlled substances.
DEA, along with HHS, and FBI is part of the Attorney
General Opioid Fraud and Detection Unit that is in 12 select
districts, Federal districts in this country. So we are getting
better at intelligence, sharing intelligence, providing
additional resources.
Mr. McKinley is no longer with us in the room, but I wanted
to address his concerns about West Virginia. We have devoted
tremendous resources to West Virginia in the last 2 years,
namely, an upgrade in the office in terms of leadership,
tactical diversion teams, mobile tactical diversion teams, and
data analytics. So we are very concerned, as the committee is,
with respect to rural areas and we are doing all we can. Thank
you.
Mr. Kinzinger. Thank you. And let me just conclude by
saying I am still a pilot in the Air Guard and we do a lot of
border stuff. And the amount of drugs coming over the border is
just absolutely mind-blowing.
With that, I will yield back.
Mr. Walden. I thank the gentleman.
I will now turn to the gentleman from New Mexico, Mr.
Lujan, for 5 minutes. Mr. Lujan?
Mr. Lujan. Mr. Chairman, thank you very much. I really
appreciate you calling this important hearing, Mr. Chairman,
and I think I will begin where Mr. McKinley left off.
I also represent a rural district, 47,000 square miles
across the entire Colorado border, Arizona to New Mexico. I
have heard at least two of the witnesses today talk about
resources that they are taking to the State. We have a problem.
And people at home don't feel like they are getting help. There
is a big concern.
I would highlight the handout that the CDC gave us today,
which those red dots that follow that top brown dot show that
there is 18 for every one; 18 heroin users for every one that
we are also seeing with prescription or illicit opioid deaths
in 2015 alone.
Even as we take a step back, Mr. Chairman, I think that you
know sometimes we need a history lesson, understanding that we
tried to curb opium use and addiction in the 1800s. There was a
response by a drug manufacturer in Germany to come up with
morphine. And then in response to the morphine epidemic that we
saw across America, a drug manufacturer said well, in 1874, we
have another answer and it is called heroin. We will
manufacture that and we will ship it to the United States.
Then in 1937, another manufacturer said well, we can come
up with methadone. And that hit the streets and hit the
communities.
This isn't a new problem. And I just hope that we are
asking are we doing something different.
I appreciate the testimony associated with looking at non-
addictive pain treatment. There is a letter, Dr. Gottlieb, that
I sent to you. I appreciate your testimony today, the work that
you are doing. I just put that on your radar so that way we can
work with your team to get a response. And it is in the area of
non-opioid drug products.
We need to have something game-changing with all that we
are doing in this space. We can't repeat what was done in 1800,
and 1847 to 1850, to 1874, to 1927, and then 1947, and we
wonder why people are dying in our communities. They are
getting the same stuff.
But that heroin that is coming in, we know that 90 percent
of those poppies are grown in Afghanistan. We know that less
than four percent of that is making its way to the United
States. We know that Southeast Asia heroin is coming into the
United States as well. We also know about the heroin from
Mexico and from South America.
We also know that it is coming in through Canada. It is not
just the southern border. It is the norther border and it is
the ports.
We have a huge problem. And I hope that when we talk about
the expansiveness of what we are dealing with that we look at
it through that lens.
And I just, in the limited time that I have, one question
that I wanted to bring to your attention is, like many of our
colleagues, I went to visit a few facilities this last week.
One is in Espanola, New Mexico in Rio Arriba County. It is
called Hoy Recovery. Some incredible leaders committed to our
community but, Mr. Chairman, this is going to impact all of us
in rural communities.
They told me about a few of these grants that they were
going after, one in particular, by the way, that was trying to
get someone to help them go after additional grants for
capacity building but they were told that because they didn't
have the person to write the grant that they were trying to get
to expand capacity, that they didn't qualify.
Another one that said that unless they were serving a
community of 100,000 people, that they wouldn't qualify. These
are small rural towns.
We have got a problem and I am hoping that we can get a
commitment to work with you, Dr. McCance-Katz, to work with you
on this issue.
And then the last question I would ask is the budget that
you all submitted to us on behalf of the administration, are
you getting what you need to do what we are talking about
today? Yes, no?
Mr. Doherty. Sir, from a DEA perspective, we fully support
the Department of Justice budget that we are a part of. Some of
our major initiatives with respect to cartel infrastructure
investigation, intelligence initiatives, and the----
Mr. Lujan. Let me just interrupt, Mr. Doherty. It is not
necessarily towards you, sir. This is towards the others around
the table.
The Trump administration budget cuts HHS by 60 percent. The
CDC gets cut by 17 percent. The National Institutes of Health
gets cut by 19 percent. The funding for addiction research
treatment and prevention, even the White House Office on
National Drug Control Policy takes a hit.
So we are talking about not enough out of here. And I know
we need to be smart. These are tough times. I get that. But as
we dig in here and, Mr. Chairman, the impacts to these rural
communities and what we can be doing across the country, this
hearing and pulling everyone in here is critically important.
And I just thank the chairman. I will submit my full
statement and all my questions into the record, Mr. Chairman.
Mr. Walden. Without objection.
Mr. Lujan. But please, we need your help in a profound way.
Mr. Walden. The gentleman's time has expired. I thank the
gentleman.
We will now go to the gentleman from Virginia, Mr. Griffith
for 5 minutes.
Mr. Griffith. Thank you very much, Mr. Chairman.
Mr. Doherty, isn't it true an immediate suspension order is
a law enforcement tool that can empower the DEA to freeze
suspicious narcotics shipments from companies? Yes or no,
please.
Mr. Doherty. Yes, sir.
Mr. Griffith. Thank you. And isn't it also true that a
similar enforcement measure would be a show cause order?
Mr. Doherty. Yes, sir.
Mr. Griffith. Thank you. And all these questions are going
to be yes or no. Thank you.
The DEA told this committee, in response to an Oversight
request dated May 8, 2017, that the ``DEA is unaware of
documents related to delayed or blocked enforcement actions and
suspension orders.''
Over the last 6 years, have there been enforcement actions
proposed by DEA personnel that were not approved by DEA; yes or
no?
Mr. Doherty. Yes.
Mr. Griffith. And if you could detail those for me at a
later time, I will follow up with that after the hearing.
Over the last 6 years, to the best of your knowledge, was
there any communication within the DEA about suspension orders;
yes or no?
Mr. Doherty. Yes.
Mr. Griffith. Likewise, we will want to get copies of
those. Thank you.
Over the last 6 years, to the best of your knowledge, were
there any communications at DEA related to additional evidence
needed to support a proposed suspension order that resulted in
delays; yes or no?
Mr. Doherty. I am not sure of that, sir. I would have to
check.
Mr. Griffith. I would appreciate that.
Over the last 6 years, to the best of your knowledge, as a
DEA enforcement official, when a DEA enforcement action is
approved or not approved, was such a decision ever communicated
writing; yes or no?
Mr. Doherty. I would have to check on that as well, sir.
Mr. Griffith. All right.
Over the last 6 years, to the best of your knowledge, has a
DEA enforcement official, when there were discussions by DEA
enforcement officials with DEA attorneys about the need for
additional evidence in an enforcement action, would such
concerns only be conveyed verbally and never in writing; yes or
no? Were these communications oral only?
Mr. Doherty. No.
Mr. Griffith. No. So there are some written documents is
what you are telling me; yes or no?
Mr. Doherty. So are you referring to documents that would
request additional evidence, sir?
Mr. Griffith. Yes, sir.
Mr. Doherty. Yes.
Mr. Griffith. They were all oral or there are writings?
Mr. Doherty. There would be documents----
Mr. Griffith. Thank you.
Mr. Doherty [continuing]. That would have requested case-
related evidence.
Mr. Griffith. Thank you.
Do you an attorney in the DEA by the name of Clifford
Reeves; yes or no?
Mr. Doherty. Yes, sir.
Mr. Griffith. And did you ever have any communications with
Mr. Reeves about cases brought by the DEA's Diversion Control
Office; yes or no?
Mr. Doherty. Yes, sir.
Mr. Griffith. And were any of these communications with Mr.
Reeves in writing; yes or no?
Mr. Doherty. Yes, sir.
Mr. Griffith. Is it your experience with DEA lawyers that
they never communicate in writing?
Mr. Doherty. No, sir.
Mr. Griffith. Thank you.
Both 60 Minutes TV program and the Washington Post, in
their reporting, featured former DEA law enforcement officials
such as Mr. Jim Geldhof, who detailed their concerns about the
handling of enforcement cases at the DEA.
Because of your denial of documents to this committee,
should we assume that these officials never put anything in
writing about their concerns while they were at the DEA; yes or
no?
Mr. Doherty. Sir, having not been assigned to the Diversion
Control Division at that time, I don't know what the
correspondence would have been. I don't have the background to
answer that question.
Mr. Griffith. You don't have the correspondence, don't have
the background, but it would be--OK, never mind.
Are you familiar with DEA's Chief Administrative Law Judge
John Mulrooney; yes or no?
Mr. Doherty. Yes, sir.
Mr. Griffith. And were you aware that the Washington Post
reported that Chief DEA Judge Mulrooney wrote in a 2014
quarterly report that there was a decline in the number of
orders to show cause or enforcement actions by the DEA?
Mr. Doherty. And what was the date of that, sir?
Mr. Griffith. June 2014.
Mr. Doherty. I am unaware of that, sir.
Mr. Griffith. You are not aware of that.
Would such a quarterly report be in the form of a written
document; yes or no?
Mr. Doherty. Yes, sir.
Mr. Griffith. Mr. Doherty, did you play any role in the
development or clearance of the answer to the committee that
``DEA is unaware of documents related to delayed or blocked
enforcement actions and suspension orders?'' Yes or no?
Mr. Doherty. No, sir, that was provided by my staff, by the
Diversion Staff.
Mr. Griffith. By the Diversion--somebody that works under
your division?
Mr. Doherty. Someone that works in the Diversion Staff,
yes, sir.
Mr. Griffith. All right. Mr. Doherty, were you asked to
search your documents in your possession to respond to the
committee's request; yes or no?
Mr. Doherty. I don't believe I was asked directly, sir.
Mr. Griffith. And do you personally have emails or document
going back to 2011; yes or no?
Mr. Doherty. Yes, sir, but not on this subject. So I have
documents from my employment prior to my assignment to the
Diversion Control Division, yes, sir.
Mr. Griffith. All right, thank you.
And do you know if there was--because former Agent Jim
Geldhof told the Washington Post that before Reeves' arrival in
the DEA Diversion Control Office in December of 2012, DEA
investigators had to demonstrate that they had amassed a
preponderance of evidence before moving forward with criminal
enforcement cases which are administrative not criminal? And
prior to December 2012, was there a preponderance of evidence
standard for enforcement cases on opioid distribution; yes or
no?
