[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]



 
 
  COMBATING THE OPIOID CRISIS: PREVENTION AND PUBLIC HEALTH SOLUTIONS

=======================================================================

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED FOURTEENTH CONGRESS

                             SECOND SESSION

                               __________

                          MARCH 21 & 22, 2018

                               __________

                           Serial No. 115-112
                           
                           
                           
                           
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]                          
 
 


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov
                        
                        
                            _________ 

                U.S. GOVERNMENT PUBLISHING OFFICE
                   
 30-951                   WASHINGTON : 2018                             
 
 
 
                        
                        
                    COMMITTEE ON ENERGY AND COMMERCE

                          GREG WALDEN, Oregon
                                 Chairman
JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
  Vice Chairman                        Ranking Member
FRED UPTON, Michigan                 BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
MICHAEL C. BURGESS, Texas            ELIOT L. ENGEL, New York
MARSHA BLACKBURN, Tennessee          GENE GREEN, Texas
STEVE SCALISE, Louisiana             DIANA DeGETTE, Colorado
ROBERT E. LATTA, Ohio                MICHAEL F. DOYLE, Pennsylvania
CATHY McMORRIS RODGERS, Washington   JANICE D. SCHAKOWSKY, Illinois
GREGG HARPER, Mississippi            G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey            DORIS O. MATSUI, California
BRETT GUTHRIE, Kentucky              KATHY CASTOR, Florida
PETE OLSON, Texas                    JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia     JERRY McNERNEY, California
ADAM KINZINGER, Illinois             PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia         BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida            PAUL TONKO, New York
BILL JOHNSON, Ohio                   YVETTE D. CLARKE, New York
BILLY LONG, Missouri                 DAVID LOEBSACK, Iowa
LARRY BUCSHON, Indiana               KURT SCHRADER, Oregon
BILL FLORES, Texas                   JOSEPH P. KENNEDY, III, 
SUSAN W. BROOKS, Indiana                 Massachusetts
MARKWAYNE MULLIN, Oklahoma           TONY CARDENAS, California
RICHARD HUDSON, North Carolina       RAUL RUIZ, California
CHRIS COLLINS, New York              SCOTT H. PETERS, California
KEVIN CRAMER, North Dakota           DEBBIE DINGELL, Michigan
TIM WALBERG, Michigan
MIMI WALTERS, California
RYAN A. COSTELLO, Pennsylvania
EARL L. ``BUDDY'' CARTER, Georgia
JEFF DUNCAN, South Carolina
                         Subcommittee on Health


                       MICHAEL C. BURGESS, Texas
                                 Chairman
BRETT GUTHRIE, Kentucky              GENE GREEN, Texas
  Vice Chairman                        Ranking Member
JOE BARTON, Texas                    ELIOT L. ENGEL, New York
FRED UPTON, Michigan                 JANICE D. SCHAKOWSKY, Illinois
JOHN SHIMKUS, Illinois               G.K. BUTTERFIELD, North Carolina
MARSHA BLACKBURN, Tennessee          DORIS O. MATSUI, California
ROBERT E. LATTA, Ohio                KATHY CASTOR, Florida
CATHY McMORRIS RODGERS, Washington   JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey            BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia         KURT SCHRADER, Oregon
GUS M. BILIRAKIS, Florida            JOSEPH P. KENNEDY, III, 
BILLY LONG, Missouri                     Massachusetts
LARRY BUCSHON, Indiana               TONY CARDENAS, California
SUSAN W. BROOKS, Indiana             ANNA G. ESHOO, California
MARKWAYNE MULLIN, Oklahoma           DIANA DeGETTE, Colorado
RICHARD HUDSON, North Carolina       FRANK PALLONE, Jr., New Jersey (ex 
CHRIS COLLINS, New York                  officio)
EARL L. ``BUDDY'' CARTER, Georgia
GREG WALDEN, Oregon (ex officio)

  
                             C O N T E N T S

                              ----------                              

                             March 21, 2018

                                                                   Page
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................     2
    Prepared statement...........................................     3
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     5
    Prepared statement...........................................     6
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     7
    Prepared statement...........................................     9
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................    10
    Prepared statement...........................................    11

                               Witnesses

Scott Gottlieb, M.D., Commissioner, Food and Drug Administration.    13
    Prepared statement...........................................    16
    Answers to submitted questions...............................   222
Anne Schuchat, M.D., Acting Director, Centers for Disease Control 
  and Prevention.................................................    23
    Prepared statement...........................................    25
Christopher M. Jones, PharmD, MPH, Director of the National 
  Mental Health and Substance Use Policy Laboratory, Substance 
  Abuse and Mental Health Services Administration................    34
    Prepared statement...........................................    36
Sue Thau, Public Policy Consultant, Community Anti-Drug 
  Coalitions of America..........................................   126
    Prepared statement...........................................   128
Cartier Esham, Executive Vice President, Emerging Companies, 
  Biotechnology Innovation Organization..........................   137
    Prepared statement...........................................   139
Jeffrey Francer, Senior Vice President and General Counsel, 
  Association for Accessible Medicines...........................   146
    Prepared statement...........................................   148
John Holaday, PHD, Chairman and Cofounder DisposeRX..............   155
    Prepared statement...........................................   157

                           Submitted Material

H.R. 5228........................................................    50
Documents submitted by Mr. Lance
    Statement of various groups..................................   185
    Statement of the National Association of County and City 
      Health Officials...........................................   190
    Statement of the National Alliance of State and Territorial 
      AIDS Directors.............................................   191
    Statement of the National Viral Hepatitis Roundtable.........   192
    Statement of the American Liver Foundation...................   194
    Statement of the AIDS Institute..............................   195
Bipartisan letter to appropriators in support of full funding for 
  the Minority Fellowship Program, submitted by Mr. Butterfield..   197
Documents submitted by Mr. Green
    Statement of EVERFI..........................................   203
    Statement of Congressman Hakeem Jeffries.....................   205
    Statement of Representative Ann Kuster.......................   207
    Statement of the Campaign to Protect Patient Privacy Rights..   209
    Statement of the National Alliance for Medication Assisted 
      Recovery, Inc..............................................   215
    Statement of the Pennsylvania Recovery Organizations Alliance   217
    Statement of Congresswoman Katherine Clark and Congressman 
      Hal Rogers in support of H.R. 5102.........................   220

                             March 22, 2018
                               Witnesses

Eric C. Strain, MD, Director, Center for Substance Abuse 
  Treatment and Research, Johns Hopkins University School of 
  Medicine.......................................................   228
    Prepared statement...........................................   231
Kenneth J. Martz, PSYD MBA, Special Projects Consultant, 
  Gaudenzia, Inc.................................................   236
    Prepared statement...........................................   238
    Answers to submitted questions...............................   547
Brad Bauer, Senior Vice President of New Business Development and 
  Customer Relationship Management, Appriss Health...............   249
    Prepared statement...........................................   251
William Banner, MD, PHD, Medical Director, Oklahoma Center for 
  Poison And Drug Information and Board President, American 
  Association of Poison Control Centers..........................   260
    Prepared statement...........................................   262
Michael E. Kilkenny, MD, MS, Physician Director, Cabell-
  Huntington Health Department of West Virginia..................   272
    Prepared statement...........................................   274
Jessica Hulsey Nickel, Founder, President and CEO, Addiction 
  Policy ForumI60308.............................................
    Prepared statement...........................................   311
    Answers to submitted questions...............................   553
Carlene Deal-Smith, Peer Support Specialist, Presbyterian Medical 
  Services.......................................................   324
    Prepared statement...........................................   325
Ryan Hampton, Recovery Advocate, Facing Addiction................   327
    Prepared statement...........................................   329
    Answers to submitted questions...............................   557
Mark Rosenberg, DO, MBA, FACEP, FAAHPM, Chairman of Emergency 
  Medicine and Chief Innovation Officer, St. Joseph's Healthcare 
  System and Board of Directors, American College of Emergency 
  Physicians.....................................................   361
    Prepared statement...........................................   363
Stacy Bohlen, CEO, National Indian Health Board..................   371
    Prepared statement...........................................   373
    Answers to submitted questions...............................   561
Alexis Horan, Vice President of Government Relations, Cleanslate 
  Centers........................................................   384
    Prepared statement...........................................   387

                           Submitted Material

Statement of Titan Pharmaceuticals, submitted by Mr. Guthrie.....   408
Documents submitted by Mr. Burgess
    Statement of the Addiction Medicine Foundation...............   410
    Statement of the Addiction Policy Forum......................   412
    Statement of the American Academy of Addiction Psychiatry....   414
    Statement of the American Association of Colleges of 
      Osteopathic Medicine.......................................   416
    Statement of the American Nurses Association.................   417
    Statement of the American Osteopathic Association and the 
      Massachusetts Osteopathic Society..........................   418
    Statement of the American Society of Addiction Medicine......   419
    Statement of the Association for Behavioral Healthcare.......   421
    Statement of the Coalition to Stop Opioid Overdose...........   423
    Statement of the International Certification & Reciprocity 
      Consortium.................................................   425
    Statement of Legacy Community Health.........................   426
    Statement of the National Board of Certified Counselors......   427
    Statement of the National Council for Behavioral Health......   428
    Statement of the Partnership to Amend 42 CFR Part 2..........   429
    Statement of the Confidentiality Coalition...................   432
    Statement of the Premier.....................................   434
    Statement of America's Essential Hospitals...................   436
    Article entitled, ``People with addiction issues should be 
      able to control their own health data,'' The Hill, March 3, 
      2018.......................................................   441
    Statement of the National Governors Association..............   446
    Statement of the President's Commission on Combating Drug 
      Addiction and the Opioid Crisis \1\
    Article entitled, ``Treating Behavioral Health Disorders in 
      an Accountable Care Organization,'' The Journal of 
      Accountable Care, December 2016............................   455
    Article entitled, ``Drug Interactions of Clinical Importance 
      among the Opioids, Methadone and Buprenorphine, and other 
      Frequently Prescribed Medications: A Review,'' American 
      Journal on Addictions, 2010................................   469
    Article entitled, ``Protection or Harm? Suppressing 
      Substance-Use Data,'' New England Journal of Medicine, May 
      14, 2015...................................................   489
    Article entitled, ``Ten Steps the Federal Government Should 
      Take Now to Reverse the Opioid Addiction Epidemic, Journal 
      of American Medicine, October 12, 2017.....................   492
    Statement of Ascension Healthcare............................   497
    Statement of Bloomberg Health Data Management................   500
    Statement of the American Academy of Neurology...............   507
    Statement of the American College of Obstetricians and 
      Gynecologists..............................................   509
    Statement of the American Society of Addiction Medicine......   515
    Statement of the Electronic Health Record Association........   526
    Statement of Keith Pardieck..................................   528
    Statement of the National Association of Chain Drugstores....   530
    Statement of the National Coalition on Health Care...........   535
    Statement of the Ohio State University College of Nursing....   539
    Statement of the United South & Eastern Tribes Sovereignty 
      Protection Fund............................................   540
    Statement of Patrick Kennedy.................................   545

----------
\1\ The statement can be found at: https://docs.house.gov/
  meetings/IF/IF14/20180321/108049/HHRG-115-IF14-20180321-
  SD037.pdf.


 COMBATING THE OPIOID CRISIS: PREVENTION AND PUBLIC HEALTH SOLUTIONS, 
                                 DAY 1

                              ----------                              


                       WEDNESDAY, MARCH 21, 2018

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:02 a.m., in 
room 2123, Rayburn House Office Building, Hon. Michael Burgess, 
M.D. (chairman of the subcommittee) presiding.
    Present: Representatives Burgess, Guthrie, Upton, Shimkus, 
Blackburn, Latta, Lance, Griffith, Bilirakis, Long, Bucshon, 
Brooks, Mullin, Hudson, Collins, Carter, Walden (ex officio), 
Green, Engel, Schakowsky, Butterfield, Matsui, Castor, Lujan, 
Kennedy, Degette, and Pallone (ex officio).
    Also Present: Representatives Walberg, McKinley, McNerney, 
and Dingell.
    Staff Present: Mike Bloomquist, Staff Director; Adam 
Buckalew, Professional Staff Member, Health; Daniel Butler, 
Staff Assistant; Zachary Dareshori, Legislative Clerk, Health; 
Jordan Davis, Director of Policy and External Affairs; Paul 
Edattel, Chief Counsel, Health; Margaret Tucker Fogarty, Staff 
Assistant; Adam Fromm, Director of Outreach and Coalitions; Ali 
Fulling, Legislative Clerk, Oversight and Investigations, 
Digital Commerce and Consumer Protection; Caleb Graff, 
Professional Staff Member, Health; Jay Gulshen, Legislative 
Associate, Health; Ed Kim, Policy Coordinator, Health; Mary 
Martin, Chief Counsel, Energy/Environment; Mark Ratner, Policy 
Coordinator; Kristen Shatynski, Professional Staff Member, 
Health; Jennifer Sherman, Press Secretary; Danielle Steele, 
Counsel, Health; Austin Stonebraker, Press Assistant; Hamlin 
Wade, Special Advisor, External Affairs; Everett Winnick, 
Director of Information Technology; Jacquelyn Bolen, Minority 
Professional Staff; Jeff Carroll, Minority Staff Director; 
Waverly Gordon, Minority Health Counsel; Tiffany Guarascio, 
Minority Deputy Staff Director and Chief Health Advisor; 
Jourdan Lewis, Minority Staff Assistant; Tim Robinson, Minority 
Chief Counsel; Andrew Souvall, Minority Director of 
Communications, Outreach and Member Services; Kimberlee 
Trzeciak, Minority Senior Health Policy Advisor; and C.J. 
Young, Minority Press Secretary.
    Mr. Burgess. The Subcommittee on Health will now come to 
order.
    The chair at this time would like to recognize the chairman 
of the full committee, Mr. Walden of Oregon, 5 minutes for an 
opening statement, please.

  OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Mr. Walden. Thank you, Mr. Chairman. And thank you for your 
great leadership on this issue.
    Today marks the second of three legislative hearings 
advancing collaborative bipartisan legislative solutions to 
help combat the opioid crisis.
    The impressive plague of opioid addiction and substance use 
disorder in our country requires an unprecedented response. And 
while this committee spearheaded the legislative efforts in 
CARA and Cures under Chairman Upton that has already devoted a 
record amount of Federal resource to address this crisis, we 
know we must do more to meet the growing demand.
    This epidemic knows no geographic, no political, nor any 
socioeconomic bounds. I have held roundtables in my district in 
Oregon. Places like Hermiston and Grants Pass and Medford. When 
you talk to providers, to patients, to families, you can feel 
the sting of this crisis in every community.
    President Trump rightly called it the crisis next door, and 
earlier this week, rolled out an ambitious plan. I was pleased 
to see that several of his proposals overlap with the work of 
this committee. And I know that working across the aisle and 
with the administration, we can arm agencies, healthcare 
providers, researchers, and patients with the tools they need. 
We stand ready to work with the President and his 
administration to put a stop to this crisis once and for all.
    Over the span of 2 days, the Energy and Commerce Committee 
will consider a range of bills from members on both sides of 
the aisle, some 25 different pieces of legislation covering the 
full spectrum of prevention and public health, and we will hear 
from 19 witnesses.
    The bills we consider today will strengthen the Food and 
Drug Administration's ability to understand several aspects of 
the opioid crisis, including the risk of long-term opioid use 
and how authorities can better intercept dangerous illicit 
products of international mail facilities.
    We will hear about legislation that will facilitate the 
efficient development of treatments for substance use disorders 
and legislation that will encourage alternatives to opioids for 
the treatment of pain. These are two areas of medicine that 
have suffered from a lack of innovation and development, and I 
am optimistic that we can take tailored steps to encourage 
progress in the right direction.
    Representative Latta's amendment in the nature of a 
substitute to H.R. 4284, Indexing Narcotics, Fentanyl, and 
Opioids, or the INFO Act, would create a public and easily 
accessible electronic dashboard that would link to all the 
nationwide efforts and strategies to combat this opioid crisis, 
as well as create an inner agency substance use disorder 
coordinating committee to review and coordinate research 
services and prevention activities across all relevant Federal 
agencies. This will be a tremendous resource for patients, 
their families, and for our local communities.
    Representative Mullin's amendment in the nature of a 
substitute to H.R. 3545, the Overdose Prevention and Patient 
Safety Act, which would allow for limited sharing of substance 
use disorder treatment records between health providers and 
place strong discrimination provisions in statute to protect 
people seeking or receiving substance use disorder treatment. I 
understand this issue is deeply sensitive, but it is important 
that we have a thoughtful discussion about ensuring that 
patients seeking these services receive parity and the same 
quality treatment that is provided to patients with other 
chronic disorders. Substance use disorder is a medical illness 
and we must treat it that way. Removing the stigma of addiction 
is one of the most important things we as Members of Congress 
can do to respond to this national emergency and will 
dramatically change how we prevent and treat this complex 
disease.
    Representative McKinley's H.R. 5176, Preventing Overdoses 
While in Emergency Room, would provide resources for hospitals 
to develop discharge protocols for patients who have had an 
opioid overdose, such as the provision of naloxone upon 
discharge and referrals to treatment and other services that 
best fit the patients' needs.
    I would also like to thank my colleague, Representative 
Griffith, for leading a discussion draft that would authorize 
Federal spport for a number of innovative activities in state-
based prescription drug monitoring programs.
    These are just a handful of the solutions that our 
Republican and Democrat colleagues have brought forth.
    I would like to thank our four panels of witnesses that 
will be here today, hopefully, weather permitting. And I look 
forward to your feedback on these important issues.
    And with that, I would yield the balance of my time, I 
believe, to Mr. Guthrie.
    [The prepared statement of Mr. Walden follows:]

                 Prepared statement of Hon. Greg Walden

    Today marks the second of three legislative hearings 
advancing collaborative, bipartisan legislative solutions to 
help combat the opioid crisis.
    The unprecedented plague of opioid addiction and substance 
use disorder in our country requires an unprecedented response. 
While this committee spearheaded the legislative efforts in 
CARA and Cures that has already devoted a record amount of 
federal resources to address this crisis, we can and must do 
more to meet this growing need.
    This epidemic knows no geographic, political, or socio-
economic bounds. I've held roundtables in my district in 
Oregon--places like Hermiston, Grants Pass, and Medford--when 
you talk to providers, patients, and their families, you can 
feel the sting of this crisis in the community.
    President Trump rightly called it the ``Crisis Next Door,'' 
and earlier this week, rolled out an ambitious plan. I was 
pleased to see that several of his proposals overlap with the 
work of this committee and I know that working across the aisle 
and with the administration we can arm agencies, health care 
providers, researchers, and patients with the tools they need. 
We stand ready to work with the President and his 
administration to put a stop to this crisis once and for all.
    Over the span of 2 days, we will consider a range of bills 
from Members on both sides of the aisle--25 bills, in fact, 
covering the full spectrum of prevention and public health--and 
we will hear from 19 witnesses.
    The bills we will consider today will strengthen the Food 
and Drug Administration's (FDA) ability to understand several 
aspects of the opioid crisis, including: the risks of long-term 
opioid use and how authorities can better intercept dangerous 
illicit products at international mail facilities.
    We will hear about legislation that will facilitate the 
efficient development of treatments for substance use 
disorders, and legislation that will encourage alternatives to 
opioids for the treatment of pain. These are two areas of 
medicine that have suffered from a lack of innovation and 
development and I am optimistic that we can take tailored steps 
to encourage progress with the right solutions.
    Rep. Latta's amendment in the nature of a substitute to 
H.R. 4284, Indexing Narcotics, Fentanyl, and Opioids (INFO) Act 
would create a public and easily accessible electronic 
dashboard linking to all of the nationwide efforts and 
strategies to combat the opioid crisis, as well as create an 
Interagency Substance Use Disorder Coordinating Committee to 
review and coordinate research, services, and prevention 
activities across all relevant federal agencies. This will be a 
tremendous resource for patients, their families, and our local 
communities.
    Rep. Mullin's amendment in the nature of a substitute to 
H.R. 3545, the Overdose Prevention and Patient Safety Act, 
which would allow for limited sharing of substance use disorder 
treatment records between health providers and place strong 
discrimination prohibitions in statute to protect people 
seeking and receiving substance use disorder treatment. I 
understand this issue is a deeply sensitive one, but it is 
important that we have a thoughtful discussion about ensuring 
that patients seeking these services receive parity and the 
same quality treatment that is provided to patients with other 
chronic disorders. Substance use disorder is a medical illness 
and we must treat it that way. Removing the stigma of addiction 
is one of the most important things we as members of Congress 
can do to respond to this national emergency and will 
dramatically change how we prevent and treat this complex 
disease.
    Rep. McKinley's H.R. 5176, Preventing Overdoses While in 
Emergency Rooms (POWER) Act, would provide resources for 
hospitals to develop discharge protocols for patients who have 
had an opioid overdose, such as the provision of naloxone upon 
discharge and referrals to treatment and other services that 
best fit the patient's needs.
    I'd also like to thank my colleague Rep. Griffith for 
leading a discussion draft that would authorize federal support 
for a number of innovative activities in state-based 
prescription drug monitoring programs (PDMPs).
    These are just a handful of the solutions that our 
colleagues, Republicans and Democrat, have brought forward.
    I'd like to thank our four panels of witnesses for being 
here today andtomorrow, and I look forward to your feedback on 
these important issues.

    Mr. Guthrie. Thank you, Mr. Chairman. Thanks, Dr. Burgess, 
for moving forward with this leadership.
    I have introduced, with Ranking Member Green, the 
Comprehensive Opioid Recovery's Act, to approve treatment for 
those suffering from opioid addiction. The treatment system is 
fractured and complex, and patients with opioid use disorder 
are not afforded the same comprehensive coordinated care that 
patients with other chronic diseases receive. We must help all 
Americans who suffer from opioid addiction.
    The bill creates a new treatment structure that provides 
coordinated evidence-based and patient-centered care. This bill 
will also generate meaningful data that can be used to inform 
standards and best practices moving forward.
    Thank you again, and I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair now recognizes the gentleman from Texas, Mr. 
Green, 5 minutes for an opening statement, please.

   OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Green. Thank you, Mr. Chairman, for holding the hearing 
today. I want to thank Dr. Gottlieb and our other witnesses 
from the Department of Health and Human Services and engaged 
stakeholders for joining us today on this snowy morning.
    One hundred and fifteen Americans die from overdosing on 
opioids every day. The misuse of and addiction to opioids, 
including the prescription pain relievers, heroine, synthetic 
opioids like fentanyl, is a serious national crisis that 
affects public health as well as the social and economic 
welfare of communities throughout America.
    The Centers for Disease Control and Prevention estimates 
that the total economic burden of prescription opioid misuse in 
the United States is $78.5 billion a year, including your cost 
of healthcare, loss of productivity, addiction treatment, and 
criminal justice involvement.
    It is imperative that Congress and our public health 
agencies advance policies that will help our fellow Americans 
struggling with opioid addiction and prevent abuse and misuse 
from happening in the first place.
    One of the bills I am working on concurrently is a 
discussion draft that would authorize the Food and Drug 
Administration to consider the potential for misuse and abuse 
when assessing the risk and benefits of a controlled substance 
for purposes of approval.
    It is important that our committee craft legislation on the 
opioid crisis. And we give FDA clear authority to consider 
potential misuse and abuse of a product when risk outweigh the 
benefits.
    I hope to hear from our panelists today on how we can best 
tailor our proposal that will clarify the FDA authority, while 
ensuring that it is targeting the controlled substances that 
are fueling the opioid crisis.
    The second bill I am working on is with both Congressman 
Guthrie, Lujan, and Bucshon, is the Comprehensive Opioid 
Recovery Centers Act, H.R. 5327. This bill creates a grant 
program administered to the Department of HHS to fund 
designated centers where individuals can obtain comprehensive 
patient-centered care for the treatment of their addiction and 
other substance use disorders.
    Using the Comprehensive Opioid Recovery Centers Act, each 
grantee would be required to provide, either directly or 
through agreement with other entities, a set of range 
coordinated evidence-based treatment recovery services.
    Grantees would also be required to monitor and report on 
the effectiveness of the programs, as well as provide outreach 
to their communities on services they are providing.
    I have been a lifelong proponent of increasing access to 
healthcare in our communities. It is surprising to me to learn 
how confusing and limited the options are for patients with 
substance use disorder. I am hoping this legislation will help 
transform our treatment system and help patients move easily, 
navigate their options for care.
    I look forward to asking questions of our panelists as to 
how to make sure the purpose of this bill is carried out in the 
most effective way.
    While our committee is examining how best to combat opioid 
abuse, I need to remind my colleagues on the critical 
importance of ensuring Affordable Care Act coverage for the 
essential benefits as part of the solution to this crisis.
    We cannot help Americans struggling with opioid abuse if 
they don't have health insurance coverage or have coverage that 
does not provide the full range of essential health services 
that are supposed to be guaranteed under the Affordable Care 
Act.
    I would like to share some concerns before I conclude. Many 
members of our committee, including myself, are concerned about 
the number of bills we are considering during our 2-day 
hearing.
    While we all agree on the magnitude of the opioid crisis 
and the importance of concrete congressional action, I am 
concerned that we will only be able to give brief attention to 
many bills before us today and tomorrow due to the number of 
bills we are considering, 25 in total.
    While many of the bills are non-controversial and 
bipartisan, there are bills that need to be improved before 
they are ready for consideration before the House of 
Representatives, and I hope the chairman will commit to work 
with us on our concerns before bringing these bills up for 
markup.
    And I yield back the balance of my time.
    [The prepared statement of Mr. Green follows:]

                 Prepared statement of Hon. Gene Green

    Mr. Chairman, thank you for holding today's hearing on the 
opioid crisis and public health solutions.
    I thank our witnesses with the Department of Health and 
Human Services and engaged stakeholders for joining us today on 
this snowy morning.
    One-hundred fifteen (115) Americans die from overdosing on 
opioids every day. The misuse of, and addiction, to opioids--
including prescription pain relievers, heroin, and synthetic 
opioids like fentanyl--is a serious national crisis that 
affects public health, as well as the social and economic 
welfare of communities throughout America.
    The Centers for Disease Control and Prevention estimates 
that the total ``economic burden'' of prescription opioid 
misuse in the United States is $78.5 billion a year, including 
the costs of healthcare, lost productivity, addiction 
treatment, and criminal justice involvement.
    It is imperative that Congress and our federal public 
health agencies advance policies that will help our fellow 
Americans struggling with opioid addiction and prevent abuse 
and misuse from happening in the first place.
    One of the bills I am working on, currently a discussion 
draft, would authorize the Food and Drug Administration (FDA) 
to consider the potential for misuse and abuse when assessing 
the risks and benefits of controlled substances for purposes of 
approval.
    It is important that as our committee crafts legislation on 
the opioid crisis, we give FDA clear authority to consider 
potential misuse and abuse of a product when the risks outweigh 
the benefits.
    I hope to hear from our panelists today how we can best 
tailor my proposal that will clarify FDA authority while 
ensuring that it is targeting the controlled substances that 
are fueling the opioid crisis.
    The second bill I am working on, with Congressman Guthrie, 
Lujan and Bucshon, is the Comprehensive Opioid Recovery Centers 
Act, H.R. 5327. This bill creates a grant program administered 
through the Department of Health and Human Services to fund 
designated centers where individuals can obtain comprehensive 
patient-centered care for the treatment of opioid addiction and 
other substance use disorders.
    Under the Comprehensive Opioid Recovery Centers Act, each 
grantee would be required to provide, either directly or 
through agreement with other entities, a set range of 
coordinated evidence-based treatment and recovery services.
    Grantees would also be required to monitor and report on 
the effectiveness of these programs as well as provide outreach 
to their communities on the services they are providing.
    I've been a longtime proponent of increasing access to 
health care in our communities. It was surprising to me to 
learn how confusing and limited the options are for patients 
with substance use disorder. I'm hoping this piece of 
legislation will help transform our treatment system and help 
patients more easily navigate their options for care.
    I look forward to asking questions of our panelists as to 
how to make sure the purpose of this bill is carried out in the 
most effective way.
    While our committee is examining how best to combat opioid 
abuse, I need to remind my colleagues on the critical 
importance of ensuring affordable health care coverage with 
essential benefits as part of the solution to this crisis.
    We cannot help American struggling with opioid abuse if 
they do not have health coverage, or have coverage that does 
not provide the full range of essential health services that 
are supposed to be guaranteed under the Affordable Care Act.
    I would like to share some concerns before I conclude. Many 
Members of our committee, including myself, are concerned about 
the number of bills we are considering during our two-day 
hearing.
    While we all agree on the magnitude of the opioid crisis 
and the importance of concrete congressional action, I am 
concerned that we will only be able to give brief attention to 
many of the bills before us today and tomorrow due to the 
number of bills we are considering, 25 in total.
    While many of bills are non-controversial and bipartisan, 
there are bills that need to be improved before they are ready 
for consideration before the full House of Representatives. I 
hope the Chairman will commit to work with us on our concerns 
before bringing these bills to a markup.Thank you, Mr. 
Chairman. I yield the remainder of my time.

    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes himself for 5 minutes for an opening 
statement, and acknowledge that we are convening our second of 
three hearings to consider legislation addressing the opioid 
epidemic.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    The efforts in the Comprehensive Addiction Recovery Act and 
21st Century Cures have been impactful, but there is more that 
Congress must do to tackle the crisis.
    As to Cures, I would like to point out a recent story which 
reported that some of the money approved by Congress remains 
untouched, mostly at the Substance Abuse and Mental Health 
Services Administration. If true, this should trouble all of us 
here, because in communities across America, individuals are 
suffering from addiction, overdose, lost loved ones. We cannot 
allow agency inertia to get in the way of delivering those 
dollars where they are, in fact, needed. This epidemic is in 
our hospitals, in our living rooms, and on our streets. Our 
partners at the Federal agencies must elevate to the challenge 
and deliver these vital resources for the States and 
communities that have been most impacted by this crisis.
    As has previously been mentioned, this hearing is divided 
over 2 days this week. We will focus on prevention and public 
health aspects of the crisis. We are today going to hear the 
role of the Food and Drug Administration and other segments of 
the Department of Health and Human Services, including the 
Substance Abuse and Mental Health Services Administration and 
the Centers for Disease Control and Prevention, how they 
interact and how Congress can do a better job in enabling these 
agencies to do their work.
    Today's hearing is a result of the Member Day that the 
Health Subcommittee held last October where over 50 Members of 
Congress, yes, this subcommittee, yes, the full committee, but 
any Member of Congress was invited in to tell their story. And 
we did hear their personal stories about how the epidemic has 
affected their communities. I do want to commend these members 
and their staffs and our committee staff for developing many of 
the policies under consideration today, 25. I acknowledge that 
that is a large number, but the crisis demands that we provide 
the attention necessary. These bills today range from amending 
laws relating to the confidentiality of substance use disorder 
and patient data, to establishing comprehensive opiate recovery 
centers, to streamlining and enhancing the tools for the Food 
and Drug Administration to intercept illegal products in 
international mail facilities. I would like to be able to 
describe each bill in detail, but that task would take up more 
time than I have allotted myself.
    But I just want to point out that this challenge in front 
of us does require a multifaceted approach. For example, 
Representative Latta's bill, the INFO Act, embodies an all-
encompassing approach by directing the Department of Health and 
Human Services to create a public and easily accessible 
electronic dashboard linking to all nationwide efforts and 
strategies to combat the crisis.
    An all-hands-on-deck approach also means that we should 
help interested stakeholders, such as biopharmaceutical 
manufacturers, make the necessary investments in novel 
treatments for the market. A bill that I am sponsoring will 
require the Food and Drug Administration to provide more 
clarity through guidance on how these stakeholders can utilize 
the accelerated approval and breakthrough therapy programs to 
expedite the availability of innovative therapies for pain and 
addiction.
    I am sure that many Members of Congress, especially those 
who sit on this subcommittee, have heard from doctors, they 
have heard from pharmacists in their districts about the 
inefficiencies of the State-run prescription drug monitoring 
programs. Representative Griffith's bill would realign 
prescription drug monitoring programs under the Centers for 
Disease Control to coordinate efforts to improve data 
collection into physician workflow. Passage of this bill would 
allow doctors to make better informed decisions leading to more 
effective treatment for patients.
    When narcotics, when opiates go unused, they frequently sit 
in someone's medicine cabinet and instead of being properly 
discarded and their disposal secured. Representative Hudson's 
bill addresses this problem from the packaging and disposal 
angle. His bill would direct the Food and Drug Administration 
to work with manufacturers to establish programs for an 
efficient return or destruction of unused schedule II drugs, 
with an emphasis on opiates.
    Many of us have seen the Centers for Disease Control's most 
recent report on emergency departments' admissions. There were 
30 percent increase from July 2016 through September 2017. Two 
bills up for consideration would reverse that trend.
    I again want to welcome our witnesses. And I will yield the 
balance of my time to Mrs. Blackburn from Tennessee.
    [The prepared statement of Mr. Burgess follows:]

             Prepared statement of Hon. Michael C. Burgess

    This morning, we convene for our second of three hearings 
to consider legislation addressing the opioid epidemic. While 
our efforts in the Comprehensive Addiction and Recovery Act and 
21st Century Cures have been impactful, there is much more that 
Congress can do to tackle this crisis. As to Cures, I would 
like to point out a recent story which reported that most of 
the money approved by Congress remains untouched, mostly at the 
Substance Abuse and Mental Health Services Administration. If 
true, this should trouble all of us here because in communities 
across America, individuals and families are suffering from 
addiction, overdose, and loss of loved ones.
    This epidemic is in our hospitals, in our living rooms, and 
on our streets. Our partners at federal agencies must rise up 
to the challenge and deliver these vital resources for the 
states and communities most hurt by this crisis.
    This hearing, which will be split between today and 
tomorrow, focuses on the prevention and public health aspects 
of the crisis, particularly addressing the role that the Food 
and Drug Administration, and other segments of the Department 
of Health and Human Services, including the Substance Abuse and 
Mental Health Services Administration, can play, and how 
Congress can enable these agencies to better do its job.
    Today's hearing is the result of the Member Day the Health 
Subcommittee held last October, where over 50 bipartisan 
Members of Congress--both on and off the Energy and Commerce 
Committee--shared their personal stories on how the opioid 
epidemic has devastated their communities. I commend these 
members, their staffs, and our committee staffs for developing 
many of the policies under consideration today. Twenty-five. 
This is the total number of bills being reviewed. They range 
from amending laws relating to confidentiality of substance use 
disorder patient data, to establishing comprehensive opioid 
recovery centers, to streamlining and enhancing the tools for 
FDA to intercept illegal products in international mail 
facilities. While I wish I could describe each bill in detail, 
that task itself may take the full two days we have slotted for 
this hearing.
    The opioid epidemic requires a multi-pronged, comprehensive 
approach involving almost all facets of our society. For 
example, Rep. Latta's bill, the INFO Act, embodies an all-
encompassing approach by directing the Department of Health and 
Human Services to create a public and easily accessible 
electronic dashboard linking to all nationwide efforts and 
strategies to combat the crisis.
    An all-hands-on approach also means we should help 
interested stakeholders, such as biopharmaceutical 
manufacturers, make the necessary investments in novel 
treatments for the market. A bill I am sponsoring will require 
the Food and Drug Administration to provide more clarity 
through a guidance on how these stakeholders can utilize the 
accelerated approval and breakthrough therapy programs to 
expedite the availability of innovative therapies for pain and 
addiction.
    I am sure that many members of Congress, especially those 
who sit on this Subcommittee, have heard from physicians and 
pharmacists in their district about the inefficiencies of 
state-run prescription drug monitoring programs, or PDMPs. Rep. 
Griffith's bill would realign PDMPs under the Centers for 
Disease Control and Prevention to coordinate efforts that will 
improve data collection and integration into physician 
workflow. Passage of this bill would allow physicians to make 
better informed decisions, leading to more effective treatment 
for their patients.
    When opioids go unused, they frequently sit in people's 
medicine cabinets instead of being properly disposed, 
increasing the likelihood of diversion. Rep. Hudson's bill 
fights this problem from the packaging and disposal angle. His 
bill would direct the Food and Drug Administration to work with 
manufacturers to establish programs for efficient return or 
destruction of unused Schedule II drugs, with an emphasis on 
opioids.
    Many of us have seen the Center for Disease Control and 
Prevention's most recent report on emergency department 
admissions due to opioid overdoses where there was a thirty 
percent increase from July 2016 through September 2017. Two 
bills up for consideration today aim to reverse this trend. A 
bill introduced by Rep. Pascrell would establish a 
demonstration program to test alternative pain management 
protocols to limit the use of opioids in hospital emergency 
departments. Another bill, introduced by Rep. McKinley, would 
assist hospitals in developing protocols on discharging 
patients after they overdose.
    Clearly, we have our work cut out for us over the next 2 
days as we examine the policies within these bills. But, it 
will be a worthwhile exercise that will produce a well-thought-
out and well-vetted package of legislation to aid our public 
health workforce in overcoming this public health crisis.
    I again want to welcome our witnesses and thank you for 
being here. I look forward to your testimony.

    Mrs. Blackburn. Thank you, Mr. Chairman.
    And another report that I saw yesterday was the AEI report 
that goes through the cost per capita of the opioid epidemic. 
It is $2,000 per person in Tennessee, is what it is costing us. 
But I think the emotional cost is something that we will want 
to visit with you all today about too.
    Yesterday, I talked with a friend who was recounting how, 
12 years ago, I sat with her, cried with her, talked with her 
as she discovered a high school child had an opioid addiction 
and how things have changed and the attention that is paid to 
the issue now. And it is a heart-wrenching issue. And we thank 
you all for being here and working with us on the issue.
    And I yield back.
    Mr. Burgess. The gentlelady yields back.
    And the chair will yield back.
    The chair now recognizes the ranking member of the full 
committee, Mr. Pallone, 5 minutes for an opening statement, 
please.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. Thank you, Mr. Chairman.
    Today, we continue a series of hearings to address the 
complex opioid abuse crisis that is devastating lives across 
the country. While we have worked together to pass CARA and the 
21st Century Cures Act, more must be done. And that is why I am 
pleased that Congress agreed in the budget agreement to provide 
a total of $6 billion in additional funding for efforts to 
respond to the epidemic for fiscal years 2018 and 2019. Without 
this funding commitment, many of the laws we have passed and 
the bills being discussed during this hearing are nothing more 
than empty words.
    Over the next 2 days, we have a lot of bills to consider, 
and I hope we can have a thorough conversation about all of 
them. However, I am concerned that it will be difficult to 
properly address all of the bills since there are so many. In 
going forward, it would be nice if the Republican majority 
scheduled multiple hearings so that we have the time to fully 
evaluate the proposed solutions.
    The bills we will consider during the next 2 days are 
diverse and span multiple disciplines, and that is essential 
because there is no single solution to the opioid crisis. No 
single individual, group, field of study, or agency can solve 
this problem alone. Everyone must do their part.
    And one of the major ways we can impact the prevalence of 
opioids available for abuse is to limit the importation of 
synthetic opioids that have infiltrated our international 
mailing facilities, and that is why I have introduced a bill, 
the SCREEN Act, to expand FDA's authority to crack down on the 
counterfeit drugs entering the country. Currently, FDA has 
limited authority to act on parcels with mislabeled, unlabeled, 
or counterfeit drug products. This bill will provide greater 
oversight of packages in international mail facilities allowing 
the FDA to refuse importation or destroy illegal drugs being 
shipped into the country and recall and prevent distribution of 
products that pose a danger to public health. Importantly, it 
will also authorize resources for FDA to expand capacity to 
meet this challenge.
    It is unfortunate that the chairman chose not to notice 
this bill for today's hearing since I have been working on this 
issue for years, and I hope that we can still consider this 
bill as we move forward.
    We are also reviewing other important bills, such as H.R. 
3692, the Addiction Treatment Access Improvement Act of 2017, 
which will increase the number of providers that can treat 
patients through the DATA 2000 waiver. Also, H.R. 5140, the 
Tribal Addiction and Recovery Act, which would provide funding 
to Tribes and Tribal organizations for substance use disorder 
prevention and treatment efforts in Indian Country. And a 
discussion draft that would enhance and improve State-run 
prescription drug monitoring programs, known as NASPER.
    I am not able to speak on every bill in such a short amount 
of time, but I do want to highlight the concerns I have with 
one of the bills under discussion today, and that is H.R. 3545, 
the Overdose Prevention and Patient Safety Act, which I think 
could dangerously erect a barrier to patients seeking and 
remaining in treatment and, therefore, harm our efforts to 
respond to this crisis. It would be nice if we could eliminate 
discrimination for good in this country by simply passing a law 
that makes discrimination illegal. But, unfortunately, that is 
simply not the case. And, therefore, I do not think the 
additions to the underlying text of the bill cures the issue of 
the risk of stigma, discrimination, and negative health and 
life outcomes that could result from a rollback of regulations 
that protect a patient's privacy.
    So I look forward to discussing each of these bills during 
this and future hearings continuing to work towards finding 
solutions to this very severe opioid crisis.
    And I yield the remainder of my time to the gentlewoman 
from California, Ms. Matsui.
    [The prepared statement of Mr. Pallone follows:]

             Prepared statement of Hon. Frank Pallone, Jr.

