[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:]


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    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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