Mr. Doherty. Yes.
Mr. Griffith. Was that standard later changed to a beyond a
reasonable doubt standard; yes or no?
Mr. Doherty. I am not aware of that change, sir, no.
Mr. Griffith. All right, I appreciate you answering the
question. I see that my time has expired and I yield back.
Mr. Walden. I thank the gentleman.
All right, so we go to Mr. Cardenas next, is what I am
instructed. So the gentleman from California. I will let you
two fight it out, but----
Mr. Cardenas. We are both from California.
Mr. Walden. Yes, there you go.
Mr. Cardenas. Well, thank you, Mr. Chairman. I appreciate
this opportunity for us to bring this important issue before
the public with so many of our dedicated Federal individuals in
various departments who are somehow involved in making sure
that we get in front or on top of this epidemic.
My first question is, Is there anybody on the panel that
would like to defend whether or not we, in the United States of
America, were in front of this issue and on top of this issue
and it is already getting under control?
[No response.]
Mr. Cardenas. So the answer is no. OK. So we have much work
to do, correct?
Is part of the effort of making sure that we go from
crisis--I would like to describe it as a crisis. I don't know
if anybody on the panel is saying that it is not a crisis.
Does anybody on the panel want to defend that it is not a
crisis in the United States at the moment, this opioid
epidemic?
[No response.]
Mr. Cardenas. OK. So that being the case, if we, Congress,
were to reduce the access, or in some way by policy, or
allowing the providers of health care out there in the United
States to reduce the current level of care, such as mental
health and/or substance abuse care that is now afforded
individuals since the ACA has now become law, if we were to
reduce that, would that make the situation better or worse in
the United States for individuals and families who are faced
with this crisis?
Would anybody like to say whether it would be better or
worse if we were to roll back the current status within the ACA
law that many insurers today are now providing more substance
abuse and mental health services today that they were not
providing before the ACA?
[No response.]
Mr. Cardenas. Anybody that would like to say or give me an
example of whether or not you believe it would be better to
reduce those benefits to millions of Americans or worse?
Please.
Dr. Volkow. Well I think that evidently we need to address
the treatment needs of those that are suffering from an opioid
use disorder if we are going to solve the problem and we need
to prevent the overdoses. But we also need to look at the
structure and understand how changes that we are making
ultimately are having an impact and that is where the data is
still lacking.
And I was expecting that there would be a significant
increase in number of individuals given access to opioid use
disorder with the expansion of the insurance to these
individuals. And what is surprising is because many of these
treatment programs don't have the knowledge of how to get
reimbursement, something as simple as that, they are not taking
advantage of it.
So my perspective in all of this is that we need to create
a structure that will increase the likelihood of people that
are suffering from the disease to get treatment. That is what
we need to achieve.
Mr. Cardenas. OK. So if we were to reduce the access, that
would not help, correct?
Dr. Volkow. Anything that decreases access that does not
provide an alternative--that does not provide an alternative--
--
Mr. Cardenas. Would it make the situation worse?
Dr. Volkow. If it does not provide an alternative. And all
evidence, good quality care, if you don't provide that,
anything that doesn't provide that will not help us address the
crisis.
Mr. Cardenas. Will it make it worse; yes or no?
Dr. Volkow. Without, it is----
Mr. Cardenas. OK, I am sorry. I only have 1 minute left.
I contend that it would make it worse. I contend that it
would make it worse. I understand that you went into a bit of
a--tried to go into detail in a limited amount of time as to
the some of the issues that we still have yet to tackle. But I
truly do believe that, for example, by repealing mental and
substance--access to substance abuse disorder coverage,
provisions that are currently in the ACA, this would impact
working families across America.
And one last question that I would like to ask in the
limited time. Please point out to me what community in the
United States of America is immune to this crisis. Has this
affected every strata of the United States' individuals? Are
rich people immune? Are poor people immune? Are people who work
for a living immune? Are people who work on Wall Street immune?
My point is this, ladies and gentlemen: This is something
that is affecting every part of America, and it is, in fact, a
crisis. And I would venture to say that this was a crisis in
what we believed--and we were wrong--we believed that this was
a crisis of poor communities. And this has always been an
American crisis, and it is about damn time that we are actually
facing this. But Congress has a lot of work to do, and with it
comes the resources necessary to combat this crisis.
I yield back.
Mr. Walden. The gentleman yields back.
The Chair recognizes the gentleman from Florida, Mr.
Bilirakis, for 5 minutes.
Mr. Bilirakis. Thank you, Mr. Chairman; I appreciate it.
And I really appreciate you holding this hearing. You know, I
am glad for the most part it is a bipartisan hearing and this
is a major issue. I can't think of a more important issue to
tackle.
So but I want to start with Mr. Doherty, if that is OK. The
law has been written again about the Ensuring Patient Access
and Effective Drug Enforcement Act. I want to take the
opportunity to ask you a couple of questions. Yes or no,
please, because of time.
Was DEA part of the negotiation for the final language of
this particular bill?
Mr. Doherty. Yes, sir.
Mr. Bilirakis. OK. Did DEA recommend that President Obama
veto the bill?
Mr. Doherty. No, sir.
Mr. Bilirakis. OK. Has DEA made any communication to this
committee, this particular committee, Energy and Commerce
Committee, about the need to change statute?
Mr. Doherty. Not to my knowledge, sir, no.
Mr. Bilirakis. Did DEA include any requests for statutory
changes in their budget submission this year, dealing with this
particular law?
Mr. Doherty. Not to my knowledge, sir.
Mr. Bilirakis. OK. Has DEA's ability to enforce our
Nation's drug laws been compromised because of the passage of
this particular bill?
Mr. Doherty. This changes the way we look at the ISO, sir,
but we use an array of other tools.
Mr. Bilirakis. All right. Let me ask you this briefly
because I have other questions.
Give us suggestions. Talk to us. We want to do the right
thing. We all, everyone on this panel, wants to do the right
thing and solve this public health crisis. I commend the
President for addressing it tomorrow, as well.
So, please, give us suggestions. We need to know the tools
that you need to handle this. We are on the same team with
regard to this. So please, I want you to respond to me,
personally, but I am sure every member of the committee,
particularly the chairman, would like a response as well.
OK, Dr. McCance-Katz, currently there isn't a clear
standard for medication-assisted treatment, MAT, prescribing.
And we have heard reports of an increasing number of rogue
actors offering MAT. In many cases, these popup clinics
actively recruit vulnerable client populations to provide
substandard service with minimal oversight.
While we support consumer choice and market competition, we
also want to balance this with the consumer safeguards to
ensure that this problem improves and not worsens--so we need
to solve this--and that bad actors are not rewarded via Federal
dollars.
Additionally, questions have been raised as to whether
States are requiring evidence-based practices to be used in the
STR Grant Program.
The question is, What is SAMHSA doing to ensure rogue
actors are not the recipient of Federal dollars and evidence-
based practices are being used so that the funds expended go to
providing the best possible treatment and recovery services?
Dr. McCance-Katz. So, as I mentioned earlier, we have a
program in place to review the State plans. The States make the
decisions about what providers in their States they wish to
fund with dollars that SAMHSA has oversight for. And we assist
them with determining and making sure that evidence-based
practices are being used.
In terms of the kinds of rogue providers that you
mentioned, SAMHSA has purview over a couple of things. One, we
regulate opioid treatment programs and, two, we also certify
physicians and other practitioners named in law that can
provide office-based treatment of opioid use disorder, nurse
practitioners, physicians' assistants. So we regulate and
manage that.
However, we don't have, we do not have any jurisdiction
over these other types of providers within States. What we do
is we try to inform States about what constitutes best
practices so that they can decide how they want to regulate
within their boundaries.
Mr. Bilirakis. Thank you.
A question for Commissioner Gottlieb. Last August, FDA
authorized a blog post titled FDA Supports Greater Access to
Naloxone to Help Reduce Opioid Overdose Deaths. I know you are
familiar with that.
Can you provide this committee with an update on the
development of any over-the-counter version of naloxone?
Dr. Gottlieb. We have had conversations with a number of
sponsors about naloxone over the counter. And as you know, we
are working on an actual use study, where we would, I think for
the first time, actually publish in the Federal Register the
specifications, the scientific specifications on how a sponsor
could demonstrate that a product can be properly labeled for
the purposes of bring it over the counter.
So rather than putting the obligation on the sponsors to go
out and do that study, we would proactively, effectively
publish the specification that they can follow to help
facilitate a more rapid entry of an OTC alternative into the
marketplace. And we are fully committed to that and working
pretty actively on it.
Mr. Bilirakis. I appreciate it. Please, we need to work
together and solve this problem. It is a real crisis in this
country.
Thank you very much and I yield back.
Mr. Walden. The gentleman's time has expired.
The Chair recognizes the gentleman from Iowa, Mr. Loebsack,
for 5 minutes.
Mr. Loebsack. Thank you, Mr. Chair. This is one of those
rare opportunities that we can take here in Congress, where we
all have the same concerns, I think. And we may differ about
how to resolve the problems but we share the very same concerns
about this crisis.
You know this epidemic is more than tragic, I think, and it
has hit every corner of America, rural, urban, suburban areas
alike. I am in a rural area. I have got 24 counties in my
district. The Chair likes to remind me that his district is
bigger than the whole State of Iowa but, nonetheless, I have
got a lot of rural areas.
And I get around. This weekend, I am going to go with the
police chief or one of his deputies, a small town in Iowa, in
Pella, Iowa. And I hear these stories all the time more and
more. I have been in--this is my 11th year now and we really
didn't think too much about opioids at that time but, clearly,
we do now.
Just some quick numbers, according to the University of
Iowa. In the past 15 years, heroin deaths have increased nine-
fold in the State of Iowa and prescription opioid overdose
deaths in Iowa have quadrupled since 1999.
Clearly, we have got to do more about this. And maybe some
folks--I have to go sort in it now, maybe some folks have
covered kind of the rural aspect of this but given that I
represent so much rural area and I do hear of the same concerns
in rural America as I do in some of my bigger towns and
probably the bigger cities in the country.
What are the differences, if there any, and I will open
this up to the whole panel, that you are seeing in the rural
opioid crisis compared to urban counterparts? And given the
differences, if there are any, how do your agencies--how do you
strategize, if you will, for rural communities? How do your
rural community strategies differ from our urban areas?
I am going to open that up to whoever wants to answer that
question.