    Today we continue a series of hearings to address the 
complex opioid abuse crisis that is devastating lives across 
the country. While we have worked together to pass CARA and the 
21st Century Cures Act, more must be done. That is why I'm 
pleased that Congress agreed to provide a total of $6 billion 
in additional funding for efforts to respond to the epidemic 
for fiscal years 2018 and 2019. Without this funding 
commitment, many of the laws we've passed and the bills being 
discussed during this hearing are nothing more than empty 
words.
    Over the next 2 days, we have a lot of bills to consider, 
and I hope we can have a thorough conversation about all of 
them. However, I'm concerned that it will be difficult to 
properly address all of the bills since there are so many. 
Going forward, it would be nice if the Republican Majority 
scheduled multiple hearings so that we have the time to fully 
evaluate the proposed solutions.
    The bills we will consider during the next 2 days are 
diverse and span multiple disciplines, and that's essential 
because there is no single solution to the opioid crisis. No 
single individual, group, field of study, or agency can solve 
this problem alone, everyone must do their part.
    One of the major ways we can impact the prevalence of 
opioids available for abuse is to limit the importation of 
synthetic opioids that have infiltrated our international 
mailing facilities. That is why I have introduced a bill, the 
SCREEN ACT, to expand FDA's authority to crack down on the 
counterfeit drugs entering the country. Currently, FDA has 
limited authority to act on parcels with mislabeled, unlabeled, 
or counterfeit drug products. This bill will provide greater 
oversight of packages in International Mail Facilities, allow 
the FDA to refuse importation or destroy illegal drugs being 
shipped into the country, and recall and prevent distribution 
of products that pose a danger to public health. Importantly, 
it will also authorize resources for FDA to expand capacity to 
meet this challenge.
    It's unfortunate that the Chairman chose not to notice this 
bill for today's hearing since I've been working on this issue 
for years. I hope that we can still consider this bill moving 
forward. We're also reviewing other important bills such as 
H.R. 3692, the Addiction Treatment Access Improvement Act of 
2017, which will increase the number of providers that can 
treat patients through the DATA 2000 waiver. H.R. 5140, the 
Tribal Addiction and Recovery Act, will provide funding to 
tribes and tribal organizations for substance use disorder 
prevention and treatment efforts in Indian Country. And a 
discussion draft that would enhance and improve State-run 
Prescription Drug Monitoring Programs--known as NASPER.
    I'm not able to speak on every bill in such a short amount 
of time. But I did want to highlight the concerns I have with 
one of the bills under discussion today. H.R. 3545, the 
Overdose Prevention and Patient Safety Act could dangerously 
erect a barrier to patients seeking and remaining in treatment 
and therefore harm our efforts to respond to this crisis. It 
would be nice if we could eliminate discrimination for good in 
this country by simply passing a law that makes discrimination 
illegal, but unfortunately that simply isn't the case. 
Therefore I do not think the additions to the underlying text 
of the bill cures the issue of the risk of stigma, 
discrimination, and negative health and life outcomes that 
could result from a roll back of regulations that protect a 
patients' privacy.
    I look forward to discussing each of the bills during this 
and future hearings and continuing to work towards finding 
solutions to the opioid crisis.
    I yield back.

    Ms. Matsui. Thank you very much, Mr. Pallone. And thank 
you, Mr. Chairman, for holding this hearing. And thank you to 
the witnesses for being here today.
    I am pleased that we are taking on the issue of the opioid 
epidemic in our committee. We are examining a lot of bills 
today, and I think we are ahead of some of the other committees 
in the House and Senate in doing so. I am glad we are moving 
forward, but do want to make sure that we do it in a way that 
avoids unintended consequences.
    It is important that we take a comprehensive look at all 
aspects of this problem, from opioid manufacturing and 
distribution, to prescribing, to research and alternatives for 
pain management, to access of substance use treatment and 
services.
    As we examine all the different factors that contributed to 
where we are today, I hope we approach solutions with a shared 
sense of responsibility. I know that the policy pendulum often 
swings to extremes. So I think we need to be careful to avoid 
creating new problems as we try to solve the problems facing us 
today.
    Lastly, as we examine an array of targeted solutions with 
FDA, CDC, and SAMHSA today, I hope we take a holistic look at 
this epidemic and assure we are making a coordinated effort to 
provide solutions for families and prevent future strategies.
    With that, thank you, and I yield back.
    Mr. Burgess. The chair thanks the gentlelady. The 
gentlelady yields back.
    And that concludes member opening statements. The chair 
would like to remind members that, pursuant to committee rules, 
all members' opening statements will be made part of the 
record.
    And we do want to thank our witnesses for being here today 
and taking the time to testify before the subcommittee. Each 
witness will have an opportunity to give a summary of their 
opening statement. That will be followed by questions from 
members.
    Our first panel today, we will hear from Dr. Scott 
Gottlieb, the Commissioner of the Food and Drug Administration; 
Dr. Anne Schuchat, Acting Director, Center for Disease Control 
and Prevention; and Dr. Christopher M. Jones, Director of the 
National Mental Health, Substance Use Policy Laboratory, 
Substance Abuse and Mental Health Services Administration, and 
a Pharmacist, as I understand, and from Georgia.
    So we welcome all of you to our witness table today.
    Dr. Gottlieb, you are recognized for 5 minutes, please.

STATEMENT OF SCOTT GOTTLIEB, M.D., COMMISSIONER, FOOD AND DRUG 
 ADMINISTRATION; ANNE SCHUCHAT, M.D., ACTING DIRECTOR, CENTERS 
 FOR DISEASE CONTROL AND PREVENTION; AND CHRISTOPHER M. JONES, 
    PHARMD, MPH, DIRECTOR OF THE NATIONAL MENTAL HEALTH AND 
  SUBSTANCE USE POLICY LABORATORY, SUBSTANCE ABUSE AND MENTAL 
                 HEALTH SERVICES ADMINISTRATION

               STATEMENT OF SCOTT GOTTLIEB, M.D.

    Dr. Gottlieb. Good morning, Chairman Burgess, Ranking 
Member Green, and members of the subcommittee. Thank you for 
the opportunity to discuss FDA's role in combating the ongoing 
crisis of opioid addiction.
    Confronting this epidemic remains one of my highest 
priorities. I am committed to reexamining all of our 
authorities and further steps FDA can take, and I am grateful 
for this committee's commitment to the role FDA has in 
combating the epidemic and for your interest and additional 
tools that could enhance FDA's ability to respond, such as 
those that would support our work in the interdiction of 
illegal drugs, including narcotics, inside the international 
mail facilities.
    To address this crisis, FDA is working across three broad 
domains. First, we are taking steps to improve our medical 
technology. This means better drugs to treat addiction through 
medication-assisted treatment and new pain remedies that are 
resistant to manipulation and misuse or aren't as addictive as 
traditional opioids.
    Second, we are pursuing measures to reduce the rate of new 
addiction. This means trying to reduce overall prescribing and 
the number of pills that get dispensed with each prescription. 
So among other things, we are taking new steps to require 
sponsors to provide education to providers and other healthcare 
practitioners. We are also exploring ways to change how opioids 
are packaged to allow better management of their prescribing.
    One of the things we are considering is steps to require 
sponsors to ensure prescribers provide specific documentation 
for prescription above a specified amount. Such a framework 
would be based on evidence-based guidelines that define the 
proper length of treatment for a given indication.
    Third, we are ramping up our efforts aimed at the 
interdiction of illegal drugs, including narcotics. This 
includes new authorities and resources aimed at our work in the 
international mail facilities. There is a virtual flood of 
dangerous products entering the United States through mail 
packages that expose Americans to dangerous pills. We are 
dealing with sophisticated bad actors that are aware of the 
gaps and weaknesses in our tools and try to exploit them.
    Primary responsibility for imported narcotics falls to 
Customs and Border Protection. Anything believed to contain 
controlled substances goes to CBP before packages are sent to 
us at FDA. But we are still seeing more and more controlled 
substances hitting our investigators. In fact, in one recent 6-
month period where FDA inspected 5,800 packages, 376 contained 
controlled substances, including opioids.
    I am increasingly worried that those sneaking opioids 
through the mail will disguise them as ordinary drugs to evade 
detection. It is estimated that less than one-tenth of 1 
percent of the packages that contain drugs actually undergo the 
physical inspection. The risk is that many illicit drugs are 
slipping through our grasp.
    As you know, we have prioritized our work in the IMFs and 
invested to strengthen our presence and capabilities there, but 
there is more that we must do. We have increased our staffing 
and are seeking support to grow our footprint for interdiction 
work still further.
    Additional staffing is critical. But to maximize what we 
can do, I want to focus on some additional authorities that we 
have discussed with Congress. These include certain detention 
and destruction authorities.
    First, our operations at the IMFs routinely see packages of 
unlabeled or partially labeled pills coming through the 
facilities, some in boxes and blister packs, and many simply in 
thousands of loose pills and huge boxes. We are required to 
open every package, document the contents, and find supporting 
evidence of the article's intended use as a drug in order to 
detain, refuse, or destroy that article. Where the evidence is 
insufficient, under our existing standard for destruction, we 
often simply refuse entry and send the package back to its 
source. It is not uncommon for our investigators to see the 
same package again and again as shippers resend the same box a 
second and even third time.
    This process is not a deterrent. If FDA had the authority 
to detain, refuse, and destroy unlabeled imported products that 
are found to contain active ingredients or analogues that are 
FDA-approved drugs, we could more quickly remove potentially 
dangerous products from the supply chain.
    Second, this is also a numbers game. The bad actors can 
send in hundreds or thousands of small parcels via 
international mail to individual recipients in the U.S. These 
shipments are wholesale quantities of illegal, often 
counterfeit drugs, that are intended for further domestic 
distribution, and each package may violate FDA law. But they 
know that FDA can't examine or stop them all, because current 
law requires us to detain and pursue legal proceedings against 
each package separately. They simply overwhelm our system with 
volume. Improving FDA's authority so we can more efficiently 
detain or refuse bulk shipments of individual packages from a 
single source would create a big difference and better protect 
Americans from dangerous imported substances.
    And, third, while substances already scheduled are 
generally referred to CBP at the border, when FDA-regulated 
articles contain substances that haven't yet been scheduled, 
FDA is responsible for that product. This is an issue with the 
high volume of synthetic narcotics coming primarily from China. 
Right now, we can't refuse or destroy these unlabeled products 
or those without a drug claim, such as fentanyl analogues, 
simply because they are articles of concern to DEA.
    Extending FDA's ability to refuse, detain, or destroy 
products in this gap right before DEA's scheduling takes place 
would keep dangerous articles that currently are not easily 
detained off the streets. These are just some of the tools that 
could enhance our mission.
    I appreciate your support and your interest in our work in 
this effort, and I look forward to working close with you to 
help safe lives.
    [The prepared statement of Dr. Gottlieb follows:]
    
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]    
        
    Mr. Burgess. The chair thanks the gentleman.
    The chair recognizes Dr. Schuchat, 5 minutes, for an 
opening statement please.

                STATEMENT OF ANNE SCHUCHAT, M.D.

    Dr. Schuchat. Good morning, Chairman Burgess, Ranking 
Member Green, and members of the Committee. CDC has vast 
experience tackling epidemics, and I appreciate the chance to 
talk today about our work fighting the Nation's opioid crisis.
    At CDC, we are focused on using data for actions to inform 
strategies to prevent opioid misuse, abuse, and overdose, and 
to prevent health-related consequences of opioid use, including 
the spread of infectious diseases, like HIV and hepatitis, and 
the impact of opioids on mothers and babies. CDC leads 
comprehensive prevention efforts by promoting responsible 
opioid prescribing, tracking trends, and driving community-
based prevention activities to reduce opioid overdose deaths 
and related harms.
    America's opioid overdose epidemic affects people from 
every community. The problem is getting worse. In 2016, more 
than 63,000 people died of drug overdose, and preliminary data 
indicate that the trend worsened in 2017. We have seen 
increases in babies born withdrawing from narcotics. New data 
suggests one baby is born with signs of neonatal abstinence 
syndrome every 15 minutes, about 100 babies a day. We have also 
seen a drop in life expectancy for the first time since 1993. 
For every one person who dies of an opioid overdose, over 60 
more are already addicted to prescription opioids, and almost 
400 misuse them.
    CDC supports State health departments providing resources 
and guidance to implement evidence-based prevention 
interventions so States can rapidly adjust as we learn more 
about what works best in this very fast-moving epidemic. A 
nimble Federal and State response is crucial.
    CDC now funds 45 States and Washington, D.C., to advance 
prevention, including by improving prescription drug monitoring 
programs, or PDMPs, improving prescribing practices, gathering 
timely high-quality data, and evaluating policies. We hope to 
expand this funding to 50 States.
    States are making progress in working toward more 
comprehensive and effective monitoring through their PDMPs, 
which is essential to improve clinical decision-making and use 
data as a public health surveillance tool. With CDC funds, many 
are increasing use by providers and pharmacists, enhancing the 
timeliness of reporting, and integrating with electronic health 
records.
    For example, in North Carolina, they have integrated 
prescribing data from the PDMP within the clinical workflow of 
existing health information systems across the State. 
Improvements like that show how we can make vital data 
actionable with the goal of saving lives.
    CDC is also leading improvements to the public health data 
needed to understand and respond to the crisis. We improved the 
timeliness of reporting, updating preliminary data on overdose 
deaths, on our website every month. Through our funding to 
States, we are ramping up our efforts to get more comprehensive 
and timely data from emergency rooms, emergency medical 
services, medical examiners, and coroners. We are tracking 
nonfatal overdoses. And as you have heard, we recently reported 
on the 30 percent increase across the country.
    We also recently released data using toxicological and 
death scene evidence from 10 funded States, allowing for a more 
robust characterization of opioid overdose deaths. That 
analysis found that fentanyl was involved in more than half of 
the recent opioid overdose deaths.
    CDC continues to educate providers and the public on opioid 
use through the implementation of our Guideline for Prescribing 
Opioids for Chronic Pain and the Rx Awareness communication 
campaign. We are making the guideline more accessible to 
clinicians through interactive training and a mobile app. The 
campaign focuses on the risks of prescription opioids, and it 
features real life accounts of individuals living in recovery 
and those who have lost someone to this terrible problem.
    In addition to our partnership with States, CDC believes 
this epidemic requires a collaboration across sectors. We have 
been working side by side with law enforcement, like the DEA, 
to determine risk factors for illicit opioid overdose and 
target implementation plans for community specific prevention 
strategies. We draw on experts from across our agency to 
address the many facets of the crisis. The comprehensive public 
health approach is playing a key part in addressing the 
epidemic. We didn't get into this epidemic overnight, and we 
are not going to get out of it overnight. We need intensified 
sustained efforts to reverse the epidemic.
    Thank you.
    [The prepared statement of Dr. Schuchat follows:]
    
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    Mr. Burgess. Thank you, Doctor.
    Dr. Jones, you are now recognized for 5 minutes for an 
opening statement, please.

           STATEMENT OF CHRISTOPHER M. JONES, PHARMD

    Dr. Jones. Thank you. Chairman Burgess, Ranking Member 
Green, and members of the committee, thank you for the 
opportunity to discuss the opioid crisis and the Federal 
Government response.
    From the start of his administration, President Trump has 
made addressing the opioid epidemic a top priority. And at 
SAMHSA, we share the President's commitment to bringing an end 
to the crisis. Families and communities across our Nation have 
been impacted by increasing prescription and illicit opioid 
abuse addiction and overdose. And the emergence of illicit 
fentanyl and other potent synthetic opioids has only fueled the 
crisis in recent years.
    As the department's lead agency for behavioral health, 
SAMHSA has been at the forefront of the response to the opioid 
crisis. Under the HHS opioid strategy, our work focuses on 
advancing prevention, treatment, and recovery services and 
overdose prevention through funding to build State and local 
capacity, providing education, training, and technical 
assistance, and data collection analysis and evaluation to 
track emerging trends, identify what works, and support the 
integration of evidence into practice.
    Today, I want to focus on several recent actions SAMHSA has 
taken to enhance our response to the opioid crisis. In the area 
of funding, SAMHSA distributed $485 million to States and 
territories under our State targeted response to the opioid 
crisis grants in May 2017. This funding supports State efforts 
to reduce opioid overdose deaths and provide the full 
complement of prevention, treatment, and recovery support 
services.
    In November of 2017, SAMHSA announced that it was accepting 
applications for $1 million in supplemental STR grants to 
expand and enhance those efforts in States hardest hit by the 
epidemic. On Monday of this week, SAMHSA awarded supplemental 
STR grants to New Hampshire, Massachusetts, and West Virginia. 
SAMHSA also provides critical funding for treatment and 
recovery services for specific high risk and vulnerable 
populations, such as those involved in the criminal justice 
system and pregnant and postpartum women.
    In September 2017, SAMHSA awarded nearly $10 million over 3 
years for new State pilot grants authorized by CARA that enable 
outpatient based care for pregnant and postpartum women and 
nearly $50 million over 5 years in new grants to support 
residential treatment services for pregnant and postpartum 
women.
    SAMHSA has been a leader in efforts to reduce overdose 
deaths by increasing access and availability to naloxone to 
reverse overdose. In September 2017, SAMHSA awarded funding to 
grantees in 22 States from programs authorized by CARA to 
provide resources to first responders and treatment providers 
who work directly with populations at high risk for opioid 
overdose.
    Developing a well-trained workforce and facilitating the 
integration of evidence-based interventions into practice are 
key goals of SAMHSA's education, training, and technical 
assistance efforts. In January 2017, SAMHSA awarded $12 million 
to create--I'm sorry, January of 2018, we awarded $12 million 
to create the Opioid STR Technical Assistance program. This new 
program is providing direct technical assistance to States and 
local jurisdictions to support the implementation of evidence-
based practices that are tailored to the State-specific 
context. And last month, SAMHSA released TIP 63, medications 
for opioid use disorders, which now includes information about 
all of the FDA-approved medications for the treatment of opioid 
use disorder as required in CARA.
    In addition, SAMHSA's providers clinical support system for 
medication-assisted treatment, which provides national training 
and mentoring to support clinicians interested in providing 
addiction care, has also revised its DATA waiver training to 
include information on all FDA-approved medications for 
treatment of opioid use disorder.
    Given the importance of providing clinicians and patients 
with actionable information about opioid addiction and 
pregnancy, last month, SAMHSA released clinical guidance for 
treating pregnant and parenting women with opioid use disorder 
and their infants. This guidance provides clear information on 
a range of real-world scenarios faced by healthcare providers 
who are caring for mothers and infants.
    And in January 2018, SAMHSA issued a final rule pertaining 
to substance use disorder treatment records, commonly referred 
to as Part 2. As required in 21st Century Cures, SAMHSA also 
held a public meeting in January to obtain feedback from 
stakeholders on Part 2. The vast majority of those who spoke at 
the meeting expressed their support for further aligning Part 2 
and HIPAA, and acknowledge that congressional action would be 
needed to achieve many of their goals.
    In the area of data analysis and evaluation, SAMHSA is 
standing up the National Mental Health and Substance Use Policy 
Laboratory, created under the 21st Century Cures Act. The 
policy lab, charged by Congress with supporting innovation, 
evaluating promising approaches, and facilitating the adoption 
of evidence-based policies is prioritizing its efforts on 
opioids.
    Finally, the President's fiscal year 2019 budget for SAMHSA 
includes $15 million to reestablish the Drug Abuse Warning 
Network, or DAWN, a national public health surveillance system 
that will improve emergency room monitoring of substance use, 
including opioid misuse.
    SAMHSA is committed to combating the opioid crisis and 
looks forward to working with Congress to advance this 
important work.
    Thank you for inviting me to testify, and I look forward to 
your questions.
    [The prepared statement of Dr. Jones follows:]
    
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    Mr. Burgess. Thank you, Dr. Jones.
    I want to thank all of our witnesses.
    We now move to the question portion of the hearing. I am 
going to recognize myself for 5 minutes.
    And, Dr. Jones, let me start at your end of the table. You 
saw the reports that were printed in the press in the past 
couple of weeks. About $500 million was set aside in Cures for 
the purposes of addressing this epidemic, and yet those funds 
have yet to be directed toward State efforts.
    So first off, is that as that was reported? Is that 
accurate, what we were reading in the papers a couple of weeks 
ago?
    Dr. Jones. So I think it is important to clarify that the 
money to the States under the STR program was distributed May 
1. So the States have the money. The sort of bottleneck for 
spending down the money is at the State level, largely due to 
variations in how States go through their procurement process 
to contract with providers to provide services. So the money is 
not at SAMHSA. It is actually at the State.
    Mr. Burgess. So let me just ask you, and I am sure the 
answer will be yes, but will you work with any Member who feels 
that they are having difficulty getting those funds accessed by 
folks in their State? That is the whole purpose of putting the 
money there in the first place, correct?
    Dr. Jones. Absolutely. And we have put a process in place 
to look at the implementation of STR more broadly where we have 
our grants' management officials who are in regular contact 
with the States to address questions that come up around can 
these things be covered under this, as well as meeting 
regularly and the assistant secretary to really help provide 
leadership and top-down approach to helping the States advance.
    I will also say the $12 million STR Technical Assistance 
program, which I mentioned in my opening statement, is really 
intended to support the States to achieve their strategic goals 
under the STR program. And one of those is specifically looking 
at how are we providing the services that the funding is 
intended to provide. So I think the TA in particular will be 
very helpful to the States in spending that down.
    But we are certainly open and happy to talk to any Member 
or constituent who has raised issues with being able to spend 
down the money.
    Mr. Burgess. Thank you.
    And Dr. Schuchat had mentioned in her testimony about--I 
think it was 100 neonatal abstinence cases a day that are being 
now acknowledged. Did I get that correctly, Dr. Schuchat?
    So the money that you have put forward in SAMHSA, I 
appreciate that, but at 100 new cases a day, are we even coming 
close to scratching the surface there?
    Dr. Jones. Well, I think that what is important in looking 
at neonatal abstinence syndrome is that it really is a 
comprehensive approach. So some individuals may be prescribed 
opioids for pain during their pregnancy, which may result in a 
neonate being born physically dependent on opioids, others may 
be misusing or using illicit opioids. And at SAMHSA, we 
certainly have tried to put out guidance, as I mentioned, the 
clinical guidance around treating parenting and pregnant women.
    Mr. Burgess. I don't mean to interrupt you, but I am 
running out of time. And I get that, and I appreciate that. But 
at 100 neonatal abstinence cases a day that Dr. Schuchat is 
talking about, I mean, that is a pretty big problem. And from 
the perspective of for every neonate with a syndrome, there is 
a mother who also has a problem. And with what we have given 
you so far, are you able to meet that challenge?
    Because many of us do have a concern that some of the 
changes, the increase in maternal mortality that they reflect 
around the country may be as a consequence of this opiate 
activity.
    Dr. Jones. So I will say I certainly think that we are 
trying to put out money as quickly as possible and to help 
advance evidence-based practices. The magnitude of the issue, 
as Dr. Schuchat mentioned, continues to grow, and we need to 
make sure that resources are commiserative with the scale of 
the problem.
    Mr. Burgess. Well, again, we may communicate more about 
that, because it is an important topic.
    And, Dr. Gottlieb, once again, I want to thank you for 
including me in your visit to the International Mail Facility. 
You testified to the fact that one-tenth of 1 percent of 
packages are actually being inspected. Really, it is hard to 
imagine the volume of stuff that is coming in that requires you 
and CBP to inspect and intervene. Can you speak to that just a 
little bit more about what your needs are?
    Dr. Gottlieb. Thank you, Congressman. Thanks for joining us 
on that visit to the JFK International Mail Facility. That 
facility in particular, there is about a million packages a day 
going through that facility. We get 2.4 million packages a day 
going through the combined international mail facilities. And 
based on estimates that are derived from some analysis we did 
from 2004, we estimate that about 9 percent of all packages 
contain some form of drugs, either prescription drugs, 
counterfeit drugs, or controlled substances. And to your point, 
we estimate that we are physically inspecting less than 
probably 0.05 percent of them.
    Now, we target packages. And we target certain packages for 
x-ray, and then we target certain packages for physical 
inspection. And so intelligence is key here in terms of 
targeting the right packages. And we do do a good job of that, 
but getting more information is better. But we know we are 
missing packages.
    And so, the key is getting more personnel into those 
facilities, being able to operate more quickly and more 
efficiently with our authorities, and getting better 
intelligence in terms of targeting our resources more 
effectively. And we could do more across all three domains.
    Mr. Burgess. And it is just so important. The agent who 
intercepted a flip-flop, sliced it open, and pulled out a 
counterfeit passport, I was just astounded, number one, that 
they picked it up, and, number two, who thought that was a good 
idea in the first place?
    With nothing implied, I would now recognize Mr. Green of 
Texas, 5 minutes for your questions, please.
    Mr. Green. Well, I appreciate that intro.
    Dr. Gottlieb, I want to thank you for all your efforts and 
seriously look at how FDA can play a role in combating the 
opioid crisis facing our country. We must examine how we 
prescribe and dispense opioid, how we can limit or deter 
diversion, and how we can treat those that suffer.
    In your testimony, you noted the majority of the people who 
become addicted to opioids are first exposed through the lawful 
prescription. Many of us on the committee have committed to 
examining how lawful prescriptions have contributed to this 
crisis and what steps Congress and Federal agencies can take to 
reduce the rate of addiction from lawfully obtained opioids.
    The FDA took unprecedented action last year when it 
requested the withdrawal of an opioid treatment due to the 
concern that the benefits associated with the product were 
outweighed by the risk of abuse and manipulation. One of the 
bills noticed today is a discussion draft that offered to allow 
the FDA to take into consideration the potential risk of abuse 
and misuse of making approval decisions. Currently, FDA 
examines a drug for safe and efficacy for their intended use 
when making approval decisions.
    Will you discuss how FDA's approval and assessment of a 
drug would change if the agency's authority was modified as 
proposed in the draft?
    Dr. Gottlieb. Thanks for the question, Congressman. As you 
mentioned, we recommended the withdrawal of Opana ER earlier 
this year based on a consideration around a risk that was only 
manifested when that drug was used illicitly. In this case, it 
was when the drug was crushed and injected, it created a 
certain autoimmune phenomenon in particular that wouldn't have 
been manifested if the drug was taken as intended.
    We believe we have the legal authority to look at risks 
associated purely with illicit use as a component of how we 
assess risk and benefit both pre- and post-market. We exercised 
that authority in this case. But I do think that this is an 
opportunity for Congress to think about how that authority can 
be tailored specifically against this challenge and 
particularly with respect to controlled substances.
    For drugs outside of controlled substances, if we are 
trying to address an unlabeled use, a risk associated with an 
unlabeled use, typically, we would use our REMS authority, and 
that would be adequate. But in the setting of drugs that have 
an abuse liability associated with them and are used in an 
illicit fashion, having carefully constructed authority, I 
think, could benefit the agency and benefit consumers.
    Mr. Green. I understand that some stakeholders must be 
hesitant to make modifications to the FDA's current risk 
benefit assessment. As we continue to work on the legislation, 
how would FDA recommend that we target this legislation to 
ensure that we are appropriately targeting the controlled 
substances that are fueling this opioid crisis?
    Dr. Gottlieb. We can certainly tailor this kind of 
consideration to controlled substances to scheduled products. 
Congress clearly recognized that there needed to be certain 
controls and certain special considerations with respect to 
controlled substances in the formation of the Controlled 
Substances Act. The Controlled Substances Act creates a lot of 
controls on the prescription and prescribing of a narcotic that 
don't exist for any other drug.
    And so we have already crossed the Rubicon, if you will, 
with respect to trying to create special considerations with 
respect to controlled substances. I think this would just be, 
you know, furtherance of that and basically just a 
clarification of an authority that we not only believe we have 
but we have exercised. And so it is an opportunity, I think, 
for Congress to tailor that authority behind the specific 
challenge that we face.
    Mr. Green. OK. Thank you. And I am looking forward to 
working with you and the FDA so we can make sure this 
legislation is really a benefit and can do it. Thank you. And 
we must closely examine how we can limit the ability of opioids 
to be wildly prescribed as also abused and misused, while also 
balancing the need to ensure accessibility for those who suffer 
from more chronic pain, and I look forward to continue working 
with you.
    In my last minute, Dr. Jones, I would like to turn to talk 
to a bill introduced earlier this week by Congressman Guthrie, 
Lujan, and Bucshon, the Comprehensive Recovery Centers Act. 
That seems like something that would be useful. But to create a 
pilot program to support opioid treatment centers, or CORCs in 
the legislation, we always have to have an acronym. Essential 
requirement of CORCs in our legislation is a must-have, 
dedicated outreach efforts in the community, including a large 
public health system, criminal justice system, higher 
education, and community partners.
    Do you agree that this connectivity with the community 
stakeholders is important?
    Dr. Jones. Thank you for the question. I think that 
providing comprehensive services for individuals who have 
opioid use disorder is really critical to their success. As a 
person in long-term recovery from opioid addiction, I am very 
familiar with navigating the fragmented system. And so 
providing that as a sort of a one-stop shop I think really sets 
people up for success. And we need to make sure they have 
access to evidence-based care like medication assisted 
treatment, but housing supports, employment, other supports to 
really make them successful in the long run is very important.
    Mr. Green. Well, I am out of time. But I also know that we 
have a network already of federally qualified health centers 
and that we just need to expand to give them that opportunity 
to see how they can treat the whole person, including their 
addiction.
    So, Mr. Chairman, I know I am out of time. Thank you.
    And I will submit some questions.
    Mr. Burgess. The chair thanks the gentleman.
    The chair recognizes the Chairman of the Full Committee, 
Mr. Walden, 5 minutes for questions.
    Mr. Walden. Thank you, Mr. Chairman. I really appreciate 
the work you are doing here and the other members of the 
committee and our witnesses.
    And, Dr. Schuchat, thank you for being back here before the 
committee. At least two of the three, maybe all three of you 
have been here on multiple occasions. So we really appreciate 
your leadership at CDC and the work you have been doing.
    As PDMPs have evolved in recent years, incorporating PDMP 
data into a prescriber or pharmacist clinical workflow seems to 
be the key to ensuring that the data are used effectively while 
also increasing efficiency and saving time for providers. So, 
Dr. Schuchat, what are the barriers currently that prevent more 
States from incorporating PDMP data in the clinical workflow? 
And aside from prescription dispensing data, what other 
information can be collected by PDMPs, and how can this help 
CDC's surveillance efforts?
    So what currently do you find or do you hear from the 
States create barriers?
    Dr. Schuchat. Yes. We are making substantial progress, 
particularly in selected States that have really integrated the 
prescription drug monitoring program into the electronic health 
record. Making it easy for clinicians is the only way to make 
it work, making it universal so all clinicians are using it, 
which involves registering them and getting them onboard. But 
integrating it into the clinical workflow in the office or in 
the pharmacy will make it a one-stop shop for folks. The 
technology is not that complicated, but every State is starting 
from a different place, and each State has different laws that 
also get incorporated.
    But in the past couple years, we have seen an increase in 
the use of them in many States and an increase in the 
attributes that they have so that people can get active 
management. You get alerts when you are overprescribing or when 
you have interactions with other drugs. That is a feature that 
is very important. You can also link the data for public health 
use and find the hot spots: Where are the providers that are at 
the extreme level of prescribing and where are the counties 
that have the higher use. So, really, it is about integrating 
with electronic health record and also integrating with other 
systems in the State.
    There is also the cross-State lookup, the interstate 
operability, which is--most States have that ability, but not 
to look up with all other States. They have agreements with 
neighboring States. So I would say that the barriers are very 
insurmountable. It is attention, resources, and policies.
    Mr. Walden. All right. Good. And I know our resident 
pharmacist, Dr. Carter, and I were talking yesterday--or 
Congressman Carter--about some of the issues he has 
encountered. And I am sure he will dig into this deeply with 
his great experience on this.
    Dr. Gottlieb, thanks for the good work you are already 
doing in this area and interdiction and everything else to give 
us guidance and what you are doing through the agencies. I 
think it is important to understand the role you see the FDA 
playing in the fight against opioids. And I, again, commend 
you.
    Can you speak to the mission of your agency and how it fits 
in the larger efforts of fighting this opioid crisis?
    Dr. Gottlieb. I think we have responsibilities across 
multiple domains. I think we have a responsibility to, and in 
terms of places we can effect this crisis, I think we have the 
opportunity to reduce overall prescribing, to rationalize 
prescribing through things like education or application of the 
REMS. We recently, as you know, extended our REMS authority to 
all the IR drugs to try to rationalize prescribing, trying to 
effect dispensing to make sure that when prescriptions are 
written, the amount that is dispensed is appropriate for the 
clinical circumstances.
    We obviously have a role to play in interdiction. I have 
talked about that here today. And I think we also have a role 
to play with respect to new technology, trying to bring onto 
the market abuse-deterrent formulations. We have taken steps to 
do that, trying to bring onto the market drugs that don't have 
all the abuse liabilities that are associated with opioids, 
trying to create innovation for medically assisted treatment.
    So we have taken steps to cross all those domains. Those 
are the large areas where we are working.
    Mr. Walden. Thank you very much. And we appreciate your 
input and guidance on these various bills that are before the 
committee today and tomorrow.
    Dr. Jones, you mentioned in your testimony the listening 
session on the topic of alignment of 42 CFR Part 2 and HIPAA 
that was required by 21st Century Cures. Can you elaborate upon 
those discussions at the listening session and explain how the 
bills were examined, did they either align or conflict with 
what participants were saying? And also, can you discuss the 
enforcement authority for Part 2 infractions in comparison to 
HIPAA enforcement?
    Dr. Jones. Thank you. So from the listening session, again, 
there is passion on this issue across the spectrum. But I think 
there was a consistent recognition that, from the stakeholders, 
that Part 2 may in and of itself--the constraints around 
treating information differently may in and of itself be 
stigmatizing, sort of reinforcing the idea that people who have 
addiction or substance use disorders should be treated 
unfairly.
    I think on the side of addressing and making sure that 
people have parity to healthcare, that people who have 
substance use disorders should be given the best treatment that 
they can. And often having all the information about the 
patient is a really critical part of that. I think those were 
sort of the common themes that were shared.
    And from our standpoint, and we certainly are encouraged 
that Congress is looking at better alignment of Part 2 and 
HIPAA. And as I said in my opening statement, we do think, and 
certainly from the listening session, it was fairly clear that 
many of the folks felt that congressional action would be 
needed. We have taken a lot of flexibilities that we can take 
under our administrative rulemaking authority. I think it is 
now at the point where Congress would need to take action.
    Mr. Walden. I think so too.
    Thank you to our panelists. Again, thank you, Mr. Chairman. 
Thank you for your leadership.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentleman from New Jersey, the 
Ranking Member of the Full Committee, Mr. Pallone, 5 minutes 
for questions, please.
    Mr. Pallone. Thank you, Mr. Chairman.
    I wanted to start with Dr. Gottlieb. I wanted to thank you 
for appearing before the committee again and for your forward 
thinking when it comes to the opioid crisis this country is 
facing.
    And I have long been concerned about the number of illicit, 
unapproved, and often counterfeit drugs that are entering our 
supply chain through our mail facilities. I work with FDA and 
my Democratic colleagues to provide the agency with additional 
authority and FDASIA to help combat this problem, but 
understand from you that more must be done.
    So first question is would you discuss briefly some of the 
problems related to illicit drugs that FDA is witnessing at our 
international mail facilities? I know the chairman asked a 
similar question, but maybe be a little more specific about the 
drug packages. You said in your testimony that they are often 
unlabeled or shipped with bulk and disguise. You want to talk a 
little bit more about that more specifically?
    Dr. Gottlieb. That's right, Congressman. One of the keys to 
our ability to destroy packages or seize them is the ability 
for us to establish intended use. And so when people who are 
shipping drugs into the country engage in label stripping, 
where they strip away the information from the package itself 
or from the drug product, we often can't establish intended 
use. And so we have to just return the package to the sender, 
effectively, because we can't destroy it. We can't go through a 
destruction proceeding because we can't establish it is a drug.
    And our concern around this is that it is not a good 
deterrent. And we often see the same packages coming back a 
second and third time. In fact, sometimes, we will see packages 
that will be sent back, and then they will come back in with 
the same investigator's writing on it through the same mail 
facility.
    The other thing we are seeing is more and more small 
packages. And so the shippers know that we have to initiate an 
individual proceeding against each package. And so if you send 
in sort of a bulk package with thousands of small boxes in it, 
we would have to initiate a proceeding against each individual 
box to establish that it is a drug, what the intended use is. 
And this is often prohibitively difficult for us. So, again, we 
are in a position of holding these packages in the 
international mail facilities while we go through a 
notification process to the consignee and then just returning 
them to the sender, because we can do that based on an 
appearance standard. We can't get to the ability to destroy 
these packages because it is a higher standard, and we would 
have to establish intended use. And so they are purposely 
shipping these in in a way to evade our authorities. They know 
what our gaps are, if you will.
    Mr. Pallone. All right. Well, as I understand it, hundreds 
of millions of packages go through international mail 
facilities each year. But as you said--well, FDA only has the 
resources to examine about 40,000 of these packages per day. So 
that is why I introduced the bill I mentioned, H.R. 5228, or 
the SCREEN Act, which would provide FDA with additional 
authority and resources to combat this problem.
    Mr. Chairman, I would ask unanimous consent to submit the 
text of H.R. 5228 for the record for the hearing.
    Mr. Burgess. Without objection, so ordered.
    [The information follows:]
    