Dr. McCance-Katz. So we know that we have difficulty with
getting providers to rural areas.
Mr. Loebsack. Definitely.
Dr. McCance-Katz. And so we, as I mentioned earlier, we try
to use innovative ways of reaching individuals by extending the
ability of a practitioner, say in an urban area, to reach out
to rural areas and provide care.
We also try, as best we can, to leverage primary care. We
do a lot more work now with integration of behavioral health
care into primary care settings, which rural areas still don't
have as much as they need but are much more likely to have
primary care services often than they would behavioral health
services.
Mr. Loebsack. And I have a bill that attempts to address
that by providing more behavioral health training for those
primary care folks as well.
Dr. McCance-Katz. And so that is where I was just going to
go with that and talk about that we do have programs. We do
work very hard to expand those programs as best that we can and
we agree that that is one of the keys to providing care to
those communities.
Mr. Loebsack. Thank you. And we did have, unfortunately,
have something happen a few years back. Our Governor did close
down a couple of mental health institutes and one of them also
dealt with substance abuse. And so that dual purpose is really,
really critical, clearly there.
Yes, anyone else? Yes.
Dr. Schuchat. Just to say CDC has been doing a series of
tracking the health issues in rural America and there are a
number of disparities. The opioid overdose problem has now
started to be worse in rural areas than urban or metropolitan
areas and there are a number of other chronic conditions that
are worse off. The solutions are probably going to be
different. And one of the things that we do is support States
to get better data that is locally granular and to track
interventions into the hot spots, if they are rural, or urban,
or suburban.
Mr. Loebsack. So that is great. We have got to have good
data. There is no question about it.
Yes, anyone else?
Dr. Volkow. So and we are planning also pilot trials to
actually address the unique needs of the rural communities in
places that have been hard hit by the epidemic to try to
understand why the interventions are the most effective.
Mr. Loebsack. Right. And when meth was--and meth is still a
problem but when that was a real problem, even greater than it
is now, it hit rural areas big time. There was a lot of cooking
of meth that was going on at that time, too. We cracked down on
some of that through some State laws but you know, again, we
can't leave out the rural areas. I think that is the important
thing to keep in mind. We don't hear much about them but it is
important for someone like me to continue to voice those
concerns.
So thanks to the panel. Thank you, Mr. Chair, I really
appreciate it. Thanks, everyone.
Mr. Walden. Thank you, Mr. Loebsack, I appreciate it.
The Chair now recognizes the gentleman from Ohio, Mr.
Johnson, for 5 minutes.
Mr. Johnson. Thank you, Mr. Chairman, and I thank the
panelists for being here today. This is a critical, critical
issue that we are talking about.
In my district, as in so many communities around the
country, the opioid and drug abuse epidemic is a blight that is
infecting and engulfing entire communities.
We here on the Energy and Commerce Committee did some
important work when we passed the 21st Century Cures Act and
CARA on a bipartisan basis last year, but we can't rest on our
laurels. There is a lot more work to do. We must ensure that
our efforts empower communities, healthcare providers,
patients, and families to fight back against this vicious cycle
of substance abuse.
I recently visited an organization called Field of Hope. It
is a facility, a faith-based, nonprofit treatment facility in
my district. It is founded by a father whose daughter struggled
with and eventually overcame addiction herself and now she
works in the facility there.
And in hearing the stories of the dozens of men, women, and
children impacted by the work done by organizations like the
Field of Hope, it becomes glaringly apparent that we are in
danger of losing an entire generation. I mean hundreds of
Americans are dying every day as a result of this epidemic and
many of those people are in some of the most impoverished, low-
income, high unemployment places around our country.
Too many people began their slide into addiction as young
people, as young as 12 years old, through prescription drugs
for a sports injury, or getting in with the wrong crowd, or
even taking what parents think are safe medications over the
counter for common cough and cold. We see that happening, too.
So many of the testimonies document years of unrealized
potential, frayed or destroyed relationships, and physical,
emotional, and spiritual suffering but the testimonies also
speak to the hope and the joy of recovery, if only people have
access to the resources and the support that they need.
And I am proud of the work that we have done on this
committee and I am grateful, Mr. Chairman, for the continued
focus that our committee is putting on it.
So Dr. Gottlieb and Dr. Volkow, innovative non-opioid
treatments for pain are being developed that can prevent
addiction before it starts. How can we better align the
approval process with Federal reimbursement policies for
approved medications and devices so that, once new treatments
are approved, patients are not barred from accessing them
because they are not covered by Medicare, for example?
Dr. Gottlieb. I can start, Congressman. I echo your
sentiment. I think the Nation has weathered epidemics before
but the current affliction is very different and very
pervasive.
We don't speak specifically to issues of reimbursement but
it is the case that a lot of the drugs that are most commonly
used are now generic drugs and they are very inexpensive. So
you do see preferential treatments on formularies for some of
the drugs that are more addictive, or lack the abuse-deterrent
formulations.
We have taken steps recently, we will be issuing a final
guidance document to delineate a more efficient pathway to
bring generic versions of abuse-deterrent formulations to the
market. And we have also taken steps to try to facilitate non-
addictive forms of pain relievers. But it will be the case that
some of those newer drugs will be more expensive than the older
formulations and I think we need to think about how we provide
incentives for those to be used, perhaps preferentially, if we
think the public health outcome is going to be better.
Mr. Johnson. OK, my time has actually expired but can Dr.
Volkow respond as well?
Mr. Walden. Yes.
Dr. Volkow. Yes, and I will just echo what Dr. Gottlieb
said. And that is why in this public-private partnership not
only are we working very closely with the FDA but it is
important that we work with CMS. Because it is not just in
terms of the patients being prescribed but in order to
incentivize pharmaceuticals to develop products to invest, they
need to have assurance that there will be a mechanism by which
they are going to be able to recover their investments.
Because if we are going to develop an opioid that has much
less vulnerability for abuse, diversion, and addiction, this is
going to be more expensive but no one is going to cover for it,
then they don't even start there. So it is also at the essence
of being successful in getting them engaged in development of
other medications.
Mr. Walden. The gentleman's time has expired.
Mr. Johnson. Thank you, Mr. Chairman.
Mr. Walden. I recognize the gentleman from Maryland, Mr.
Sarbanes, for 5 minutes.
Mr. Sarbanes. Thank you, Mr. Chairman. I want to thank the
panel.
Dr. Volkow, I want to thank you for your terrific work. I
had the opportunity, as you know, to come out to Bayview and
see some of the research that is being done there, particularly
with respect to kind of the brain response to these various
medications and opioids and so forth and how we can use that
research to develop effective responses to it.
I also want to thank you, Ms. McCance-Katz in terms of your
describing the importance of making naloxone available. I was
proud that we were able to have included in one of the bills
that we passed here on the Hill, a demonstration program to
look at the co-prescribing of naloxone. And that is an
important best practice, I think, for physicians to take up.
And as more physicians are examining their practices, we can,
hopefully, make some progress in addressing this crisis.
So thank you for referring to that. And that was a very
bipartisan approach I wanted to add.
I wanted to focus a little bit on the issue of workforce
because I have been very focused for many years now on the kind
of workforce side of our healthcare system and whether we have
adequate people to provide whatever the particular care needs
are but in this context, it is around the issue of treatment.
And certainly we heard from Commissioner Gottlieb about some of
the important medication responses that can be undertaken in
response to this crisis and that is a critical component of it.
But I am interested in hearing from you about what we need to
do with some of these other treatment elements.
I mean who are the kinds of professionals that need to be
deployed as part of robust, meaningful treatment programs that
can make a difference? I think, Dr. Volkow, you talked about
key elements, being addressing the stigma, the lack of
treatment slots in a lot of these programs, the lack of
reimbursement for certain kinds of things.
So let me ask--why don't I start here? And then any others
who want to come, I invite your perspective on the workforce
side of this. Are there gaps? Are there shortages? Which of the
kinds of professionals along the care continuum that we need to
respond to this crisis where we have got put more resources,
recruit people into this?
Dr. McCance-Katz. Well there definitely are gaps. We have,
I don't have the exact number but I will guess around 10,000
physicians who are addiction specialists in this country. We
graduate only 1200 psychiatric residents a year to go into
psychiatry, a very high-need area, where a lot of addiction
work is done. We don't have enough advance practice clinicians.
But what we need to do, one of the ways we can address
this, is to integrate better addiction curriculum into the pre-
graduate training. I actually wrote about a model that my
colleagues and I at Brown University developed for our medical
school, where every medical student will graduate qualified for
a DATA waiver. And we do that through the addiction curriculum
that we have put into our medical school. This not only makes
people eligible to practice, once they become residents that
are fully licensed with the DEA registration, but it also
legitimizes addiction treatment. It makes addiction treatment a
regular part of medical care, regardless of specialty. We need
to do that in all medical schools, in all advance practice
clinician programs, and we also need more psychologists, more
counselors, more peer professionals. We lack all of these and
it is one of the reasons-
Mr. Sarbanes. I would love to get more information from you
on that initiative.
Dr. Volkow, I am going to run out of time so maybe I will
just come to you. You talked about sort of the psycho-social
services component of the treatment response.
Can you speak to the needs we have there in terms of the
workforce?
Dr. Volkow. One of the issues that has been brought up in
the opioid crisis is yes, we over-prescribe opioids in our
country. But the question is, What allowed it to disseminate so
rapidly? And there is this concept of addiction being a disease
of distress, and the fact that we have addiction is very, very
frequently comorbid with mental illnesses, and there is some
diseases that relate to adverse conditions that make you
vulnerable.
So as we are discussing the opioid crisis, we need to be
mindful that we are going to need to have interventions that
address those behavioral needs and psychological and
psychiatric needs that many of these patients have.
Mr. Sarbanes. Thank you. I yield back.
Mr. Walden. The gentleman yields back.
Just for the committee and for our witnesses, who I am sure
would appreciate a break here at some point, we are going to go
to Mr. Bucshon for 5 minutes.
We have votes on the House floor that have been scheduled.
So we will take a break. I think we have got three or four
votes; probably half an hour, 45 minutes before we would
reconvene. Dr. Burgess will take over as subcommittee chair and
run the remainder of the hearing.
So there are Members I know who want to ask some additional
questions. So, Mr. Bucshon, we will go with you, then we will
recess, then we will return after the votes.
Mr. Bucshon. Thank you, Chairman.
The question is for Dr. McCance-Katz. Section 303 of the
CARA Act, which I co-authored, requires that all office-based
providers of addiction treatment have, and I quote, ``the
capacity to provide directly, by referral, or in such other
manner as determined by the Secretary,'' all drugs approved by
the FDA for the treatment of opioid use disorder and
appropriate counseling and appropriate ancillary services.