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    Mr. Pallone. Thank you.
    Dr. Gottlieb, in examining this issue, will you please 
outline for me what key authorities or actions Congress could 
take? I know you talked a little bit about it. But if you get 
more specific about key authorities or actions Congress could 
take to help you address the problem that you are witnessing at 
our international mail facilities.
    Dr. Gottlieb. Well, one authority would be to be able to 
establish that product as a drug based on its chemical 
composition, whether it has similar chemical composition to an 
already approved FDA drug or is an analog of an FDA-approved 
drug. If we were able to establish that a drug is a drug based 
on chemical composition, then we could establish that as 
misbranded under 505 just by looking at the labeling associated 
with the product. And this would allow us to be more efficient 
in making the determinations as to violative product and we can 
then enter into a destruction proceeding.
    Another efficiency that we can gain is changes to our 
seizure authority. Right now seizure authority allows the FDA 
to bring a lawsuit to seize a violative product. But a judge 
must first make a finding of probable cause, if probable cause 
exists. And I have been personally engaged in situations since 
I have been back at the agency where we have gone through a 
multi-week process to try to get a proceeding before a judge to 
affect a seizure of a product that we had concerns around and 
wanted to take off the market quickly. So we could go back to 
the way FDA used to operate with respect to seizure authority 
prior to 2006 and the agency operated this way for decades and 
decades and allow us to affect a seizure based on an imminent 
public health hazard standard, so we can go before a clerk in 
the court and get an order to seize a product, and then have 
the hearing before the judge after that. That would allow us if 
there is an imminent public health hazard and we want to take a 
product off the market in advance of the due process 
proceeding, which obviously has to occur, it would allow us to 
intervene more quickly.
    FDA, there was a change in some law in 2006 that 
unfortunately swept FDA in, I think inadvertently. I will leave 
it to Congress to determine the legislative history. But if we 
can revert back to how we used to exercise our seizure 
authority, that would be helpful.
    Finally, I would just highlight the ability to bundle 
products coming in and treat a light shipment as one shipment, 
if you will, for purposes of bringing a proceeding against it 
rather than having to look at the individual boxes or packages, 
because that is a gap that people who are intent on trying to 
slip drugs into the U.S. are unfortunately exploiting.
    And all of this is about getting to your point about how 
many packages we look at each day, one of the keys is getting 
more resources into those facilities and we have targeted more 
resources to the IMF for money that we found inside the agency. 
We are obviously looking to increase our capacity even further. 
But even as we bring on more resources, we want to make sure 
those resources are used in an efficient way. So a lot of these 
authorities are aimed at making our people more efficient. 
Right now an individual investigator in the IMF can open maybe 
up to 15 packages a day. We want to make those individuals more 
efficient so that they can be opening more packages and we can 
get that 0.05 percent up to a more representative sample.
    Mr. Pallone. Thank you. Thank you, Mr. Chairman.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman from Kentucky, the Vice 
Chairman of the Subcommittee, Mr. Guthrie for 5 minutes for 
your questions.
    Mr. Guthrie. Thank you, Mr. Chairman. Again, thank you for 
your leadership on this issue and for everybody's focus on this 
issue, I appreciate it.
    I am going to talk about a bill that Congressman Green, 
Lujan, Bucshon, and I have introduced titled the Comprehensive 
Opioid Recovery Centers Act or CORCs. We proposed a new 
standard of care for the treatment of opioid use disorders. And 
I would like to get your views on the importance of required 
features of the CORCs from Dr. Jones from SAMSHA.
    SAMSHA's new publication titled treatment improvement 
protocol number 63, medications for opioid use disorder 
repeatedly emphasizes the need for patient centered 
individualized care in which the medications are prescribed to 
a patient based on that person's clinical needs. Yet according 
to a recent analysis of SAMSHA's data, published by Health 
Affairs, fewer than 3 percent of all licensed substance abuse 
treatment facilities in the country are able to offer all 
three.
    Most programs offer only one or two types of medications at 
the most and some offer none at all. Do you agree, Dr. Jones, 
do you agree that the current opioid addiction treatment system 
is not offering a full range of medication options?
    Dr. Jones. I would say that there are regulatory 
constraints on how medications can be offered. So methadone 
under current statute and regulation can only be offered 
through opioid treatment programs. For buprenorphine you would 
have to have a waiver so physicians, nurse practitioners, PAs 
would have to have a waiver after receiving training to 
prescribe buprenorphine in their limits on the number of 
patients. Extended release, naltrexone or vivitrol which is the 
antagonist version of the three medications can be prescribed 
by anybody within their scope of practice.
    So there are constraints in saying that every treatment 
facility should be able to offer that because it may not be 
possible for every treatment facility to be an opioid treatment 
program. I think what is important is that we build the system 
so that patients have access to the treatment that is most 
appropriate for them. So it is not that everybody has to be an 
OTP, but that there is some relationship for if methadone is 
the best thing for that patient access that they would be able 
to access that, same with buprenorphoine or naltrexone.
    And we have seen opioid treatment programs increasingly 
start to offer buprenorphine and naltrexone, recognizing that 
patient preference is a really important part of the long-term 
trajectory of someone with opioid use disorder.
    Mr. Guthrie. Those options need to be available if somebody 
presents to a center that only does one and it is not the best 
treatment for them, they are not getting the best treatment. 
That is what we are trying to look for in our bill. So we 
appreciate your help on it as well.
    Do you see the current fragmented, siloed approach as a 
problem? I guess that feeds to the answer you just gave.
    Dr. Jones. Fragmentation and siloing always works well. No, 
no.
    It clearly is a problem for individuals, because when 
somebody comes in with opioid addiction, there is a lot going 
on with that individual. So they may have legal issues, they 
may have issues with safe and supportive housing, they may have 
issues with family care. And we are really at SAMSHA with our 
STR dollars and our other programs trying to build that system 
which I think is analogous to what you are trying to accomplish 
that allows that patient to receive those services in a 
comprehensive manner where they are not trying to show up in 
different places and say, oh, wait, you have to go here, you 
have to go there. That there are places that are doing that. 
And we are seeing States like Rhode Island that are 
implementing centers of excellence, which are essentially 
taking that model and putting that into place where people if 
they are coming from the criminal justice system are connected 
in to these centers of excellence so they can look at things 
like insurance coverage, housing, employment, vocational 
training. And we are seeing success with those areas. I think 
we need to continue to scale up those types of interventions.
    Mr. Guthrie. Well, thanks. I just had someone from 
Louisville come in who said that they have a recovery center 
that is trying to do the holistic complete person approach. And 
so you really addressed it, but I just want to specifically 
pull out one specific of all the comprehensives and that is job 
training. One of the unique provisions of our bill is a 
requirement that they provide job training and job placement 
assistance. A recent analysis published by Brookings Institute 
found that about one-third of the people who were no longer 
looking for work had opioids being prescribed to them.
    Do you agree that this focus on supporting successful 
reentry into the workforce should be a valuable addition to 
establishing long-term recovery? The relationship between work 
and recovery I would like for you to address.
    Dr. Jones. I think certainly people want to have purpose 
and structure in their day. And so a job provides some purpose 
and structure for individuals. I think that is an important 
thing among the array of services an individual would need to 
be successful.
    Mr. Guthrie. Thank you. I am about out of time. That 
completes--I can't really get to the next questions. So, I 
appreciate you being here. We look forward to working with with 
my fellow colleagues to move this bill forward. I appreciate 
it.
    Thank you. I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentlelady from California, Ms. 
Matsui for 5 minutes for your questions.
    Ms. Matsui. Thank you very much, Mr. Chairman.
    Dr. Schuchat, thank you for your testimony today. I have 
heard concerns about how increasing injection drug use is 
resulting in increased incidents of HIV and hepatitis C. As you 
look at solutions to the opioid epidemic, we should also 
examine how the opioid crisis may have a cascading impact on 
the rest of the our public health. That is why I am 
cosponsoring eliminating opioid related infectious diseases act 
discussion draft with my colleagues on the committee 
Representatives Lance and Kennedy to support additional public 
health surveillance activity at CDC on this topic.
    Dr. Schuchat, what is a concurrence rate of opioid use in 
infectious diseases?
    Dr. Schuchat. The infectious disease complications of 
opioid use are really are tragic and they were most 
dramatically seen in Scott County, Indiana, where over 200 
people developed acute infectious disease, acute HIV infection 
and most had also hepatitis C. We have seen hepatitis C 
increase 140 percent recently. We have seen particular 
increases in young people. And we have recently seen multistate 
outbreaks of hepatitis B and hepatisit A as well. Most recently 
we have had salmonella associated with the kratom botanical and 
we have also got a group A strep outbreak that is associated 
with injection.
    So injecting drugs and also other opioid use can lead to 
these infectious disease complications, sometimes clustered and 
sometimes throughout the Nation. We think it is really 
important to improve surveillance and also to assure wraparound 
services when we are dealing with addiction to make sure there 
is infectious disease screening as well so that people who do 
have hepatitis C or HIV can get into appropriate care.
    Ms. Matsui. Thank you.
    Dr. Jones, has SAMHSA done any work in this space?
    Dr. Jones. Yes. So SAMHSA had funding programs in place for 
colocation of HIV and hepatitis C services within substance 
abuse treatment. Again, as Dr. Schuchat said, it is a really 
important part to address the comprehensive issues of 
individuals who are coming in. And now that we have curative 
therapy for hepatitis C, it is really important that we are 
testing people as they come in. And our funds have been put 
into place to help build that system.
    Ms. Matsui. Good, good.
    Now the solutions to this epidemic will come from a lot of 
different places and angles and requires to examine all of the 
different problems that led us to where we are today. One of 
the main ways that I have heard of are people becoming addicted 
to opioids whether prescriptions or illegal started with 
prescription opioids found in the home. Maybe it is left over 
prescription drugs, a teenager has had their wisdom teeth 
pulled, they got 30 day's worth of pills, but they only needed 
one or two. And the bottle is still sitting in the medicine 
cabinet.
    Dr. Gottlieb, do you see potential for technology to play a 
role in ensuring the efficient return or destruction of unused 
opioids?
    Dr. Gottlieb. I do, Congresswoman. I agree with your point 
the chief risk of the liberal prescribing wasn't so much that 
the patients would become addicted. Although, we know that that 
happens, but that the excess meds feed the river of pills that 
are coursing through our communities. And so we do see an 
opportunity to try to inspire sponsors and others in the supply 
chain to provide tools that could allow patients to dispose of 
those pills. This can be something that Congress could provide 
some authorities around, it is something that could be 
encouraged by the provider community as well, but there are 
tools to do that. We don't regulate the tools. Many of them 
they are not medical devices, some of them allow the patient to 
destroy the pills themselves or render them inert, but they are 
available.
    Ms. Matsui. OK. Thank you. UC Davis Medical Center in my 
district of Sacramento houses an entire division devoted to 
pain management, including a pain management clinic. The 
doctors and researchers there participate in a program called 
Project ECHO which allows experts in effective pain management 
at UC Davis to remotely train less specialized doctors 
practicing in remote or isolated areas.
    Opioids is certainly one method of pain management and one 
that can be very necessary. For example to improve a patient's 
quality of life at the end of their life in hospice. However, 
opioids are not the only option for pain treatment and more 
should be done to explore both existing and new alternate 
options.
    Pain is not something that people should have to live with 
but clearly taking the convenient way out by using opioids has 
led to serious problems. However, there is a middle ground. We 
shouldn't get rid of opioids completely, but we can better 
understand when and how to use them.
    Dr. Gottlieb, can you comment on any potential for FDA to 
contribute in this area?
    Dr. Gottlieb. We have taken a lot of steps in recent months 
to try to use our tools, particularly our REMS authority to 
increase provider education. I think it is a point well taken 
that part of what got us here is a change in prescribing 
patterns that led to more liberal prescribing. Many people who 
became medically addicted, their first exposure was through a 
lawful prescription, often that was for an immediate release 
formulation of the drugs.
    So we have take steps to expand our REMS authority that 
asks sponsors to provide education to physicians to the 
immediate release formulations of the drugs, which represents 
about 90 percent of all the pills. We are looking at other 
things that we can do, for example packaging, if we can get 
more of IR drugs into blister packs that might encourage more 
rational prescribing. Physicians might opt for a blister pack 
that maybe had a 3 or 5 day unit of dose in it as opposed to a 
30 day bottle. So we are continuing to look at other tools that 
we could adopt and practices that we could pursue to try to 
affect physician behavior here.
    Ms. Matsui. OK. Thank you very much. And I yield back.
    Mr. Burgess. The chair thanks the gentlelady. The 
gentlelady yields back.
    The chair recognizes the gentleman from Michigan, Mr. 
Upton, former chairman of the committee to ask your questions.
    Mr. Upton. Well, thank you, Mr. Chairman. And I appreciate 
this hearing, and appreciate the good work by our distinguished 
panel. I know we all have tremendous concerns about this. And 
it is something that has grilled down to all of our 
constituents.
    I hosted a meeting in Kalamazoo at the WMed School, a place 
where Dr. Burgess came for a hearing on 21st Century Cures a 
few years ago. The governor's office, to our State mental 
health folks, to our law enforcement people, treatment folks, 
it is an issue that people really do care about. In fact, the 
local sheriff, a good guy said that they knew that as we look 
at these staggering statistics of people that have died because 
of the overdoses that they had personally knew of at least 150 
folks just in that county that they saved because of Narcan. By 
having that available to their officers. And I have talked to a 
number of--all of my Sheriffs in my six counties that I 
represent. It is a standard procedure, sadly.
    And one of the things that a number of us have discussed is 
maybe somehow being able to reduce the cost of these lifesaving 
drugs because it is a real financial burden, particularly in 
rural areas where perhaps they don't have the resources to be 
able to have that available as it reaches out.
    A couple of things that I would like to ask this morning. 
First of all, I want to commend our chairman, Greg Walden, this 
is a huge issue. I have a list of just 20 some different bills 
that are all bipartisan as far as I know that we intend to move 
through this committee. He has reached out to our leadership. 
We have time, I believe, that is reserved a little bit later 
this spring to get the bills to the floor and hopefully provide 
the time to get the Senate to be able to endorse and embrace 
these and get them to the President.
    I know a number of us on both sides of the aisle have had 
personal discussions with the President about it. He cares 
deeply about this issue and something where we could work on 
together.
    And a couple questions that I have, Dr. Gottlieb in your 
written testimony for our hearing back in October you said that 
the FDA strongly supports a transition from the current market 
dominated by conventional opioids to one in which the majority 
of opioids have meaningful abuse deterrent properties. Can you 
update us on the FDA's efforts on the abuse deterrent 
formulations in terms of where we are?
    Dr. Gottlieb. We continue to take steps to try to help 
transition this market including through the approval of some 
additional drugs, we have abuse-deterrent features associated 
with them. We have approved 10 in all. We also recently issued 
guidance that lays out the pathway for how you can genericize 
these abuse-deterrent formulations because you don't want to 
create a monopoly market where there is no potential for 
generic entry to compete with abuse-deterrent formulations out 
there after the IP has lapsed on these drugs.
    We are also taking efforts to reevaluate the nomenclature 
in terms of how we refer to these to make sure that we are not 
convening to prescribers something that isn't intended, that 
there is not a perception somehow because these are an abuse 
deterrent they can't be abused and people can't get addicted to 
them. They are resistant to manipulation, that is the feature 
that they have and we want to make sure we adequately conveying 
that.
    But ultimately to get to the essence of your question, 
Congressman, we need to maybe a policy decision as to whether 
or not we can make a determination that the advent of abuse 
deterrent formulation lowers the rate of addiction over a 
population, that if you converted the market to abuse deterrent 
formulations, would you bring down the rate of overall 
addiction. And we continue to collect data to make that 
determination.
    That is a determination we want to make as a matter of 
policy and not have to do it in the context of each individual 
occupation. We have some data forthcoming soon that will help 
inform that question where we have looked at the conversion 
rates to heroin addiction from prescription opioid use and 
looked at whether or not areas where there was a higher use of 
abuse-deterrent formulations had a lower conversion to the 
abuse of street drugs. That kind of data is going to help us, 
help inform our view and get closer to being able to make that 
threshold determination.
    Mr. Upton. So like Chairman Burgess and Ranking Member 
Pallone indicated, the difficulty of identifying these packages 
that are coming in, whether it is FedEx, UPS, Postal Service--I 
sat down with my local law enforcement folks a number of months 
ago, actually almost a year ago, and they described to me the 
situation of west Michigan. There is literally one postal 
inspector for all the packages that come into Grand Rapids, 
which is the distribution point for the whole west side of the 
State.
    And they indicated one postal inspector is certainly an 
issue. But as we look at fentanyl coming in, what type of 
capabilities have you been able to provide for our local law 
enforcement to identify fentanyl as you look at these tens of 
thousands of packages that inundate all of these facilities 
literally every single day.
    Dr. Gottlieb. Well, Congressman, Customs and Border 
Protection has primary responsibility in the international mail 
facilities where we are for the controlled substances when they 
are identified. But we do identify an increasing number of 
packages that aren't perceived a controlled substance on first 
blush. Either they get through a screen or through a dog that 
is sniffing packages. And we are only X-raying in those 
facilities 1 percent of the priority mail packages. I don't 
want to get too detailed into the statistics of what we do in 
there to reveal our weaknesses. But we are not looking at 
everything, we are targeting what we do to packages that we 
believe are more likely to contain controlled substances.
    But with respect to fentanyl in particular, we have 
scientific expertise and tools that allow us to identify 
fentanyl analogs and we assist CBP in that effort in trying to 
inform that process and inform the tools that they use in those 
facilities to identify those drugs. But it is a challenge, I 
will tell you that. And the vulnerability that I worry about 
the most is this bad actor who dresses up an opioid as an 
ordinary pharmaceutical product or an OTC product because that 
is an area of vulnerability right now if you are looking to 
evade detection.
    Mr. Upton. I know my time has expired. Thank you.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentlelady from Florida, Ms. 
Castor for 5 minutes for your questions please.
    Ms. Castor. Thank you, Mr. Chairman. And thank you to all 
of you for work on this public health crisis.
    Dr. Jones, I want to continue on the line of questioning by 
my colleague Mr. Guthrie from Kentucky on treatment. A 2015 
study published in the Journal of the American Medical 
Association found that 80 percent of Americans with opioid 
addiction do not receive treatment. In your testimony you 
identified the lack of treatment as one of the primary factors 
in the growing opioid epidemic. You say, the lack of a health 
system and healthcare provider capacity to identify and engage 
individuals with opioid use disorders and to provide them with 
high quality evidence based opioid addiction treatment, in 
particular the full spectrum of medication assisted treatment. 
It is well documented that the majority of people with the 
opioid addiction in the United States do not receive treatment. 
And even among those who do, many do not receive evidence-based 
care.
    In the last Health subcommittee meeting we had I asked Dr. 
Colony from Brandeis University about this, he heads an opioid 
research center, the head of the physicians for responsible 
prescribing. In answer to my question he said, I think the only 
way we are going to get there is a massive Federal investment 
in the billions. We have to create a treatment system that 
doesn't really exist yet. The majority of the State drug and 
alcohol license programs don't offer buprenorphine, many don't 
even have enough physician time. Many people often have to pay 
from their own pocket for medication. If we really want to see 
deaths start to come down, it has it to be easier to get 
treatment than it is to get a bag of dope.
    When someone who is opioid addicted wakes up, they are 
going to need to use. They often have something by their 
bedside. They will feel very sick when they start to wake up. 
If they have got $20 and they know where to go get heroin even 
with Fentanyl in it, that is what they are going to do. If 
finding a doctor is more expensive and difficult we are not 
going to see the overdose deaths start to come down. We really 
have to build a system that doesn't exist yet. And I don't see 
any other way than investing billions of dollars to create it.
    And this is informed by a constituent back home in Tampa I 
have been working with. A middle class family, this father has 
come to Members of Congress because he doesn't know anywhere 
else to turn. He has a 22-year old son who has been addicted to 
opioids since he was 15 years old. They have good insurance. He 
stated though even with good insurance he has personally 
invested over $100,000 trying to help his son. He learned that 
the cost to combat his son's addiction could be limitless.
    As healthcare carriers are unwilling to fund addiction 
healthcare beyond the point of immediate physiological safety. 
His son as of December 2017 celebrated 4 months of good health 
before relapsing again. And he has gone through so many 
different treatment methods. Clearly there has to be a paradigm 
shift here. I know there are some important bills. I like Mr. 
Guthrie's bill with others on the recovery centers. The 
workforce is a significant issue, Ms. Clark of Massachusetts 
has a bill. But what do we have to do? It has to be something 
much more extensive than we are even thinking about now.
    If you could redesign a system now and really we are 
spending so much on lost productivity and healthcare dollars 
that don't really get to the heart of the problem. How would 
you design the system now? What do we need to do for this 
paradigm shift?
    Dr. Jones. Thank you for the question. I think that you 
raise a number of really important issues. And I think they are 
the exact conversations that we are having at SAMHSA in 
thinking about how are we being good stewards of the dollars 
that Congress has given us as we are investing $1 billion over 
the last 2 years, the President's budget up to $1 billion for 
STR funds? How are we building that system? Because the system 
is fragmented and too many times individuals are paying a lot 
of money for ineffective care.
    And so part of that is to actually look at the innovations 
and how services are provided. And as I mentioned earlier 
thinking about centers of excellence, or hub and spoke models, 
or nurse care management models. Those are things that have 
been studied in different States that have shown increased 
retention, reduced drug use, improved outcomes. And that is how 
we are trying to frame our dollars in how we are requiring 
those dollars to be spent by States----
    Ms. Castor. Is that just building on the current system or 
is there something you needed like almost a VA type of system 
for this healthcare emergency.
    Dr. Jones. It is sort of enhancing the system that doesn't 
exist so that the services are collocated and that the 
evidence-based treatments, i.e., medications are being 
provided. So moving away from a siloed fragmented system where 
it may be an abstinence based approach that medications are not 
even considered, to a system where medications are a central 
component of what is being offered to patients, but that it is 
also taking advantage of treatment on demand.
    So when somebody comes in, that is again connection of the 
emergency departments, where somebody experiences an overdose 
or somebody has an infectious disease complication, using that 
touch point in the health system to connect that individual 
into treatment. That is the system that we are trying to build.
    I will use Rhode Island as an example, they had a nice 
study that came out in JAMA psychiatry recently where they 
expanded medication assisted treatment within their 
incarcerated population in Rhode Island within the Department 
of Corrections. They offered all three medications, they were 
able to do that within their regulatory schemes and they found 
that there was a 60 percent decline in overdose deaths in the 
first 6 months of 2017 compared to the first 6 months of 2016. 
So Rhode Island is certainly a State that has been hard hid by 
fentanyl and other illicit fentanyl analogs and they are seeing 
that progress because they built the system. And as people are 
coming out of incarceration they are connected into these 
centers of excellence so they can continue to get those 
supportive services.
    And while certainly we put a lot of money towards 
treatment, I don't think I can underscore enough the importance 
of recovery support services. So we want patients to get on 
medications, we want them to do well. But we also need them to 
be successful in the long run in providing those supports 
whether they be peer supports, recovery coaches, employment, 
housing, legal services, those types of things, they are all 
critical pieces to having that individual success in the long 
run. There is a lot of structure that needs to be provided and 
support that needs to be provided and I think we are building 
the system but make sure the resources are there to really 
amplify that system.
    Ms. Castor. Thank you very much, Dr. Jones.
    Mr. Burgess. The gentlelady's time has expired.
    The chair recognizes the gentleman from Illinois, Mr. 
Shimkus for 5 minutes for your questions please.
    Mr. Shimkus. Thank you, Mr. Chairman. I will try to ask 
quick questions, and get quick responses, and help my 
colleagues and you all survive this long period of questions 
and answers.
    Dr. Gottlieb, in your testimony you talk about the 
difference between addiction and physical dependence and part 
of that is how long can physical dependence develop? In your 
medical----
    Dr. Gottlieb. I would defer to Dr. Jones. But it could 
develop fairly quickly. Anyone who is prescribed opioids for 
any sustained period of time is going to become physically 
dependent on the drug, that is very different than being 
addicted to the drug. Addiction is a state where you have more 
than just a physical dependence on a drug, you have a 
psychological dependence on a drug and you are engaging in 
behavior that is not constructive in your life to get access to 
the drug so there is a very specific----
    Mr. Shimkus. In my experience when someone has addiction 
they would tell me that their brain has been changed, this is 
part of the debate, discussion with this individual was that 
just said his brain--in essence he used the term pickled in 
that he not only has this physical dependence, but his--can 
someone comment about that and how quickly can that occur?
    Dr. Jones. Individuals are very different and so they will 
respond to medication or substance of abuse in very different 
ways. I do think very have a robust set of research studies 
that look at changes that do happen in the brain. And for some 
individuals that change may occur very quickly, for others it 
may take a longer period of time for changes in the brain to 
occur.If we look at functional MRI studies it shows that brains 
of people who are currently addicted light up in different ways 
than people who are not exposed to substances. Even those 
effects carry on many years even after they have----
    Mr. Shimkus. Our challenge is to stop people from being 
hooked and then deal with those who are addicted. That is why 
there are a multitude of bills being presented to try to 
address a lot of these different concerns. I also believe there 
is a practice of pharmacy, there is a practice of medicine I am 
sure you all would agree with that. I am also concerned in a 
rush to judgment on some of the proposed positions because I 
really want to ensure that those who have chronic pain do not 
get thrown under the bus or are collateral damage in a response 
on prescription because those with chronic pain in their lives 
would be significantly changed if they can't have access or a 
long set through a prescription through a doctor.
    And so some of these short-term, get a new prescription 
after 3 days, I am actually concerned about that from the 
patient aspect of--and I want just to throw that on the table.
    Dr. Schuchat, on the prescription drug monitoring debate, I 
live in Illinois, three different States border my 
congressional district, some have it some don't. How do we fix 
this whole system so that we know and there can be 
identification?
    Dr. Schuchat. Right. We need interstate interoperability so 
a clinician can easily essentially automatically have the 
information about any place that a person has received a 
prescription. We also need those systems to automatically 
calculate what is the total dose that the person has gotten to 
make sure you are not going too high. CDC's been funding 45 
States to strengthen these prescription drug monitoring 
programs, as well as hubs that will help with the----
    Mr. Shimkus. We have done this under the meth debate and it 
was somewhat successful when we allow and get the States act 
together and we can get our act together, to be able to 
identify this stuff.
    Dr. Schuchat. Right. And most States are doing data 
sharing. It is just we basically need to speed it up and we 
need to make it very easy.
    Mr. Shimkus. You need to help us figure out how we can do 
that because I think----
    Dr. Schuchat. I think the resources we have been getting 
have helped but additional resources that are proposed will 
help tremendously----
    Mr. Shimkus. And let me finish on this one. I am sorry to 
be so short. Fred Upton went down this rabbit hole on the long-
term aspects of different drugs that aren't addictive. And I am 
going to go to Dr. Gottlieb, I think we talked about this 
personally to about the CMS funding dilemma as far as how do 
you get that on the actuary so these things get paid? Anyone 
want to mention that?
    Dr. Gottlieb. I can't speak specifically to the policies 
related to CMS. I will tell you that there are a multitude of 
products available that treat pain and you do want to see the 
alternatives available as well.
    Mr. Shimkus. And paid for and on an actuary.
    Dr. Gottlieb. Yes. One of the challenges right now is that 
the IR formulations of opioids are very cheap. Vicodin, 
percocet are generic drugs and they are very cheap.
    Mr. Shimkus. I yield back the balance of my time.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman from Massachusetts, Mr. 
Kennedy for 5 minutes for your questions please.
    Mr. Kennedy. Thank you, Mr. Chairman. I want to thank you 
and the Ranking Member Green and all of our witnesses for being 
here convening an important hearing during another historic 
snowstorm in Washington. Took me a whole 30 seconds to wipe off 
my car, but the government is shut down so grateful that you 
all are here. Thank you.
    The wind. Yes, the wind.
    The heart of today's hearing is a simple question I believe 
that is facing our government. Are we doing enough to combat an 
opioid epidemic that is tearing families apart every single 
day? I think that despite best efforts of many across 
government legislative branch and others the answer is an 
emphatic no. It is an answer that ends up being scrawled across 
the headlines of our local papers far too often because 
recently a headline in my own district read that Attleboro 
quote, ``Attleboro sees 200 percent increase in opioid 
deaths.''
    And it was illustrated by every father, brother and sister, 
son and daughter who will never again laugh or cry with a loved 
one they couldn't reach help, get them the help they needed in 
time. An answer written by police officers, fire fighters whose 
resumes now include a line about being addiction counselors and 
lifesavers in their own communities.
    And as many of us are painfully and personally aware of 
because we have watched friends and family struggle to overcome 
this disease. And we know then that we have not done enough. 
Because it isn't enough to offer local governments a one time 
funding boost on one hand and then just turn around and cut 
Medicaid, the single largest payer of behavioral health 
services in the country by $800 billion with the other.
    Is it enough to provide law enforcement with more Narcan 
only to erode essential health benefits that would guarantee 
treatment after a life has been saved? Is it enough to call for 
more treatment beds only to oppose Medicaid lifetime caps and 
work requirements that will create barriers to care for those 
battling substance use disorder?
    Hearings like this one are a positive step forward, but we 
know that they are not enough and we know that there are 
conflicting messages coming out of this administration. So 
until our colleagues end an assault on Medicaid, an assault on 
those that are seeking to make themselves and families heal and 
better, again the largest payer of behavioral health services 
in this country. The answer to that question is not going to 
change.
    So with that as an umbrella, I wanted to follow up a little 
bit on what our colleague Chairman Burgess had commented about 
earlier in his comments about neonatal abstinence syndrome, 
which has been an issue that many of us have been focused on. 
One of my colleagues from Massachusetts, Katherine Clark, made 
a priority of her work in Congress.
    Dr. Jones, you had I believe mentioned it a little bit 
about the influence and the importance of parity when it comes 
to some of these issues. Neonatal abstinence syndrome is an 
issue that obviously affects as it impacts on newborns because 
of addictions in pregnant women. We have a bill that is 
bipartisan, that is bicameral and believe it or not has a CBO 
score of zero that seeks to ensure that pregnant women are able 
to get and newborns are able to get access to the mental and 
baby health services that they need, including addiction 
services. And I was wondering if you could expand a little bit 
on, in your eyes, the importance of access to those services 
and the importance of parity?
    Dr. Jones. Certainly parity is a really critical component 
to addressing the opioid issue, but more broadly mental health 
and substance abuse issues. Through requirements set forth in 
the 21st Century Cures Act, HHS, SAMHSA being a part of that as 
well as Departments of Labor and Treasury have been working 
through issuing different pieces of information that can 
provide facts around parity violations, tools for health plans 
and other to see if they are in compliance with parity. We have 
been trying to put the tools in place to address parity more 
broadly.
    Mr. Kennedy. Do you believe there is sufficient enforcement 
of those violations?
    Dr. Jones. I would say I would defer that to colleagues who 
are charged with the enforcement side, but we have been trying 
to put out information on what are the expectations to 
frequently asked questions around treatment limitations not 
quantitative treatment limitations, step therapies or other 
payment and reimbursement strategies, and then providing 
examples of what are violations. But as far as the enforcement 
actions, I would defer to those who are actually charged with 
that.
    Mr. Kennedy. Any additional witnesses want to comment on 
the enforcement side?
    Doctor.
    Dr. Schuchat. Just to say that taking a holistic approach 
as you mentioned is critical and the public health public 
safety working together is critical, but the same issue making 
sure the care is there for who need them. And we know that 
wraparound service, comprehensive services work better than 
fragmented ones.
    Mr. Kennedy. And so cutting Medicaid by $800 billion, would 
that strengthen or hinder those services?
    Dr. Schuchat. It wouldn't be the best to comment on that.
    Mr. Kennedy. Mr. Gottlieb.
    Dr. Gottlieb. I used to work in Medicare 15--10 years ago 
so I am not up to speed and can't comment on it.
    Mr. Kennedy. Appreciate that.
    Eight hundred billion dollars less than Medicaid though you 
were there a little while ago. Eight hundred billion dollars 
cut to Medicaid, will it strengthen or hinder the program?
    Dr. Gottlieb. You can certainly do more with more in any 
program. There is no question about that. If we are properly 
using our resources we can always do more with more. So I think 
it is an undebatable proposition.
    Mr. Kennedy. Thank you.
    I yield my 30 second overtime back.
    Mr. Burgess. The gentleman's time has expired.
    The chair recognizes the gentlelady from Tennessee 5 
minutes for your questions, please.
    Mrs. Blackburn. Thank you, Mr. Chairman.
    And Dr. Gottlieb I want to come to you. The hearing we had 
back in October, I went right down the dais with you all, NIH, 
CDC, SAMHSA, DEA and said, ``Is there any Federal statute that 
prohibits you from doing your job?'' And you spoke up and 
talked about the international mail facilities and I thank you 
for that. And I thank you for the subsequent work you have done 
with my team, as we have worked to do the discussion draft to 
address the issues with the international mail facilities.
    And I want to talk with you for just a minute about section 
2(a) of that draft, which looks at the unlabeled or minimally 
labeled products that come through these facilities and to 
include those active ingredients that are in some FDA approved 
drugs and biologics. So let's talk about what authorities you 
currently have when you encounter these products in the IMF and 
how this bill will change that authority?
    Dr. Gottlieb. Thanks a lot, Congresswoman. Thanks for your 
support of our work on this and we are happy to work with your 
office and provide technical assistance as you work through 
these issues. Right now we have to, if we see a drug that we 
believe is violative in the IMF, in the International Mail 
Facility, we open a package or a package is pulled by CBP. It 
comes to us for physical inspection, we open it and we find 
drugs in it that we believe are counterfeit or illicit drugs, 
we have to establish intended use. We have to establish that it 
is a drug based on its labeling. And what we are seeing more 
and more are minimally labeled drugs.
    Sometimes we are seeing whole boxes of just pills with no 
labeling whatsoever associated with them. And in that setting, 
if we can't establish that it is a drug based on its intended 
use based on its labeling effectively we have to return it. We 
typically will return it to the sender based on an appearance 
standard, which is lower bar. But if we wanted to destroy that 
product or enter into some other kind of proceeding against it, 
we would have to establish that it is a drug based on the 
labelling.
    And so what we have talked about is being able to establish 
that as a drug based on chemical composition and then being 
able to go from there to establishing as violative based on 
some lapse in the requirements under 505, the labeling 
requirements under 505 section of our statute which would be a 
more efficient threshold for us to reach in the IMF. The 
challenge is also that a lot of times the labeling is online. 
So what we have is our investigators in these facilities going 
online and doing a lot of research around these products to try 
to find some link between the product and its shipper that can 
establish the labeling. That is why we are only able to 
physically inspect a small number of packages per investigator. 
So this could make us far more efficient in those facilities.
    Mrs. Blackburn. OK. Let's talk just a little bit about the 
bulk, the shipment because the bill will address that and the 
needed authority there when you have got that adulterated and 
mislabeled, misbranded drugs that are identified in this bulk 
shipment.
    So, and you have mentioned a couple of times some of the 
problems that exist there. And as we change that authority, how 
will that speed up provide those efficiencies? You have talked 
a little bit about intel, the need for intel, the need for 
efficiencies. So when we change this, what would the agency 
gain through the new authority?
    Dr. Gottlieb. The agency would gain the ability to bundle 
like packages so that we are not overwhelmed by the same 
shipper shipping a lot of small packages in. We can bundle the 
light packages from the same shipper and take one action 
against them. We would also gain the ability to destroy more of 
the packages as opposed to just returning them to sender.
    So if we know something is clearly violative, believed to 
be counterfeit, we can destroy it, which we think would be a 
stronger deterrent than returning it back to the sender only to 
see the same package come in again in another IMF through 
another port of entry, or sometimes the same facility. So this 
is really about gaining efficiencies in the IMFs and trying to 
use our limited footprint, but nonetheless a footprint that we 
are trying to grow to look at many more packages a day so we 
can get to what we believe is a representative sample of what 
is coming in.
    We are never going to be able to inspect any significant 
percentage of all of drug packages coming in. I think the key 
is to make sure we are targeting our resources effectively. 
That requires intelligence, but it also requires the ability to 
work efficiently so that we can use the resources that we have 
in a better way.
    Mrs. Blackburn. Thank you. I yield back.
    Mr. Burgess. The chair thanks the gentlelady. The 
gentlelady yields back.
    The chair recognizes the gentlelady from Colorado, Ms. 
DeGette for 5 minutes for your questions please.
    Ms. DeGette. Thank you very much, Mr. Chairman. I just want 
to comment on this questioning and other questioning.
    Dr. Gottlieb, I am really happy we are talking about 
improving our assessments of what is coming in in the mail. 
This committee had a hearing many years ago which was one of 
those totally revelatory hearings about the importation of 
drugs. And I can only imagine that the situation has greatly 
worsened with the opioid crisis.
    We have somewhere in the archives of this committee some 
pictures of what it looks like at these mail facilities with 
the overwhelming amount of drugs we have coming in and the tiny 
number of people we have for enforcement. So I am happy we are 
working on this and I will work with the majority on making 
sure this bill works.
    I did want to ask you, Dr. Schuchat, about the PDMPs, the 
prescription drug monitoring programs, because those are really 
a valuable tool to prevent the misuse and abuse of prescription 
opioids and of course it is administered by the States. The 
problem is that these systems can have a lag of a few hours to 
almost a week before the prescription drug data is available. I 
am wondering what the CDC is doing to help encourage real-time 
opportunities for detection in the PDMPs?
    Dr. Schuchat. Yes the real-time nature is critical so that 
you get the information current today, not a week old or a 
month old. The funding that we are providing to 45 States right 
now helps them get there, but most of them aren't there yet.
    Ms. DeGette. So what can we do to improve it?
    Dr. Schuchat. Yes. The information technology is there, it 
is getting the upgrades it to the systems that they have.
    Ms. DeGette. If we can work with you on that let us know.
    Dr. Schuchat. Absolutely. Absolutely.
    Ms. DeGette. The other thing is some of the States, like in 
my State in Colorado, they are putting together regional PDMPs 
and that would seem to be something that you can really 
encourage.
    Dr. Schuchat. We think that the States have a good 
platform, but having a national platform that they can plug 
into will help with the interstate interoperability and getting 
really the upgrades to everyone.
    Ms. DeGette. OK. Dr. Jones, Dr. Burgess asked you about the 
recent press reports about the SAMHSA funding of $500 million 
from Congressman Upton's and my 21st Century Cures bill that 
this whole committee worked so hard on. And we were really 
proud that we got $1 billion to help expand States' treatment 
programs. We have already had $15.7 million in Colorado. It has 
already helped 22,000 people in Colorado. You said the States 
are having trouble getting that money out. What can we do to 
help encourage the States to be more efficient and get that 
money out? And also, do we really need to give them more money 
if they can't get the money that we have already given to the 
treatment and prevention?
    Dr. Jones. So I think that some of this is working through 
the procurement process at the State and there are wide 
variations and what that looks like at each individual State--
--
    Ms. DeGette. I understand you said what the problem was. 
What can we do to help?
    Dr. Jones. Right. So I think one that can be done is to 
share information where you hear that there are bottlenecks in 
the system. We would like to----
    Ms. DeGette. With you? Great.
    Dr. Jones. Absolutely. We would like to engage on that. And 
as we implement the technical assistance at the State level I 
think that is also another place to engage and provide 
information to SAMHSA.
    Ms. DeGette. OK. And do you think that we need more money 
right now or do we need to get this money out?
    Dr. Jones. I think that when you look at the magnitude of 
the problem while there have been challenges in getting the 
money out, the scale of the epidemic is large and growing.
    Ms. DeGette. You think it is worth getting more money?
    Dr. Jones. It is important and certainly the 2019 budget 
supports increases in funding for that.
    Ms. DeGette. OK. Great.
    Dr. Gottleib, I just want to finish with you. One of the 
bills that we are considering would direct the FDA to issue 
guidance outlining how and when the FDA would provide 
accelerated approval and breakthrough therapy designation for 
treatments to treat pain or addiction. Breakthrough therapies, 
that is another bill that I worked on and it has really worked, 
but sometimes--and we know that it can benefit patients, but we 
need to make sure that it is not unduly taking a toll on the 
FDA's resources.
    You know in 21st Century Cures we also paired new pathways 
with new funds. What has the experience with the agency been 
with the resources required for accelerated approval pathways 
and do we have appropriate resources?
    Dr. Gottlieb. I will just say that pain is an immediate and 
subjective endpoint. We can establish it fairly quickly with a 
limited dataset using scales, analog scales that we have like 
measure your pain from 1 to 6 or the smily face. With respect 
to accelerated approval, we don't have a good prototype for an 
objective buyer marker in this context. The issue with respect 
to the approval of new pain drugs and drugs that might not have 
all the abuse liabilities associated with opioids, is typically 
not demonstrating efficacy. We could demonstrate that fairly 
efficiently, I don't want to say small but in a very reasonably 
sized clinical trial, dozens of patients not thousands and 
hundreds of patients. The issue is more on the safety side.
    We have not seen a drug in any pain drug for chronic 
administration that hasn't had some liabilities associated with 
it, some safety issues associated with it. So this has been 
when you are administering one of the drugs over a prolonged 
period of time, whether it is acetaminophen or the unsaid class 
now gabapentin, certainly the opioids we have seen side effects 
associated with just about every drug. So that is where we 
usually require more robust data premarket to try to discharge 
any safety concerns.
    Ms. DeGette. Sort of the opposite of what often happens. 
Thank you, Mr. Chairman.
    Mr. Burgess. The lady yields back.
    The chair recognizes the gentleman from Ohio, Mr. Latta, 5 
minutes for your questions.
    Mr. Latta. Thank you very much, Mr. Chairman and thank you 
very much for our panel for being here today because as we all 
know about every member in this committee represents the 
district is having a real epidemic on their own.
    Unfortunately Ohio, we all know what is happening there. We 
are behind Florida and Pennsylvania, we saw in 2015, 3,050 
people pass away, we saw in 2016 that number went up to 4,050, 
in the fiscal year ending on June 30 of last year it was 5,232 
people. So it is affecting lives across this country and it is 
destroying too many families. And so many babies are being born 
with complications with addiction issues and losing their 
parents so it is truly an epidemic in this country.
    With my legislation the INFO Act, that I have introduced it 
is important, in my belief, is because one of things that I 
have run across in my district and talked with professionals 
out there, law enforcement, it is very difficult for 
individuals out there to find especially from smaller areas 
that I represent they doesn't have grant writers that can go 
out and get help. So what we want to be able to do is have a 
dashboard out there for these individuals to go to and not only 
find help but also to find what really takes finding the money.
    Dr. Schuchat if I could start with my questions to you, in 
your testimony you stated that data are crucial and driving 
public health action, timely high quality data can help public 
health, public safety, and mental health excerpts under the 
problem focus resources where they are needed most and evaluate 
the success or prevention and response efforts. And I couldn't 
agree more.
    Making that data publicly available is a large component of 
my bill the INFO Act because again I believe this crisis is 
going to get worse and we need to fight it. Would you speak in 
depth to how the data derives public health action results?
    Dr. Schuchat. This has been a fast moving epidemic and we 
have seen changes in the principle factors that are driving it 
so the more timely our data are, the more rapidly we can target 
interventions. In some States having timely, complete data 
helps them identify hot spots with increased drug supply or 
increased overdose occurrences and helps target the resources 
that can be built there. Whether it is the wraparound services 
or strengthening the Narcan distribution so we can resuscitate 
people.
    At the clinical level, it can be very important to know 
what happened to your patient. And so one of the innovative 
approaches being used right now in some States is after there 
is a fatal overdose alerting anybody who gave a prescription to 
the individual who overdosed in a period before the fatality so 
that the clinician actually gets that reinforcing behavior that 
sometimes prescriptions can be contributing to unintended 
consequences.
    We know from medical practice that feedback on how you are 
doing helps you improve and most of us think we are doing 
better than we are, so getting feedback into how you are 
prescribing and the outcomes for your patients.
    The other point of data is to know what works and how we 
can scale that up, and so with all of the expansion, we hope, 
of the medically-assisted treatment we need to really 
understand more in a more timely way which approaches work best 
for which kinds of patients. We are working with SAMHSA right 
now to evaluate different courses of medically assisted 
treatment and multiple outcomes for patients.
    Mr. Latta. Dr. Jones, you also mentioned strengthening 
public health data and reporting. Do you have anything to add 
about how data can serve to combat this epidemic that we are 
in?
    Dr. Jones. I will just add that I think it is important the 
more timely data we have the better we can help States as they 
are thinking about how are they spending down dollars and where 
are the needs, rural versus urban, different populations. The 
more granular we can get and the more timely we can get we can 
be more efficient and targeted with our resources.
    Mr. Latta. Thank you.
    And also Dr. Jones, the common thing and again as I 
mentioned I hear in my district, is finding that grant 
opportunities or other funding streams, which is very 
difficult. And that is again why I introduced my legislation 
this dashboard. How is SAMHSA currently putting out information 
on their targeted grant programs to support prevention 
treatment and recovery?
    Dr. Jones. So we use a variety of different means to get 
information out about grants. So we have a specific grant web 
page on the SAMHSA website that is right at the top where you 
can find information what are the application processes, we 
also post on grants.gov so as a more centralized hub for 
funding. And then we put out press releases or different 
announcements to stakeholders who would likely be the potential 
grantees so that they know that today SAMHSA announced X amount 
of funding for this and then articulate who is eligible for 
that.
    After we make announcements of funding opportunities we 
often hold webinars or calls with potential grantees to walk 
through what is the intent, what are the deadlines, what do you 
need to put in your application and to answer questions to 
really help people be successful in their grant application.
    Mr. Latta. OK. Thank you very much. Mr. Chairman, I yield 
back.
    Mr. Burgess. The gentleman's time has expired.
    The chair recognizes the gentleman from New Mexico for 5 
minutes for your questions, please.
    Mr. Lujan. Thank you Mr. Chairman. Quickly, it is my 
understanding that you had a very good hearing yesterday in O&I 
specific to West Virginia, Mr. Chairman. And I just want to 
thank you for holding that important hearing. I think it would 
be fruitful to find out what is happening in other States as 
well. In New Mexico our Attorney General Hector Balderas has--
--
    Mr. Burgess. If the gentleman will yield. That was actually 
oversight investigation so that was a gentleman from 
Mississippi who actually chaired that committee.
    Mr. Lujan. I apologize, Mr. Chairman. Well, Mr. Chairman, I 
know that you share the goals of what was conducted in O&I as 
well. All of these States are trying to get this level of data 
including New Mexico and our Attorney General Hector Balderas, 
the automation reports and consolidated order system, ARCOS. 
The data is invaluable. And I think all Members and States 
would benefit from seeing this data. I think that it is 
important that the committee work together to make sure we are 
able to being access that information.
    Dr. Schuchat, I know that the opioid crisis put a major 
issue that your agency has been dealing with over the past 
decade or more correct?
    Yes? I see a nod yes.
    I also know the CDC has been concerned about the opioid 
prescribing rates for quite some time as well. Is that correct?
    Dr. Schuchat. Increased concern since 2010.
    Mr. Lujan. Increased concern since 2010, not since before 
2010?
    Dr. Schuchat. No. There has been concern, but I would say 
there has been accelerated concern as we saw some of the data.
    Mr. Lujan. I appreciate the clarification. In fact, isn't 
it true that you issued prescribing guidelines to providers 
last year because of the concern that an over supply of these 
drugs has contributed to the opioid epidemic.
    Dr. Schuchat. Yes, in 2016 we issued guidelines for chronic 
pain.
    Mr. Lujan. As you know, this committee has been trying to 
investigate some of the distribution trends regarding opioids 
in certain communities. We have tried to understand where 
increases have occurred and whether those increases represent 
over distribution. So I would like to share with you a chart 
showing some of the opioid trends in my district.
    I think that there should be a hardcopy in front of you as 
well. This chart is based on DEA's public ARCOS data. It showed 
the total amount of hydrocodone and oxycodone a distributor 
sent to the zip codes in my district from 2000 to 2016. As you 
can see, the amount of oxycodone increased dramatically by over 
400 percent between 2000 and 2012. So the question that I have 
actually in my district population actually fell during this 
time period. So what I am interested in understanding is which 
of these numbers reflects true medical need of opioids in my 
district?
    Dr. Schuchat. There is excess opioid prescribing throughout 
the country and what we have right now is a sixfold variation 
from the highest prescribing counties to the lower prescribing 
counties. We think we can decrease opioid prescribing 
substantially with best practices about treatment both for 
chronic pain and for other conditions because too many people 
get started on opioids who don't need them and some people are 
continued on opioids after the time where they are necessary.
    Our prescribing guidelines from 2016 began a process to 
improve prescriber practices, the upgrades to the prescription 
drug monitoring programs and the consumer facing awareness 
campaign, that we are running, should reinforce improving 
practices. We have done this before with prescribing for 
antibiotics in pediatrics where we did start to see decreases, 
and we think we can do this again.
    So I would not say that one of these numbers is the right 
one. Currently in the United States we have threefold the 
prescribing of opioids that they have in Europe but we do not 
have threefold the pain that they have there.
    Mr. Lujan. So, well you may not be able to identify now or 
suggest that any of these numbers are correct, would you agree 
that this trend is alarming and concerning?
    Dr. Schuchat. Absolutely, it is terrible.
    Mr. Lujan. And so does the CDC use this information to 
identify trends in States so that they can alert us when there 
is a problem?
    Dr. Schuchat. That is right. And we issued a report last 
summer of the county level opioid prescribing and shared the 
data, the more granular data with the counties and States so 
that they could take action at their hotter spot localities, 
but we also think working with the healthcare professional 
groups, the licensing groups, the education of our trainees 
will help us get prescribing into better order.
    Mr. Lujan. Mr. Chairman, as we can see, these trends in New 
Mexico there is another slide that we have, we don't have it up 
for the big screen today, it is consistent with the national 
trends across the country and what is concerning to me is it is 
only because of the attention that has been brought by one of 
our colleagues on the Committee from West Virginia about a 
small community and what is happening with distributors out 
there, that now we have staff majority and minority that are 
looking into this issue.
    And which of the Federal agencies is supposed to be doing 
this work? That is my concern. I don't know that they are doing 
it because these problems are continuing to grow, get out of 
control. And so we will continue to submit questions, take a 
deeper dive and I want to thank the majority and minority staff 
for the work that they are doing. These oversight hearings are 
critically important and us making sure that we can do 
everything that we can to get to the bottom of this. So Mr. 
Chairman, thank you for the indulgence and to the staff I 
appreciate the work on the issue.
    Mr. Burgess. The chair thanks the gentleman. The chair 
likewise appreciates the work of the staff on this.
    I recognize Mr. Lance of New Jersey, 5 minutes for 
questions, please.
    Mr. Lance. Thank you very much, Mr. Chairman.
    And before I ask questions, I would like to submit for the 
record letters from various groups in support of legislation, 
which I am working, eliminating opiate-related infectious 
diseases, a letter from the National Association of County and 
City Health Officials, a letter from the National Alliance of 
State and Territorial AIDS Directors, a letter from the 
National Viral Hepatitis Roundtable, a letter from the American 
Liver Foundation, and a letter from the AIDS Institute.
    Mr. Burgess. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Lance. Thank you very much, Mr. Chairman.
    Dr. Schuchat, I note that in your testimony you mentioned 
opiate-related harms of infectious disease and how surveillance 
for viral hepatitis is limited. I commend you for that because 
my questions are on this topic.
    Why is understanding the scope of infectious disease 
important with regard to the opiate's Federal response and how 
does the work of the CDC dovetail into the broader strategy?
    Dr. Schuchat. Yes. Many of the infectious disease 
complications of opioid use or injecting drug use can have 
lifelong consequences, not just for the individual, but also 
for those they are in contact with. Clearly, hepatitis C can 
lead to long-term complications, including liver failure and 
cancer, and hepatitis B can be passed from mother to baby and 
lead to chronic infection in the child as well. Of course, HIV 
is treatable but at terrible consequences, injecting drug use. 
While we have seen decreases in HIV in injecting drug use, we 
are starting to see that pattern change right now with our 
recent opioid problem. So improving surveillance for the 
infectious disease complications of opioid use is very 
important in order to better target resources and get screening 
and care to those who need it.
    Mr. Lance. Thank you. I hope you will review legislation I 
just introduced with my colleague, Congressman Kennedy, on the 
other side of the aisle on this committee, completely 
bipartisan in nature.
    My understanding is that currently CDC is running a 
hepatitis C surveillance program in 14 States, including the 
State I represent, New Jersey, at a cost of $3.2 million. The 
current program is passive surveillance, but I have been told 
by CDC that, with additional resources, the agency could plus 
up to active surveillance.
    Doctor, Could you please speak to the types of tools and 
resources that the CDC could activate with additional funding?
    Dr. Schuchat. Yes. The hepatitis C surveillance isn't wide 
enough spread. And, in fact, broader surveillance for viral 
hepatitis, the other types as well, could help, because we are 
seeing consequences of hepatitis A outbreaks in addition to the 
hepatitis C and B problem.
    The problem with hepatitis C is that a single lab test 
doesn't necessarily tell you if it is a new infection or an old 
infection, and so the active surveillance approach, collecting 
more data, could be very helpful in broadening from the 14 
States.
    Mr. Lance. Thank you. Congressman Lujan mentioned the 
incidence of opiate abuse across the country, and I believe you 
indicated in your response that it may vary, I guess this would 
be county by county, up to a sixfold. Is that right?
    Dr. Schuchat. It is the prescribing that varies sixfold, 
but the overdose rates vary substantially as well.
    Mr. Lance. Are those figures readily available county by 
county?
    Dr. Schuchat. Yes. We posted the figure last July, and it 
is available from our website, for the county level data.
    Mr. Lance. Thank you. I would be interested. I have not 
reviewed that. I would be interested to know where the counties 
I represent might stand in that. Thank you for that 
information.
    Dr. Gottlieb, you have spoken extensively to the challenges 
the agency is facing when it comes to intercepting illegal 
drugs at international mail facilities, and we have had a 
discussion about that this morning. Can you give us any idea of 
the sheer volume of unlabeled drugs that come into this 
country?
    Dr. Gottlieb. Well, if I may, Congressman, I brought some 
pictures from our visit to the IMF at JFK, if we can just walk 
through them.
    Mr. Lance. Thank you.
    Dr. Gottlieb. So this is the JFK International Mail 
Facility. This just shows you the package volume coming into 
the facility.
    If we can go to the next slide. These are parcels that were 
refused and subject to destruction under 708, the FDASIA 
authority that was mentioned here today. And this is 318 
parcels shown in the background, this photo.
    Mr. Lance. This photo was taken recently?
    Dr. Gottlieb. Recently. This is from the visit that 
Chairman Burgess and I did to this facility.
    These are about a million counterfeit and misprinted drugs 
scheduled to be destroyed early this spring.
    The next slide.
    [Slide shown.]
    These are, again, packages that were flagged for refusal. 
We are going to send them back. And you see the red stickers on 
them.
    Next slide.
    [Slide shown.]
    I had mentioned that we see packages with unmarked tablets. 
This is one such box that we saw that day of a box of purple 
pills. I am not sure what they are. I wouldn't suggest trying 
one.
    Mr. Lance. I will not.
    Dr. Gottlieb. Next slide.
    [Slide shown.]
    This is another shipment of unknown green pills that came 
in from Hong Kong. This was shipped as cosmetics. These haven't 
been tested. We are not sure what they are right now.
    Next slide.
    [Slide shown.]
    This is another box containing loose blister packs, again, 
with no labeling, so it is unable to determine what they are 
based on labeling.
    Next slide.
    [Slide shown.]
    This particular photo was taken at our Secaucus mail 
facility. We have another IMF in Secaucus.
    Mr. Lance. To the Nation, Secaucus is in New Jersey. And 
the Kennedy Airport is owned by the Port Authority of New York 
and New Jersey, a bi-State facility.
    Dr. Gottlieb. I know it well. I grew up nearby.
    This, again, is unmarked pills. And so this is typically 
what we see when I am talking about the difficulty in 
establishing labeling.
    Next slide.
    [Slide shown.]
    When I talked about multiple shipments of boxes or small 
boxes, this gives you a good indication. These are 10,000 
separate boxes from one shipper.
    Next slide.
    [Slide shown.]
    Just some more photos of those individual small boxes from 
one shipper. This came into the Miami IMF, actually.
    Next slide.
    [Slide shown.]
    This shows you what we are increasingly seeing, which is 
small packages with a lot of different drug contents in them. 
And since we take a risk-based approach in the IMFs, typically 
we might not be opening for inspection the very small packages 
where it looks like it might be for personal use.
    The next slide.
    [Slide shown.]
    This, again, shows you an individual package, again, with a 
potpourri of different drugs in it, including opioids. The 
drugs on the far right with the green labeling are actually 
narcotics.
    Next slide.
    [Slide shown.]
    These are two individuals watching----
    Mr. Lance. Who is the person on the left there?
    Dr. Gottlieb. Well, we were bravely watching this package 
being opened while the CBP official was masked. We braved it. 
It is a fair point that the CBP officers, and our own, but 
particularly CBP, which is the first line of defense looking at 
the narcotics, do gown up and mask themselves because they 
don't know what they are going to be cutting into.
    This was a big box of different drugs that we opened right 
off the line. So it had been x-rayed right when we were 
standing there, and we opened it up and found a lot of 
different kinds of drugs, including OTC products, which is 
unusual to find and raises some suspicions.
    Next slide.
    [Slide shown.]
    This is a teddy bear. We didn't set out to seize the teddy 
bear, but--next slide.
    [Slide shown.]
    This is what we found inside the teddy bear. Again, 
unlabeled drug products. This is actually counterfeit Viagra.
    And then final slide, if we can go to it.
    [Slide shown.]
    This is our laboratory facility in the IMF. So when we talk 
about trying to increase our footprint and improve the physical 
resources that we have there, this would be something that we 
would be looking to augment. And we have put some additional 
resources into this recently, but this is the lab that we use 
to do the testing in the JFK IMF facility.
    Mr. Lance. Well, thank you. My time has elapsed. But I 
point out how dramatic this is. And on a bipartisan basis, this 
committee intends to get to the bottom of it and to rectify the 
situation.
    Thank you, Mr. Chairman.
    Mr. Burgess. The chair thanks the gentleman.
    The chair recognizes the gentlelady from Illinois, Ms. 
Schakowsky, 5 minutes for questions, please.
    Ms. Schakowsky. All right. Dr. Gottlieb, where were those 
packages going? There were addresses on there.
    Dr. Gottlieb. I don't know the consignees offhand. All 
different places in the United States. I would just make one 
more observation that these are volumes that are clearly 
intended for secondary distribution. We are not typically 
seizing, unless a package comes in and we have some targeted 
information around it that would lead us to believe that it is 
a violative package, it might contain illicit substances, we 
wouldn't be looking at the small volumes. We are typically 
opening up the big packages or the packages that come from 
known locales or from shippers that we know to be shipping 
dangerous products into the U.S.
    Ms. Schakowsky. They are going to pharmacies?
    Dr. Gottlieb. Pharmacies, overseas pharmacies?
    Ms. Schakowsky. No. Directed to pharmacies.
    Dr. Gottlieb. It wouldn't be commercial pharmacies. These 
are typically going to illegal routes of distribution in the 
U.S. Again, we are looking at volumes that are intended for 
secondary distribution. That big box of purple pills isn't 
going to an individual.
    Ms. Schakowsky. Is there follow-up to the receiver of these 
pills?
    Dr. Gottlieb. Depending on what we find, sometimes we refer 
hundreds of cases for investigation, and sometimes criminal 
investigation, depending on what we find. And sometimes when we 
hold up a package, we will then give a notification that it is 
coming through and maybe do a dummy drop, if you will, to try 
to find who is going to pick it up. A lot of times these are 
going to drop shipment points. They are not going to an 
individual's home or a business. So we will do investigations 
off of what we are finding in the IMF, depending on what it is 
and what our level of concern is. But we refer hundreds of 
cases away from these.
    Ms. Schakowsky. Thank you.
    On the opioid issue, Advocate hospital system in the 
Chicago area, I went to visit the Advocate Lutheran General 
opioid unit, actually a substance abuse unit. And they provide 
detox in their medically managed withdrawal unit. And it is an 
inpatient process. They only have 12 beds. It is 4 to 7 days. 
And many of the patients have mental health issues as well as 
substance abuse, including depression, anxiety, an undiagnosed 
mental health problem. But when the detox is over, there are 
not enough programs available to provide essential ongoing 
follow-up treatment. And so we talked about that.
    So, Dr. Jones, I wanted to ask you, there is only a certain 
number of substance abuse beds available in facilities there, 
and there is a really long wait. Mental health resources for 
people have been steadily declining in Illinois and around the 
country. They were telling me that sometimes it takes 6 to 9 
months to place somebody. So they do the detox. They say this 
is not treatment. This is just getting them stable. And then I 
said, and then what? In some cases, if a person is homeless, 
they are just out on the street again.
    So I am just concerned about, and we have heard the 
President talk a lot about mental health, and we all talk a lot 
about mental health, behavioral health. And so how do we really 
address this problem once we find people in need and get them 
sober?
    Dr. Jones. I think it is a really important point that we 
move away from the idea that we need more beds. The vast 
majority of people who have an opioid use disorder can be 
treated very effectively in the outpatient setting, whether 
that be in an intensive outpatient treatment in combination 
with medications or in an office-based setting with the use or 
buprenorphine or naltrexone or methadone in an opioid treatment 
program.
    So we certainly want to make sure that beds are available 
for those people who have, say, opioid use disorder with a co-
occurring serious mental illness, and they need that acute care 
to stabilize before they are then moved into an outpatient 
setting or some sort of community-based setting.
    Ms. Schakowsky. I think it is real obvious what we need to 
do. But my real question is what are SAMHSA or other HHS 
agencies actually doing to address this problem. It is not 
really mysterious on what we need more beds for detox, we need 
more behavioral health outpatient. What----
    Dr. Jones. So the STR dollars, which are the opioid 
specific dollars that have gone out to States, are trying to 
build the capacity to provide that treatment on demand and 
moving away, again, from an inpatient treatment perspective to 
the outpatient setting.
    I think it is also important to clarify that detox is not 
treatment. And if someone is detoxed, they absolutely should be 
connected to ongoing care. In particular, you could take 
advantage of the fact that they have been detoxed to induct 
them into Vivitrol or extended release naltrexone, because 
people need to be detoxed before they can be on that.
    So we are putting dollars into States to build this system 
of care that can provide care for people with opioid use 
disorders. We are also making investments in workforce, because 
we could have all the money in the world for----
    Ms. Schakowsky. Exactly.
    Dr. Jones [continuing]. Capacity, but if we don't have 
people who can provide the care, we are not going to move the 
needle. So part of our work on the workforce side is, again, 
through our technical assistance that we are providing to the 
States, money within that TA program can actually be used to 
create teams that can train people to get a waiver to prescribe 
buprenorphine that can address other workforce-related issues. 
We have our providers clinical support system, which provides 
that mentoring and training network.
    We often hear from primary care doctors that they are 
hesitant to engage with patients who have opioid use disorder 
because they don't feel supported. They are not sure that they 
can manage these patients, so we have a mentoring network that 
can be used to help shore that up.
    And then we are also looking at things like Project ECHO, 
Centers of Excellence hub-and-spoke models that can handle, 
really, the acute phase, get somebody stabilized, and then pass 
them off to a primary care doctor who can manage them 
holistically moving forward.
    So those are the things that we are using our dollars to 
invest in with the States. And through the TA, we are really 
trying to support the rapid scale-up of those innovations, 
because people are at such high risk of dying if they are 
coming out of detox and they are not connected to treatment or 
if they are on a waiting list. And human life is too great to 
lose, and we should be building those systems that when 
somebody is ready, they can get the treatment that they need.
    Ms. Schakowsky. Exactly. Thank you so much.
    Mr. Burgess. The chair recognizes the gentleman from 
Virginia, 5 minutes for questions, please.
    Mr. Griffith. Thank you very much, Mr. Chairman.
    Dr. Gottlieb, you all are not the only ones who are looking 
at some of these things. Am I correct in that? And the reason I 
raise that issue is you have said several times you all don't 
look at when the international mail facilities and so forth--
and I guess I am trying to figure it out, because we recently 
had one of those drop sting operations in my district, but it 
was for a small amount of fentanyl to what would appear to be 
personal use for somebody who was just ordering it over the 
internet and coming in. They said in the newspaper article that 
was Customs. Would that have been you all as well?
    Dr. Gottlieb. Customs has primary responsibility in the IMF 
for things identified as controlled substances. We will 
oftentimes work with them. We have criminal investigators that 
will sometimes work with them. We provide certain expertise.
    Mr. Griffith. But you focus on the big shipments. Is that 
correct?
    Dr. Gottlieb. So what Customs will do, they will x-ray all 
the packages, and they will also do some detection, including 
with dogs, to try to pull out the ones that they believe have 
controlled substances. They will pull a certain number of 
packages that they identify with pills that they believe are 
for secondary distribution, based on either volume or where it 
is coming from. They will pull them for physical inspection for 
FDA in those facilities. They will only pull the number of 
packages on a given day that they think we can physically 
inspect inside each facility.
    Mr. Griffith. All right. Let's talk about that. The 
Blackburn bill is very interesting, and we heard comments from 
Mr. Lance, and you showed us all those slides. So what I am 
asking you is should we put into the Blackburn bill authority 
for you all to say a shipment has to have this specific 
labeling and give you the authority if that labeling does not 
exist for all those pictures we saw of the boxes and boxes of 
drugs that were unlabeled? You just automatically get to 
destroy those. Wouldn't that be helpful if we added that in?
    Dr. Gottlieb. Well----
    Mr. Griffith. Yes or no, because I am running out of time.
    Dr. Gottlieb. It would make us more efficient. The 
Blackburn bill does provide for that, because it allows us to 
make a determination that it is a drug based on chemical 
composition, if I am remembering the bill correctly.
    And then we go to the secondary question of whether or not 
it is labeled appropriately. Most of these products wouldn't 
be. They would be misbranded.
    Mr. Griffith. And what I am indicating to you is if it is 
not labeled at all, before you even get to try to test it, if 
it comes in and it is not labeled----
    Dr. Gottlieb. Information targeting, yes.
    Mr. Griffith [continuing]. Destroy it.
    Dr. Gottlieb. You are speaking about the information with 
the manifest date and the information we have about the package 
or the labeling on----
    Mr. Griffith. Yes. You showed us pictures of all these 
unlabeled items coming in. You didn't know what they were. The 
purple pills, you weren't sure what they were. We know what 
they are supposed to be, and so forth. Wouldn't you all like 
the authority just to be able to say if it is not labeled in 
accordance with what you have set forth in your standards, it 
is coming from some foreign country, let's just destroy it? 
Wouldn't that free up a lot of time for going after the folks 
who might be shipping something in that is labeled but labeled 
improperly?
    Dr. Gottlieb. If it is not established that it is drug at 
all----
    Mr. Griffith. Yes. Not labeled, destroy it.
    Dr. Gottlieb. I haven't contemplated it. There would be 
dietary supplements----
    Mr. Griffith. Think about it and get back to me.
    Dr. Gottlieb. Thank you.
    Mr. Griffith. I appreciate that.
    Dr. Gottlieb. Thanks, Congressman.
    Mr. Griffith. Dr. Schuchat, we have got a discussion draft 
being considered to help the CDC and, in turn, the States build 
upon it and improve the State PDMPs, the prescription drug 
monitoring programs, to achieve maximum effectiveness. How 
would that discussion draft help CDC?
    Dr. Schuchat. Yes. We think that improving the State-
specific PDMPs and access to a national platform, that would 
help them share data across States and have everybody benefit 
from the upgrades that individual States have done would be 
helpful. We need to make sure that we reflect the State-
specific laws and policies and that they need access to their 
data to be able to use it and improve it, and we don't really 
want the lowest common denominator State to be what a new 
interoperable system would be. But greater attention to the 
prescription drug monitoring programs and the flexibility to 
improve them rapidly is important.
    Mr. Griffith. All right. Now, I know this is going to sound 
controversial, but you said something earlier that triggered my 
brain to work on something.
    Dr. Schuchat. OK.
    Mr. Griffith. You said that some of these programs will 
alert the healthcare provider if they are overprescribing an 
opioid. Is that correct?
    Dr. Schuchat. About high dose. If you have many different 
types of opioids, you can't, in your head, calculate what is 
the morphine milligram equivalent. In our guideline, we alert 
people that, over a certain level, special attention is needed, 
because the border between safely taking those medicines and 
unintentionally overdosing is small. So we want clinicians to 
recognize when the cumulative opioid level is very high so that 
they can look into it and assess whether it is needed or not.
    Mr. Griffith. All right. Yesterday on O&I, we were talking 
with DEA and all the problems we are having there with 
pharmacies and some doctors. Would it be helpful or would it 
create problems if we shared that information when a doctor 
consistently, or a healthcare provider, consistently is giving 
too high doses out? Would it be helpful to share that 
information with the DEA so that we can maybe identify more 
quickly where we might have a problem? Try to educate first, if 
it is not criminal, but then look at it if it is.
    Dr. Schuchat. In most States, the medical boards would be 
looking at this high-level prescribing. I think we do think 
sharing information across systems is really helpful to alert 
for whatever the issue is. But in terms of what the 
prescription drug monitoring programs are doing is they are 
looking at prescribing to the patient, not the pharmacy level 
data. And Dr. Jones might have something to add there.
    Mr. Griffith. Dr. Jones, you want to add to that?
    Dr. Jones. I will just say the States are--because PDMPs 
sort of fall under the rubric of practice of medicine, practice 
of the health professions, they have different variations in 
their State statutes. But many of them do have proactive 
reporting. So it is looking at, you know, outlier prescribers 
and either sending that, in some cases, to the medical board, 
in some cases to law enforcement.
    Mr. Griffith. OK. One of the issues yesterday was getting 
the information to show that a healthcare provider, whether it 
be a pharmacist or a doctor, was not following standard medical 
procedures in order to get a show-cause order. Now, I was more 
concerned with the ISOs, because I think they are not using 
those effectively and should be more aggressive on that. But in 
the show cause, this is information that could be very helpful. 
And I would hope we could figure it out. I know it is a little 
dicey.
    And I appreciate your time and yield back.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentleman from North Carolina, Mr. 
Butterfield, 5 minutes for questions.
    Mr. Butterfield. Thank you, Mr. Chairman.
    I too would like to thank you, Dr. Jones, for your 
testimony today, and all of you, as that goes.
    Dr. Jones, I appreciate the many counter programs that you 
highlighted in your testimony earlier. This committee worked 
diligently on a bipartisan basis on 21st Century Cures and on 
CARA. One of those programs, the Minority Fellowship Program, 
is not mentioned at all in your testimony. I believe it to be 
appropriate to fully fund this bipartisan effort that we passed 
in the first iteration of CARA.
    Dr. Jones, through research, has HHS come to the conclusion 
that there are significant behavioral health disparities in 
diverse communities across the country?
    Dr. Jones. We certainly know that health disparities and 
social determinants of health play an important role in the 
overall health as well as behavioral health for individuals. 
And creating culturally appropriate interventions that are 
evidence based are really important. Again, as I mentioned, we 
have the State TA program for STR dollars focusing on opioids, 
because we recognize that there are State-specific contexts in 
which interventions are going to be implemented.
    So I think that is certainly an important area, and it is 
part of our overall rubric for how we think about dissemination 
and adoption of evidence-based practices.
    Mr. Butterfield. So this research is ongoing and continues 
to be on your radar?
    Dr. Jones. Absolutely. We continue to put out data and 
analyses from our National Survey on Drug Use and Health around 
different disparities that exist around behavioral health 
issues, whether they be substance use or mental health, among 
different racial ethnic groups, among different age groups, 
among people with lower socioeconomic status in a variety of 
different ways to really get a more comprehensive and holistic 
picture of how different individuals in our country are being 
impacted by these issues.
    Mr. Butterfield. Very important.
    This committee, Dr. Jones, unanimously approved the 
reauthorization of the minority fellowship program and an 
increase in its authorization. There is no other program that 
will focus on preparing behavioral health practitioners to more 
effectively treat and serve people of different cultural and 
economic backgrounds. We have heard that at SAMHSA's Center for 
Mental Health Services National Advisory Council meeting 
recently, the newly appointed assistant secretary for Mental 
Health and Substance Abuse expressed her support for this 
program.
    Why did HHS propose elimination of this program in the 2019 
budget?
    Dr. Jones. I will just say, some of the specifics of our 
budget are still working through and, we have a budget and 
brief that is out, but the other specifics are still in 
process. We are committed to workforce development that is a 
priority for the assistant secretary in making sure that 
workforce development incorporates different racial ethnic 
groups who may have different impacts and differential impacts 
of substance use and mental health.
    Mr. Butterfield. Well, considering the strong congressional 
and bipartisan support for this program, I would ask that you 
really take a serious look at reauthorizing and funding this 
program.
    Chairman Burgess, I would like to submit for the record a 
bipartisan letter to appropriators in support of full funding 
for the Minority Fellowship Program, if I can find it. Here it 
is.
    May I include it in the record?
    Mr. Burgess. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Butterfield. Thank you.
    Dr. Gottlieb, a number of your colleagues have highlighted 
the tragedy of neonatal abstinence syndrome that occurs when a 
mother takes prescription or illicit opiates during her 
pregnancy, and her baby is born with a physiological dependence 
to that drug. Far too many babies are born into a life that 
begin with opioid dependency because their mothers used or at 
least abused these drugs while she was pregnant.
    Would you agree or disagree that there should be special 
treatments for these newborns?
    Dr. Gottlieb. Congressman, I would welcome the opportunity 
to try to help any sponsor that is trying to develop treatment 
that could specifically address this tragic condition.
    Mr. Butterfield. Well, it is my understanding that there 
are few options for treating opioid withdrawals in infants. If 
that is not correct, I would like to know it. But it is my 
understanding that there are few options for treating opiate 
withdrawal in infants. And existing options for these babies in 
the first month of life are not streamlined or standardized and 
none of the currently used therapeutics are FDA approved for 
the population.
    Would you be willing to work with companies--you said you 
would work with us, of course. But would you be willing to work 
with companies and other stakeholders to help identify 
incentives to accelerate research into this area?
    Dr. Gottlieb. We would be delighted to work with sponsors 
in this regard, Congressman. And I would be delighted to work 
with Congress to see what additional incentives we can try to 
craft to incentivize, you know, development for what is a very 
small population but a critical medical need.
    Mr. Butterfield. Let me address in closing the testimony 
about the types of packaging and excess opiate disposal. Mr. 
Hudson and I are working on legislation to help assist with the 
FDA's efforts. Can you describe whether additional authority 
could be helpful in those efforts to limit the number of 
opiates dispensed to patients and to make it easier for 
patients to dispose of leftover opiates?
    Dr. Gottlieb. Well, we are actively contemplating what we 
can do under our existing authorities to try to create pathways 
to blister pack some of the immediate release formulations of 
drugs. We have a working group that we stood up in the agency 
looking at this question. This might be something that is hard 
to reach under our current authorities to either mandate that 
or to require to be offered as an option that, then, the 
healthcare system could try to incentivize use of.
    But we do believe, at a policy level, that if the IR drugs 
were in blister pack formulations that were--the number of 
pills that were appropriate for 3 days, 5 days, 7 days, I think 
you would see more default prescribing for those shorter 
duration uses. More physicians would opt for that. We see, in 
other areas of clinical medicine where there is convenience 
packaging, physicians will opt for that.
    This is an opportunity, I think, for Congress to address 
this. Congress could conceivably direct it to be done, 
particularly for the IR drugs. But we will continue to work 
within the scope of our authorities to see whether this makes 
sense from a public health standpoint; if it does, how we reach 
it based under our current authorities.
    With respect to disposal, we think that there are a lot of 
opportunities to provide for avenues to dispose of these drugs 
for consumers. I think it would very clearly take more pills 
out of circulation that didn't go on to be diverted. Because we 
have developed data that shows a lot of pills are left over on 
an average prescription.
    Mr. Butterfield. Thank you. I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The gentleman from Texas.
    Mr. Green. Mr. Chairman, I ask unanimous consent to place 
into the record a letter from EVERFI and also a statement by 
Congressman Hakeem Jeffries on H.R. 449.
    Mr. Burgess. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Burgess. The chair recognizes the gentleman from 
Florida, Mr. Bilirakis, 5 minutes.
    Mr. Bilirakis. Thank you, Mr. Chairman. I appreciate it.
    Dr. Schuchat, the CDC released new prescribing guidelines 
for opioid back in March 2016, yet a recently released report 
by the agency indicates that, despite this change, ER 
admissions due to opioid overdoses have since increased by 30 
percent nationwide, the Midwest by 70 percent, and by 54 
percent in large cities in 16 States.
    What is CDC currently doing to address this issue?
    Dr. Schuchat. Yes. We are funding 45 States and the 
District of Columbia to strengthen their community-based 
prevention work. We are particularly focused on the 
prescription drug monitoring programs so that we can improve 
prescribing and not have people start down the path toward 
addiction to begin with. But we are also doing work in part of 
the heroin response strategy on community level projects that 
explore innovative approaches like having recovery coaches in 
the emergency room to help people navigate into care from the 
emergency room.
    So this is a big problem. It is getting worse. But we are 
supporting States, working with the medical community, trying 
to have system changes, and also doing consumer outreach as 
well.
    Mr. Bilirakis. Why did we not see any type of an 
improvement with these new prescribing guidelines?
    Dr. Schuchat. We have actually started to see a decline in 
prescriptions of opioids. The recent increase in emergency 
department visits is likely related to the illegally 
manufactured fentanyl that we have been hearing about through 
the international mail facilities. While the prescribing is 
starting to come down, it is actually still too high. So there 
is a lot more room for improvement, and we are trying to scale 
up the uptake of our guidelines through medical care, through 
technology improvements, through academic detailing.
    Mr. Bilirakis. What do you suggest we do as legislators?
    Dr. Schuchat. Well, I think the focus on this is critical, 
and the resources that have been coming in, are being proposed, 
are also very important. There are some authorities that could 
help speed things up. As you hear about the workforce gaps in 
the medication-assisted treatment world, there are similar 
workforce gaps in public health information specialists and so 
forth. So there are some things like direct hiring authority or 
loan repayment for certain kinds of these special needs that 
really need to increase for us to turn the epidemic around.
    Mr. Bilirakis. Thank you.
    And I appreciate you holding this hearing, Mr. Chairman.
    Dr. Gottlieb, in your testimony, you mentioned that FDA's 
regulatory oversight over lawfully prescribed drugs gives your 
agency some important opportunities to impact prescribing in 
ways that can reduce the rate of new addiction, while making 
sure patients with medical needs have access to appropriate 
therapy, and that is all very important. We need a balance 
there.
    Would you discuss these opportunities, sir.
    Dr. Gottlieb. Thank you, Congressman. I just want to echo 
your closing statement about patients who have medical need. We 
have to remember that there are a lot of patients with chronic 
pain conditions, including patients with metastatic cancer pain 
who require long-term use of opioids. In some cases, opioids 
are the only drug that is going to work for certain patients, 
particularly patients with metastatic cancer pain. So we need 
to remember that in terms of what we do and how we titrate our 
policies, that we don't lock those patients out of critical 
drugs.
    But we have taken steps with respect to the use of our 
authorities, particularly under the risk management plans that 
we promulgate, in conjunction with the prescribing of drugs, to 
try to put in place certain measures that will try rationalized 
prescribing and try to steer the provider towards more 
appropriate prescribing.
    So earlier this year, we updated our REMS to include all 
the immediate release formulations of drugs. Previously, it was 
just applied to the long-acting formulations, the higher dose 
formulations of the drugs. But we know that most of the 
prescribing and most of the new addiction is through 
immediately released formulations of drugs. At least that will 
be the first medications that patients use.
    We also expand that to include, not just physician 
prescribers, but anyone who comes into contact with the 
patients. So, for example, nurses and pharmacists. So we 
updated the education. And we also expanded it to include 
education around alternatives. So instead of just educating 
providers around the abuse liability associated with opioids 
and the proper prescribing of opioids, we are now requiring 
education to include alternative treatments for pain so that 
they have a full complement, a full picture, of what the scope 
of prescribing could be.
    We are looking at other ways to try to steer prescribing in 
a better direction. Packaging, I have talked about trying to 
make potentially the education mandatory or make it mandatory 
if you want to prescribe higher volume, longer duration drugs. 
We are talking about maybe requiring sponsors to impose 
requirements where physicians have to document if they are 
prescribing certain patterns of use that we know comport with a 
higher rate of addiction, potential addiction, from the use of 
prescription products. So there is a range of things we can do.
    I will say in response to the question you asked earlier on 
what can we do to get at this problem, it is very clear there 
is not a magic bullet here. There is no one solution. It is 
going to be a complement of many steps that we all take working 
together to try to effect a crisis of this magnitude.
    Mr. Bilirakis. Thank you very much.
    And I know my time has expired, Mr. Chairman, so I will 
yield back. Thank you.
    Mr. Burgess. Correct. The gentlemen's time has expired.
    The chair recognizes the gentleman from New York, Mr. 
Engel, 5 minutes for your questions, please.
    Mr. Engel. Thank you, Mr. Chairman.
    I am pleased to be the Democratic lead on two of the 
bipartisan bills we are considering during this hearing: The 
Poison Center Network Enhancement Act and the RESULTS Act. And 
during this panel, I would like to focus on the RESULTS Act, 
which is a bill I have introduced with Congressman Stivers in a 
bipartisan way.
    The goal of the RESULTS Act is to ensure that Federal 
grants intended to treat mental health and substance abuse 
disorders fund activities that are backed by sound evidence so 
it will help build the evidence-based innovative interventions. 
And while the concept is obviously straightforward, I want to 
be sure that it is executed carefully.
    As we work to end the opioid crisis, we need to ensure that 
results drive decision making and that we always keep the door 
open to new and innovative approaches that could be game 
changers. And I hope that this discussion will help us strike 
the right balance.
    One of the objectives of the RESULTS Act is to ensure that 
there are tools available for stakeholders looking to emulate 
activities and intervention that have shown results and may 
work in their communities. It is my understanding that SAMHSA 
intends to use the National Mental Health and Substance Use 
Policy Laboratory, or policy lab, created by the 21st Century 
Cures Act, which we are all proud about here, to make 
information about evidence-based mental health and substance 
use disorder interventions available to the public.
    So in light of the suspension of the National Registry of 
Evidence-Based Programs and Practices, I am anxious to learn 
more about what the plans are for the policy lab. So, Dr. 
Jones, would you explain exactly what types of tools and 
information will be made available to the public for the policy 
lab? And when would you expect that policy lab to be fully 
operational?
    Dr. Jones. Thank you the for question. I think it is really 
important that we are good stewards of our Federal dollars and 
that we are helping support, whether it be community programs 
or practitioners implement evidence-based practices. And that 
is really the frame that we are using as we are setting up a 
new resource center within SAMHSA, helmed by the policy lab, to 
accomplish that goal.
    So what we are doing now is we are actually going through 
resources that already exist at SAMHSA that are broader than 
just sort of a program-by-program listing, which is largely 
what NREPP was, that can actually help facilitate communities 
and practitioners to understand what the context in which they 
want to implement an intervention based on that information, 
sort of a needs assessment, what are the right interventions 
that fit our needs, and then how do we actually implement that?
    And so SAMHSA has spent quite a lot of time and resource in 
creating different types of evidence-based toolkits around a 
sort of community treatment or other mental health treatment 
approaches or medication-assisted treatment or community-based 
substance use prevention, where those resources are somewhat 
buried on the website at SAMHSA. And we want to bring those to 
the forefront, because they really do provide the roadmap for 
how a community or a practitioner would implement evidence-
based practices.
    So we have been culling through that information. We have 
reached out to our colleagues across HHS who also have that 
type of information that could be useful. And we are 
synthesizing that in creating a website that we believe is 
quite useful across the spectrum so people from the public who 
are interested in these issues who are not expert in different 
topics would be able to point and click into the specific 
areas. So if they want to learn about youth substance use 
prevention, they would be able to quickly identify what are the 
fact sheets that might exist for that versus a community 
implementation guide, which might not be the most appropriate 
thing for them.
    And similarly, we are doing that for clinicians. There are 
a number of clinical guidance documents that SAMHSA has put 
out. As I mentioned earlier, TIP 63 around medications. We have 
the CDC opioid prescribing guideline. And putting that into 
sort of a one-stop shop where individuals can get to that. We 
are absolutely committed to advancing the adoption of evidence-
based practices. That is what has been asked of us by Congress 
for the policy lab, and the assistant secretary as well is 
committed to that.
    Mr. Engel. Well, I am glad to hear it. Let me ask you one 
more question. How will the policy lab help expand access to 
evidence-based treatment and promote results-driven activities? 
And the second part to that is how can we in Congress help 
SAMHSA achieve those goals?
    Dr. Jones. So certainly the charge that was given to the 
policy lab is a tremendous step forward in helping us to do 
that, to identify what is working and to help disseminate that 
information. So one thing that we are doing specific to 
medication-assisted treatment, with our STR opioid dollars, 
there are quite a lot of natural experiments that are happening 
in the States. Sort of a natural laboratory of people looking 
at how do we initiate buprenorphine in the emergency department 
and connect people to care? How do we scale up medication-
assisted treatment in the correctional population? How do we 
look at these different systems of care?
    And so what we are doing now is engaging with States to 
actually evaluate those innovations and interventions. And the 
plan would be to very quickly, once we identify what is 
working, to then disseminate that information out. But also to 
infuse it into our funding announcements so that we are 
actually helping to drive evidence into practice through our 
funding streams and not continuing to support non-evidence-
based practices to the money that we are putting out.
    Mr. Engel. Thank you very much.
    Thank you, Mr. Chairman.
    Mr. Burgess. The gentleman's time is expired.
    The chair recognizes the gentleman from Missouri, Mr. Long, 
5 minutes for questions, please.
    Mr. Long. Thank you, Mr. Chairman. Thank you for having the 
hearing. And I thank the witnesses for being here today.
    In Missouri, from 2012 to 2016, we experienced a 78 percent 
increase in opioid overdose deaths. I experienced three of 
those myself, people, friends of mine, lost children in their 
20s in those same years, 2012, 2016. They were children from 
Columbia, Missouri, University of Missouri; Springfield, 
Missouri, 160,000 population; Kansas City, Missouri. So these 
were not rural areas.
    However, in that study that the Missouri Hospital 
Association did that showed a 78 percent increase from 2012 to 
2016, the biggest spike was in the rural areas. I do a farm 
tour every year, an agricultural tour, where we tour through 
our district. I have a lot of rural areas in my district. And 
we were driving along on the bus one day, riding along in the 
bus, and looking out. It was just picturesque. It was just 