What has been SAMHSA's role in implementing this particular
statute in CARA?
Dr. McCance-Katz. Yes, so SAMHSA has implemented the
required 24 hours of continuing education for nurse
practitioners and physician assistants who wish to obtain a
waiver for office-based treatment of opioid use disorder and we
manage these. We keep the certifications. We provide that
certification to the practitioners. And we continue to provide
ongoing education through our provider clinical support system
for medication-assisted treatment.
Mr. Bucshon. OK, that is not specifically what I asked but
so what is the current status of fully implementing Section
303?
Because you described expanding providers that are
available but you haven't implemented what the providers
actually have to do. I mean because--is that true or not true?
The capacity to provide direct, by referral, or such other
manner determined by the Secretary for all treatment options.
Does that make sense?
Dr. McCance-Katz. Yes, so the education, the waiver
education requires that all forms of approved medication-
assisted treatment be taught.
Mr. Bucshon. OK because I am just being told that you
haven't implemented a lot of Section 303.
Dr. McCance-Katz. We have implemented all of Section 303.
Mr. Bucshon. OK, then I stand corrected.
Within 18 months of enactment, HHS is required to update
the practice guidelines for office-based treatment settings so
as to conform with Section 303. What is the status of the
practice guidelines?
Dr. McCance-Katz. I got to SAMHSA 2 months ago. I will tell
you that I have reviewed that document. That document, in my
opinion, needs additional work but it is in the clearance
process and we will get that done.
Mr. Bucshon. Very good to hear that. Thank you very much.
Mr. Doherty, what percentage of illicit drugs that are in
the United States come across our southern border, do you have
any idea?
Mr. Doherty. Sir, I could not give you an exact percentage
but we determined that the Sinaloa Cartel, who currently has
the control of the U.S. market share for heroin and now,
alarmingly, fentanyl, they control a predominately large
portion of the southwest border in terms of importation routes
and transportation routes.
Mr. Bucshon. So at least for them, it is 100 percent?
Mr. Doherty. Yes, sir.
Mr. Bucshon. And so do you think we are doing enough to
stop it?
Mr. Doherty. Sir----
Mr. Bucshon. That is not a criticism, by the way. I mean
overall, as a country, do you think we doing enough to stop it?
Mr. Doherty. Sir, as a DEA agent for 28 years and someone
that worked in Arizona and knows the border area, I would say
that a comprehensive strategy, one that involves technology and
power, boots on the ground, as well as intelligence is crucial
to stopping the, for lack of a better term, polycriminal
organizations, ones that traffic in drugs, humans, contraband,
weapons along our southwest border.
So we would stand with all of our Federal, State, and local
partners in coming up with new innovative solutions; however,
it has to be a comprehensive approach, sir.
Mr. Bucshon. Yes, I don't want to cause you too much grief
but is a physical barrier part of that?
Mr. Doherty. Sir, again, it would have to be a
comprehensive strategy and any measure that would lend itself
to stop drug trafficking and other means of illegal activity
from entering the United States, fold into an overall approach.
As I said, technology, manpower, and intelligence I think would
be beneficial.
Mr. Bucshon. Great. Thanks for that.
So I don't think we can overstate the importance of
decreasing the demand for the product but also it is very
important to prevent the supply. And I would encourage all my
colleagues across Congress to work with the administration to
secure the southern border using, as described, a multi-pronged
approach, which may or may not include a physical barrier, and
to quit actively preventing the administration from trying to
secure the southern border.
With that, Mr. Chairman, I yield back.
Mr. Walden. The gentleman yields back.
I recognize the gentleman from New York.
Mr. Tonko. Mr. Chair, I ask that three letters be included
in the record. They include the American Hospital Association,
a second from Protecting Access to Pain Relief Coalition, and
finally, the American Society of Addiction Medicine.
Mr. Walden. Without objection, they will be entered into
the record.
[The information appears at the conclusion of the hearing.]
Mr. Walden. For our witnesses, we probably won't be back
for half an hour. So if you want to grab something to eat and
whatever else, probably at least a half an hour before the
committee starts, probably closer to 2:30.
And Dr. Burgess will take over there because I know we
still have members that want to ask questions.
So with that, we will stand in recess.
[Recess.]
Mr. Burgess [presiding]. Very well, I will ask everyone to
take their seats, and I will call the subcommittee back to
order.
When the subcommittee adjourned for votes, pending for
questions was Dr. Raul Ruiz. So we will recognize Dr. Ruiz for
5 minutes for questions, please.
Mr. Ruiz. Thank you, Mr. Chairman. Welcome back, everybody.
I hope you had a little nice break. I would like to thank all
the witnesses for joining us.
Many of you know I am an emergency physician. I have taken
care hundreds of patients who have come in respiratory arrest
from opioid overdose. I have taken care of toddlers who
accidently got into the cabinet. I have taken care of
adolescents and young adults who took it for the high, while
they were partying. And I have taken care of seniors who have
gotten addicted throughout the time because of chronic pain
usage of opioids and took that extra sedative to help them
sleep, you know the sleep pill, and also maybe a little
cocktail, two cocktails at night. The next thing you know, they
stop breathing during the night, and their spouses wake up, and
they are blue, and they bring them into the emergency
department.
And most of the time, we are able to resuscitate and put
them on mechanical ventilation, give them the appropriate
medication soon enough to reverse it but sometimes, it is
unfortunate, they are pronounced dead on the field or, after an
incredible amount of resuscitation, their hearts don't come
back, and so we can't get a beat, and we have to pronounce them
dead.
So this is something that I know firsthand in the community
and in emergency departments that we are faced with. And I am
extremely proud of our first responders who, in the patient's
home, in the streets, at the clubs, at the bars, like are the
first people on scene and provide the first live-saving
resuscitation, anywhere from paramedics, EMTs, the firemen and
women, men and women who wear the badge in our law enforcement.
You know they are there. And they oftentimes then come to us in
the emergency department with the handoff and we take over.
We know that last Congress and during the Obama
administration, we took some steps to expand the workforce and
efforts to ease the access due to buprenorphine so that these
first responders and healthcare providers can provide a
treatment.
I want to revisit the workforce effort because we know
there is folks in prevention that oftentimes we don't really
think of. These are the high school counselors and teachers,
the public health educators, the community health workers, the
primary care docs, family medicine, internal medicines that can
identify risks and education. Then we have the acute crisis,
right, the emergency medicine, the first responders, the law
enforcement, the nurses in the emergency departments. And then
we have the detox and treatments, the addiction services for
adolescents, adults, emergency physician nurses, psychiatrists,
psychologists, mental health. And then we have the long-term
rehabilitation services.
So in your opinion, are we working in a coordinated
mechanism with a strategic vision to provide enough training to
all these different workforce healthcare providers with a clear
set of priorities and understandings or is it scattered from
here and there?
I will ask Dr. Schuchat.
Dr. Schuchat. Yes, I can begin and then I think my
colleagues will probably expand.
Our piece is the prevention piece, prevention for
prescribing, and then supporting State and local public health,
who have a role in the data to speed up the information so we
know where the hot spots are, and a role in evaluating the
policies.
Mr. Ruiz. Is it coordinated in curriculum and outreach to
these individuals?
Dr. Schuchat. Yes, so what I can say is that the guidelines
for treatment of chronic pain have been adopted by dozens of
States and medical societies and are now being taken up by the
medical schools, the pharmacy schools, and the nursing schools.
Mr. Ruiz. So your answer is no because every different
groups are working in silos and what we need is a coordinated
response with leadership from the top.
Let me ask another question. I have a minute left.
We know what the public health motto is. We do have a plan.
There is a framework. You are trained in it. I am trained in
it. You know the framework to come to the answer to identify
high risk, to institute programs catering to high risk, and
then measuring the outcomes of those and expanding those to the
population.
So what are the highest risk individuals, and what are the
programs out there where we are addressing them to prevent them
from being evicted, and also the highest risk for relapse, and
what are we doing for them, Dr. McCance-Katz?
Dr. McCance-Katz. So we have training programs that one is
our Providers' Clinical Support System for Medication Assisted
Treatment and that provides structured training and mentoring--
--
Mr. Ruiz. What is the population base most at risk of
starting an addictive addiction and what are you doing to
combat those in the public?
Dr. McCance-Katz. So we know from a lot of research studies
that people who are at highest risk are people who have a
history of substance use disorder, a history of previous opiate
addiction, a history of mental illness. We know that. And that
is curriculum that is taught within our Providers' Clinical
Support System, which is a consortium of a large number of
different types of professional health organizations that do
outreach to their members so that we can train them.
We also have the Addiction Technology Transfer Centers that
have the Nation divided into ten regions and we have one that
also focuses on Native American issues. And those provide
training to other types of practitioners, counselors, nurses,
et cetera.
Mr. Ruiz. Thank you.
Mr. Burgess. The gentleman's time has expired. The
gentleman yields back.
The Chair recognizes the gentleman from Michigan, Mr.
Walberg, for 5 minutes for questions please.
Mr. Walberg. Thank you, Chairman, for that opportunity and
thank you for being here today. As has been noted on numerous
occasions--I am having a hard time working with one wing here,
Doctor, but we will get it working right--we all share the
concerns together. It is how we meet the needs, and how we can
be an assist to all the things that you do, and have the
communications that make us a resource and a partner alongside.
Dr. McCance-Katz, PDNPs normally include a patient's
history of prescriptions for controlled substances using data
submitted by pharmacies and dispensing practitioners. Under
Jessie's Law, a bill that I have introduced with Representative
Dingle, HHS would be required to develop best practices for
including a patient's history of addiction treatment with
patient consent, of course, in their electronic health records.
This information helps to better inform, I believe, a provider
and avoids risk for relapse or dangerous side effects when a
patient seeks treatment for a condition or illness separate
from their addiction. And that was the genesis for this piece
of legislation because of a very unfortunate outcome where
things were missed.
For similar reasons, should this same information be made
available in PDNPs across the country as a way to better inform
providers?
Dr. McCance-Katz. So those kinds of questions I think are
best left to Congress and the administration. The
administration, to my knowledge, does not have a position on
that but we would be happy to work with you and provide any
technical assistance to move that forward.
Mr. Walberg. I appreciate that and I understand that a
position has to be taken when the administration takes a
position but this is something that would be of great help so
that we don't run amuck of a lot of things that you have to
consider in the day-to-day practice in meeting the needs. And
while we want to make sure those needs are met, we provide
resources, we need the support. So we will take you up on that.
Dr. McCance-Katz. Thank you.