gorgeous. It looked like you could have a farmland ad on their, 
pop on TV, even with the green fields and everything. And the 
fellow leading the tour said that their number one problem in 
that area was heroin addiction of the high school kids.
    And so my question is this, for Dr. Schuchat, with that 
sharp increase in the rural areas, how do we ensure that rural 
areas are getting the resources they need to combat opioid 
abuse? And what else do you think needs to be done to make sure 
the rural areas can adequately address abuse?
    Dr. Schuchat. Yes. Thank you for that question. It is a 
terrible problem in some of the rural areas. One of the things 
we have been doing is working with SAMHSA on evaluating the 
distribution of naloxone to help wake people up who have 
overdosed. And there are some gaps in rural areas in a lot of 
States. So trying to make sure there is the naloxone 
distribution, but also ability to link to care and the 
recognition that, perhaps, you know, telemedicine may be 
helpful for some of the treatments where there are low access 
areas.
    I think it is a big problem that is going to take a lot of 
time, but the way that CDC is helping is by providing resources 
to the State health departments and letting them improve their 
data so they know where the hot spots are so they can improve 
prevention, treatment, and recovery in the hot spot areas, 
which in many places are rural.
    Mr. Long. Dr. Jones, you care to elaborate on that?
    Dr. Jones. Sure. I would just add that we have actually 
worked collaboratively with CDC. We did a paper last year 
looking specifically at drug overdose and drug use disorders or 
substance use disorders in rural areas to highlight this 
important issue.
    With our STR dollars, again, looking at the system's 
innovations is a way to help address some of the capacity 
issues in rural areas. I will use Project ECHO as an example, 
which started in New Mexico, which has historically had very 
high rates of opioid addiction and overdose in very rural 
communities that have very little infrastructure for 
healthcare. And Project ECHO is at the University of New 
Mexico. And they actually worked with the rural providers to 
train them, to provide them with resources that really help 
support them to provide addiction care in the community so that 
the individual from the rural area didn't have to travel to the 
academic medical center 2 hours away in order to get care.
    So with our opioid State-targeted response grants, a number 
of States are looking at that Project ECHO model, looking at 
other innovative models that you can build that capacity in 
those areas to address those issues. And I think, again, 
underscoring the importance of the data to understand where do 
we need to be targeting those resources is really critical, and 
working with the States to analyze that data to say, you 
thought you had a problem in city X, but it is actually city Y, 
and we need to make sure that we are deploying resources to 
that area.
    Mr. Long. There is a fellow that sits behind you all 
occasionally in here, comes in here, quite a few times. He has 
a son that, I think when he was 19 or 20 years old a few years 
ago, got out of rehab for his third time. They had, I believe, 
Christmas, whatever dinner, and opened packages. And the son 
went upstairs, and they found him on the floor in the bathroom. 
And they thought he was dead. They got him to the hospital. The 
EMTs revived him, got him to the hospital.
    And he looked at his dad the next day in the hospital, and 
he said, Dad, I knew when I got out of rehab that I couldn't do 
the same amount of heroin that I used to do. But I can hardly 
get it to melt on a spoon, and it about killed him. So they got 
him on whatever drug it is, the high-price injection thing. I 
say high price, $1,000 a month. YAnd he has done really, really 
well since then.
    Is it money? If you had all the money in the world, can we 
attack this problem or not? If you had said, Dr. Gottlieb or 
Schuchat or Jones, whoever, if you just sit there and write 
checks all day, is there anything we can do that--what would be 
the most effective thing we could do if you had an unlimited 
budget for this problem?
    Dr. Jones. Well, certainly, resources are helpful. But as I 
mentioned earlier, a workforce is equally as important. And we 
have a lack of sufficient workforce to address the addiction 
and mental health problems that face our country. So I think--
--
    Mr. Long. So if you had the money, could you hire the help, 
or there is just nobody in those fields?
    Dr. Jones. We have to think about how resources are used. 
So part of that is to build that capacity, which is what we are 
doing with the funding that we have now. So it is building the 
workforce, it is building the systems, it is building the 
infrastructure.
    So many of the issues that we are talking about today are 
really the things that we need to be doing to advance that. It 
is just how do we more quickly scale those things up, and 
resources are clearly a part of that.
    Mr. Long. OK. I am way past my time.
    I yield back. Thank you.
    Mr. Guthrie [presiding]. I thank the gentleman for yielding 
back.
    And the chair recognizes Dr. Bucshon from Indiana for 5 
minutes for questions.
    Mr. Bucshon. Thank you, Mr. Chairman. I was a physician 
before I was in Congress, so we have kind of seen this coming 
for quite a while, and I am really pleased that now there is a 
national attention on this issue.
    Dr. Schuchat, I am interested in finding solutions to the 
opioid epidemic partially by focusing on addressing the 
underlying causes of the opioid use disorder and specifically 
looking at innovative solutions to address acute and chronic 
pain. Does the CDC collect statistics information about how 
many Americans suffer from chronic pain or information related 
to access to treatment?
    Dr. Schuchat. That is not a core part of our surveillance 
systems right now. We don't think that pain itself has 
increased over the past few decades, but we have changed how we 
were prescribing for pain with the availability of the longer 
acting opioids.
    Mr. Bucshon. Is there a need for more information, you 
think, in that space?
    Dr. Schuchat. There has certainly been an increase in 
people with chronic diseases that we are tracking, and so I 
think better understanding of pain and the different factors 
contributing to it will be important, as well as access to 
alternative approaches for pain management, which are safer and 
perhaps more effective.
    Mr. Bucshon. OK. Yes. Because pain is very subjective, and 
it is sometimes difficult to put your finger on it. I can tell 
you just doing the surgery that I did, the variance in the 
amount of postoperative discomfort that people would claim to 
have, that did have, but the severity of that is across an 
entire spectrum. So that is difficult.
    So information on people that truly have chronic pain 
syndromes that may require long-term opioid treatment might be 
important, because I think that is one of the concerns that I 
think patient advocacy groups in that space are concerned 
about, and information on the actual number and how we deal 
with that might be helpful.
    Dr. Schuchat. Yes. I think it could be helpful, but also 
knowing what are the best approaches for that. Recently there 
was a randomized control trial that compared opioids with 
nonsteroidal anti-inflammatories for back pain and some other 
things. And at a year out, people who were on the nonsteroidals 
actually were doing better.
    Mr. Bucshon. I know. I know that. I just read that.
    Dr. Schuchat. Yes. So I think we have been taught that we 
were undertreating pain, and people thought the way to treat 
pain was with the opioids, and probably there are better ways 
to treat many kinds of pain. But, of course, not all. And our 
guidelines were not to take pain medicine away from people with 
palliative care, metastatic cancer, and end of life, and so 
forth. But there is a lot of overprescribing.
    Mr. Bucshon. The treatment of pain itself, people become 
tachyphylactic to the treatment, right? They get resistance so 
they need more and more. And it may ultimately allow these 
patients, like you pointed out, the pain actually initiated the 
therapy in the first place is not the reason why they are 
continuing to take the medication.
    Dr. Gottlieb, successfully tackling the opioid crisis 
requires, in part, ensuring that patients have access to 
alternative effective treatments for chronic pain. I would like 
to note the recent FDA education blueprint for healthcare 
providers involved in the treatment of monitoring patients with 
pain highlights the importance of provider awareness regarding 
the range of therapeutic options for managing pain, including 
nonpharmacological approaches and pharmacological nonopioid 
therapies. And further, that nonpharmacological approaches 
include the use of approved, cleared medical devices for pain 
management.
    And I know there are a number of existing medical 
technologies on the market today, including spinal cord 
stimulation, implantable drug pumps for nonopioid medications, 
radiofrequency ablation, among a variety of other things.
    Could you speak to your perspective on the role of medical 
technology such as these and others in advancing the treatment 
of pain and alleviating, partially helping with the opioid 
crisis?
    Dr. Gottlieb. Well, I think it plays a critical role. We 
have over 200 approved medical devices for different pain 
indications. About 10 of those are very novel technologies. And 
I think that there is a lot of opportunity for medical devices 
for a lot of different pain syndromes, particularly where you 
have regional pain, where you might be taking a systemic drug 
for what is a regional condition, a regional musculoskeletal 
pain, in particular, where you might be able to address it with 
a medical device that is delivering localized anesthesia. So 
there is a big opportunity.
    We are looking at what we can do through our policy tools 
to try to incentivize development there. We are looking at 
particularly some challenge programs and trying to get out 
better guidance on the development of devices that could 
address pain as a way to try to incentivize more development of 
those kinds of products.
    Mr. Bucshon. Do you think you have the tools that you need 
in your toolbox to get some of these innovative products to the 
consumer or are there barriers that are legislative that might 
be necessary to help you along in that process?
    Dr. Gottlieb. I would be happy to give that some thought, 
Congressman. I can't say right now that there are limitations 
in our review authorities where we don't have adequate 
flexibility to make some accommodations here or think in 
innovative ways. We do have flexibility under the medical 
device statute, which allows us to titrate the regulatory touch 
to the sort of complexity of the product and the risk inherent 
in the product. We do have flexibility on the medical device 
side of our house to address unique situations where we might 
want to foster more innovation. So I can come back to you. I 
will take it back to my folks. I have asked the question 
internally, and we have come up with things that we think we 
can do under our existing authorities.
    Mr. Bucshon. OK. I appreciate that. Yes. The actual barrier 
could be over at CMS at the end of the day, sometimes. I think 
I found that to be true since I have been in Congress. So we 
are trying to address that side of it also. Thank you.
    I yield back.
    Mr. Guthrie. I thank the gentleman for yielding back.
    And the chair recognizes Mrs. Brooks from Indiana, 5 
minutes for questions.
    Mrs. Brooks. Thank you, Mr. Chairman.
    Some time ago, in about 2015, Indiana, Scott County in 
particular, experienced a horrific HIV outbreak. And I know the 
CDC, a lot of different agencies, were very involved in helping 
us curb that outbreak. And now most recently, we are seeing, 
and papers are reporting, a massive increase in hep C cases 
throughout our State, and in some of my counties I represent 
specifically, and them being directly connected in many ways to 
opioid abuse.
    And so we know that the majority of these infectious 
diseases are attributable to injection drug use, and we know 
public health officials are focusing hard on these problems and 
on solutions. But I guess I am curious, I want to come back to 
the CDC. I believe we have talked about this in the past having 
to do with the HIV outbreaks.
    But can you talk to us about, Dr. Schuchat, what you are 
doing to continue to monitor the infectious disease outbreaks, 
particularly as we are not turning the tide on the opioid use, 
and what kind of levels are we seeing nationally, and what 
tools are available to States to help them react or to try to 
get ahead of it maybe faster than we are right now? Because I 
think we are losing another battle, in addition to the opioid 
battle, but they are, I think, very related.
    Dr. Schuchat. Yes. The Indiana outbreak in Scott County was 
a wake-up call, and we did modeling to identify over 200 
vulnerable counties around the country that could be just like 
Scott County, in terms of outbreaks of HIV or hep C in the 
context of the opioid use. We distributed that information to 
the State and local health departments, but much more is needed 
in terms of improving the surveillance for those infectious 
disease complications of opioid use disorder. And also the 
screening treatment and longer term care. The hepatitis C is 
increasing in many areas, but we don't have as good 
surveillance for it as we would like.
    Mrs. Brooks. Can you talk to us, though, about surveillance 
tools that either you use or do you need any additional 
authorities? How are you surveilling for these outbreaks?
    Dr. Schuchat. Yes. The surveillance is usually laboratory 
based, that the labs do the testing, but there is often a need 
for active followup to determine is it a new infection? Has it 
already been reported somewhere else? So it is really 
strengthening that public health front line infrastructure in 
the labs and the health departments to be able to improve the 
quality of surveillance and see the information back more 
rapidly.
    Mrs. Brooks. So that collaboration that you have with the 
State and county labs in many ways and State health 
departments, is there additional funding that as we are 
hopefully getting ready to in this next budget provide a lot 
more funding to State and locals who are on the front lines of 
this, is this something that we need to make sure or that 
SAMHSA and the grants they put out, that you all can make sure 
there is more funding for this type of surveillance?
    Dr. Schuchat. Yes. This type of surveillance does need to 
be better supported. We are tracking some of the infectious 
complications, but not all of them. And we are not doing it 
quickly enough. We think that better data on prescribing, 
better data on overdoses, and better data on infectious 
complications will all help us turn the epidemic around.
    Mrs. Brooks. Are there any other infectious diseases 
specifically that we ought to be looking for, monitoring for, 
and raising the level of awareness with our State and local 
health officials?
    Dr. Schuchat. Yes. I would like to signal the need for a 
nimble and flexible public health response. We wouldn't have 
expected hepatitis A to increase and associated with injecting 
drug use, but it has. And we have had large outbreaks in 
Michigan, in multiple States, California, many States around 
the country, of hepatitis A. So we think that the broader 
infectious disease complications of injecting drug use or of 
the opioid epidemic would be helpful.
    Right now, we have a group A strep, the flesh-eating 
bacteria outbreak that is associated with the injection of 
drugs. So I think----
    Mrs. Brooks. Would you repeat that?
    Dr. Schuchat. The group A strep, which people have heard of 
as the flesh-eating bacteria, we are having an outbreak of that 
that has been traced back to injecting drugs. It can come in 
through the skin.
    So I think just as we started this wave of overdoses with 
prescriptions complicated later by heroin and most recently 
fentanyl, in terms of infectious diseases, we have to have our 
eyes wide open. I was talking to a colleague earlier about an 
outbreak in Scotland of cutaneous anthrax that was associated 
with injection drugs there. So we need to really look broadly. 
And certainly, the viral hepatitis infections are the leading 
ones that we have to be worried about.
    Mrs. Brooks. Thank you. My time is up. And thank you all 
for your work.
    Mr. Guthrie. I thank the gentlelady for yielding back.
    The chair recognizes Mr. Carter from Georgia for 5 minutes.
    Mr. Carter. Thank you, Mr. Chairman. And I thank all of you 
for being here.
    Dr. Gottlieb, I will start with you. And I wanted to ask 
you about something that former Chairman Upton asked you about, 
and that is the abuse deterrent formulations. I know that in 
your 2018 action plan, your plan states: Among our science-
based efforts, we will assist in the conversion of the market 
toward wider use of opioid drugs with improved formulations 
that are harder to manipulate and abuse.
    I just wanted you to comment on that and what you see as 
the role of these particular formulations in the future.
    Dr. Gottlieb. We do think that there is an opportunity for 
these drugs to potentially reduce the rate of overall abuse and 
addiction in the market, and do see a potential opportunity 
from converting more of the market to abuse-deterrent 
formulations that are harder to manipulate in ways that allow 
people who are trying to misuse them to get a dose dump, if you 
will.
    Mr. Carter. Right. One of the problems is getting coverage 
for them. How can we assist you in that? I know that insurance 
companies don't want to cover them because they are more 
expensive and they are not on formularies. And if they are, 
they are not on a top tier, and that causes the access to them 
to be decreased.
    Dr. Gottlieb. Yes. It is a fair point, and it is one that 
we observe as well. Obviously, we don't have a direct line into 
the coverage environment. I think where we could potentially be 
helpful in the overall scope of that challenge is in trying to 
facilitate avenues for claims that are more seductive to people 
who are paying for these drugs.
    And so that is why we are trying to move in the direction 
of accumulating data that can allow us to make a determination 
that when these drugs are used over a population, they do, in 
fact, reduce the rate of addiction and abuse. And we are 
continuing to collect that data.
    I made the point before: We are going to have a make a 
policy decision at some point whether or not, as a policy 
matter, we think the totality of the data demonstrates that, as 
you convert the market to abuse-deterrent formulations, you cut 
down on abuse.
    Mr. Carter. OK. Let me ask you about unit-dose packaging. 
Some years back, you put Halcion under unit-dose packaging, and 
it worked very well. And I am just wondering what the holdup 
is. What will you base that decision on if you decided to go 
that route with opioids? Is there something you have to base it 
on?
    Dr. Gottlieb. We would want empirical data, public health 
data to demonstrate that, as you move toward blister packs, 
you, in fact, are going to cut down on the rate of addiction 
and abuse.
    Mr. Carter. Hasn't that been proven with Halcion?
    Dr. Gottlieb. Well, we would want to prove it in this 
context, but you would also want those to be evidence-based 
insofar as you would want to be blister packing drugs in unit 
of doses that comport with what common prescribing is.
    Mr. Carter. Right.
    Dr. Gottlieb. And we are in the process of developing that 
data. We now have very good data from our Sentinel database 
that we will be making public at some point in the near future.
    Mr. Carter. OK. All right. Thank you very much, Doctor. I 
am sorry. I have just got so much time.
    Dr. Jones, always good to see you. Thank you for being 
here. Let me ask you something. I know that health professional 
education is going to be extremely important, particularly as 
it relates to doctors and to pharmacists. I remind you that 
pharmacists are not law enforcement officers. It is unfair to 
ask us to profile and say that this patient does not need this 
pain medication.
    I have often said that the only thing worse, as a 
pharmacist, for me, than to fill a prescription that is going 
to be diverted or used in an unwarranted way is to not fill a 
prescription for a patient who truly does need it. So I just 
give you that warning.
    But I want to thank you and compliment you on your points 
that you have made today about comprehensive complete 
rehabilitation. I have often said that we have got two problems 
here, two distinct problems. One is tangible. One is, how do we 
get this under control? How do we limit the number of 
prescriptions? How do we educate patients and healthcare 
professionals about the danger of these drugs?
    But the other is, what do we do with those people who are 
addicted? And that is a big, big challenge. Addiction is a 
lifelong challenge. And I appreciate the emphasis that you are 
putting on complete rehabilitation and comprehensive 
rehabilitation. That is so very important, and I want to thank 
you for that.
    Dr. Schuchat, I wanted to ask you, how many States right 
now require doctors to look at PDMP before they write a 
prescription for an opioid? I know that Georgia is starting 
that July 1st.
    Dr. Schuchat. Yes. I may need to get back to you on that. I 
was going to say it might be 36, but let me double check.
    Mr. Carter. OK. That will be fine.
    All right. I have got one last question. As was mentioned 
numerous times during this hearing--we had a hearing yesterday 
in Oversight and Investigations with the DEA. And, Dr. 
Gottlieb, you will be glad to know that they have made the top 
of my list and replaced you now. So I am on them, OK.
    But I just want to ask you: I realize you are not under 
oath, and I realize it is a very uncomfortable situation to 
talk about other agencies, but how do you interact with them? 
Because I just don't think they are doing their job.
    When you have pharmacists who are not filling prescriptions 
for doctors, who have a legitimate license and they haven't 
been for years, yet the DEA does nothing about them, can you 
imagine how frustrating that is to us?
    I can tell you that there are doctors in my community now 
that the pharmacists won't fill their prescriptions because 
they are out of control, yet they still have a valid DEA 
license. They have a valid license. That is unconscionable that 
that happens.
    And I put that blame, yes, on the composite medical boards, 
but also I put it on the DEA, because I am convinced that they 
can do something about that. So I just wanted to ask you very 
quickly, how is your interaction with that agency?
    Dr. Gottlieb. Who is it for? Is it for me?
    Mr. Carter. Anybody. All three of you. And if you could be 
quick, because I have got one last thing. All of you.
    Dr. Schuchat. Yes. We actually did an exchange with DEA and 
are trying to strengthen the interactions, but I think you just 
speak to the system needs improvement.
    Mr. Carter. Oh, it does, so bad.
    Dr. Gottlieb. I will just comment, Congressman, it is 
actually very good right now. Historically, there have been 
challenges if you go back 15 years, but right now we have a 
good working relationship with them at a staff level and at a 
leadership level.
    And I have met with Mr. Patterson a number of times and 
talked to him about things we could be doing together to 
further expand our footprint together.
    Mr. Carter. OK. Dr. Jones.
    Mr. Guthrie [presiding]. We have got to run over time on 
this. We need to move on because we have got another panel we 
are going to bring forward. I appreciate the gentleman's 
questions. And I now yield 5 minutes to the gentleman from 
Oklahoma, Mr. Mullin, for questions.
    Mr. Mullin. Thank you, Mr. Chairman.
    And, buddy, if you want to, if I get time, I may ask your 
questions.
    Mr. Carter. Thank you very much.
    Mr. Mullin. You are very passionate about this, and I like 
that.
    Mr. Carter. I am.
    Mr. Mullin. But he is a guy that does 500 pushups and 500 
situps every day. At his age, that is impressive. I had to get 
there. Sorry.
    Dr. Jones, I am going to be speaking to you most of the 
time. I thank you for being here. I would like to thank the 
whole panel for being here. My colleague Representative 
Blumenauer and myself sent a letter to SAMHSA asking the 
Assistant Secretary's thoughts on legislation, H.R. 3545, the 
Overdose Prevention and Patient Safety Act.
    Yesterday, I received this response from the Assistant 
Secretary stating that SAMHSA is encouraged to see that 
Congress examines the benefits of aligning part 2 with HIPAA. I 
take this to mean that they are supportive of the committee's 
efforts to align part 2 with HIPAA. Am I correct in saying 
that?
    Dr. Jones. Right. We do favor achieving greater alignment 
between part 2 and HIPAA.
    Mr. Mullin. I know the chairman had already mentioned this 
to Chairman Walden, but I want to--and this letter that I want 
to submit for the record, when--I found one part of it 
extremely interesting, and I will quote from the letter.
    It says: The practice of requiring substance-use disorder 
information to be more private than information regarding other 
chronic illnesses, such as cancer or heart disease, in itself 
can be stigmatizing.
    I know you already answered that, but would you like to 
elaborate a little bit more on what you meant by that?
    Dr. Jones. Well, I think it is just the issue of 
marginalization. So, these protections were put in place to try 
to reduce stigma, to make sure that people would be able to go 
forward and receive treatment without concerns that they might 
lose their job or people wouldn't provide care for them.
    Mr. Mullin. Right.
    Dr. Jones. I think we are in a different time in that there 
is a movement among the recovery community to be more open 
about being in recovery. As I shared today, I am in recovery.
    And so the idea that we are somehow different or what it 
might do in meaning that your healthcare providers might not 
have all the information that would be relevant to providing 
you with high-quality care just further stigmatizes the idea 
that we are different in some way. And I think that was really 
the point that she was trying to raise in the letter.
    Mr. Mullin. I literally couldn't agree more with that. We 
have placed a stigma, and unlike with other diseases, be it 
through addiction or mental illness, it does seem to carry some 
type of stigma with it, but it can be overcome. And the more we 
talk about it and the more we try to allow everybody to see 
what is happening with the patient, the better that patient can 
be treated, because that is what it is all about.
    I am going to do my good friend and colleague, Buddy 
Carter, a favor and yield him the remainder of my time to you.
    Mr. Carter. Thank you.
    Dr. Gottlieb, I know that you talked about international 
mail and what is coming through there. Can you speak about 
domestic mail, particularly about mail-order pharmacies who are 
sending 90-day supplies of many medications with the intention 
of--they encourage patients to get a 90-day supply for a lower 
copayment and they don't have to get it as often. Is that not a 
concern as well that they are getting so much of these 
medications through the domestic mail as well?
    Dr. Gottlieb. Congressman, that question relates to just 
the overall prescribing, I think, rather than the issue of the 
illicit flow. I think you are talking about legal prescribing. 
I am not sure that would be shipped through the domestic mail.
    I think it would have to be picked up at the pharmacy under 
the CSA, right? Yes. So, if it is prescription opioids that are 
shipped domestically from a pharmacy to a patient, I think it 
wouldn't be shipped through a domestic mail facility. They can 
receive them? OK. They can receive them in the mail. The 
prescription would be controlling the size in that 
circumstance.
    Mr. Carter. Right. Right. OK. Well, I just want you to be 
aware that that is a problem too. You would be shocked at the 
number of opioids that are going through our mail right now 
that are coming from mail-order pharmacies, coming through the 
VA, and many others like that. And that is something we need to 
look at as well.
    And I do appreciate the gentleman yielding his time.
    The one last thing I want to say to all of you--and this 
may be somewhat anticlimactic, but it is very important--
Representative Shimkus mentioned this earlier. Please be very 
careful not to swing this pendulum too far.
    I was a hospice consultant for many years. There are people 
out there who have long-term pain. Hospice patients need these 
medications. Let's, please, don't go so far that we hinder and 
block access for those patients who truly do need it.
    Thank you, Mr. Chairman. I yield back.
    Mr. Guthrie. Thank you. I thank the gentleman from Oklahoma 
for yielding back his time.
    And I recognize the gentleman from North Carolina, Mr. 
Hudson, 5 minutes for questions.
    Mr. Hudson. Thank you, Mr. Chairman.
    Thank you to the panel for your time today.
    This is such an important issue. As has been said by many 
of my colleagues, it affects all of our districts. It affects 
people all across every demographic around this country, and so 
I appreciate your great work and the time you have devoted 
today to this hearing.
    Dr. Gottlieb, in your testimony, you note, the FDA, through 
its Sentinel database, is using data to assess prescribing and 
usage patterns by medical indication and provider specialty. 
You note this analysis is still ongoing. But can you talk more 
about the Sentinel database and any preliminary findings FDA 
has on potential overprescribing?
    Dr. Gottlieb. What we have been able to do is use our 
Sentinel database to look at prescribing by indication and look 
at how many pills are being prescribed based on an indication. 
We have looked across about 15 different common indications and 
then look at how many pills are left over after the patient 
completes the prescription.
    And so we have been able to derive where we see excess 
prescribing. We actually found a couple of indications where we 
see patients seeking another prescription. But in the majority, 
in the vast majority of the indications, there is excess 
supply, and sometimes there is significant excess supply, which 
leads to the problems that we have been discussing here today.
    We are going to find a venue to make this information 
public at some point in the future. It is proprietary 
information, but we will be finding a way to publish this. This 
is a very important tool for us, because this clearly informs 
the policy decisions that we are making.
    Mr. Hudson. I appreciate that.
    You also mentioned FDA's reviewed published literature on 
pills dispensed, used, and leftover by patients who were 
prescribed opioids. Can you give me any specifics on the number 
of pills leftover, or if not, have you been able to determine 
how often pills are leftover?
    Dr. Gottlieb. If I remember the data correctly, and I would 
be happy to follow up with your office to get you a more 
precise answer, we looked across about 15 indications, and in 
all but two, there was leftover. And in most, there was a 
significant percentage of the pills that were prescribed were 
leftover. So it is a common phenomenon.
    Mr. Hudson. Appreciate that, if you would help us get that 
information.
    But do you believe then that if consumers had easier access 
to convenient disposal methods that would help mitigate this 
oversupply of opioids?
    Dr. Gottlieb. We do. We think that could help.
    Mr. Hudson. Great. Well, we look forward to working with 
you on that.
    And if my colleague, Buddy Carter, would like some of my 
time, I would be happy to yield.
    Mr. Carter. Thank you. I thank the gentleman for yielding.
    Just very quickly, Dr. Gottlieb, I wanted to also follow up 
on what I believe one of the other Members on the other side of 
the aisle had mentioned about when the drugs come through the 
international mail system in there.
    That seems to me like that is a perfect opportunity for a 
sting operation. Follow it to the end, and do you ever do that? 
I mean, find out where it is going. Yes, we need to attack the 
supplier, but we need to attack the users as well. Are we doing 
that?
    Dr. Gottlieb. Yes, we are.
    Mr. Carter. OK. Well, thank you. I appreciate that, because 
that is so vitally important.
    Dr. Jones, I wanted to ask you also, and I believe Dr. 
Gottlieb mentioned it about the use of the opioids, the 
immediate release, which are cheaper and used more frequently. 
How do you educate physicians on the proper use of these 
medications, and is there anything available for them to 
understand exactly what should be used and when it should be 
used?
    Dr. Jones. So we do have educational programs, as I 
mentioned earlier, the providers' clinical export system, which 
focuses on medication-assisted treatment but also on opioid 
analgesic prescribing for pain. So, really, it is essentially a 
roster of experts who can provide training on the appropriate 
use of medications, whether they be for treatment or pain.
    We also, in our opioid STR grant program, allow States to 
use funding around education on CDC's guidelines specifically. 
So we are trying to work across agencies to make sure that we 
are not putting out conflicting messages but that the CDC 
guideline, the 12 recommendations are really the blueprint for 
moving that forward and States can use those STR dollars to 
educate clinicians.
    We are, again, trying to do this holistically. We are 
trying to look at the pain side but also on the addiction side, 
so that providers, if they are facing that issue, whether it be 
on pain or addiction or co-occurring pain with someone who has 
addiction, they are equipped to have that interaction with the 
patient.
    Mr. Carter. Right. Thank you very much.
    One last thing, Dr. Schuchat, I just wanted to ask you, do 
you monitor prescribing rates in different regions or different 
areas?
    Dr. Schuchat. Yes. We have been using some proprietary 
databases in order to do that, and we issued a report last 
summer on county-specific levels of prescribing.
    Mr. Carter. Right. When you see that, do you give that to 
the DEA or to any other agency and say, ``Look, there is a 
spike here, will you please check it out?''
    Dr. Schuchat. We actually gave it to the public as well as 
to the health departments and other partners. So it is in the 
media. So it was very well publicized. But it was somewhat 
delayed, so we were talking, it was 2015 data that we reported 
last year.
    Mr. Carter. Right. Thank you very much. And I yield back.
    Mr. Guthrie. The gentleman's time is expired.
    Mr. Walberg, from Michigan, is recognized for 5 minutes.
    Mr. Walberg. Thank you, Mr. Chairman.
    And my colleague from Georgia, are you out of questions?
    Mr. Carter. That is all I have got.
    Mr. Walberg. I want you to know, I would be willing so that 
I get some support in the future myself too. I appreciate 
that--without having to do 500 pushups.
    In my townhalls in my district, I am constantly hearing 
from families who have been impacted by this issue 
aggressively, and it touched their lives. So I appreciate, Mr. 
Chairman, not only the opportunity--since I don't sit on this 
august subcommittee but have deep interest in it--to be able to 
sit here today and thank you for putting this hearing together.
    Earlier this Congress, I introduced Jessie's Law, with 
Congresswoman Debbie Dingell. It is named in memory of a 
Michigan resident, Jessie Grubb, who tragically died of an 
opioid overdose in 2016.
    Jessie's parents informed the hospital that she was a 
recovering addict. And despite informing the hospital of her 
history with this addiction, the information never made it to 
her discharging physician, and that made all the difference in 
the world. Jessie was unknowingly discharged from the hospital 
with a prescription of oxycodone, which ultimately led to her 
death the following day.
    It is a heartbreaking and entirely preventable story, I 
think. And it is why we need to pass Jessie's Law, so medical 
professionals are equipped to safely treat their patients, 
prevent overdose tragedies, and ultimately save lives.
    Dr. Jones--and I would open it up to the other two 
panelists as well, if you would care to comment, Jessie's Law 
aims to help healthcare providers more easily identify patients 
who have substance abuse disorder.
    The bill is focused on patients who have already 
consented--and that is the key. They have consented to share 
this information with healthcare providers. This is critical to 
ensure that mistakes such as what tragically happened to Jessie 
never happen again and we avoid medical errors that lead to any 
unnecessary deaths.
    Now, this, to me, as uninitiated interested party in this 
whole situation, seems to be pretty straightforward. And I am 
surprised that it isn't currently happening.
    Could you describe what this information currently looks 
like in the patient's medical records and what the barriers 
might be for healthcare providers to see the information 
quickly, efficiently, and deal with it?
    Dr. Jones. I think, certainly, as I have mentioned 
throughout the conversation today around part 2, equipping 
healthcare providers with information to understand what is 
going on with their patients is really important. And often 
people in recovery have to be their own advocates to self-
disclose that they have an addiction.
    And the population of that information in electronic health 
records is pretty varied in how that information may be there. 
And in some cases, it may still be in paper charts depending on 
the practice setting, and so it may be very difficult for a 
clinician to have that information.
    I think what you are advocating for in the bill complements 
the work that we are trying to pursue within the department and 
provides an additional tool for clinicians to have really 
important information. I think we have to think about how do we 
do this in complement with equipping providers with the 
knowledge of what to do when they have that information.
    So we want them to have it. We want them to be accessible. 
But we also want them to be able to make informed decisions 
based on having that knowledge. And I think that goes hand in 
hand with our training efforts around understanding what is 
addiction, understanding what is the role of pain management in 
people who have opioid addiction in particular so that you are 
not--even if you are trying to do the right thing, you are not 
having an unintended consequence of someone dying from an 
overdose because you didn't understand as a clinician what risk 
that was putting the patient at.
    Mr. Walberg. But a discharging physician, wouldn't they, if 
they had the records in front of them, and I guess that is my 
concern, if they had in front of them, knowing that this person 
had voluntarily notified that they were a recovering addict, 
wouldn't they automatically not give the opioid under 
discharge?
    Dr. Jones. I would not assume that. I will speak from my 
own personal experience. I had a colonoscopy, which I am sure 
everyone likes to talk about.
    Mr. Walberg. I am trying to forget it.
    Dr. Jones. But I had a colonoscopy. I disclosed to the 
gastrointestinal surgeon who was performing it and an 
anesthesiologist who was there, and I said: You know, I am in 
recovery; I want to do this without medication.
    And the anesthesiologist said: Well, it is propofol; it is 
not addictive.
    And I am an educated person. I am a pharmacist. I 
understand that that was not a good choice for me.
    But I had to, in that moment, be my advocate and be very 
stern to say, ``No, this is, I made my decision, this is how I 
want to proceed,'' while getting pressure from the 
anesthesiologist that, ``Well, you need this.''
    Partly I think she was probably interested in getting paid. 
If she didn't deliver the medication, she wouldn't get paid. 
But I would not assume that just because the information is 
there, while critically important, we have to make sure that we 
are packaging that with education on then what do you do.
    So we put out guidance from SAMHSA on how do you manage 
pain in patients who have co-occurring substance-use disorders 
and pain conditions to really try to help move that forward for 
clinicians. I think the CDC guidelines as well have specific 
callouts around people who have addiction and how do you manage 
pain in those individuals.
    Mr. Walberg. Any additional comments?
    Mr. Guthrie. Thank you. The time is expired.
    Mr. Walberg. I appreciate that. Thank you.
    Mr. Guthrie. Thank you for yielding back.
    I now recognize the gentleman from California, Mr. 
McNerney, 5 minutes for questions.
    Mr. McNerney. I thank the majority for allowing me to wave 
on.
    I thank the panel. It has been very informative, and I 
don't know a whole lot about this subject.
    But, Dr. Gottlieb, I am working on a bill that would give 
the FDA the authority to ask opioid manufacturers to examine 
long-term efficacy of an opioid drug, and these studies would 
take place after the manufacturer receives approval for the 
drug from the FDA. Does the agency currently have this 
authority?
    Dr. Gottlieb. We have authority to request post-market 
studies that aren't mandated as a condition of approval on a 
basis of safety considerations, not purely on an efficacy 
consideration, Congressman.
    Mr. McNerney. Do you think it would be helpful for the 
agency to have this authority?
    Dr. Gottlieb. Well, one of the questions that continues to 
come up around opioids is the issues associated with their 
long-term use. A lot of these have not been studied for chronic 
administration, yet they are chronically administered.
    And so there are certain important questions that we could 
answer by properly studying the chronic administration, looking 
at the efficacy over time, whether efficacy declines, and what 
the complications of that is.
    Mr. McNerney. Well, how would the agency use the 
information then it receives from those studies?
    Dr. Gottlieb. Well, if we had such studies, if they were 
collected in the same way we do under the authorities we have 
to look at to request post-market safety studies, we would seek 
to make the results public.
    We would seek the ability to incorporate it into labeling 
as well so it can inform the provider and inform the healthcare 
system. That is typically how we handle post-market safety 
studies under the authorities we have right now to request 
post-market studies.
    Mr. McNerney. Very good. And you think that will be useful 
too late in fighting the opioid epidemic?
    Dr. Gottlieb. We certainly think that having more 
information around the long-term efficacy of these drugs could 
be very useful to prescribers, could be very useful to our own 
regulatory decisionmaking, yes.
    Mr. McNerney. Thank you.
    In your opinion, do you think that building a southern 
border wall and using the death penalty would be useful in 
fighting the opioid epidemic?
    Dr. Gottlieb. Congressman, I certainly think that there are 
things we need to do from the standpoint of deterrence and 
interdiction. I have talked about what I want to do here today, 
which is to step up our work in the international mail 
facilities.
    I stick to my knitting, and I stay within the scope of 
where I can affect this crisis. And for us, interdiction is a 
key component of trying to address the overall crisis.
    Our footprint is in the international mail facilities in 
that regard and on the dark web, actually. I haven't talked 
about that today, but we do a lot of investigative work on the 
dark web to target rings that are bringing in, for example, 
illicit fentanyl.
    Mr. McNerney. Dr. Schuchat, do you have an opinion on that?
    Dr. Schuchat. All I will say is that having good data about 
the factors that are driving the epidemic is important, and the 
most recent wave of overdose deaths has been associated with 
the illicit products that are coming in from other countries.
    Mr. McNerney. Well, Dr. Schuchat, and you mentioned data 
several times in your testimony. Can we refer to this as Big 
Data, and are you considering using tools such as artificial 
intelligence and data mining?
    Dr. Schuchat. The data that we need is complex. We need it 
locally for rapid response. We need it at the State level to 
target resources. We need it nationally to understand the 
trends and to actually understand what strategies are improving 
things and what strategies are making them worse.
    In terms of the automated learning kinds of issues, that 
can be really important for things like medical examiners and 
coroners and coding of the death certificates. We are using 
some systems now to take the natural text and try to extract 
information in more timely ways so that we can even just figure 
out for the emergency department visits or the overdose deaths 
which ones are drug associated and, of the drugs, which drugs 
were around.
    Mr. McNerney. Well, the war on drugs that started in the 
last century has been not only a tragic failure but very costly 
and actually counterproductive. There have been lessons 
learned, but I am afraid there are lessons that haven't been 
learned or are being ignored.
    Can you assure me that we will benefit from the lessons 
learned from that undertaking?
    Dr. Schuchat. My highest priority is rapid quality data so 
that we don't make mistakes. And if we have unintended 
consequences like we have experienced with the overprescribing 
of opioids, we find them rapidly and take action quickly. So I 
think we need to have good data that provides evidence-based 
interventions.
    Mr. McNerney. So what about putting more people in jail or 
taking those sorts of hardline actions?
    Dr. Schuchat. Well, I guess, I can make a comment that I 
think I have seen very innovative work in the drug courts in 
terms of alternative approaches to getting people into care 
rather than sentencing. So there is a lot of innovative work 
going on at local levels around the country.
    Mr. McNerney. Thank you.
    I yield back.
    Mr. Guthrie. Thank you. The gentleman yields back.
    The gentlelady from Michigan, Mrs. Dingell, is recognized 
for 5 minutes for questions.
    Mrs. Dingell. Thank you, Mr. Chair, and thank you for 
letting all of us wave on.
    And I actually had some of the same questions my colleague 
from Michigan had, so I won't go there. But I think, in 
Michigan, we are working in a very bipartisan way on a very 
serious issue.
    And as you know, for me--most of you do. I know two of you 
do--this is a very personal issue. Having a father who was 
addicted to opioids when I was growing up, long before anybody 
understood the power of these drugs or what it did to people, 
but living with a man who is in chronic pain and every doctor 
says he needs to have serious pain medicine, I see both sides 
of this.
    And I am very active on this issue, as you know. And more 
and more people are coming to me, the oncologists, and saying: 
We can't deny people.
    I had someone scream at me last week about how we were 
denying people who needed pain to get by, and they weren't 
getting it. So what I really do know is that we need to be 
doing the research.
    Dr. Gottlieb, do you agree that developing more nonopioid 
pain medications is an important part of solving the opioid 
epidemic?
    Dr. Gottlieb. It could certainly help, Congresswoman. We 
are working with sponsors on that.
    Mrs. Dingell. And thank you.
    And I think that promoting more research into nonopioid 
pain medications is one of the most important things we can do 
to ensure that people that are legitimately suffering from pain 
still get the relief that they need. We have got to make sure 
pendulums don't swing that far.
    That is why I have introduced H.R. 5002, the ACE Research 
Act, with my friend and colleague from Michigan, Fred Upton. 
This legislation provides NIH with new, flexible authorities to 
conduct innovative research on ways to respond to public health 
threats, like the opioid epidemic.
    I know that NIH isn't here today to discuss this, but it 
really is essential that we give them the tools they need to 
support much-needed research into these nonopioid pain 
medications.
    Dr. Gottlieb, can you talk about how FDA works together 
with NIH on this type of research and how giving NIH more 
flexible authorities, like those envisioned in the ACE Research 
Act, will help us find new drugs faster?
    Dr. Gottlieb. Well, thank you for the question. I think 
that there is a critical need for more translational research. 
We do see new classes of drugs, new potential classes of drugs 
with new mechanisms that might not have all the addictive 
qualities of opioids but offer some of the same pain relief.
    And so it is important--these are in early development. We 
don't fully understand the issues associated with these 
mechanisms and potential safety issues. And so having the 
translational research in place and the scientific foundation 
to better develop these products is going to be critically 
important.
    We are working closely with NIH on these efforts, and so we 
have been partnering with them on the things that they are 
doing to try to foster and facilitate early research into some 
of these new mechanisms. So they are a very important partner 
to us.
    Mrs. Dingell. I think it is really critical.
    I am just going to make an editorial comment off the books 
too, that one of the things that I know is really happening is 
that people with legitimate pain are being stigmatized.
    And they go to get their prescriptions filled; they are 
feeling like they are dirty somehow. We have to have that 
compassion, but we also have to educate kids at the early age: 
This is complicated. We are dealing with something really 
complicated. So I thank all three of you for the work that you 
are doing. We just have to accelerate it.
    One thing I am also concerned about is that we are doing 
everything we can to treat children who are born with an opioid 
dependence and how we can stop that situation from happening in 
the first place. Two thousand women a month report using heroin 
or misusing painkillers while pregnant, which is a staggering 
number.
    This question is for Mr. Jones of SAMHSA. I blew that 
pronunciation. Sorry. Your testimony notes that you recently 
released a new clinical guidance document regarding how to best 
treat mothers and their infants who are born addicted to 
opioids.
    How do you recommend to best treat a newborn with an opioid 
addiction, and how are you disseminating that clinical guidance 
to providers?
    Dr. Jones. So, again, I think there are different 
situations in what is the best treatment. I think we are still 
also learning what is the best treatment. I think, several 
years ago, there was a focus on using morphine or methadone or 
even buprenorphine to withdrawal, that the neonate would be 
placed in the NICU, so high acute care, high, expensive, longer 
stays.
    And now we are learning that rooming in with the mother in 
a regular floor in a quiet environment tends to improve 
outcomes and shorten the duration of treatment. And so, along 
with NIH and others across HHS, we are working on an action 
plan around the Protecting Our Infants Act, sort of an 
implementation plan which gets to some of these issues.
    In the clinical guidance, what we really focused on there 
is that, again, there are a variety of situations that 
clinicians may come across. So it is not that there is a one-
size-fits-all, but we present different vignettes that allow 
them to navigate different situations that they may come 
across.
    Mrs. Dingell. Thank you. I will yield back.
    Mr. Guthrie. I thank the gentlelady for yielding back.
    Seeing no others here for questions, I will dismiss the 
first panel. We appreciate you for being here and taking the 
time to testify before the subcommittee. And we will bring, of 
course, our second panel as we transition. So thank you very 
much for being here.
    Thank you. The subcommittee will come back to order.
    I appreciate the opportunity for all of you to be here and 
so each of you will be given the opportunity to do an opening 
statement, and it will be followed by questions from members. 
And I will introduce each witness, and I will call in for your 
opening statement.
    I will make sure I say this correct, Thau or Thau?
    Ms. Thau. It is Thau.
    Mr. Guthrie. Thau, OK. I am glad I asked. So Ms. Thau, she 
is a Public Policy Consultant, Community Anti-Drug Coalitions; 
Ms. Cartier Esham, Executive Vice President, Emerging 
Companies, Biotechnology Innovation Organization; Mr. Jeffrey 
Francer, Senior Vice President and General Counsel, Association 
for Accessible Medicines; and Dr. John Holaday, Chairman and 
Cofounder DisposeRx. We appreciate you being here today.
    And, Ms. Thau, you are now recognized for 5 minutes to give 
an opening statement.
    Ms. Thau. Thank you so much to these----
    Mr. Guthrie. Your microphone, please. You have to activate 
your microphone, please. There you go.