Mr. Walberg. Mr. Doherty, drug diversion remains a serious
problem and I have become aware of a particular challenge that
exists in circumstances of in-home hospice care. DEA
regulations issued in 2014 specifically forbid hospice staff
from destroying leftover controlled substances, unless allowed
for by State law. As a result, leftover pills belong to the
family, which has no legal obligation to destroy them or give
them up.
I believe hospice staff could play a very meaningful role
in helping to prevent instances of diversion but those
regulations prohibit hospice personnel from taking a more
active role in disposing or removing medications from the home.
And so for the first question, I would ask is your agency
willing to work with me and this committee to help establish a
uniform set of practices that will allow hospice professionals
better to assist families to dispose of leftover drugs?
Mr. Doherty. Congressman, thank you for that issue. And of
course we can all look to all of our resources to do better and
do more. We will be happy to work with Congress and the
Department of Justice on that issue.
Mr. Walberg. Well along that line, in addition to
prescription takebacks, what other opportunities exist for
families in this situation to properly dispose of opioids?
Mr. Doherty. Sir, DEA has been a leader in the proper
disposal, safe and effective disposal of unwanted and unused
prescription drugs through our Take Back Initiative. As you
mentioned, sir, we have run that program since 2011. We have
had 13 iterations of that program and, collectively, we have
taken in 8.1 million pounds of unused and unwanted prescription
pain medication. And we feel it is terribly important due to
the fact that we need to keep these things out of the medicine
cabinet.
Another issue I would point to, sir, is under CARA we have
a provision that we worked on in conjunction with our partners
that allows the option to not fill a complete prescription when
you are going to get your medication. We think that is
certainly important for, for example, teenagers that have their
wisdom teeth out and you have a parent caring for them. It is
certainly ethical and reasonable to take only take 5 out of 30
oxycodone if you are caring for a teenager with that procedure.
So we think that is another important factor. DEA has
worked hard with HHS on that issue. Thank you for your concern,
sir.
Mr. Walberg. We appreciate that and we will be looking
forward to working with you.
I yield back.
Mr. Burgess. The Chair thanks the gentleman. The gentleman
yields back.
The Chair recognizes the gentlelady from Florida, Ms.
Castor, for 5 minutes for questions, please.
Ms. Castor. Thank you. I would like to focus on an issue
that this committee has been investigating and that I raised in
committee last spring after the reports in the Charleston
Gazette Mail that drug distributors shipped 780 million
hydrocodone and oxycodone pills to West Virginia over 6 years,
which amounted to 433 pills for every man, woman, and child in
the State. And another news network further reported that one
pharmacy in the small town of Kermit, with just 392 residents
received 9 million hydrocodone pills in just 2 years.
So after our previous hearing in March, the committee asked
the DEA what actions it took in response to the reported
oversupply of opioids in West Virginia over the course of the 6
years. In DEA's response that we just received last night, DEA
noted that it established a tactical diversion squad in
Clarksburg, West Virginia in December 2016. But DEA's own data
would suggest that the distributors began sending large
shipments of opioids to West Virginia well before that date.
Mr. Doherty, please refer to the committee's October 13th
letter to DEA. The charts in this letter, which utilized DEA's
ARCOS data, showed that these massive shipments began taking
place as early as 2007 and 2008.
I am glad that DEA has now established a greater presence
in West Virginia but, in hindsight, should DEA have spotted
these trends earlier?
Mr. Doherty. Ma'am, thank you for that question. And DEA
agrees the amount of pills going into that area was excessive
in looking back. At the time that you referenced, ma'am, and to
your point, we had another phenomenon going on in this country.
It was the proliferation of rogue pain clinics and pill mills
in Florida. Florida was the epicenter of the beginning, in some
ways, of the opioid crisis that we face today.
DEA devoted a tremendous amount of resources and then we
shifted our resources. We shifted our resources to areas like
West Virginia when we realized this problem.
Ms. Castor. So that tells me, though, that maybe DEA did
not have the information on the flood of opioids going into
West Virginia because certainly if you knew 780 million
hydrocodone/oxycodone pills--I mean that is your own, the data
of the pills flooding in there.
How were you monitoring the flood of opioids into a
particular community at that time?
Mr. Doherty. Ma'am, I was not assigned to the Diversion
Control Division at that time. I could tell you----
Ms. Castor. How as the agency?
Mr. Doherty. I could not speak to that, ma'am.
Ms. Castor. Don't they have the tools to monitor shipments,
a flood of opioids into a particular community? Weren't you
able to monitor that?
Mr. Doherty. Ma'am, the way these are monitored in
conjunction with distributors, they are monitored through the
submission of suspicious orders. And the distributors have an
obligation to report that to DEA and that was a flaw and that
is why----
Ms. Castor. Are you saying they did not report it and DEA
had to rely on news reports? That can't be the case.
Mr. Doherty. No, ma'am, that is not what I am saying. What
I am saying is in combined with the suspicious orders that are
reported in oversight of our regulatory registrant community,
specifically the distributors, as you mentioned, we realized
that some were not reporting as required. And then we shifted
resources to those areas and we became more stringent with our
distributors by initiating a----
Ms. Castor. So besides some suspicious, besides the
distributors reporting and some suspicious filing, DEA didn't
have any other tools at its disposal to understand the flood of
opioids into a community?
Mr. Doherty. Ma'am, we do have, as you mentioned, in these
charts, ARCOS data, which is not real-time data. And we use
data analytics and we are getting better at data analytics to
prevent this from happening again.
Ms. Castor. What is the lag time in the ARCOS data?
Mr. Doherty. I do not have that information, ma'am.
Ms. Castor. So clearly, there is a breakdown here.
What can you say to other communities across the country
that maybe experiencing something similar right now, a flood of
opioids, some new epidemic, some hot spot? What is DEA able to
do to monitor that situation so it is not too late?
Mr. Doherty. Ma'am, as I mentioned earlier, we are
providing threat assessments to our 21 Domestic Field
Divisions, with respect to ARCOS data specifically, and we are
conducting a long-term overhaul of our SORS system, Suspicious
Order Report System, to keep distributors in line and to
prevent this from ever happening again.
Ms. Castor. And then what other tools do you need from the
Congress?
Mr. Doherty. Ma'am, we would be happy to work with Members
of Congress through the Department of Justice and we would also
advocate for full support of the President's budget.
Ms. Castor. Well, we need to get to the bottom of this to
protect communities that have been damaged by opioids and to
ensure that other communities do not suffer the same fate.
And people are relying on DEA to be the safeguard. And I
hope the agency can be more proactive and use all the data at
its disposal.
Thank you very much.
Mr. Burgess. The gentlelady yields back. The Chair thanks
the gentlelady.
The Chair recognizes the gentleman from Pennsylvania, Mr.
Costello, for 5 minutes, please.
Mr. Costello. Thank you.
Mr. Doherty, what is your title with DEA?
Mr. Doherty. Deputy Assistant Administrator Office of
Diversion Control Operations.
Mr. Costello. Amongst your duties is to stem the flow or
ensure that the excessive illegal distribution of opiates
around this country does not occur. Is that correct?
Mr. Doherty. Yes, sir.
Mr. Costello. If we could refer to the chart, if you could
put that chart up, I am going to reference the bill that passed
last year that is the subject of some journalistic inspection
right now.
Clearly, between 2011 and 2016, prior to this bill being
passed, the number of immediate suspension orders has reduced
substantially, correct?
Mr. Doherty. Yes.
Mr. Costello. And an immediate suspension order is an order
that, without prior notice, terminates a distributor's ability
to distribute controlled substances. It is an extraordinary
measure intended to supplement standard agency procedures in
cases of imminent danger. Is that correct?
Mr. Doherty. Yes, sir.
Mr. Costello. And the legislation sought to define the term
imminent danger because there was litigation and concern raised
by many patient advocate groups, local pharmacies, et cetera,
that that standard was unclear. Is that correct?
Mr. Doherty. That is my understanding, sir.
Mr. Costello. Is it true that since passage of the bill the
number of ISOs has actually increased?
Mr. Doherty. That is not true, sir.
Mr. Costello. I believe that eight orders have been issued
subsequent to the passage of the bill. Isn't that correct?
Mr. Doherty. I stand corrected, sir. Since the passage of
the bill, yes, sir.
Mr. Costello. It has increased. Has the amount of opiates
distributed decreased since passage of the bill?
Mr. Doherty. I would have to confer with my diversion staff
and get back to you on that.
Mr. Costello. If I read data points that indicated that
amount of opiates manufactured and distributed in 2017 is less
than 2016, would that be accurate?
Mr. Doherty. That would be accurate, sir.
Mr. Costello. So is it fair to say that since passage of
the bill, the number of opiates manufactured and distributed
has been less than before it was passed?
Mr. Doherty. Yes, sir, and that would be directly in line
with the reduction in the APQ, the aggregate production quota--
--
Mr. Costello. Yes.
Mr. Doherty [continuing]. That DEA oversees.
Mr. Costello. So if someone says the law has helped fuel
the opiate epidemic, would that have any basis in fact, given
the fact that the number of ISOs has increased since passage of
the bill and then the number of opiates manufactured and
distributed has decreased since the passage of the bill?
Mr. Doherty. No, sir, I don't believe the data shows that.
Mr. Costello. OK, thank you.
DEA and DOJ contributed significantly to the language of
the bill that was passed. This has been generally represented
by Senator Hatch and Senator Whitehouse, a Republican and a
Democrat, in the Senate. Do you agree that the DEA and the
Department of Justice provided technical assistance to the bill
that was ultimately passed and signed into law?
Mr. Doherty. Yes, sir, that is my understanding.
Mr. Costello. And if DEA had opposed the bill, they would
have provided testimony, or correspondence, or done some level
of advocacy with Members of Congress. Is that correct?
Mr. Doherty. Yes, sir, I believe there was a technical
advisement period and then, ultimately, the bill moved forward
and was signed into law last April.
Mr. Costello. And it is fair to say that there were
previous iterations of the bill that the DEA took issue with
and they did object to it. Is that correct?
Mr. Doherty. That is my understanding, yes, sir.
Mr. Costello. Is it further true, based upon reports that
the Obama administration actually requested of the DEA whether
or not they recommend that the President sign it and the DEA
must have said, in some form or fashion, yes, this bill is
appropriate to sign. Is that correct?
Mr. Doherty. That is correct, sir.
Mr. Costello. Let's talk about this. Do you think that the
law should be repealed?
Mr. Doherty. Sir, in terms of the bill that affects, as you
say, the ISOs that we use in our administrative toolbox, we
also use criminal tools.