  STATEMENT OF SUE THAU, PUBLIC POLICY CONSULTANT, COMMUNITY 
                ANTI-DRUG COALITIONS OF AMERICA

    Ms. Thau. Thank you so much. My name is Sue Thau. I am the 
Public Policy Consultant for Community Anti-Drug Coalitions of 
America, CADCA. CADCA is the national nonprofit organization 
whose mission is to build and strengthen community coalitions 
to create safe, healthy, and drug-free communities.
    It is on behalf of the more than 5,000 CADCA coalition 
members that I want to thank you all for the opportunity to 
testify today on behalf of H.R. 449, the Synthetic Drug 
Awareness Act. This important legislation would require the 
Surgeon General to report to Congress on the public health 
effects caused by synthetic drug use among 12- to 18-year-olds.
    We applaud H.R. 449's focus on youth who disproportionately 
suffer the negative consequences of drug use because of its 
deleterious effects on the developing brain.
    Preventing or delaying substance use is the single most 
critical tool in stopping the pathway to addiction and 
overdose. Primary prevention to stop substance use before it 
starts is the most cost-effective way to deal with the 
addiction issues facing our Nation.
    Research shows that, for every dollar invested in 
prevention, between $2 and $20 in treatment and other 
healthcare costs can be saved. Substance-use prevention has 
historically been underresourced and underutilized in combating 
drug issues, including the current opioid epidemic, with most 
of the emphasis on funding being directed towards downstream 
approaches that deal with the problem after it has already 
reached crisis proportions.
    This Surgeon General's report will be invaluable in 
garnering more attention and resources to address the synthetic 
drug issue. The best example of Surgeon General's reports that 
have changed the course of a public health crisis were on 
smoking and health.
    These have provided universally accepted scientific 
findings that increased awareness, changed social norms, and 
built broad support for tobacco prevention, cessation, and 
control programs that ultimately resulted in major population 
level reductions in smoking among Americans, most notably 
youth.
    Given that more potent and deadly synthetics are being 
designed almost daily to skirt the Controlled Substances Act 
and that these drugs are increasingly accessible and available 
in communities across the entire Nation, this report could not 
be more timely.
    To achieve population level reductions in substance use, a 
data-driven community coalition infrastructure is needed to 
plan, implement, and evaluate comprehensive strategies 
throughout multiple community sectors.
    Raising awareness through this report would be incredibly 
useful at the community level, as it would provide critical 
science-based information needed to help prevent drug use, 
intervene with those who have started using, and treat those 
who become dependent on synthetic drugs.
    Communities would use the report to not only raise 
awareness but to plan and implement a mutually reinforcing 
combination of evidence-based strategies that are laid out in 
more detail in my written statement.
    These include providing information, enhancing skills, 
enhancing access and reducing barriers to programs and 
services, changing consequences and incentives, changing the 
physical design of the environment, and modifying and changing 
policies and laws.
    This type of synergistic action is what resulted in the 
massive reductions in tobacco use we have witnessed over the 
past 55 years. This multiple-strategies-across-multiple-sectors 
approach is currently how the Drug-Free Communities Program 
housed in the Office of National Drug Control Policy has 
achieved major population level reductions in reducing 30-day 
use of alcohol, tobacco, marijuana, and prescription drugs in 
12- to 17-year-olds.
    Drug-free community coalition grantees working to combat 
youth synthetic drug use will find this report extremely useful 
and use it to raise awareness with scale and scope among 
community sectors such as parents, youth, schools, and 
healthcare providers.
    This report would also further the ability of community 
coalitions to design a robust set of locally appropriate and 
evidence-based interventions capable of resulting in 
population-level reductions in youth use of synthetic drugs.
    CADCA and its members are proud to support H.R. 449. Thank 
you for the opportunity to testify today, and I am happy to 
answer any questions you may have.
    [The statement of Ms. Thau follows:]
    
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]    
        
    Mr. Guthrie. Thank you. I appreciate your testimony.
    I will now recognize Ms. Cartier Esham, who doesn't look 
like she could be the childhood friend of our own Thomas 
Massie, and a proud Kentuckian. So you are now recognized 5 
minutes.

STATEMENT OF CARTIER ESHAM, EXECUTIVE VICE PRESIDENT, EMERGING 
        COMPANIES, BIOTECHNOLOGY INNOVATION ORGANIZATION

    Ms. Esham. Thank you, Chairman, and thank you, members of 
the committee. Thank you, and thank you for the opportunity to 
speak with you today about policy solutions put forward by this 
committee to address America's opioid crisis.
    As mentioned, my name is Cartier Esham, and I work for the 
Biotechnology Innovation Organization. BIO is the world's 
largest trade association representing the entire ecosystem of 
biotechnology companies from the entrepreneurial to the 
multinational companies.
    Our members are dedicated to the development of the next 
generation of biomedical breakthroughs for the millions of 
patients suffering from diseases for which there are no 
effective cures or treatments.
    It is this mission focused on innovation that guided the 
development of BIO's objectives and policy proposals designed 
to change the paradigm of how we treat pain and addiction in 
this country and eliminate prescription opioid drug abuse in 
the future.
    They include advancing our scientific understanding of pain 
and addiction diseases; ensuring that patients have knowledge 
of and access to the right treatment at the right time with the 
right support and without stigma; and stimulating R&D for 
innovative treatments that improve care and prevent abuse.
    The current state of innovation for the next generation of 
pain and addiction therapies holds promise. There are currently 
125 clinical development programs looking at novel chemical 
entities in the pipeline today, 87 percent of which are for 
nonopioid treatments.
    However, less than 4 percent of total venture investment in 
the biopharmaceutical sector is being directed into companies 
whose lead product is a novel pain therapy. This is even 
significantly less for companies working on novel treatments to 
treat addiction.
    By comparison, this is 17 times less than funding we see 
for the development of oncology drugs. We need to develop and 
support a more conducive policy environment focused on changing 
the paradigm of how we treat patients suffering from pain and 
addiction to realize the full potential innovation could have 
in creating an America free of prescription opioid addiction.
    I would like to highlight three bills today under 
consideration that, if enacted, would help make these goals a 
reality. The bill focusing on FDA opioid sparing that would 
enable FDA and stakeholder collaborations to discuss and 
develop guidance on ethical and efficient data collection for 
opioid sparing and availability of that information to patients 
as part of the label of a product would be extraordinarily 
helpful.
    Enactment of this legislation would provide FDA, 
biopharmaceutical companies, and investors with an improved 
understanding about how data sources can be utilized to support 
demonstrations that a novel therapy reduces opioid use.
    BIO believes the same approach focused on other critical 
areas, such as improved approaches for evaluating pain, 
utilization of innovative clinical trial designs would also 
further improve drug development and review processes for 
better and safer pain and addiction treatments.
    We also support the legislation under consideration that 
would enable better utilization of accelerated approval and 
breakthrough therapy pathways. Enactment of this legislation 
would, again, provide FDA, as well as the biopharmaceutical 
industry, investors, and other stakeholders with a greater 
understanding of what is required to meet the criteria to be 
able to participate in these pathways and ensure that processes 
intended to expedite approval meet the unique needs of pain and 
addiction.
    These actions would serve as critical signals to not just 
biopharmaceutical companies but their investors that the 
development of pain and addiction therapies that are safer, 
improve quality of care, and reduce the use of opioids is a top 
priority.
    Lastly, we also wanted to highlight the Advancing Cutting-
Edge Research Act. This is legislation that would provide NIH 
with a much needed transactional authority to better enable 
them to more efficiently distribute funds to conduct or support 
research required to respond to public health threats such as 
the current opioid crisis.
    In our written statement, we also call for the development 
of a transparent and focused research strategy to ensure that 
we continue to advance our understanding of the biology of pain 
and addiction and develop tools that would improve the 
diagnosis and treatment of these diseases.
    BIO strongly believes that innovation is a key component of 
efforts to address the opioid crisis. We look forward to 
working with the committee to put forward policies that will 
change the paradigm of how we treat pain and addiction, improve 
patient lives, and advance our ability to achieve our shared 
goal of eliminating prescription opioid drug abuse in the 
United States.
    Thank you.
    [The statement of Ms. Esham follows:]
    
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    Mr. Guthrie. I thank you for your testimony.
    I now recognize Mr. Francer for 5 minutes for an opening 
statement.

STATEMENT OF JEFFREY FRANCER, SENIOR VICE PRESIDENT AND GENERAL 
         COUNSEL, ASSOCIATION FOR ACCESSIBLE MEDICINES

    Mr. Francer. Thank you, Mr. Chairman, members of the 
committee. I am Jeff Francer, Senior Vice President and General 
Counsel of the Association for Accessible Medicines. AAM's core 
mission is to improve the lives of patients by advancing timely 
access to affordable FDA-approved generic and biosimilar 
medicines.
    Generic and biosimilar medicines serve as the backbone of 
prescription drug savings and now represent greater than 89 
percent of all prescriptions in the United States at only 26 
percent of total drug expenditures. We, therefore, save 
patients, payers, and taxpayers nearly $5 billion every week.
    AAM commends the subcommittee for its continued efforts to 
address the public health crisis of opioid prescription drug 
abuse and this excellent hearing. We are also encouraged by the 
continued focus of the administration, including FDA 
Commissioner Scott Gottlieb, on addressing this challenge.
    Ensuring patients' safety is of the utmost importance for 
generic drug and biosimilar manufacturers. Enhanced prescriber 
training, patient prescription adherence, safe storage, proper 
disposal, all can help prevent medication abuse and ensure that 
patients get the full benefit of safe, effective, more 
affordable generic medicines.
    It is critical that we combat the misuse of prescription 
drugs while also maintaining the legitimate, uninterrupted 
access to patients who need medical treatment. Generic drug 
manufacturers play a key role in producing affordable FDA-
approved therapies for the treatment of patients.
    Importantly, under the Hatch-Waxman amendments that govern 
the approval of generic medicines, our manufacturers create 
bioequivalent versions of brand name drugs using the same 
labeling, and if necessary, the same or equally protective 
safety programs.
    Typically, generic drug manufacturers do not promote drugs 
to physicians or directly to patients as the brand name 
manufacturers do. Moreover, once our companies sell generic 
drugs to the wholesaler, the company does not control the 
further sale of the medicine to retail pharmacies.
    Currently, three large purchasing consortia made up of 
wholesale distributors and retail pharmacies control the sale 
and destination of 90 percent of the generic medicines in the 
United States. AAM believes that a comprehensive approach to 
the opioid crisis should help ensure responsible drug 
promotional activities as well as prescribing.
    My written statement outlines our recommendations in full, 
but let me take a moment to summarize. AAM and its members 
support a range of collaborative strategies and public policies 
to reduce drug abuse while ensuring appropriate access to 
medicines for patients who need them.
    Specifically, we support expanding and improving 
prescription drug monitoring programs; enhancing initiatives to 
assist physicians and other prescribers; and the proper 
prescribing of prescription drugs, particularly opioids; 
mandatory ongoing training for providers on best practices in 
pain management; reducing the potential for divergent and 
fraudulent prescribing by requiring the use of electronic 
prescribing for controlled substances; consideration of a 7-day 
limit on prescriptions of opioids for acute pain; and proper 
disposal of unused or unwanted prescription drugs through 
national DEA take-back days.
    Lastly, I wanted to share with the subcommittee how AAM and 
its members are partnering with leading national organizations 
dedicated to promoting public health and preventing abuse.
    Last year, AAM approached EVERFI, a leading provider of 
electronic training for our Nation's colleges and universities. 
We asked the organization to develop a module to help students 
understand the importance of safe use, storage, and disposal of 
prescription drugs.
    With AAM's financial support, EVERFI has developed and made 
available a prescription drug abuse prevention curriculum free 
of charge to any college in America in order to help this at-
risk demographic make healthy decisions. More than 36,000 
students have already taken this course since its launch just 
last fall.
    In addition, AAM and EVERFI have brought together national 
business leaders and pharmaceutical supply chain partners to 
fund the rollout of a K through 12 prescription drug program to 
some of the hardest hit communities in our country.
    In conclusion, we look forward to continuing to work with 
the subcommittee to help address this national opioid crisis 
and help ensure the proper prescription and use of FDA-approved 
medicines. I would be happy to answer your questions.
    [The statement of Mr. Francer follows:]
    
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    Mr. Guthrie. Thank you for your testimony.
    And, Dr. Holaday, you are now recognized for 5 minutes for 
an opening statement.

   STATEMENT OF JOHN HOLADAY, PH.D., CHAIRMAN AND COFOUNDER 
                           DISPOSERX

    Mr. Holaday. Thank you, Mr. Chairman, and for the committee 
for giving me the opportunity to be before you today. My name 
is Dr. John Holaday. I am the Chairman and CEO of DisposeRx, 
the country's leading site-of-use medication disposal company. 
Our president, William Simpson, was unable to attend because of 
weather problems today.
    Our country is in crisis, not only from opioid addictions 
but from the dangers of prescription drug abuse. Drug overdose, 
as you know, is the leading cause of accidental death in the 
United States.
    And the failure to properly dispose of unused or expired 
prescription drugs from our home medicine cabinets, managed-
care facilities, hospitals, hospices, and others dramatically 
contributes to the rapid increase of prescription drug abuse, 
accidental poisonings, opioid overdoses, and the pollution of 
our Nation's public drinking water supplies.
    National policies have long encouraged improper drug 
disposal. None of the methods currently recommended for drug 
disposal are convenient, responsible, secure, and, most 
importantly, do not prevent diversion of controlled substances. 
None of these methods incorporate an education component which 
is directly related to the success of any such program. There 
is a better way.
    DisposeRx is invested in developing a solution that can 
help eliminate one of the root causes of prescription drug 
misuse and abuse, which is exposure to unused, unwanted 
medications in the home.
    DisposeRx is the gold standard for at-home drug disposal. 
We have developed a product that safely, conveniently, and 
securely allows customers to dispose of their unused 
medications in their own home when it is convenient to them. 
This ensures that there is no time lag between dispensing and 
disposal, eliminating the opportunities for diversion.
    Consumers are reaching out for a solution that is simple 
and safe to use. Data have shown that items returned to drug 
take-back locations often include such things as nasal sprays, 
Flintstone vitamins, ointments, and creams.
    A survey of the Journal of Drug Abuse revealed that 1.4 
percent of consumers returned their unused medications to the 
pharmacies or take-back kiosks. In fact, 54 percent threw their 
medications in the trash and more than a third or 35.4 percent 
disposed of their medications in the sink or the toilet.
    And what is more surprising is that fewer than 20 percent 
of patients reported having received any education as to 
correct disposal methods. The CDC states that the best way to 
curb opioid addictions is to stop their diversions from 
medicine cabinets.
    DisposeRx provides patients with an easy solution for drug 
disposal. Each packet contains a patented blend of nontoxic 
ingredients that will create a viscous gel when mixed with warm 
tap water. Simply take your pills, add some water, pour in the 
contents of the packet, shake it up, and within 30 seconds to a 
minute, the drugs are dissolved and permanently sequestered in 
a gel from which they can't be extracted for abuse and won't 
leech into landfills.
    The components of this sequester the gel so it can't be 
diverted and it can't be extracted. Our product is the most 
tested and trusted product in the market today. We have been 
subjected to rigorous third-party testing for extractability 
and environmental friendliness.
    Extractability testing has shown that, once sequestered, 
our patented cross-linking polymers, using commonly available 
household solvents, cannot be extracted or the contents cannot 
be extracted. So it is nontoxic, and the majority of the 
components are listed as generally regarded as safe by the FDA. 
It is not dangerous nor harmful to the environment.
    Incorporated into the mission of the DisposeRx team is the 
commitment to educating the community on the cycle of 
medication management. This begins in the pharmacy. We realize 
that successful drug disposal is dependent upon the inclusion 
of targeted instruction and patient education. Cleaning out the 
medicine cabinet will become second nature if the mechanism to 
do so makes it a realistic and obtainable goal for the 
consumers.
    One of the examples is the time that it took between 
legislation of seatbelt use and the decrease in deaths from 
automobile accidents. And the same thing occurs with tobacco 
and other matters that really require legislation in order to 
jump start the people to start adopting changes in behavior to 
save their lives.
    In closing, we are proud to be bringing patients and 
families a simple and effective solution for drug disposal. We 
are honored to be working with a team at Walmart, as they are 
the leading retail pharmacies that have been the first to 
supply a consumer site-of-use solution that is both fighting 
our Nation's opioid epidemic as well as the dangers of 
prescription drug overdose.
    Our mission is to solve the problem of drug disposal. We 
focus on driving patient education with simple and safe 
solutions. We fundamentally believe this education of the 
patients is important in the process, and we remove some of the 
barriers facing safe disposal and encourage the adoptions of 
nontoxic site-of-use home solutions.
    Thank you very much for your attention.
    [The statement of Mr. Holaday follows:]
    
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    Mr. Guthrie. Thank you. I appreciate your testimony.
    That concludes all witness testimony. We will now move to 
member questions. And I will now recognize myself for 5 minutes 
to begin the questioning period.
    Ms. Esham, thank you for being here today. And in your 
testimony, you mention the importance of ensuring patients 
suffering from pain or addiction were able to receive the right 
treatment at the right time with the right support without 
sigma. I could not agree more, which is why I introduced the 
Comprehensive Opioid Recovery Centers Act.
    Can you please expand on your statement and elaborate on 
what specific coverage and reimbursement barriers that prevent 
patient center decisions?
    Ms. Esham. Certainly. Thank you. And I would like to 
commend you for the legislation that you are putting forward. 
As a resident, a person that grew up in Kentucky, having a 
multifaceted, multidisciplinary approach to treating addiction 
and making it easier for people to get that help is critically 
important, so I want to thank you for that work.
    In direct response to your question, there are a multitude 
of proposals and recommendations that we have put forward, but 
it is our assessment and our recommendation that there are 
specific barriers and practices that need to be examined and 
removed and things that are basically precluding access to 
patients for alternative nonopioid treatments, safer 
treatments, et cetera.
    And that includes looking at or removing barriers that are 
based on root or administration, so bundling practices that 
make it difficult to get alternative--nonopioid alternative 
medicines, step therapy requirements, fail-first requirements. 
There is a multitude of steps that we think we could take. But, 
again, there are barriers that exist, and we need to examine 
them in a holistic way to make sure people are getting the 
right care.
    Mr. Guthrie. Thank you. I appreciate your answer.
    And, Dr. Holaday, can you please explain--I like the 
demonstration there--but can you please explain why the cross-
polymer technology is such an effective method of 
sequestration?
    Mr. Holaday. Certainly. Our product is made up of things 
which one often derives from corn, generally recognized as 
safe, so it is actually edible should you choose to do so. But 
the secret sauce enables these polymers to form rapidly over 
time after dissolving the drugs that are exposed to them in 
water.
    So, without telling you what the entire product is made of, 
about five or six different ingredients that, when mixed 
together, along with one particular key, rapidly forms the gel 
from which these drugs cannot be extracted for abuse, and they 
also won't pollute landfills.
    Mr. Guthrie. That is an effective method there. That is for 
sure.
    So, Mr. Francer, one of the bills being considered today 
would give FDA additional authority to require modifications to 
packaging of opioids or that opioids be dispensed in 
conjunction with the convenient disposal method. I think it 
makes a lot of sense, but do you have any concerns about these 
additional measures impeding access?
    Mr. Francer. So, first and foremost, we support a science-
based method of regulation. And I think Dr. Gottlieb indicated 
before that they want to develop data on how these different 
features could affect the protectiveness of patients.
    We would support such power for the FDA to protect the 
public health. We would want to make sure that there is equal 
application across both the brand and the generic. And we would 
want to make sure that opportunities for gamesmanship and the 
patents of packaging don't harm access to the generic drugs. 
But, overall, we would be happy to work with the committee to 
provide technical assistance to ensure access.
    Mr. Guthrie. Again, thank you for your answer, and that 
concludes my questions.
    I will recognize Mr. Green for 5 minutes for questions.
    Mr. Green. Thank you, Mr. Chairman.
    We heard from our first panel that--Dr. Gottlieb--the 
majority of patients who will become addicted to opioids are 
first exposed to a lawful prescription. I know that all of us 
here today are exploring creative solutions to addressing the 
opioid crisis, including addiction abuse and misuse.
    I know many of us were pleased to see the FDA take action 
last year when it requested the withdrawal of an opioid 
treatment due to the concern that the benefits associated with 
the product no longer outweigh the risk of abuse and 
manipulation.
    Mr. Francer, one of the bills noticed today is the 
legislation I am offering. It would allow FDA to take into 
consideration the potential risk for abuse and misuse in making 
approval decisions. This seems to be an important and unique 
decision that the agency should take into account when 
approving controlled substances.
    I understand that some stakeholders may be hesitant to make 
modifications to the FDA's current risk-based assessment. And 
as we continue to work on this legislation, how would the AAM 
recommend that we target this legislation to ensure that we are 
appropriately targeting the controlled substances that are 
fueling the opioid epidemic?
    Mr. Francer. I think it is entirely appropriate to consider 
the risks of misuse and abuse, and we would be happy to support 
the development of legislation in that regard.
    Mr. Green. I think you answered my second question from the 
chair saying that will you continue to work with us and our 
colleagues to perfect all the legislation that we are 
considering today.
    Mr. Francer. Absolutely.
    Mr. Green. Thank you.
    Mr. Simpson, effective and safe medication disposal is a 
critical piece of the puzzle in order to reduce access to 
addictive prescription drugs, including opioids. Mr. Simpson, 
as you notice in your testimony, easy access and leftover 
prescription opioids is a dangerous way people become addicted. 
Improper disposal from our homes, hospitals, managed care 
facilities, and hospice centers is critical in addressing 
misuse and diversion. Mr. Simpson, you noted that the drug 
take-back efforts and the kiosk may not be utilized as often 
because it requires individuals to identify and visit locations 
outside their homes, which may be inconvenient, time consuming, 
and difficult to certain individuals.
    Dr. Holaday, I apologize. That was for the previous panel.
    Well, that concludes the questions, Mr. Chairman.
    Mr. Holaday. I must say I am not as young or handsome as 
Mr. Simpson who was unable to be here today because of weather, 
but I would be delighted to answer your questions, sir.
    Mr. Guthrie. I just want to say that this committee has a 
bill on the floor in the House, so people are going and coming.
    Mr. Green. That's why we are running back and forth.
    Mr. Guthrie. So it is an honest mistake.
    Mr. Holaday. No problem. I will answer Mr. Simpson's 
question, though.
    Mr. Green. OK. Well, then I will finish it. I thought we 
were just messed up.
    Mr. Holaday. Surprisingly, as you pointed out, people are 
not inclined to get in their cars and drive to take-back 
facilities to bring their products to a place where they could 
be destroyed. They are more likely to do that at home.
    We were surprised to find out from some studies of Egan and 
colleagues that in studying five counties in Kentucky and 
looking at all the drugs that were dispensed and then looking 
at all that came back to take-backs and kiosks, less than 
three-tenths of a percent of the drugs that were dispensed came 
back. Most of those were Flintstone vitamins and the like. Only 
5 percent of those were drugs of abuse.
    So take-back facilities are not really very effective. 
Often they cause liabilities for the facilities, like the 
pharmacies and others. They also are often diverted from these 
take-back facilities, as you may know.
    We think if one can offer a safe solution that is at home, 
permanent, and biodegradable, and environmentally friendly, 
that will stop a lot of the losses and the difficulties of 
other programs. But I must say we are all for anything that can 
help stop the cycle of addiction and overdose that begins in 
the medicine cabinet, including ours and others.
    Mr. Green. Thank you, Mr. Chairman.
    Mr. Guthrie. The gentleman yields back.
    I now recognize Mr. Shimkus, 5 minutes for questions.
    Mr. Shimkus. Thank you, Mr. Chairman. Thanks for being 
here. I know it is a long day. And I know a lot of you are 
sitting in on the first panel, which I appreciate.
    What I have been trying to get my arms wrapped around, I 
mean, we do have a pharmacist on the panel with this, 
obviously, the prescriptive authority, and then the legal 
authority to destroy and who that is, especially in the case--
and I know we have a bill that is going to address hospice 
issues when the prescribee passes. And I think it is a very 
good debate to have the attending nurse there being able to do 
this in whatever manner. And I think there is a lot of exciting 
things going on in that issue.
    So it really is a debate on, for me, and this line of 
questioning, who--is there things that we need to clear up in 
law as far as who we can designate to do that, who is 
authorized to do that, who can we educate? Is there an 
educational aspect of this aspect and is there ambiguity in the 
law that prohibits this from occurring?
    And so I will just go, Ms. Thau and then just down the 
table, and then I will go to my second question.
    Ms. Thau. Yes. I can't speak about ambiguity in the law. I 
can say that a lot of our coalitions have worked with long-term 
care facilities. I can give you an example in Fayette County, 
Ohio, where somebody went to take their loved one's 
prescriptions. And when they were told they couldn't have them, 
they said, but this is our inheritance, because they obviously 
intended to sell them. So it is a gigantic problem, and our 
people are working piecemeal community by community trying to 
make sure that those medications are actually withdrawn and are 
not diverted.
    Mr. Shimkus. Yes, great.
    Anyone else want to weigh in on this? Dr. Holaday?
    Mr. Holaday. I would say that we were surprised when we 
began this quest several years ago to find that there is no 
mandate by the FDA, the DEA, EPA or others to take care of 
leftover drugs and to encourage their disposal in a safe way. 
We think that this is an important aspect of managing the 
entire cycle of drugs from their dispensing to the time that 
they are gotten rid of. And that if they were properly managed 
at the end, that could prevent a lot of the divergence. Seventy 
percent of opioid addicts get started with leftover drugs in 
medicine cabinets.
    Mr. Shimkus. Yes. Look at the hospice patient who may be on 
painkillers and other addictive drugs. And so if there is a 
million in our country and there is five pills per individual, 
that is 5 million uncontrolled addictive drugs that could be--
and our culture does have a challenge with ownership. You are 
prescribed nine pills, you use four pills, and by golly, those 
are your five pills. Right? Paid for by you or your insurance 
company or whatever. And so that is the educational part that I 
kind of mentioned in that outline.
    So I appreciate that. I think that is something we have to 
wrestle with some authority by a healthcare professional whose 
got primary care to be able to have the authority to take and 
seize and destroy. I think I would support that.
    Ms. Thau, obviously, we are pulling out all the stops on 
the opioid crisis. Earlier, I had mentioned the meth issue. 
There is still cocaine, there is new synthetic drugs. I don't 
want them to get lost in this whole debate. So you want to 
comment on these other aspects, given the time left?
    Ms. Thau. Yes, absolutely. Thank you so much. I think what 
is really important is that we have an addiction crisis in this 
country. It is it not just an opioid crisis. When coroners look 
at what is on board when people have overdosed, it is opioids, 
it is fentanyl, but it is also marijuana, alcohol, Ambien, 
benzodiazepines; you are absolutely right, meth and cocaine are 
back.
    So what we really need is a permanent infrastructure for 
prevention, intervention, treatment, and recovery support that 
is not so drug specific, so that when we sort of fix this 
opioid problem, we do--and a lot of you were around for the 
whole Combat Meth Act. You know, oh, well, we dealt with that, 
and then all the money for that went away. So we really do need 
permanent infrastructure for the entire continuum of care for 
this issue for all drugs.
    And there is no MAT for stimulants, by the way. So it is 
fabulously important that there is for opioids, but for cocaine 
and meth, there is no equivalent for medication-assisted 
treatments.
    Mr. Shimkus. Thank you very much.
    My time has expired. Thank you, Mr. Chairman. I yield back.
    Mr. Guthrie. The gentleman yields back.
    The gentlelady from California, Ms. Matsui, is recognized 
for 5 minutes for questions.
    Ms. Matsui. Thank you, Mr. Chairman. And thank you to all 
the witnesses for being with us today.
    We have heard a lot of discussion today about how to 
address the opioid crisis, how to treat patients with opioid 
use disorders, and what can be done to ameliorate the impact of 
the crisis in our communities. However, I also believe that we 
must be focusing on the roll of primary prevention and what 
steps we can take to bring awareness to addiction, 
implications, and how opioid usage and addiction can be 
prevented in the first place.
    I appreciate that Ms. Thau from the Community Anti-Drug 
Coalitions of America--CADCA, right? --is here testifying and 
can speak to the importance of prevention efforts and community 
strategies.
    Ms. Thau, what more can be done and should be done to move 
upstream to prevent opioid misuse in the first place?
    Ms. Thau. Thank you so much for the question. Just like 
there are no simple solutions in general for the opioid 
problem, when it comes to prevention, it really does take a 
whole community. So it takes all of the sectors: parents, 
schools, law enforcement, the healthcare community, youth 
providing, working together to do everything literally from 
raising awareness, providing information, building skills in 
youth, doctors, parents, and getting rid of unused and unwanted 
medication.
    We also have worked in two States to give out 300,000 
Deterra packets, which are basically different packets than Dr. 
Holaday talked about, but that actually render drugs inert. But 
we have to do everything we can to decrease access and 
availability and change social norms.
    And I just want to give you a great example in Carter 
County, Kentucky. They, 10 years ago, had a horrible overdose 
problem, but also the schools came to the coalition and said, 
listen, we have 23 percent college and career readiness. So 
they did everything I have talked about across their community. 
And from 2006 to 2016, their 30-day misuse of prescription 
drugs for 10th graders went from 12 percent, which is two or 
three times the national averages, to 1 percent. And that is 
literally through doing a comprehensive communitywide approach 
that involved everybody. And they did change social norms.
    Chairman Guthrie, you are from Kentucky. So they did this 
gigantic media campaign called Forget Everything Your Mama Told 
You About Sharing, and it was done with scale and scope. 
Because that was one of the problems, people were sharing their 
meds. So when you do things across--and they did school-based 
prevention programs, they got a substance use counselor in the 
schools.
    Ms. Matsui. It was a multisector, everybody.
    Ms. Thau. They did everything across all the sectors. And 
interestingly, not only did their use rates go down 
exponentially, like for 10th and 12th grade, from 12 percent to 
1 percent, but that college and career readiness score went 
from 23 percent in 2010 to 76.5 percent in 2016, and their 
graduation rate went from 81 percent to 98.8 percent. So there 
are major secondary effects when we can reduce the initiation 
into drug use and stop kids from using in the first place.
    Ms. Matsui. OK. Keeping the same vein, I have a few 
questions about the roll reports by the Surgeon General play in 
bringing awareness to public health issues and impact lives of 
all Americans, how these reports can help prevention efforts in 
the longterm. Today, we are considering H.R. 449, the Synthetic 
Drug Awareness Act, which would require the Surgeon General to 
report to Congress on the public health impacts resulting from 
the usage of synthetic drugs by adolescents age 12 through 18.
    Synthetic drugs are designed to evade the Drug Enforcement 
Administration's scheduling regime, and drugs like synthetic 
cannabinoids, such as Spice and K2, are only increasing in 
prevalence among youth. I think having a report on use access 
and use of synthetic drugs can bring heightened awareness to 
this issue, just as other important Surgeon General's reports 
have, such as the famous 1964 report on smoking and how it has 
served as a critical tool in acknowledging the deadly health 
impacts of smoking.
    Ms. Thau, can you explain why providing information through 
reports like this is important to have information collected 
through this kind of report would be used in the future?
    Ms. Thau. Oh, absolutely. People around the country are 
looking for science-based information that can be paired down 
into what I will call snackable bites, where people can 
actually take things out of the report and use them to raise 
awareness with scale and scope. And I don't think we know 
enough about the effects of all of these synthetic drugs, how 
they affect the brain, health. They have some horrible, 
horrible side effects. They are very addictive. And I think a 
report like this would do a lot to bring awareness to the issue 
that people across the country could actually use to educate 
parents, the healthcare community, youth, schools, and 
everybody else that comes into contact with youth.
    Ms. Matsui. Thank you very much. I yield back.
    Mr. Guthrie. Thank you. The gentlelady yields back.
    The gentlelady from Tennessee, Mrs. Blackburn, is 
recognized for 5 minutes of questions.
    Mrs. Blackburn. Thank you so much. And we appreciate your 
patience today and for all of you being here.
    We do want to get legislation finished that is going to 
make resources or provide resources that can help with 
addressing this on the education prevention, the medically 
assisted treatment and, of course, the rehab and recovery. And 
to that end, Ms. Thau and Mr. Francer, I want to talk with you 
about the education component.
    In the mid-1980s, I was chairman of the board for the 
American Lung Association in Middle Tennessee. And, Ms. Thau, 
you are need nodding your head. I think you know where I am 
going. We developed what was called the School Health 
curriculum. And we raised the money. We paid for teacher in-
service training so they could come take this, and then teach 
this curriculum in K through 3 on the dangers of smoking and, 
likewise, the dangers of secondhand smoke. And it was an 
incredibly successful program.
    And over the past couple of months, I have lamented a 
couple of times that we didn't seem to have that type 
infrastructure that had a scalable program that we could work 
through schools and begin to--and it sounds, Mr. Francer, like 
you are moving this way--look at K through 3, look at 
elementary, at middle school, at high school and provide the 
education that is necessary to, first of all, realize addiction 
is a disease, and then secondly, to be very specific about 
these Schedule II drugs, the opiates, the psychotropics, what 
it does, and the effect that it has on your body.
    And I would like to hear from the two of you. You are 
talking about Carter County, Kentucky. Is there something that 
is scalable? And, Mr. Francer, to you, is there a curriculum? 
And do you have a way to scale and to get your curriculum into 
schools and communities?
    And, Ms. Thau, we will go with you first.
    Ms. Thau. Absolutely. Carter County used something called 
Generation Rx curriculum, it is a ninth grade curriculum, but 
they didn't do it in schools. They did it through the Boy 
Scouts, churches, and youth groups. They also did life skills 
training, which is a science-based, evidence-based program, in 
third through ninth grades. So there are the tools.
    One of the issues is, unless the schools are part of the 
larger conversation and the coalition, they don't necessarily 
want to own this. And I don't know at this point without safe 
and drug free schools, which we lost the funding for a while 
ago, unless we can show schools that spending time on this is 
going to increase educational outcomes, which I think we can 
do, they are not all that interested in spending the time on 
doing it. It is a little bit hard to get into the schools at 
this point. But with this epidemic, I think we have an amazing 
opportunity to bring them back into the fold as full partners 
in prevention.
    Mrs. Blackburn. Sir.
    Mr. Francer. Well, if there is anything this hearing today 
has shown is that we need to take an all-hands-on-deck approach 
to this problem. And I think that one of the keys is early 
education, as you mentioned.
    We have partnered, as I mentioned in my testimony, with a 
company called EVERFI, which is one of the largest online 
educational providers. They have developed this curriculum with 
experts. They started in colleges and universities, and now 
they are beginning to go younger. And speaking for myself, I 
remember growing up with drunk driving education early in life 
and the type of education that you discussed. And so I think 
that the more, the better, and it is going to take all of us in 
a comprehensive way to approach this problem.
    Mrs. Blackburn. Thank you.
    Ms. Thau, I have to tell you, I saw the Deterra bag 
recently, and it is so simple to use. And I thought then for 
older patients how easy that would be, just to put the unused 
portion of that prescription, close that top, and throw it 
away. And then you have eliminated a big part of that problem. 
So I appreciate that you all are giving those out, making them 
available.
    Ms. Thau. Thank you so much.
    Mrs. Blackburn. I yield back.
    Mr. Guthrie. I thank gentlelady for yielding back.
    The chair now recognizes Mr. Lujan for 5 minutes for 
questions.
    Mr. Lujan. Mr. Chairman, thank you very much. And, Ms. 
Thau, and all our witnesses, thank you so much for being here 
today. And thank you for working so tirelessly with my team 
over the last few months, and your expertise has been 
invaluable.
    In your testimony, you state that, ``Primary prevention to 
stop substance use before it ever starts is the most cost 
effective way to deal with the addiction issues facing our 
Nation.''
    You continue to say, ``Research shows that for each dollar 
invested in prevention, between $2 and $20 in treatment and 
other health costs can be saved.''
    Substance use prevention has historically been 
underresourced and underutilized in combating drug issues, 
including the current opioid epidemic. Most of the emphases in 
funding have been directed towards downstream approaches that 
try to deal with the problem after it has already reached 
crisis proportions.
    While I know that we are here to talk about H.R. 449, I was 
hoping to chat with you a little bit about prevention in 
general. As you might know, I have had the honor and pleasure 
of working with my colleagues, of course, Mr. Guthrie, our 
chair, Mr. Green, Mr. Bucshon, on the Comprehensive Opioid 
Recovery Centers Act. I am pleased that we can work across the 
aisle on important issues to better integrate, coordinate, and 
ensure quality at our substance use disorder programs across 
the Nation.
    As we drill in on prevention, though, in your expert 
opinion, does a substance use disorder program need to include 
prevention in order to be comprehensive?
    Ms. Thau. Yes. I would say absolutely in general it does. 
And especially if you are going to do something with 
comprehensive recovery centers and you want strong linkages 
with the community, two things: The same community conditions, 
not a lot of access and availability. Social norms where people 
don't necessarily think that it is a great thing to use. The 
same things that keep kids from using are what keep people in 
recovery in recovery.
    So we need to develop, I think, community conditions that 
are conducive to both preventing use in the first place and 
keeping people clean and sober when they reenter.
    That said, addiction is a family disease. So there is 
universal prevention, which is aimed at everyone who hasn't 
used, and then there is selective prevention for very high-risk 
kids who haven't used yet, like the children of drug abusing 
parents. So I would say you definitely would want programs 
involved in these comprehensive opioid recovery centers for the 
children of people who were getting recovery services at a 
minimum. And I would also hope that those centers would have 
strong linkages to the community prevention coalitions that 
were doing the environmental strategies and the other work in 
the community to build down the demand for drugs.
    Mr. Lujan. While I understand the world of prevention 
efforts is broad, let me attempt to drill in and ask you to 
help me narrow in in a few areas. So if I were to ask you to 
narrowly focus prevention efforts in this bill, where would you 
recommend that we start? How would we be able to narrow this?
    Ms. Thau. One, I would probably have linkages to the drug-
free communities' coalitions in the same places where these 
centers were going to be housed so that they could work 
together. And two, I would figure out how to have selective 
programming for the kids of parents who were being treated in 
the centers, both for treatment and recovery support.
    Mr. Lujan. I would also like to ask your opinion about two 
other areas, again, as we narrow in on prevention. Do you think 
it would be reasonable to begin with individuals who are using 
opioids appropriately for pain management but not addicted, as 
well as individuals whose family struggle with substance use 
disorder but who are not addicted themselves, as a narrowing 
area----
    Ms. Thau. No, I definitely think so. So dealing with people 
who are using opioids and are at high risk for becoming 
addicted is an indicated approach. So, basically, it is 
screening, brief intervention, figuring out if somebody does 
need a referral to treatment. And then, yes, absolutely.
    Mr. Lujan. And then one last question as my time is about 
to expire. Do you know of any data suggesting that these would 
be effective prevention efforts?
    Ms. Thau. Yes. There is a lot of data saying that selective 
interventions, as well as indicated interventions, are very 
effective.
    Mr. Lujan. Mr. Chairman, again, I want to acknowledge your 
leadership and the work that you have done in this space.
    And, Ms. Thau, I look forward to working with you on 
compiling that data so that we can continue to have these 
conversations with all the staffs involved. And again, thank 
you for your expertise.
    Mr. Chairman, thanks for this important hearing.
    Mr. Guthrie. Thank you. It has been a pleasure for us to 
all work together on these issues.
    The chair now recognizes Mr. Latta from Ohio, 5 minutes for 
questions.
    Mr. Latta. Thank you, Mr. Chairman. And thanks very much 
for our panel for being here today, it is really important, on 
this issue and lifesaving is what we have to be doing out 
there.
    Ms. Esham, if I could start with you, I strongly support 
using data to help combat the opioid epidemic, which is why I 
introduced the INFO Act. Would you elaborate on Bio's 
recommendation to utilize data to better understand clinical 
pain and addiction and improve medical decisionmaking?
    Ms. Esham. I will certainly try. And I have actually been 
learning a lot myself today. And I think as we have heard from 
the various panels, there is a lot of data collection being 
done.
    I think our recommendations are not basically designed to 
say that there is not data or the data is not being collected, 
as much as to ask the question how can we use data to inform 
and improve how we treat patients suffering from pain and 
addiction. And so our recommendation is really calling on NIH 
perhaps to take the lead and work with other governmental 
agencies and look at the data that exists to determine, are we 
able to use that information to help us determine what 
treatment works best for a particular patient? Are we treating 
people in a way that delineates acute pain from chronic pain? 
Are we able to identify and make sure we are treating people 
that have psychic pain in the appropriate way? How can we learn 
about what the optimal duration is for specific treatments? And 
we have many others that are outlined in my written testimony.
    The bottom line is, how can we use data to provide better 
care today and inform how to provide better care in the future 
as we have new treatments coming online? And so that is 
something, I think, that would bear critical information that 
could really help us examine how we could not only mitigate the 
opioid epidemic, but just treat patients better.
    Mr. Latta. OK. Thank you.
    Dr. Holaday, and thank you for coming in today. The 
committee is focused on improving prescription drug disposal as 
an important strategy to help reduce diversion and the 
resulting misuse or abuse. At the same time, it is important 
that safe disposal of prescription drugs is not impeded by 
strength as approaches develop. How should we ensure that the 
disposal system standards are sufficiently rigorous to 
providing meaningful improvement and safety?
    Mr. Holaday. What we have done with our own product was to 
have it evaluated by a third-party laboratory to ensure that 
once the drugs were sequestered in this product, that they 
could not be extracted. Although my Ph.D. Is in pharmacology, 
the guys on the street that want something out of these are 
going to be far more creative. And what they will do is they 
will use vodka or other sources to extract and or inject opioid 
drugs in others.
    I think there needs to be, if you will, a fundamental focus 
on making sure that the drugs left over in the medicine 
cabinets are disposed of by some manner that is convenient. We 
think an at-home solution is the best one. We think we have got 
an appropriate way of getting rid of them, but that will also 
prevent diversion for abuse and also prevent pollution of 
landfills and water supplies.
    Mr. Latta. Let me just follow up on that. Do you think a 
disposal system review process that would be conducted in a way 
that is efficient--because again, when things get started, 
sometimes there is always a question on that review, but should 
it be efficient--how do we do it without necessarily raising 
the cost out there?
    Mr. Holaday. I wouldn't recommend that this be something 
that is demanded in terms of rigorous for evaluations of 
products that may remove products, such as assessments of 
whether something is effective or not. I do think, however, 
that much in the same way that the 1970 Poison Prevention Act 
required the childproof closures be put on all drugs, it was 
legislated; before then it was available, but nobody used it. 
After legislation, within 2 years, there was a 45 percent 
reduction of childhood deaths from leftovers or from drugs in 
medicine cabinets.
    And we think that something should be legislated to 
encourage the use of a system, perhaps at home, we believe, for 
getting rid of leftover drugs that they wouldn't be available 
for abuse or diversion.
    Mr. Latta. Well, Thank you very much, Mr. Chairman. I am 
going to yield back the balance of my time.
    Mr. Guthrie. I thank the gentleman for yielding.
    The chair now recognizes Mr. Pallone from New Jersey, the 
ranking member of the full committee, 5 minutes for questions.
    Mr. Pallone. Thank you.
    I wanted to ask Mr. Francer some questions. The committee 
has heard concerns from FDA regarding the public health 
concerns associated with illicit, unapproved, or counterfeit 
drugs entering our supply chain. And as Commissioner Gottlieb 
noted on the first panel, these could be products that do not 
have, or don't contain the right active ingredient, the wrong 
amount of an active ingredient, or toxic ingredients. And I am 
obviously concerned about the potential risk this poses to 
patients, but also about the impact on our supply chain.
    I have long been concerned about the number of illicit 
drugs entering our supply chain and worked with the FDA and 
many in the generic industry to strengthen FDA's authority in 
FDASIA, and most recently introduced H.R. 5228, the SCREEN Act, 
which provides FDA with greater authority and resources.
    So, Mr. Francer, obviously you are aware of this issue of 
illicit or unapproved drugs entering the supply chain through 
these international mail facilities, but can you describe 
briefly how this impacts the integrity of the supply chain?
    Mr. Francer. Sure. And I think like everyone who sat 
through the first panel, I thought it was extremely concerning 
to see that deaths from illicit opioids are increasing. 
Ensuring the safety and integrity of the supply chain is 
critical. It is one of the features of what keeps drugs safe in 
our country. And we are supportive of enhancing the FDA's 
ability to do its job and specifically to try to get at these 
illicit drugs that are trying to get into our country.
    Mr. Pallone. Well, many of us have talked about how there 
are millions of these packages that come in through 
international mail facilities every day, and the FDA only has 
the resources to inspect a small fraction; I think about 
40,000. And the bill I mentioned, my bill would provide FDA 
with additional authority and resources to combat this problem.
    I don't know if you have looked at the bill, but would you 
support, you know, the types of things that we have in the bill 
to provide FDA with additional authority and the resources for 
enforcement in trying to address some of this? I don't know if 
you want to specifically mention some of the things that we are 
trying to accomplish.
    Mr. Francer. Yes. We are looking at the bill. We are 
supportive of the concept, and I am happy to work with you and 
your staff.
    Mr. Pallone. What about the resources aspect? We really 
haven't talked much about that. I know that Commissioner 
Gottlieb said he did need additional resources. Have you looked 
to see what all the agencies are always reluctant to say 
anything more than we need more resources, so if you ask them 
how much they need, they won't tell you because they probably 
think they shouldn't. You have any idea what we would be 
talking about?
    Mr. Francer. I don't know. I would try to get an answer 
from the FDA.
    Mr. Pallone. Yes. I know it is hard to get an answer from 
them on something like that.
    All right. Well, then I just would ask that--anybody else 
want to comment on this, any of the other panelists? I still 
have 1 1A\1/2\ minutes.
    All right. Let me ask Ms. Thau. I am interested in your 
perspective on the importance of prevention and finding 
prevention services, if you wanted to comment.
    Ms. Thau. Yes. I would love to. So I think one of the 
problems here is because of the tremendous death toll and the 
horrific way this is presenting in our society, everybody is 
really moving downstream. And so we are not doing much about 
prevention, really, in this. And it would be like with the 
smoking stuff, only doing cessation and not doing the truth 
campaign and not raising the price of cigarettes and stopping 
advertising, or for polio just building more iron lungs. So we 
really do need to move upstream.
    The point is there is no silver bullet in prevention 
either. It really does take a comprehensive, communitywide 
approach that involves everybody. It doesn't take a lot of 
money, but it actually does take concerted effort in doing a 
needs assessment, figuring out why kids are starting, what they 
are starting with, how they are getting the drugs. For are the 
most part we know it is from the medicine cabinets and from 
friends and families. So we do need to do a lot more raising 
awareness, education, reducing access and availability, 
changing prescribing practices. And the point is, all of that 
together is really what is going to solve this upstream.
    Mr. Pallone. Well, I think I agree with you. I am sure you 
realize that many of us, all of us probably, on the committee 
are so frustrated because we see the opioid problem getting 
worse. And we know that we need additional resources for 
prevention and enforcement, and that is why I am happy that the 
budget deal has that extra $6 billion. But there is no easy 
answer. And I always go out of my way to say, look, I don't 
have any easy answers, because I don't want anybody to think 
the committee is going to magically pass some bill or throw 
some money and that is going to eliminate the problem. But 
thank you so much.
    Thank you, Mr. Chairman.
    Ms. Thau. Thank you.
    Mr. Burgess [presiding]. The gentleman yields back. The 
chair thanks the gentleman.
    The chair recognizes the gentleman from Oregon, the 
chairman of the full committee, Mr. Walden, 5 minutes for 
questions, please.
    Mr. Walden. Well, thank you, Mr. Chairman. Again, thanks to 
all of our witnesses on these various panels. I think you will 
hear from all the committee members how concerned we are and 
how helpful we want to be to all of you and the people in our 
communities that are dealing with this terrible, terrible 
situation.
    As you may know, we are also doing an investigation through 
our Oversight Investigative Subcommittee arm and have been for 
well over a year, and it is pretty disturbing what you learn on 
that side of this as well. The goal is then to get to good 
public policy and try and help people back home. So I just 
appreciate your comments today, all of you.
    And, Ms. Thau, how can community-based prevention and 
multisector coalition approaches effectively reduce the rates 
of youth substance abuse, especially prescription opioids? And 
I was meeting with some people from Oregon this morning in my 
office. And voters legalized marijuana in Oregon. I just came 
from a meeting with some of the community action folks, and 
they talked about a young kindergartner who they thought maybe 
had been born drug-addicted and all, and later realized, later 
in the afternoon of meeting with this young girl, that she was 
just actually high on marijuana from the morning; that that is 
what they think it was. And you see that happening, you see 
this happening.
    And so, we all want to get our hands around--obviously, the 
adults in the room are part of the problem, but what can we do 
from a community-based prevention multisector coalition 
approach?
    Ms. Thau. Well, basically what we can do is get everybody 
around the table, all 12 sectors, as I mentioned before: 
parents, the schools, law enforcement, the faith community, 
youth serving organizations. And then we really do need to do 
what we call the strategic prevention framework. We need to 
look at how the problem presents in a community, who is using, 
where they are getting, how they are accessing what they are 
using, what the social norms are, and then do is a strategic 
communitywide plan where everybody has a part in implementing 
it. And then evaluate where you are.
    And I can tell you I have three case studies, one of which 
I talked about a minute ago from the epicenter of the opioid 
epidemic, so Carter County, Kentucky; Scioto County, Ohio, 
where Dreamland, the book, was actually written about; as well 
as Jackson County, West Virginia.
    Mr. Walden. There you go.
    Ms. Thau. These are places a decade ago where people were 
dying of fentanyl overdoses. Like in West Virginia and Jackson 
County, they had 17 overdoses in this tiny thing of fentanyl a 
decade ago. And they built the coalition, and they have been 
able to build down demand and stop the pipeline to addiction by 
lowering the usage rates among their youth, and it is 
exponential reductions. So they have seen less need for 
treatment and fewer people overdosing.
    Now, there are always going to be people who use and we 
always need treatment and recovery. But the point is that the 
fewer people who start using, the fewer people who are going to 
get in trouble downstream. So it is critical, I think, that we 
do everything we can to build this comprehensive community 
capacity.
    Mr. Walden. I was with an oncologist yesterday from Oregon, 
Dr. Bud Pierce. And he talked about years ago, years ago, they 
had to take 8 hours of mandatory education on pain management, 
where they were told that it would be malpractice not to 
prescribe opioids and manage the pain. You think about how far 
we have come to now realizing what a horrible thing we have 
built as a result, in part by that false knowledge and a push 
from the government, frankly, in how we reimburse. That was one 
of the criteria, what kind of smiley face do you have on pain 
when you left the hospital or wherever.
    And it strikes me that this new Veterans Department study 
that showed that people who took Tylenol or that type of pain 
reliever, in this study, reported less pain than those who were 
on opioids. Now, that really makes you stop, and you wonder, do 
we need all of this? Are there alternatives that are better in 
terms of pain management?
    So it seems to me we have got an addicted age group here, 
if you will, and to get to where you are at is preventing that 
from ever starting with these children is a goal. Do you have 
anything else you want to add, or any of the other panelists? 
Anybody else?
    Well, at least nobody disagrees with that analysis, so 
thank you for that. I really appreciate you being here on a 
snowy day.
    Mr. Chairman, with that, I will yield back.
    Mr. Burgess. The gentleman yields back, and the chair 
thanks the gentleman.
    The chair now recognizes the gentleman from Virginia, Mr. 
Griffith, 5 minutes for your questions, please.
    Mr. Griffith. Thank you very much, Mr. Chairman. I 
appreciate you all being here and appreciate your testimony. 
Iapologize for not being here when you all started your 
testimony because I was on the floor with some others, as you 
have heard earlier, on another bill.
    But we are working on a lot of bills here today. And I have 
to tell you I was really interested in hearing this, because 
last week, my 18-year-old stepdaughter had her wisdom teeth out 
and was prescribed oxycodone. She took two of them. The rest of 
the prescription is at home. So you all talked about how that 
is where the danger starts.
    Dr. Holaday, I am going to let you respond first. And I 
have to tell you, I have a 12-year-old and a 10-year-old at 
home too. And your product reminds me a little bit of a 
completely different subject, but not only will it help us get 
rid of a problem, but for my 10- and 12-year-old, I think that 
would be fun, the way it fizzes up.
    But can you go back in and explain a little bit about how 
the polymers work? And you said you could eat the stuff, and I 
was assuming that you meant you could eat it before it was 
mixed with the oxycodone. But maybe once it is mixed with the 
various polymers, with the secret sauce as you called it, it is 
inert afterwards. But I would suspect it has still got some 
negative properties.
    But can you explain some of that? And then I will open it 
up for anybody else to discuss. Otherwise, we might look at it 
and what do I do now. When I go home this week, what do I do 
with that remnant prescription?
    Mr. Holaday. First thing you do is go to Walmart, they will 
give you a free packet of this product----
    Mr. Griffith. So they will give me that.
    Mr. Holaday [continuing]. That you would put into your 
prescription vial with some water, shake it up, and throw it 
away.
    The idea for this is so simple. When you buy flowers, there 
is always a little packet with the flowers. You put it in the 
water and preserve them. Why not, when you get a prescription 
for an opioid or an abusable drug, get a little packet, 
something, by which you can then dispose of the product safely 
and conveniently?
    Mr. Griffith. Well, if Walmart is giving it to me--now, we 
did not get our prescription at Walmart. Will they still give 
it to me?
    Mr. Holaday. Yes.
    Mr. Griffith. And if they are going to give it to me, what 
is the cost? It can't be a whole lot if they are giving it 
away.
    Mr. Holaday. It is a very small cost. Retail, this is $1.50 
per packet.
    Mr. Griffith. So if I were in a community without a 
Walmart, could I purchase it somewhere or buy it on the 
internet?
    Mr. Holaday. We are putting arrangements together to have 
this purchasable online through a facility that is going to 
make this available in units of six. But again, the price would 
be less than $1.50 per packet and less than 10 bucks for a six 
packet of product.
    Mr. Griffith. That is a pretty cheap fix for a serious 
problem.
    Mr. Holaday. And it is permanent.
    Mr. Griffith. That's great. Now explain to me, it combines, 
it forms polymers. And once it does it--because you said it was 
then safe to go in the landfills. I don't know if it was safe 
to put in the water supply or not, I don't remember if you said 
that or not. But tell me how that works, and is it basically 
inert once you go through that process?
    Mr. Holaday. It is basically inert, and then what happens 
is it biodegrades. So one of my colleagues calls me up about 7 
or 8 months ago and said, oh, unfortunately, we have got mold 
growing in our product. That is not nice. But this is 
biodegrading, so the drugs and its contents and this matrix 
that we have got is all biodegradeable. I am not the genius 
that came up with the secret sauce; I just had the idea. So the 
chemical engineer that came up with this actually mixed it 
first in his kitchen. You hear those types of stories. Then he 
spilled some on the driveway and his wife was upset because he 
couldn't get it off. But this is a permanent and simple 
solution to a lot of issues that begin with drug abuse in the 
medicine cabinet.
    Mr. Griffith. Well, I have already texted my wife. I will 
call her when I get out of here and say, OK, go to Walmart and 
get this stuff. And again, tell me what the name is.
    Mr. Holaday. Pardon?
    Mr. Griffith. What should she ask for?
    Mr. Holaday. DisposeRx.
    Mr. Griffith. DisposeRx. DisposeRx, got it.
    Mr. Holaday. I have got several packets, I will leave----
    Mr. Griffith. Because I think if she showed up and asked 
for the secret sauce, they might not know what she was talking 
about.
    I have got a little bit of time left. Does anybody want to 
add anything that they think we ought to be looking at or other 
folks ought to be looking at?
    Yes, ma'am.
    Ms. Thau. I just want to add too that when we gave out the 
300,000 Deterra deactivation packets throughout Florida and 
D.C., that was 13.5 million pills that were just gone. And when 
we went back and did a study, 90-something percent of the 
people were like, this is great. Exactly, we don't have to 
leave the house. We just sort of get rid of it and we are done. 
It is inert and it is not subject to abuse in any way.
    So anyway, I would also say it is a very good way to get 
rid of unused and unwanted meds without leaving your home.
    Mr. Griffith. Well, thank you all very much, and thank you 
for your time today on this very serious subject.
    I yield back.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentleman from Florida, Mr. 
Bilirakis, for 5 minutes of questions.
    Mr. Bilirakis. Thank you, Mr. Chairman. And I want to thank 
the panel for their patience this afternoon; appreciate it so 
very much.
    This question is for the panel. I know there is no silver 
bullet in solving this opioid crisis. However, if you had one 
recommendation, one suggestion in addressing this crisis, what 
would that be? If you had any suggestions for us, one 
particular suggestion.
    Let's start with you, ma'am. What would that be?
    Ms. Thau. Mine would be a lot more investing in multisector 
prevention to basically stop use before it starts and reduce 
population level rates of initiation of all drugs.
    Mr. Bilirakis. Very good. Thank you.
    Ms. Esham. I think what we are focused on is really, again, 
everybody is talking about today there are serious problems we 
have to address today, but we don't have to accept the status 
quo. So, a lot of what we are trying to think about is how can 
we change the future, still treat pain, treat addiction better 
in the future.
    And so I think, in those terms, a lot of the 
recommendations we outlined are really designed to create 
collaborations and engagement with the regulators as well as 
people developing these innovative drugs to make sure that 
there is a signal to investors that this is a top priority and 
this is something we should be investing in, and that we are 
able to, in a most efficient way possible, provide these 
alternatives to opioid treatment and better treatment for 
addiction in the future. So I think that is what we are focused 
on.
    Mr. Bilirakis. Thank you. Thank you.
    Mr. Francer. I would say it is about education. And we just 
talked about the end user education, the patient education. It 
is also the prescriber education. And we just talked about how 
the physicians and the other prescribers, their education is 
changing as we speak, and we have to encourage that.
    Mr. Bilirakis. Would you mandate the schools and the 
curriculum in the schools prevention and the effects of opioid 
and drug use and even alcohol use? Would you make sure that 
that is mandated in the schools?
    Mr. Francer. We are hoping to support some voluntary 
programs that colleges, universities, and now even high schools 
can implement. And these are online training, so it has 
obviously got a huge economy of scale. And I don't think----
    Mr. Bilirakis. Training the students, the teachers?
    Mr. Francer. In terms of the types of behaviors that we 
have been talking about today, proper disposal, what do you do 
if you have extras, who do you give them to, who shouldn't you 
give them to? But really, truly, it is not up to me to decide. 
I think right now, it is very much a decentralized decision 
with colleges, universities, and secondary schools.
    Mr. Bilirakis. I would start even earlier. I would start in 
maybe in the middle schools, elementary schools. The chairman 
just mentioned the child on marijuana in the elementary school. 
That is really scary.
    Yes, sir.
    Mr. Holaday. I would like to echo my colleagues. Education 
is going to be key. It is part of our passion. As we tell 
people about what we do, we work with sheriffs' offices with 
various high schools and others to tell people about the best 
way to get rid of drugs and stop the cycle of addiction and 
overdose is to get them out of your medicine cabinet. And the 
most convenient way to do that is through a home solution, 
whether it is ours or others that are available.
    We also think that it might be useful for it to be 
considered that, much like the Poison Prevention Packaging Act 
of 1970 that required child-resistant closures, that something 
also perhaps be legislated that requires a means by which to 
dispose of a drug be dispensed with that drug, particularly for 
those that are abusable, including opioids, benzodiazepines, 
Adderalls, and others which can be addictive and abused.
    Mr. Bilirakis. Thank you very much.
    I have a little more time, Mr. Chairman.
    State and, in some cases, local level PDMPs undoubtedly are 
a critical tool used to support the fight against the current 
opioid epidemic. However, challenges exist in the current 
system, such as the lack of interoperability with health IT and 
the lack of true real-time data reporting. These challenges are 
preventing clinicians, both prescribers and dispensers, from 
having access to all the information needed to make the best 
clinical decision.
    Would having standardized information available in real 
time to prescribers and dispensers aid in ensuring appropriate 
medication is being prescribed and dispensed? That would be for 
Mr. Francer, please.
    Mr. Francer. We support increased use of these programs and 
increased operability, I think. It is especially interesting 
here where we have D.C, Maryland, and Virginia, you don't want 
patients to be able to take advantage of weaknesses in the 
system.
    Mr. Bilirakis. So you would agree that it would?
    Mr. Francer. Yes.
    Mr. Bilirakis. OK, very good.
    OK. I will yield back, Mr. Chairman. Appreciate it.
    Mr. Burgess. The chair thanks the gentleman.
    The chair recognizes the gentlelady from Indiana, Mrs. 
Brooks, 5 minutes for questions, please.
    Mrs. Brooks. Thank you, Mr. Chairman.
    I think we have talked about education throughout. I have 
heard you all mention the importance of education. And 
something that the committee has been exploring, but I know 
there is always hesitation. Even, Mr. Francer, I know you 
noticed that mandating any type of education is controversial. 
No one really likes anything mandated. However, we are at a 
crisis, and we have been sitting here all morning--although, I 
will tell you that I wouldn't say--and I was just looking at 
the CADCA website. I wouldn't say we get a lot of calls from 
constituents about this. Our newspapers pay attention to it, we 
know we all talk about it as elected officials, but because of 
the stigma of drug addiction still, I wouldn't say that we all 
get flooded with phone calls about bills we are proposing and 
so forth.
    But one thing I know and we are certainly talking about is 
how do we reduce the number of prescriptions that are written? 
Of course, we want people who have legitimate pain and who have 
gone through surgeries or who have chronic illness or cancer 
and so forth that have pain, but I really do feel strongly that 
prescribers of all type need more education. I know med schools 
are doing a better job now, but there is still a lack of 
education out there on the amount of prescriptions. Indiana has 
a 7-day law now. And there can be exceptions for that, but the 
prescriber just has to say what the exceptions are.
    So I am really curious about a bill that we are working on 
to potentially require of all prescribers 3 hours of continuing 
medical education about opioids, for all prescribers, not just 
about prescribing, but about identifying addicts, their own 
patients and/or how to help them get into recovery. So I am 
just curious, it obviously could put a dent in the use of your 
product, Dr. Holaday, but I think it is critically important, 
and I applaud you and the others for those types of products, 
but why do we have so many leftover prescription drugs in our 
medicine cabinets to begin with? What a waste of resources in 
so many ways. And I applaud your product.
    But, Mr. Francer, talk to me about 3 hours prior to, say, a 
DEA license renewal, over a 3-year period.
    Mr. Francer. The FDA already requires some amount of 
education, not necessarily 3 hours, but they have a risk 
management program for certain types of opioid products. And I 
think Dr. Gottlieb would like to expand on that, which we would 
applaud. I think that it doesn't seem unreasonable to expect 3 
hours before you get your DEA license approved, given the 
amount of risk involved.
    Mrs. Brooks. From CADCA point of view?
    Ms. Thau. Well, we totally agree with you. We support it, 
and we also think that some of that education should be about 
understanding addiction as well. Because there is very little 
training in medical schools, and everybody should actually be 
asked whether they have a substance use disorder before they 
are actually given anything that could cause them to relapse, 
and a lot of people do not ask the question.
    Mrs. Brooks. Does the data show, though, that people admit 
they have a substance use disorder?
    Ms. Thau. Well, I think that they do to their doctors. And 
I don't know if you had heard Dr. Jones when he said he had an 
anesthesiologist when he was having a colonoscopy--because he 
is in recovery, he told that to the committee. He had to demand 
that they not actually give him Propofol, because they kept 
saying it wasn't going to be dangerous. So people, I think, 
need a lot more education.
    Mrs. Brooks. And the education, and I know that is what 
CADCA is very focused on, is creating those coalitions in our 
communities and so forth. And I do think that over the years, 
whether it was Mothers Against Drunk Driving or Students 
Against Drunk Driving, there was that impact that was made for 
a whole generation really younger than me, I might say. It 
really wasn't as effective at my age group, but it certainly 
has been for the younger generation.
    But yet, we don't really have a set protocol of education 
for young people right now back to that point. Is there 
anything that has been proven that really is very effective in 
our schools?
    Ms. Thau. Yes, there is a lot of evidence-based prevention 
of the issue or two; one to say yes, I think it was, 
Congressman Bilirakis, do we need something that is mandated 
even in school base stuff? We were trying so hard with every 
child succeeds act not to put too many restraints and 
requirements on schools and school districts that they can 
decide how to use Title IV, and there are a hundred different 
uses for it. And drug/alcohol education and intervention is one 
of them, but it is not required. And I think that at this point 
it should be, and then schools should be working with their 
broader communities. The schools can't own this by themselves, 
but they do definitely have a piece of this.
    Mrs. Brooks. Thank you all for your work.
    I yield back.
    Mr. Burgess. The gentlelady yield back. The chair thanks 
the gentlelady.
    The chair recognizes the gentleman from North Carolina, Mr. 
Hudson, 5 minutes for questions, please.
    Mr. Hudson. Thank you, Mr. Chairman. And thank you to the 
panel for braving the storm to be here today. It is a really 
important topic and it is one that touches all of our 
constituents all across the country in all demographics. And it 
is one that deserves our attention, and so I appreciate you 
being here to help us understand this problem more.
    Dr. Holaday, glad to see you here. I am proud to say that 
DisposeRx is a company based in my district in North Carolina. 
And you are on the front line helping to fight this epidemic, 
and so I welcome you here today particularly.
    In your testimony, you noted that 70 percent of people 
studied do not use the drug take-back programs, such as mail 
back envelopes; and further, that take-back programs dispose of 
only about 0.3 percent of controlled substances that are 
dispensed.
    Do you think the end users don't use this program because 
they just don't see a need or don't want to dispose of their 
medication? Or you think it is because of the inconvenience?
    Mr. Holaday. First, I would like to thank you, sir, for 
your leadership in working with the opportunities to prevent 
drugs in the medicine cabinet from finding their way into 
abuse, misuse, and pollution. And so we are a proud North 
Carolina company in your district.
    I think that the numbers of people that use take-back 
facilities and kiosks are small, first of all, because it is 
inconvenient. You have to get in your car and go do something, 
that you are likely to say, why would I want to do that? I have 
got enough opiate in case I ever need it. I will just leave it 
in the medicine cabinet.
    But things have to change. What we do is disruptive. It 
changes the way people do things, just like seatbelts. Just 
like other changed behaviors, recycling.
    So we think with appropriate education that we can train 
people that they have got leftover drugs that are a problem for 
them, for their families, and for others. Oddly, I know of a 
real estate agent that told me stories of people that would 
follow her around and go to housewarmings and go to the 
medicine cabinets and take out the leftover drugs. So the 
urgency to get these drugs out of circulation is a real one.
    It is inconvenient to go to take-back facilities and kiosks 
because people don't want to do that. They are not very 
effective. Often the products are diverted from that, and it is 
a liability for the pharmacies. If you do it at home, then you 
prevent that liability. Throw it in the trash, it biodegrades, 
and it is not usable for anybody to abuse.
    Mr. Hudson. In our first hearing on this opioid crisis here 
at the Energy and Commerce Committee at the end of February, I 
know the story of a woman I talked to who said that she had 
moved her prescription opioids from medicine cabinet to 
medicine cabinet over 5 years that she moved from apartment to 
apartment.
    You mentioned that less than 20 percent of patients have 
reported receiving education from their provider on how to 
dispose of unused medications. I heard you testify earlier that 
you think education is a key element here. What exactly should 
the provider be educating their patients about when they give 
them a prescription for an opioid? What is the nature of what 
education they need to receive?
    Mr. Holaday. I think that begins with the physician that 
prescribes the drug to begin with, talking about not only pain 
relief, but also the problems that total with prescriptions not 
used and how you ought to get rid of it. I think that Dr. 
Carter might agree that the pharmacist has a role, a very 
important role in educating the people that come to the 
pharmacy and say, look, you are taking home a product that is 
toxic, you will need it for your pain relief, but when you are 
done with it, get rid of it so it is not going to cause further 
problems.
    Mr. Hudson. Does anybody else on the panel want to touch on 
that?
    Ms. Esham. I will. I think if you think about what is 
happening and some of the comments made earlier, I think what 
you want to have as we say, you want patients to have knowledge 
of and access to all available treatment. So if you present 
yourself and you are going into a postsurgical situation and 
you tell your doctor you are an at-risk person for addiction, 
you want that doctor to be able to clearly tell you here is an 
alternative and have that discussion. If you are a person that 
is going in to have a procedure being treated for pain, you 
want the ability to say I have children at home, is there an 
abuse-deterrent formulation.
    And the public should not be solely responsible for that. 
You want to have a very informed provider community that is 
able to help ensure that people are making the best choices 
possible.
    Mr. Hudson. Right. Anybody else want to chime in? I have 
got 30 seconds.
    Ms. Thau. I think we also have to really inform the public 
on exactly the questions to ask; what to do with this stuff? 
And just to end, a lot of our coalitions are working with 
realtors because in open houses people are going through 
medicine cabinets and actually stealing people's medications.
    So there is also a need for locked medicine cabinets and, 
you know, whatever else we can do to keep these medicines out 
of the wrong hands.
    Mr. Hudson. Great. Well, I appreciate all your testimony 
very much.
    And, with that, Mr. Chairman, I yield back.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentleman from Georgia for 5 
minutes for questions, please.
    Mr. Carter. Thank you, Mr. Chairman.
    And thank all of you for being here. We really appreciate 
your participation in this.
    Dr. Holaday, I will start with you and, first of all, thank 
you for this very innovative product that you have come up 
with. This is certainly something that we can find very useful.
    I can tell you, as a practicing pharmacist for many years, 
I wished I had a dollar for every time someone tried to bring 
their medication back to the pharmacy, saying ``Here,'' a loved 
one had passed or whatever and, ``Will you dispose of these for 
me?'' And, of course, we can't do that. By law, we can't do it, 
and I don't want to do it. There have been some take-back 
programs that have worked well, and some of the local police 
agencies had had some programs that worked well, and some of 
the drugstore chains have had some that worked well.
    But this is a safe and convenient way to get rid of it. One 
of the things, as you know, that we don't want to encourage is 
to have them flush everything. It can cause a lot of problems 
environmentally, particularly with some drugs.
    I am telling my age here, but I can remember, I was a 
nursing home consultant for many years, and I had to do drug 
disposal at the nursing homes. And we would burn them and flush 
them and everything. That was a long time ago, but it is a 
serious problem.
    But I do thank you for what you have come up with and do 
encourage people, because it is safe; it is convenient. We have 
always encouraged them to create a slurry and put in the trash 
as opposed to flushing it. So it is very innovative, and I 
congratulate you on that and thank you for that.
    I wanted to go next to Ms. Esham and ask you, one of the 
things that I have been concerned about and that I have been on 
the pharmaceutical manufacturers about is the fact that there 
is a big gap between what physicians can write for for pain 
relief and what they can't write for.
    Once you get past ibuprofen and tramadol, you go to the 
opioids, and there is really nothing in between. Now, you could 
argue you could use Neurontin, but, I mean, basically there is 
nothing in between. So I have been trying to encourage them, 
you know: You have got to come up with something innovative.
    Over the years of practice I have been in pharmacy, I have 
seen them come up with nothing short of miracles in the 
innovation they have come up with through research and 
development. But there is a big gap there.
    One of the things that--and this is not necessarily a drug, 
but what we talked about before was the abuse deterrent 
formulations of opioids and how that can help. I just wanted to 
ask you, do you find that Medicare coverage creates some 
barriers sometimes to this?
    Is that something that you have noticed that perhaps they 
are requiring a prior approval or you have got to try something 
else first? Are these barriers that cause us not to be able to 
use these medications more?
    Ms. Esham. The short answer is yes. At BIO, a majority of 
our membership are actually small, emerging companies that rely 
on venture capital. So, again, you have to take into account, 
if there is a lack of understanding or an understanding that 
you will not be able to get your products covered in the 
market, you are not going to get strong investment into those 
therapeutic areas.
    And particularly when we look at pain and the addiction 
space, I think CARA went a long way to try to address some care 
limits for people suffering from addiction. But is there more 
work to do? Yes, and we stand ready to do that.
    In terms of practices, I think, there are barriers in the 
way that pain medication is often bundled at hospitals. It sort 
of prevents, again, alternatives or full discussion and full 
access to the array of medicines available.
    There are fail-first protocols in place that we think need 
to be reexamined. Step therapies, again, we think, need to be 
reexamined. Basically what we want is a smart patient/doctor 
informed decisionmaking process and not have outdated or 
outmoded approaches to coverage that are actually getting in 
the way of providing that best care.
    Mr. Carter. Right.
    Mr. Francer, I wanted to ask you, as part of CARA, we allow 
for the partial filling of C2 prescriptions. And I was really 
in favor of that and think that that is something that we need 
to do. Have you had any experience with it? Does it seem to be 
working better?
    Mr. Francer. I don't. Happy to try to get back to you after 
the hearing though.
    Mr. Carter. OK. Well, I really do think that that was 
something that we needed to do. And right now, it is up to the 
patient and to the physician. But even if we can extend it to 
where the pharmacist might have some input on that as well, I 
think that could help as well.
    But, again, I want to thank all of you. This is the boots 
on the ground, if you will. And this is the type of thing that 
we need. And all of you are doing great work in helping us with 
what is obviously a big problem and obviously a problem that is 
not going to have just one solution. It is going to take all of 
us and many solutions to help with this. So thank you.
    And I yield back, Mr. Chairman.
    Mr. Burgess. The chair thanks the gentleman.
    The gentleman yields back.
    And, Mr. Francer, I am going to recognize myself 5 minutes 
for questions now. And, too, my apologies; I was with Mr. 
Griffith on the floor doing a bill between our panels.
    Let me ask you, when you get back to Mr. Carter on the 
partial filling issue, I would like for you to share that 
information with our office as well. I would probably have a 
different perspective than Mr. Carter, having written a lot of 
prescriptions myself.
    I kind of want to know that my patient has filled what I 
ask them to fill, and if they didn't, perhaps I need to know 
that because I might be asked to refill. So, anyway, I would 
appreciate your follow-through on that.
    Now, Ms. Esham, I will just ask you: I have been on this 
committee now since January of 2005. One of the first hearings 
that I was here for was a hearing on why doctors don't 
prescribe enough pain medicine.
    So I was intrigued, in your testimony, you said the 
importance of ensuring that patients suffering from pain or 
addiction are able to receive the right treatment at the right 
time with the right support without stigma, and so I certainly 
agree with you on that.
    You have any other thoughts that you would like to share 
with the subcommittee in that regard?
    Ms. Esham. So I would like to highlight a couple things in 
addition to the coverage barriers and the NIH data analysis 
proposals we have put forward.
    Again, going back to my earlier statements about the 
importance of signaling to investors that the development of 
treatments that are better, that provide improved quality of 
care, and are safer are our top priority. There are lots of 
ways to create an environment that will stimulate investment.
    And at the FDA, there are development issues as we look 
over lessons learned of some innovative treatments that maybe 
have not been able to obtain approval. We have identified some 
problematic areas that we think would benefit from 
collaboration and discussion and perhaps additional guidance.
    For example, when you talk about benefit-risk assessment, 
we want to make sure we understand that the context of 
presenting and proving that your drug is safer, or provides 
better care, how that benefit-risk assessment will be done in 
the context of existing options.
    We need to find better ways to develop medicines for broad 
chronic pain indications. So, right now, you have a lot of 
requirements. You have to do many, many trials. And, again, so 
people are like, ``Well, maybe I can't spend that much money in 
this risky environment to do that many trials for a single 
indication.''
    Additionally, I think we really need to look at how we can 
better measure and assess pain. So this is both in a clinical 
trial setting as well as in the clinic. Are we really doing the 
best we can?
    Are we diagnosing in the best way possible to understand 
what the needs are of a patient with acute pain versus patients 
with chronic pain versus a patient that has psychological or 
psychic pain? So there is a lot of work that we think would 
benefit from collaboration and further guidance in those areas.
    Mr. Burgess. Well, we heard Dr. Gottlieb address that issue 
about the datasets that we have for assessing pain.
    I will tell you that I am old enough to remember the 
introduction of a compound called Stadol that was supposed to 
be the answer to providing pain relief without any of the 
untoward side effects of opiates, and it turns out it was 
probably just as bad, if not worse.
    So I am always very skeptical when someone says, ``Oh, I 
have got something now here that you can now use for pain that 
has none of the stigma or the side effects.''
    And, again, I think we heard Dr. Gottlieb address that.
    But can you just talk a little bit more about some of the 
ways where you might think that private sector, Congress, and 
the FDA could work together as far as developing some of these 
novel approaches?
    Ms. Esham. So, again, we find there is a lot of value, 
again, in just holding public--where you have a topic, you hold 
a public meeting, you bring the best and brightest together to 
discuss critical issues. And then the next step that is 
critical to making this impact change is to come up with 
recommendations for change and get public reaction and expert 
input on that and then implement change.
    Mr. Burgess. That is what we are doing.
    Ms. Esham. It is really wash, rinse, and repeat, right. We 
have done this before.
    And I would like to, just if I can indulge for a moment, we 
did just put out a report really examining the historical state 
of innovation for pain and addiction treatments that you, 
particularly as a physician, may find interesting in the sense 
of really looking at targets that didn't work but really 
highlighting some new ways and new thinking that we have that I 
think do hold, again, a lot of promise.
    Again, sometimes not everything turns out the way you had 
hoped, but I think there are a lot of exciting things in the 
pipeline.
    Mr. Burgess. Very well.
    And, Dr. Holaday, before we finish up, I don't know if I 
heard the answer to Mr. Griffith's question. You have got this 
stuff emulsified in the gel. Is it inert at that point, or 
could you use it as a Jell-O shot if you were so inclined?
    Mr. Holaday. It is inert. And if you were to swallow the 
whole thing, pills and all, you would just pass it through 
because nothing extracts from this once it has been formed. It 
is a gel. It is an inert gel. It is biodegradable.
    Mr. Burgess. But if you chewed it, would you release the 
active compounds?
    Mr. Holaday. No, you would not.
    Mr. Burgess. So the active compounds are indeed----
    Mr. Holaday. They are chemically and physically bound, or 
sequestered, in a matrix from which they can't be extracted.
    Mr. Burgess. OK. And I am just asking for a friend. I was 
not going to chew the emulsified pills.
    Mr. Green, did you have a redirect?
    Mr. Green. No.
    Mr. Burgess. You have been sitting here so patiently.
    And I will yield back my time. Seeing that there are no 
other members wishing to ask questions, I once again want to 
thank our witnesses for being here today.
    I would also like to submit for the record a statement from 
the Substance Abuse and Mental Health Services Administration 
expressing support for Congress, examining the alignment of 
part 2 with HIPAA.
    Mr. Burgess. That is the wrong one.
    We are not going into recess.
    Mr. Green. I did that earlier, Mr. Chairman.
    Mr. Burgess. Oh, we are going into recess? Oh. That is 
right. We have got to do this all over again.
    The subcommittee will now go into recess, and we will 
reconvene for the third and fourth panels tomorrow morning at 
10:00 a.m.
    The committee stands in recess.
    [Whereupon, at 3:12 p.m., the subcommittee recessed, to 
reconvene at 10:00 a.m., Thursday, March 22, 2018.]
    [Material submitted for inclusion in the record follows:]
    