Mr. Costello. Absolutely.
Mr. Doherty. We also use investigative tools.
Mr. Costello. There is a lot of other things you do.
Mr. Doherty. Right.
Mr. Costello. And you do it effectively in very many
measures. But on this specific bill, which deals with ISOs, do
you think it should be repealed or do you think that it is
doing what it what it was intended to do, which was provide
clarity so that you can actually go out and issue ISOs without
having to deal with litigation that might actually call into
question your enforcement powers in the first instance?
Mr. Doherty. Sir, let me say that the bill--the law changed
the way that we looked at ISOs. It did not stop DEA from doing
its job in the diversion space and we would be happy to work
with Congress and DOJ, who is looking at this issue, as I said
earlier, currently, to make sure that DEA has all the
appropriate and updated tools.
Mr. Costello. Do you agree that if we did repeal this law,
and didn't supplement it with something else, then the same
vagueness that caused litigation to occur, that raised concerns
from a whole host of constituencies would come to bear once
again?
Mr. Doherty. Yes, sir, I believe we do need a mechanism at
that level with respect to that tool.
Mr. Costello. One final question I am going to try and
sneak in.
Was there an internal policy change why the DEA so
dramatically reduced ISOs between 2011 and 2016?
Mr. Doherty. Not to my knowledge, sir.
Mr. Costello. Thank you. 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, and thank you for this
most important hearing.
Mr. Chairman, I would ask unanimous consent to add into the
record the written testimony from the International
Chiropractors Association about nonpharmacological treatment of
pain. Mr. Chairman?
Mr. Chairman----
Mr. Burgess. Is that your unanimous consent request?
Mr. Carter. Yes.
Mr. Burgess. Would you restate it, please?
Mr. Carter. Yes, sir. Mr. Chairman, I would ask unanimous
consent to add into the record the written testimony by the
International Chiropractors Association on nonpharmaceutical
treatment of pain.
Mr. Burgess. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Carter. Thank you.
Dr. Schuchat, last year there was a study done that I
believe was done in collaboration with the CDC and John
Hopkins, and HHS, and NIH, and CMS that was called examining
insurance coverage for acute and chronic back pain treatment
pilots. Now are you familiar with this, dealing with insurance
companies and how they can actually not approve non-
pharmaceutical treatments and actually push more opioid use by
what they cover and what they don't cover?
Dr. Schuchat. I am not familiar with the specific study but
I am familiar with that issue of what is reimbursed and what
isn't and that there has been a problem with opioids being
easily reimbursed and the alternative approaches were
recommended not to be paid.
Mr. Carter. OK, well this is the study that I am speaking
of. Because I want to make sure because CMS has actually cited
this as being a problem.
Also, in the New York Times, there was an article last week
that addressed this well that I want to bring to your
attention. And essentially what it says, it gave very many
examples about how pharmacy benefit managers, PBMs, if you
will, and insurance companies are actually pushing more opioid
use by the fact that they are not approving the use of non-
pharmaceutical or non-opioids.
Whereas, I agree with Dr. Gottlieb that there is a gap
there between ibuprofen and the NSAIDs and then we go to
opioids and we need to fill in that gap but there are some
things can be used. You can use gabapentin. You can use
Neurontin, Lyrica, those type of things but, in many cases, the
insurance companies don't cover them. The PBMs don't cover
them. The copay is higher, or you have to get a prior approval,
or it is another tier, a higher tier so that you have to go
through more hoops in order to get it approved which, of
course, is leaning to more opioid use.
Do you care to comment on that? Is that something you see?
Dr. Schuchat. Yes, our incentives have been going the wrong
way to get better practice, better paying management, and
avoiding the harms of opioids.
Mr. Carter. What can you do? What can CDC do? I mean is
there anything you can do to encourage--I have not had any
success in dealing with the PBMs, I can tell you that, but
perhaps you will.
Dr. Schuchat. You know CDC's guidelines for the treatment
of chronic pain are now being taken up by a number of health
plans, insurers, medical societies and the defaults in the
electronic medical records----
Mr. Carter. OK.
Dr. Schuchat [continuing]. And the ordering are better in
many places.
But I wanted to say something about the pharmacy benefit
managers and the----
Mr. Carter. Please hurry.
Dr. Schuchat. Sorry. Just that they have actually been
helpful in spotting the problematic providers.
Mr. Carter. They have been helpful to a certain extent but
also they have been part of the problem because they have been
not approving some of the drugs that could have been used and,
instead, have been approving the cheaper opioids; therefore,
increasing the amount of opioid use. So that is the point that
I am trying to make here.
Dr. Schuchat. Yes, absolutely.
Mr. Carter. OK.
Dr. Schuchat. We need better prescribing.
Mr. Carter. OK, Dr. Gottlieb, I want to first of all
applaud you. In July you made an announcement that you were
expanding, that FDA was expanding prescriber educational
opportunities for instant release opioids. And this is a step
in the right direction. There is no question about that. As a
practicing pharmacists for many years, I can tell you we need
more physician education.
And you also said at that time that you were exploring
making prescription training mandatory. Has FDA addressed that
in any way at all?
Dr. Gottlieb. We also expanded that education for
pharmacists as well, Congressman Carter.
Mr. Carter. And thank you for doing that. That needs to be
done.
Dr. Gottlieb. Right. We are still working--we have a task
force, a working group that is looking at different ways that
we would operationalize a potential mandatory requirement for
education, some of which could be contemplated by working in
close concert, which we have been doing, with our partners at
DEA. But we are looking at alternatives for how we could make
education mandatory.
Mr. Carter. One other thing I want to get in before my time
is up and that is this. Dr. Gottlieb, I thought you made a
great point in your opening statement when you made the point
that there really are two problems we are facing here.
First of all, we are facing the prevention of this
happening and trying to prevent people from being addicted. But
another problem that we have is that we have got over 11
million people that are addicted now. We have got to deal with
that and that is a big, big problem.
My question is--you know last week I was in the treatment
centers--what will work? It is going to take more than just
throwing money at it. This is not a situation where we can say
``OK, we have hit $50 billion, therefore we have done our
job.'' That is not what I am looking for at all. I am looking
for effective treatments that are going to work.
And I can tell you from personal experience I have seen
opioid abuse firsthand. I have seen it ruin lives. I have seen
it ruin families and careers. It is tough.
What do you know, Dr. Volkow--I have served on many panels
with you and you do a great job. What works? What works in the
way of rehabilitation?
Dr. Volkow. First of all, I want to thank you for bringing
up the issue that it is not just throwing money at something.
You have to actually throw money at a solution that is going to
be effective. And I think that what we are demanding. That is
why one of the things that we are demanding is that the
treatment that is provided for individuals with opioid use
disorder with quality care treatment for which there is
evidence of benefit and that we need to actually change the way
that we provide that treatment so that we have a means to
monitor the outcomes of the patients such that we can learn
from what leads to a good response in a given patient and what
in another one.
We know, in general, that medication-assisted treatment
significantly improved the outcomes and it prevents overdoses
but we also know that not every patient responds and there is
still significant relapse.
Mr. Carter. And thank you for that.
And I am way over my time but one thing I want to warn all
of us is that let's don't become too dependent on naloxone
because it becomes a crutch and that is just not good.
We have had problems already in Jacksonville, Florida,
south of my district, where they can't even carry it on the
ambulances anymore because of the high cost and people getting
it three or four times a week. It does not need to become a
crutch for these people as well, although I understand fully
the value of it.
Thank you, Mr. Chairman.
Mr. Burgess. The gentleman's time has expired.
The Chair recognizes the gentleman from South Carolina, Mr.
Duncan, the newest member of the committee, 5 minutes for
questions, please.
Mr. Duncan. Thank you, Mr. Chairman. And I have waited a
long time to be on this committee. It is an honor to be part of
Energy and Commerce.
I would be remiss if I didn't mention the work of a good
friend of mine, State Representative Eric Bedingfield in South
Carolina, who lost his son a year ago after a decade-long
battle with opioids. And Eric and his family are very much in
my thoughts as we have this hearing today. So I want to honor
his continuing work and the State legislature on this issue.
As we have seen today, this is an issue that transcends
partisanship. It affects Americans in all 50 States. The opioid
epidemic is real.
Mr. Doherty, you mentioned tools that you had in your tool
box for combatting the opioid epidemic. Could you tell me what
some of those tools are, if not all of them? And then what
would you say is the most valuable tools you have in this
fight?
Mr. Doherty. Congressman, thank you for that question. And
I would say that from a law enforcement perspective and a DEA
perspective, first of all, the scope of the problem is enormous
and we need, literally, all hands on deck across the Federal,
State, and local level, the medical community, the scientific
community, and the law enforcement community.
In terms of addressing the problem, we need to attack
supply with the overseas suppliers with respect to heroin and
fentanyl. We need to work to take the gang element out.
Mr. Duncan. How do you do that without cooperation of the
foreign Governments? Are they cooperating, I guess is what I am
asking?
Mr. Doherty. Yes, sir, we have had great cooperation at the
international level, the bilateral level, and the multilateral
level. Yes, sir.
Additionally, I would add that domestically we are
initiating additional 360 Program cities for fiscal year 2018
and the 360 Program has been a crucial part of having, as I
said, three distinct pillars of law enforcement attack this
problem.
We are also very much into the prevention space with the
360 Prevention and also with Operation Prevention, which is a
web-based curriculum that is cutting edge and designed to teach
young adults the dangers of opioid use. And it is free. It is
distributed to educators throughout the country and it has been
viewed by hundreds of thousands of individuals so far.
And we feel that partnership across Government is key to
establishing a dialogue, number one, about new and innovative
ways to attack the opioid crisis. And I think that no idea
facing all of us is off the table with respect to this problem.
Mr. Duncan. All right. It is an immense challenge.
I came to this committee from Homeland Security Committee
and also the Foreign Affairs Committee, where I chaired the
Western Hemisphere Subcommittee. Opioids is the focus of this
today but let me just let the committee know that due to
circumstances in Colombia and Peru, the cocoa production has
been up over the last year, 18 months. Coca production has been
up. As a result, there is a lot of cocaine out there ready to
come north. They are not flooding the market with it. That is
going to be our next issue to deal with with regard to drugs.
I appreciate the work you guys do, your men and women
around the globe. And I have dealt with them in South America,
so I know the challenges they face.
Mr. Chairman, thank you so much, and I yield back.
Mr. Burgess. The Chair thanks the gentleman.
The Chair recognizes the gentlelady from Indiana, Mrs.
Brooks, 5 minutes for questions.
Mrs. Brooks. Thank you, Mr. Chairman, and I appreciate the
fact that you all got a break. I want to thank you all so very
much for your work because each of your agencies is so
critically important.
And I want to start out because in the CARA effort the
first section of that bill was a section that my colleague from
Massachusetts, Representative Kennedy and I worked on, and it
was to establish an interagency and medical professional task
force to review and, when necessary, update and modify the CDC
best practices guidelines for pain management.
And so, Dr. Schuchat, can you tell me did you know about
this formation and that it needs to be formed by the end of
December of 2018 and report? And you are looking at Dr.
McCance-Katz. So I am curious. I just want to know. Is it
happening? Is it in formation and will we get a report without
great detail? I just want to know. You know we have had a
change in administration. So I want to know that it is on
people's radars.
Dr. McCance-Katz. Yes, it is. And so we have members of the
public that the application process closed. They are in the
process of being selected now. And that committee is definitely
going to be in place and you will get the report.
Mrs. Brooks. OK, outstanding. Thank you.
Dr. Gottlieb, building on what Representative Carter talked
about with respect to prescriber education, you talked about we
are at a point, in your opening remarks you said, where we
might be doing some hard things, things we are not really
comfortable with. And you talked about prescriber education and
that we have a generation of prescribers that need more
education.
Can you--and I am interested in the entire panel's very
quick answer because I have like so many things I would like to
ask all of you. Do you believe that mandatory prescriber
education for either renewal, or for the first DEA licensure of
someone who gets a DEA license or for renewal, that should come
up with some mandatory prescriber education?
Dr. Gottlieb. I would certainly support that goal and I
have said as much.
One caveat I would add is I don't think it needs to be a 3-
day course. I think it is more efficient if it a short course
and we hit doctors with some key principles. I think there is
ways to do that.
Mrs. Brooks. OK, where does a 3-day course come in?
Dr. Gottlieb. I just threw it out there because there some
States that have these long courses.
Mrs. Brooks. OK.
Dr. Gottlieb. But I think something short, and targeted,
and focused would be the most effective way to try to
operationalize this.
Mrs. Brooks. Do you agree with that, Dr. McCance-Katz?
Dr. McCance-Katz. I agree with it in general. I think that
any prescriber who wants to prescribe controlled substances
needs to have that education.
Mrs. Brooks. Needs to have that education.
Dr. McCance-Katz. Absolutely.
Mrs. Brooks. Does anyone disagree with that?
[No response.]
Mrs. Brooks. OK, thank you.
Mr. Doherty, you may not know but I am a former U.S.
Attorney and I did an OxyContin case against a physician that
distributed to a community in southern Indiana and where people
died, an OxyContin mill that was happening.
So this type of challenge has been with us for a long time
but when I met with IMPD last week, our Indianapolis
Metropolitan Police Department, they said they took off a 55-
gallon drum of pills in our community, full of pills laced with
fentanyl. And can you tell me do you need any additional
authorities that would help DEA improve its enforcement actions
that have to do with pill presses?
Mr. Doherty. Ma'am, DEA has been very active in leaning
forward on issues with respect to pill presses. We have
formalized a rule that requires the import/export of pill
presses to be electronically sent to DEA. We work very closely
with CBP.
That said, we would certainly welcome a dialogue with
Congress and with the Department of Justice to look at----
Mrs. Brooks. Do you need more teeth? Do you need anything?
And if you would please give some thought to that, whether or
not legislation needs to happen. Because as I understand, some
of these pills that are coming in our police department
believes that the traffickers don't even know what is in them.
They don't even know that they are dealing fentanyl,
necessarily.
Is that something that you have seen?
Mr. Doherty. Yes, ma'am, we have seen the fact that
certainly the end user doesn't know what they are getting and
some individuals in the supply chain are also unwitting, to a
certain extent in terms of what they are trafficking.
So I would be happy to take that back, ma'am, and have a
dialogue on that and reengage with Congress and the Department.
Mrs. Brooks. And then finally, Dr. McCance-Katz, in the
context of the opioid crisis, do you believe it is important
that a patient's provider, their primary care or their main
doctor, has access to his or her substance use disorder
records? Because I understand there is not a connection between
the behavioral specialists--and I am seeing nodding here from
Dr. Volkow and Dr. Schuchat.
And so why is that a problem and how do we fix that, that a
primary care provider or another physician cannot have access
to the mental health provider record?
Dr. McCance-Katz. So there are several laws in place that
prevent certain types of communications and the 42 CFR prevents
organizations or treatment providers, if you will, that hold
themselves out as substance abuse treatment providers from
sharing records without specific permission from the patient.
I will tell you that this is something that the Trump
administration has been looking at since before I got here. We
will be coming out in a couple of months with some revisions to
communication that could be allowed under 42 CFR to better
serve communication with physicians who are not substance abuse
treatment providers but may be treating a patient with a
substance use disorder.
Why is this important? Because very often, somebody has got
a co-occurring illness which will require them to be on a
medication and could have a significant drug-drug interaction
that could place a person's life at risk, even on standard
doses of medication. So it becomes a very important issue
clinically.
Mrs. Brooks. Thank you.
And if I could just close with, and I know I am over time,
but I think what hopefully you have seen is that if there is
legislation that anyone on either side of the aisle of this
hearing we want to either resolve issues that occur either in
statute or in regulation and please make sure we know what
those are.
Thank you. I yield back.
Mr. Burgess. The Chair thanks the gentlelady. The
gentlelady yields back.
I recognize the gentlelady from California, Mrs. Walters, 5
minutes for questions.
Mrs. Walters. Thank you, Mr. Chairman. And I have a letter
from the Peace Officers Research Association of California that
I would like to submit for the record.
Mr. Burgess. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mrs. Walters. Thank you, Mr. Chairman.
An increasing number of reports have revealed problems
resulting from the dramatic surge of addiction facilities in
sober homes. My home of Orange County, California has a
significant number of these facilities.
These reports detail how individuals, as patient brokers,
are recruiting patients and, in many cases, are flying them to
a treatment facility across State lines, California being a
very common destination. These patient brokers receive a
generous financial kickback, amounts reportedly ranging from
$500 to $5,000 for each patient who has successfully entered
into a treatment facility or sober home.
It is appalling that there are individuals treating those
fighting addiction as a commodity and prioritizing profit over
the well-being and sobriety of these vulnerable individuals.
In light of these disturbing reports, the committee has
sent HHS a letter on this very issue on July 13th. HHS provided
a response last month and I have some questions for Dr.
McCance-Katz following up on that response.
Dr. McCance-Katz, in response, HHS noted that 80 percent of
treatment facilities are licensed or certified by State bodies.
First question: Who licenses and certifies these facilities?
Dr. McCance-Katz. The States do, and some of these
facilities are not licensed or regulated within States.
So the Federal Government--SAMHSA regulates opioid
treatment programs and certain types of credentialing of
providers but we do not have purview over what goes on in the
States regarding other types of substance abuse treatment
programs or recovery housing.
Mrs. Walters. OK so if you flip that 80 percent figure,
that means that 20 percent of the facilities are not licensed
or certified.
OK, so why aren't all facilities licensed or certified?
Dr. McCance-Katz. Different States take different
approaches to this. I would recommend that one of the things
that States consider is requiring that these types of
facilities get credentialed. There are national accreditation
bodies that could do this. States would need to require it, and
then States would charge a licensing fee.
The other thing that happens at these facilities is that
they often use practitioners, or what they call practitioners,
who have no certification or qualifications in the field. That
can also be addressed by State regulatory bodies.
Mrs. Walters. So do you know which States do require
certifications and licenses and which don't?
Dr. McCance-Katz. I don't have that information at my
fingertips.
Mrs. Walters. OK. HHS also noted in its response that
SAMHSA is working with States to share best practices on how to
address patient brokering with provider associations. And what
are those best practices and who developed them?
Dr. McCance-Katz. So SAMHSA does have a work group on this
and that work group met over the summer. There is a report that
is being put together right now.
But I can tell you that some of the best practices that
will come out will be, as I mentioned, requiring the licensure
of practitioners in these programs, requiring accreditation of
the programs themselves.
We are going to make a bigger effort than we already do to
put families in touch with our treatment locator system. We
actually have a treatment locator system on our SAMHSA Web site
that is linked to by other HHS agencies as well that has
investigation that goes on. All of the programs on our system
are approved by the SSAs in the different States. So they have
a certain quality indicator if they are on that treatment
locator.
We also think it is important for families to be able to
ask specific questions. So if I am a family member looking for
a provider, I need to ask, What are your credentials? Are you
accredited by a national organization? Have you been inspected?
And if you have been inspected, were there any citations of
your facility and what did you do about them? Those questions
right there can tell families whether that is a facility that
they would want their loved one at.
Mrs. Walters. OK, just shifting gears a bit to focus on
sober homes, which, based on the aforementioned reports, are
equal offenders in the patient broker scheme.
It is the committee's understanding that sober homes are
regulated much differently than treatment facilities. Is that
correct?
Dr. McCance-Katz. That is my understanding.
Mrs. Walters. OK and what is SAMHSA's role in overseeing or
regulating sober homes?
Dr. McCance-Katz. We have no authority over sober homes.
Mrs. Walters. OK. Well, I will yield the balance of my
time.
Mr. Burgess. The Chair thanks the gentlelady. The
gentlelady yields back.
And I believe that concludes members' questions. I was
going to yield 5 minutes for questions to Mr. Green because he
has been sitting her so patiently, if you have a follow-up or
redirect.
Mr. Green. Thank you, Mr. Chairman.
Mr. Doherty, among the things the Controlled Substances Act
establishes is a quota system that controls the qualities of
basic ingredients needed to manufacture controlled substances.
These quotas serve to try and reduce diversion, while also
providing the adequate supply of controlled substance for
legitimate medical need.
DEA sets these quotas using data regarding manufacturing
history, forecasts, prescriptions dispensed, past quota
histories, and internal DEA data on controlled substance
transactions.
Deputy Assistant Administrative Doherty, I would like to
ask about DEA's process on establishing these quotas. In
reviewing the aggregate production quota history of oxycodone,
hydrocodone, and morphine, and fentanyl, the quotas from 2007
to 2015 show dramatic increase.
For example, the quota for oxycodone doubled from 70,000
kilograms in 2007 to 149,000 in 2014. This is true for
hydrocodone, which increased from 46,000 kilograms in 2007 to
99,000 kilograms in 2014.
Can you explain to the committee the process DEA undertakes
in setting these quotas?
Mr. Doherty. Sir, thank you for that question. Sir, my
oversight responsibilities with respect to the Diversion
Control Division are over the criminal investigative side of
the house, the law enforcement side of the house.
Last year, the DEA Diversion Control Division was
reorganized in such that we are now a complete division. We
were formally an office, an Office of Diversion Control under
the Operations Division of DEA. We are now a standalone
division and we have two offices, the Office of Diversion
Control Operations, which I oversee, as the law enforcement
arm, running the criminal investigations and technology aspect.
And then we have a regulatory compliance oversight arm, which
is the Office of Diversion Control Regulatory.
So, sir, I am generally aware of the quota system, in terms
of the points you mentioned. And I can state that last year the
APQ, the aggregate production quota, was reduced 25 percent
across the board and additional reductions are proposed for, as
you mentioned, certain drugs, hydrocodone, oxycodone, and
fentanyl for an additional 20 percent.
I would be happy to take that back and get you a complete
answer, sir.
Mr. Green. Yes, if you could, just to share with the
committee, to the Chair, of how that decision is made. Because
again, from 2007 to 2015, the quotas were double and I wanted
to see why DEA decided to do that, if they felt like that was
needed.
According to DEA's history, quota history, it is not until
2016 and 2017 that DEA announced that the quotas for oxycodone,
hydrocodone, and morphine, and fentanyl would be reduced. And
if you don't know that question, if you could get it back to us
why all of a sudden they waited until 2016 and 2017 to do that.
And I understand the DEA has the authority to revise their
quota at any during the year in response to change in sales,
new manufacturers entering the market, new product development,
or product recalls.
Does DEA have the authority to revise the quota of
controlled substance in response to patterns of abuse, or
misuse, or increase diversion?
Mr. Doherty. Again, sir, not under my direct purview but I
do know, generally speaking, that that authority does rest with
DEA, as well as decreasing quota when requested by a
registrant.
Mr. Green. OK. Well, Mr. Chairman, I would hope we could
get--if you could have somebody who has that information to get
to the committee. And if we have to send a letter, hopefully
the committee would send that.
Mr. Chairman, before I yield back, when we did the
Affordable Care Act, it is crucial to address the opioid
crisis. And what we did with the Affordable Care Act, prior to
the ACA there was 34 percent of individual market policies did
not cover substance use treatment. Now all health care policies
that are sold in marketplaces must include these services for
substance use disorders. And repealing the mental health and
substance use disorder coverage provisions of the ACA will
remove at least $5.5 billion annually from the treatment of
low-income people with mental and substance use disorders.
In my early days as a probate lawyer, I also did mental
health. And so often, back in the 1980s and even the 1990s, we
did not have a place where people would go. And most insurance
policies in Texas, in their State, did not cover mental health,
unless you were very wealthy.
And so that is why the ACA was changed, to do that. And as
I recall, for mental health and substance abuse, Medicaid is
probably still the biggest provider in the country. And so by
cutting Medicaid, it is making it even more of a problem.
And I know I am running 17 seconds over my time, but I run
through the 3 minutes. So, I yield back.
Mr. Burgess. The Chair thanks the gentleman. The gentleman
is correct to observe the Chair has been very indulgent with
letting people go over because this is an important topic.
And I am also going to yield myself a time for redirect. I
want to ask a couple of additional questions on the PDMD
programs.
This committee authorized NASPER, probably in 2005. It has
been funded. In this year's Labor/HHS appropriations bill as
passed by the house in September, there was an amendment
offered and accepted by your chairman that funded, for the
first time, the NASPER program, which I think is terribly
important.
In my home community, an obituary in the paper the other
day of a young man in the mid-20s was the child of a woman who
was my daughter's best friend--my sister's best friend in high
school. And it was quite a shock to the community. And you ask
questions and it comes out that it probably was opiate-related
and probably was a rather substantial number of pills that this
young man was given his last physician visit.
So it bothers me that we have the data and Mr. Doherty,
this probably for you. I realize it is not law enforcement data
but I will even broaden it for anyone. The information is now
there. It is being collected in a prescription drug monitoring
program. There has to be some sort of algorithm and a red flag
go up, even de-identified patient data, to help identify a hot
spot, either a pharmacy--so much of the PDMP program is
provider-directed but it seems like it could also be pharmacy-
directed as well.
You identify a hot spot. Here is one prescriber where more
pills are going out the door than any other prescriber in town
or here is a pharmacy where more are filled. Is there any way
to create that nexus so that at least there is the reason to do
a little bit more investigation?
De-identify the patient data. I am not trying to out the
patient who has a problem but where are these facilities where
the difficulty is occurring?
Mr. Doherty. Sir, thank you for that question. And in terms
of data analytics, such as a PDMP, DEA supports them and DEA
supports law enforcement access to them.
Unfortunately, sir, the 49 States that currently have PDMPs
have a varying degree of access. Some require a court order.
DEA advocates for law enforcement access, obviously with the
PII, personal identification information, in mind and we feel
it is a vital tool for law enforcement to do as you said, sir,
to identify hot spots and to further our criminal
investigations and take action against registrants operating
outside the law.
As I said, 49 States have them; 41, to my knowledge,
reconnected through a program called InterConnect. We think
that is a positive step as well. However, as I stated before,
the degree of access varies. It varies quite a bit, sir.
Mr. Burgess. I think going forward that is something that
we do have to keep in mind. There has to be a way to identify
these places where problems are occurring and at least have a
chance for intervention.
Dr. McCance-Katz, you and I talked briefly before the
hearing started. You know I am not a fan of needle exchange
programs but let me just ask you this.
There is technology where a syringe and needle can only be
used one time. Retractable Technologies, in my district, has
developed such a syringe. You push the plunger all the way in
and the needle retracts up into the barrel and you cannot
retrieve the needle without destroying the device.
I don't know whether that is something that SAMHSA has
looked at but in the needle exchange programs, as they exist, I
would at least like the assurance that it is a true single-use
device that is being dispensed in a needle exchange program.
Dr. McCance-Katz. Well, what I believe to be the case, sir,
is that the Federal Government, our funds do not go to purchase
syringe equipment of any kind. What funds can be used for are
things like support staff within a program that does syringe
exchange, mainly to help people get to treatment.
So we do not have any authority over that and are not
involved in that.
Mr. Burgess. To get the continuing medical education I
required for my license this year, I took your online SAMHSA-
sponsored opioid abuse. I took two of the three modules. And
thank you for having it online. Thank you for having it at a
price I could afford.
But one of the harm-reduction strategies that they talk
about in this SAMHSA-authorized product out of Harvard Medical
School is our needle exchange programs. And again, I am not a
fan of that. But if we are involved in that, I really think the
effort should be that they be a single-use device and this
retractable technology is FDA approved. It has been around for
a while. It has never been widely used because they are a
little bit more expensive. But if we are going to the trouble
to do harm reduction, I think that is a type of harm reduction
I would like to see.
Dr. McCance-Katz. I think that is a very good suggestion.
And I actually, since you bring that up, I will take it back to
our staff at SAMHSA and we will look at that course you are
talking about.
Mr. Burgess. Thank you. I am not trying to be the Chamber
of Commerce guy for Retractable Technologies, but they do have
a good product.
I want to thank all of you. This has been a lengthy but I
think important and informative hearing. I know I have gotten a
lot of information. This coupled with the 50 members that we
heard from 2 weeks' ago with the individual opiate problems
they have in their district, I hope will form the nidus of the
ability to come together on some things. We obviously have a
problem that needs to be fixed. We have heard it expressed
passionately several times today.
Dr. Gottlieb, I do have one question for the record that I
am going to submit to you in writing because it was so
technically complicated, I didn't think I could do it justice
by reading it to you. But it is an important question, and it
deals with distribution of counterfeit products. And again, I
will submit that in writing because we have gone significantly
overtime.
Seeing that there are no further members wishing to ask
questions, I do want to thank all of our witnesses for being
here today.
We have received outside feedback from a number of
organizations and I would like to submit statements from the
following for the record: The American Medical Association, the
Academy of Integrated Pain Management, the American Dental
Association, the American Society of Addiction Medicine,
Medication Assisted Treatment Coalition, International
Chiropractors Association, Oxford Housing Incorporated,
American Association of Nurse Anesthetists, Protecting Access
to Pain Relief, and America's Health Insurance Plans.
Without objection, so ordered.
[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 their response
within 10 business days upon receipt of the questions.
Without objection, the committee is adjourned.
[Whereupon, at 3:26 p.m., the committee was adjourned.]
[Material submitted for inclusion in the record follows:]
Prepared statement of Hon. Michael C. Burgess
Thank you, Mr. Chairman, for holding this important hearing
today.
I also appreciate all of the witnesses here for coming
before our committee and sharing their agency's efforts to
fight the opioid crisis at the Federal level.
The Health Subcommittee recently heard from more than 50
members on how the opioid epidemic is affecting their
communities. The opioid crisis has touched every corner of
American society--no one is immune from this heartbreaking
problem. Just this month, our North Texas community lost a
young man in his mid-20s from a suspected overdose. This young
man, who was the son of one of my daughter's closest friends,
had his whole life ahead of him. Too many American families
have been devastated by this epidemic. The statistics on this
issue are shocking, particularly as we consider that 91
Americans die every day from an opioid overdose, and in 2016
alone, drug overdoses claimed more American lives than the
entire Vietnam War.
The debate around pain medication is not a new issue for
our committee. In fact, one of the first Energy and Commerce
Committee hearings I participated in more than a decade ago
focused on physicians' treatment of pain. However, at the time,
we were concerned that physicians were not treating pain
adequately. Today, we are hearing about a much different
situation.
As we consider solutions critical to stemming the opioid
crisis, we must strike a careful balance before casting blame.
It bothers me when I hear doctors placed at fault for this
epidemic. Physicians are our allies, not our adversaries, in
this battle against the opioid epidemic. In fact, a caring
doctor on the front line can do more to stem this problem than
any Federal Government action.
Prepared statement of Hon. Steve Scalise
Opioid abuse is a major crisis in this country. We've all
heard stories from families back home in our districts as this
horrible epidemic has swept through communities across America.
Despite everyone's best efforts, the troubling statistics
continue to rise. Louisiana was one of many States that
experienced double-digit increases in the percentage of opioid
related deaths in recent years. Last year there were more
opioid related deaths in southeast Louisiana than car crash
fatalities.
There is no silver bullet to this problem which is what
makes the committee's work so important. Today's hearing will
allow us to measure how well recent reforms passed in Congress
are being implemented, and tell us what more we can be doing in
our fight against opioid abuse.
I want to thank Chairman Walden for allowing the full
committee a chance to be a part of today's hearing, and I look
forward to working with all of my colleagues to address our
country's opioid crisis.
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