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]      
    



 COMBATING THE OPIOID CRISIS: PREVENTION AND PUBLIC HEALTH SOLUTIONS, 
                                 DAY 2

                              ----------                              


                        THURSDAY, MARCH 22, 2018

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:02 a.m., in 
room 2123 Rayburn House Office Building, Hon. Michael Burgess 
(chairman of the subcommittee) presiding.
    Members present: Representatives Burgess, Guthrie, Upton, 
Shimkus, Latta, McMorris Rodgers, Lance, Griffith, Bilirakis, 
Long, Bucshon, Brooks, Mullin, Hudson, Collins, Carter, 
Walden(ex officio), Green, Engel, Schakowsky, Matsui, Castor, 
Sarbanes, Lujan, Schrader, Kennedy, and Eshoo.
    Also present: Representatives Walberg, Tonko, and Johnson.
    Staff present: Mike Bloomquist, Staff Director; Adam 
Buckalew, Professional Staff Member, Health; Daniel Butler, 
Staff Assistant; Karen Christian, General Counsel; Zachary 
Dareshori, Legislative Clerk, Health; Margaret Tucker Fogarty, 
Staff Assistant; Adam Fromm, Director of Outreach and 
Coalitions; Caleb Graff, Professional Staff Member, Health; Jay 
Gulshen, Legislative Associate, Health; Peter Kielty, Deputy 
General Counsel; Ed Kim, Policy Coordinator, Health; Mark 
Ratner, Policy Coordinator; Kristen Shatynski, Professional 
Staff Member, Health; Jennifer Sherman, Press Secretary; 
Danielle Steele, Counsel, Health; Austin Stonebraker, Press 
Assistant; Hamlin Wade, Special Advisor, External Affairs; 
Everett Winnick, Director of Information Technology; Jacquelyn 
Bolen, Minority Professional Staff; Jeff Carroll, Minority 
Staff Director; Waverly Gordon, Minority Health Counsel; 
Tiffany Guarascio, Minority Deputy Staff Director and Chief 
Health Advisor; Tim Robinson, Minority Chief Counsel; Samantha 
Satchell, Minority Policy Analyst; Andrew Souvall, Minority 
Director of Communications, Outreach and Member Services; 
Kimberlee Trzeciak, Minority Senior Health Policy Advisor; and 
C.J. Young, Minority Press Secretary.
    Mr. Burgess. I ask all of our guests to please take their 
seats. The Subcommittee of Health will come to order. I want to 
welcome everyone to our second day of our hearing on Combating 
the Opioid Crisis through Prevention and Public Health 
Solutions. I want to thank our witnesses for taking time to 
testify before the subcommittee today. The good news for you is 
you don't have to listen to us, we spoke yesterday.
    So we will hear from you this morning. Each witness will 
have the opportunity to give an opening statement that will be 
followed by questions from members. As I mentioned to some of 
you as we started, the brief housekeeping detail, we will have 
a vote on the floor probably around 10:30 to 10:40 and the 
committee will recess briefly when we have to go vote on the 
floor.
    But today we are going to hear from Dr. Eric Strain, the 
Director for the Center for Substance Abuse Treatment and 
Research at Johns Hopkins University; Dr. Kenneth Martz, 
Special Projects Consultant, Gaudenzia; Mr. Brad Bauer, Senior 
Vice President of New Business Development and Customer 
Relationships; Dr. William Banner, Medical Director of the 
Oklahoma Center for Poison and Drug Information and the Board 
President of the American Association of Poison Control 
Centers; and, Dr. Michael Kilkenny, Physician Director, Cabell-
Huntington Health Department of West Virginia. We appreciate 
all of you being here today. Dr. Strain, you are recognized for 
5 minutes to summarize your opening statement, please.

    STATEMENTS OF ERIC C. STRAIN, MD, DIRECTOR, CENTER FOR 
     SUBSTANCE ABUSE TREATMENT AND RESEARCH, JOHNS HOPKINS 
  UNIVERSITY SCHOOL OF MEDICINE; KENNETH J. MARTZ, PSYD MBA, 
   SPECIAL PROJECTS CONSULTANT, GAUDENZIA, INC.; BRAD BAUER, 
SENIOR VICE PRESIDENT OF NEW BUSINESS DEVELOPMENT AND CUSTOMER 
 RELATIONSHIP MANAGEMENT, APPRISS HEALTH; WILLIAM BANNER, MD, 
  PHD, MEDICAL DIRECTOR, OKLAHOMA CENTER FOR POISON AND DRUG 
INFORMATION AND BOARD PRESIDENT, AMERICAN ASSOCIATION OF POISON 
 CONTROL CENTERS; AND, MICHAEL E. KILKENNY, MD, MS, PHYSICIAN 
 DIRECTOR, CABELL-HUNTINGTON HEALTH DEPARTMENT OF WEST VIRGINIA

                    STATEMENT OF ERIC STRAIN

    Dr. Strain. Thank you. Thank you, Chairman Burgess, Ranking 
Member Green, and members of the subcommittee. Thank you for 
inviting me to participate in today's hearing and for devoting 
2 full days to legislative solutions to address the opioid 
crisis and the scourge of addiction in our communities, a topic 
which has been the focus of my professional career.
    My name is Eric Strain. I am a physician who practices as a 
psychiatrist and conducts substance abuse research, and I am 
the director for the Johns Hopkins Center for Substance Abuse 
Treatment and Research. I have seen the devastating impact of 
drug abuse and the current federal regulations that limit the 
use and disclosure of patients' substance abuse treatment 
records and I am pleased that this Congress is taking a 
proactive step to update the law to be more in keeping with 
modern-day, multidisciplinary medical practice and the best 
patient care.
    The Amendment in the Nature of a Substitute to H.R. 3545 as 
offered by Representative Mullin will enhance our ability to 
share vital health information in a timely manner. Though well 
intentioned at its enactment more than 40 years ago, 42 CFR 
Part 2 is outdated and, worse, it can result in harm to 
patients and impedes the relationship between providers and 
their patients. Full alignment of federal privacy rules with 
HIPAA for the purposes of treatment and healthcare operations 
will ensure that patients with substance use disorders receive 
accurate diagnoses, integrated and coordinated treatment, and 
patient-centered care.
    Under 42 CFR Part 2, substance use disorder records must 
remain separate and segmented from any other medical record and 
cannot be shared with a patient's primary care provider or 
other specialist without the express written consent of the 
patient. Obtaining this consent can be a challenge under a 
variety of scenarios and the current segmentation of records 
runs counter to the idea of holistic and coordinated treatment 
of the patient. Not knowing a patient is in substance abuse 
treatment increases risks, for example, with medication 
interactions or in delivering care under an emergency 
situation.
    It also can interfere with effective integrated care. Let 
me give you an example. The Johns Hopkins Center for Addiction 
and Pregnancy is a substance abuse treatment program that helps 
pregnant women and their babies and includes substance use 
staff as well as OB-GYN, pediatrics, and psychiatry. This 
multidisciplinary program needs ready communication between 
providers. Full information is essential to support clinicians' 
efforts to care for the pregnant woman pre-term and then both 
patients, the mother and her child, postpartum. This example 
clearly demonstrates the varied teams of caregivers such as 
neonatologists, obstetricians, case managers, et cetera.
    Our healthcare system does not put records for other 
medical conditions such as HIV and AIDS in a separate and 
protected system. We don't put a patient's social history 
behind a wall and tell other providers they can't have ready 
access to information about what may be sensitive topics. The 
various workarounds that are offered introduce more impediments 
in an already busy healthcare system and further contributes to 
the perception that substance use is different from all other 
medical care.
    In my opinion, continuing to consider substance abuse 
disorder information distinct from other medical information 
actually perpetuates stigma. Concerns about inappropriate 
release of information are addressed in the Mullin amendment 
which includes vital antidiscriminatory language as well as 
protections against criminal prosecution.
    Finally, I have reviewed Jessie's Law as well and I support 
any effort to promote dialogue that encourages coordination of 
care and the sharing of necessary information so long as it is 
paired with the Mullin amendment. Jessie's Law relies on 
patient-volunteered information and it is my experience that 
through no fault of the patient, patient-volunteered 
information is sometimes inaccurate or incomplete, or places a 
large burden on the patient.
    Therefore, as I have already expressed, a system that 
relies on consents or patient-volunteered information is 
fundamentally flawed. Healthcare providers are on the front 
lines of treating opiate and other substance use disorders. We 
are uniquely positioned to help but we cannot do so without an 
unobstructed view of a patient's medical records. You have an 
opportunity to move us forward in these efforts and help those 
on the front lines of treating people who suffer from drug 
abuse.
    I urge the committee to report out legislation amending 42 
CFR Part 2 that allows the responsible sharing of patient 
records for the purposes of treatment and healthcare 
operations. Thank you and I would be pleased to answer any 
questions you may have.
    [The prepared statement of Dr. Strain follows:]
    
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    Mr. Burgess. Thank you, Dr. Strain.
    Dr. Martz, you are recognized for 5 minutes, please.

                   STATEMENT OF KENNETH MARTZ

    Mr. Martz. Good morning. Thank you so much, Chairman 
Burgess and Ranking Member Green, for this opportunity to come 
here and testify on this important issue. This is an issue that 
is affecting 23 million Americans who are in recovery from 
substance use disorder and who have had their experience with 
treatment and are now working through the system in addition to 
those who are actively in substance use disorder.
    I am Dr. Ken Martz. I am a licensed psychologist. I am 
working with Gaudenzia. I have been working in multiple States 
in private practice and in State government settings, in public 
settings as well as private, for 25 years. This has been my 
life's work and my passion and I love this work and I really 
appreciate this opportunity.
    42 CFR's protections are critical to maintain, to ensure 
that people enter treatment for substance use disorder. This is 
something we know from SAMHSA, which has studied this 
extensively, and they find that the top reasons why people do 
not go to treatment continue to be fear of stigma. What will my 
employer think? What will my neighbors think? What harms will 
come of me if I disclose those secret harms and guilts and 
shames? The research finds that this fear of impacts is a 
primary reason.
    And the Congress recommended this as well, back in 1972, 
they stated that, ``The conferees wish to stress their 
conviction that the strictest adherence to the provisions of 
this section is absolutely essential to the success of all drug 
abuse prevention programs.'' This was echoed by the Supreme 
Court as well, which affirmed ``like the spousal and attorney 
client privileges, the psychotherapist patient privilege is 
rooted in the imperative need for confidence and trust.''
    Treatment by a physician for his physical ailments can 
often proceed successfully on the basis of physical examination 
and the results of diagnostic tests. Effective psychotherapy, 
by contrast, depends on the atmosphere of confidence and trust 
in which the patient is willing to make a frank and complete 
disclosure of facts, emotions, memories, and fears. For this 
reason, the mere possibility of disclosure may impede the 
development of the confidential relationship necessary for 
successful treatment. I urge you to remember the wisdom of 
these chambers.
    Oddly, it is funny. We walk in here today and the news of 
the day is about hacking and data breaches and Cambridge 
Analytica with a new focus on there being death penalty for 
those who have a substance use history and have sold a drug. So 
if my child hands over some drugs to his girlfriend, she dies, 
he is now potentially at risk. We don't know what the laws will 
change in the future. This has a chilling effect on people 
being willing to attend treatment.
    The impacts on patients, I know you know you are hearing 
from many healthcare organizations that find this very 
inconvenient, but this is not about inconvenience. This is 
about patient care. This is about patient health and being able 
to access exactly what they need. If we want to discuss 
coordinated care the best way to do that is direct conversation 
with the patient and direct conversation therapist-to-therapist 
which is not impeded by 42 CFR protections. It actually gives 
the patient the respect of being involved in that process.
    If you are going to share my information about my trauma 
and my trauma histories, please do me the respect of asking me 
and letting me know where it is going to go to before it gets 
shared to thousands of other people potentially having access. 
Now, put simply, some of the important protections included 
that once they are labeled it can affect clinical decision 
making for a lifetime. It cannot be amended and you cannot fix 
things like prison time or loss of employment.
    These are professionals we are talking about like teachers, 
physicians, government workers, who may avoid treatment for 
fear of harm, for fear of being disclosed, and therefore they 
may get worse because they didn't get the care that they needed 
because they have delayed. The stigma is still alive long and 
strong.
    Looking at some recent comments, one was said, overdose is 
nature's way of taking out the trash. Oh my gosh. Overdose is 
nature's way of taking out the trash.
    I have plenty of compassion for those who deserve it. I 
have no compassion for those who made their own problems such 
as dopers, pedophiles, and murderers.
    It is hard to even say these words. These are the levels of 
stigma that is out there today that our clients are facing on a 
daily basis and it is very difficult to identify and manage 
these harms that may arise. Eliminating these Part 2 
protections will brand these individuals with like a scarlet 
letter so they when they walk in the door they can be 
identified immediately as having this problem, as having this 
history as well as the risks associated.
    Stigma affects all of us in many different ways. Remember 
that making these changes is every time we make these changes, 
every time changes are made as a provider I need to learn about 
them, I need to train the field and, worse, tell the client 
that every day what they told me yesterday in private is no 
longer private today. In all my years, I can't tell you how 
important this is. And if there was only one other thing that 
you could possibly do, and in addition to this I would be happy 
to answer other things, please get rid of that IMD exclusion. 
It is harming people and stopping care. Thank you.
    [The prepared statement of Mr. Martz follows:]
    
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    Mr. Burgess. Thank you, Dr. Martz.
    Mr. Bauer, you are recognized for 5 minutes, please.

                    STATEMENT OF BRAD BAUER

    Mr. Bauer. Thank you and good morning. Chairman Burgess, 
Ranking Member Green, and members of the Health Subcommittee, 
thank you for the opportunity to testify today on the role of 
Prescription Drug Monitoring Programs or PDMPs in combating the 
opioid crisis as well as the PDMP discussion draft from 
Representative Griffith and Ranking Member Pallone.
    My name is Brad Bauer and I am Senior Vice President with 
Appriss Health and have responsibility for our State and 
Federal PDMP solutions. We provide a common platform and 
software solution for 42 of the 52 established PDMPs throughout 
the United States and U.S. territories. State-based PDMPs 
continue to evolve and innovate in the face of our nation's 
opioid crisis. While each State faces unique challenges brought 
on by the crisis, tremendous progress has been made within a 
few critical areas each of which have been identified by 
government and research organizations as best practices to 
ensure effective and impactful PDMPs.
    First, the ability for States to share PDMP data with other 
States provides prescribers and pharmacists with a more 
complete view of the patient's controlled substance history. In 
2011, the National Association of Boards of Pharmacy created a 
PMP Interconnect with technical assistance from Appriss Health 
to allow States to securely and efficiently share data in real-
time at no cost to the States.
    [Slide shown.]
    Mr. Bauer. As you can see on the monitors, the numbers of 
states participating has grown rapidly to 45 PMPs today. For 
the remaining States not currently participating, policy issues 
not technology are the only barriers. Most recently, Florida 
passed legislation allowing the State to share their PDMP data 
with other PMP Interconnect states effective July 1st, 2018.
    Second, and probably the most impactful developments for 
State PDMPs, has been integration of PDMP data and analytics 
within the electronic health record or pharmacy dispensation 
system to enable one-click or in some cases no-click access for 
prescribers and pharmacists. The majority of States are moving 
in the direction of active integrations of their data and 
analytics within clinical workflows with about 20 percent of 
providers currently having access to integrated PDMP reports.
    However, broader adoption has been slow due to the need for 
funding to cover costs of integrations. Integration of PDMP 
data and analytics promotes efficient and consistent use of 
PDMPs by providers when making clinical decisions. For example, 
Ohio has seen a 1000 percent increase in usage of the PDMP as a 
result of their statewide PDMP integration effort.
    States are also in the process of transforming their basic 
PDMP systems into substance use disorder platforms that deploy 
the capabilities necessary to impact the epidemic and bend the 
overdose death curve down and not just drive down the number of 
controlled substances prescribed. States like Indiana, Oregon, 
Michigan, Delaware, Iowa, Ohio, and Virginia are just a few 
examples of States that have already taken steps to transform 
their PDMPs.
    Examples of new developments in PDMP capabilities include 
inclusion of additional data sources such as history of 
nonfatal overdoses; drug court information and toxicology data; 
patient-at-risk scores to help a practitioner quickly assess 
the risk and engage the patient accordingly; the ability to 
refer patients to treatment, often referred to as a warm hand-
off within the PDMP; and facilitation of care team 
communications.
    All these capabilities and clinical tools are designed to 
help the practitioners identify prescription drug overdose 
sooner versus later, mitigate the chance of an illicit drug 
encounter, and engage with their patients and assure they have 
and receive the help they need. The PDMP discussion draft from 
Representative Griffith and Ranking Member Pallone would 
incentivize States to continue to improve their PDMPs through 
evidence-based prevention grants along with evaluating 
interventions to prevent overdoses and implementing new 
projects to respond to the evolving crisis in innovative ways.
    As you have heard one of the panels yesterday, the Centers 
for Disease Control is engaged in a number of these activities 
but the legislation authorized would help to improve on CDC's 
work. Second, the draft would establish grants for an enhanced 
surveillance of controlled substance overdoses which would 
authorize and provide funding for an existing CDC program to 
collect more comprehensive, timely, and quality data on 
overdoses.
    We would recommend that this data be incorporated into the 
PDMPs. This discussion draft would allow states to continue 
their PDMP innovations to provide prescribers and pharmacists 
with a near instantaneous access to interstate PDMP information 
combined with the clinical tools to intervene in a meaningful 
way when a patient presents with a possible risk overdose 
misuse.
    Thank you for your leadership on this critical issue facing 
so many communities and for the opportunity to address the 
committee today. I look forward to your questions.
    [The prepared statement of Mr. Bauer follows:]
    
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    Mr. Burgess. Thank you, Mr. Bauer.
    Dr. Banner, you are recognized for 5 minutes.

                  STATEMENT OF WILLIAM BANNER

    Dr. Banner. Chairman Burgess, Ranking Member Green, and 
members of the subcommittee thank you for the opportunity to 
testify in support of the reauthorization of the National 
Poison Center program entitled, Poison Center Network 
Enhancement Act of 2018. This legislation was first enacted 
into law in 2000 and has been reauthorized three times. The 
measure before the subcommittee today would reauthorize the 
poison center program through fiscal year 2024.
    My name is Dr. Bill Banner and I currently serve as the 
President of the American Association of Poison Control 
Centers. I am also the medical director of the Oklahoma Center 
for Poison and Drug Information. For over 30 years, I have been 
privileged to care for critically ill children, currently 
practice in the pediatric intensive care unit at Baptist 
INTEGRIS Medical Center in Oklahoma City. I also happen to be 
downsizing to a home in Congressman Mullin's district.
    The Nation's 55 poison control centers operate 24/7/365 to 
cover all U.S. States and territories and receive three million 
calls annually including about 70,000 calls a year for 
exposures to opioids. Nearly one quarter of our calls come from 
emergency rooms and urgent care facilities. Calls are answered 
by highly trained medical professionals with 24-hour oversight 
from physicians who are board certified medical and clinical 
toxicologists, many of whom are trained in addiction medicine. 
We handle calls related to over 430,000 products and substances 
and their related toxicities.
    Poison control centers are on the front lines of the opioid 
epidemic handling approximately a half million cases of opioid 
misuse and abuse since 2011. That is an average of 192 per day, 
every day. We assist first responders and hospital personnel.
    [Slide shown.]
    Dr. Banner. As you can see from the slide, the percent of 
opioid exposure calls from healthcare facilities to poison 
centers are on the rise and we believe this will continue in 
2018. We deliver countless hours of education on topics like 
identifying emerging drugs of abuse and the safe storage and 
disposal of prescription opioids. Through national surveillance 
activities, poison centers have identified trends involving 
fentanyl and other opioid analogue penetration into communities 
which is then shared with Federal, State, and local 
enforcement.
    Centers also educate on the proper use of naloxone. With 
the rise of heroin mixed with the more potent fentanyl, the 
administration of naloxone has become far more complex and 
dangerous for emergency responders to administer. Centers also 
contribute to medical education on pain management, 
prescribing, and addiction treatment. Consultation with a 
poison control center can also significantly decrease the 
patient's length of stay in a hospital and decrease hospital 
costs. In fact, poison control centers save more than $1.8 
billion annually including $382 million in Medicaid and $307 in 
Medicare per year.
    Poison center data can often be utilized to identify new 
and emerging drugs of abuse faster than virtually any other 
resource. For example, this past summer, the Georgia Poison 
Control Center, which serves Subcommittee Carter's district, 
was the first public health entity to detect and respond to a 
novel opioid outbreak. Yellow pills stamped with Percocet that 
in fact contained a mixture of two synthetic fentanyl analogues 
that could have remained undetected indefinitely and racked up 
untold fatalities but for the work of the Georgia center.
    This unique capability exists at every poison center in the 
country. Centers are also a critical resource for emergency 
preparedness and response. For example, centers have served in 
response to Zika, Ebola, synthetic cannabinoids, e-cigarettes, 
H1N1, marijuana abuse and misuse, carbon monoxide, toxic 
exposures following national disasters, and even the social 
phenomenon, the so-called Tide Pod Challenge.
    Additionally, each center has an educator working to 
increase public awareness on the dangers of poisoning and 
opioid misuse. In fact, this week is National Poison Prevention 
Week. Examples of education outreach surrounding the opioid 
crisis include presentations to parent groups regarding 
medicine literacy and substance misuse prevention as well as 
participation in local community events.
    In summary, poison control centers are a unique combination 
of clinical care, cost effectiveness, public health 
surveillance, and interaction with those on the front lines of 
the opioid crisis from first responders to law enforcement and 
everyone in between.
    I want to thank Representatives Brooks, Engel, Barton, and 
DeGette for their continued support and bipartisan introduction 
of this critical legislation. It is a proven, highly efficient 
network most deserving of full congressional support and 
reauthorization. I am happy to answer any questions you may 
have. Thank you again for this opportunity.
    [The prepared statement of Dr. Banner follows:]
    
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    Mr. Burgess. Thank you Dr. Banner.
    The vote on the floor has been called. But, Dr. Kilkenny, 
let us hear from you and then we will recess until after votes. 
So you are recognized for 5 minutes.

                 STATEMENT OF MICHAEL KILKENNY

    Dr. Kilkenny. Chairman Burgess, Ranking Member Green, and 
members of the subcommittee thank you for inviting me today to 
testify on behalf of local health departments across the 
country that are facing unprecedented threats in the form of 
opioid-related death and disease.
    My name is Michael Kilkenny. I am the Physician Director of 
the Cabell-Huntington Health Department in Huntington, West 
Virginia. I am representing health departments today as a 
member of the National Association of County and City Health 
Officials, NACCHO. More than a hundred Americans die each day 
from overdose with a staggering economic toll impacting the 
workforce of this generation and threatening generations to 
come.
    My State has Nation leading rates of overdose death, 
Hepatitis B, Hepatitis C, and neonatal abstinence syndrome. My 
county along with 28 other counties in my State and 220 
counties across the Nation face the real threat of catastrophic 
HIV outbreaks. These challenges, however, create remarkable 
opportunities for us to save lives and prevent disease.
    In 2015, Huntington leaders implemented a comprehensive 
opioid response plan that is changing those statistics at home. 
With help from CDC we started the first sanctioned harm 
reduction program in West Virginia. We trained and supplied all 
our law enforcement agencies with naloxone. Cabell County 
community members and first responders reversed more than 2,500 
overdoses last year, saving countless lives and a new Quick 
Response Team is linking overdose survivors to treatment. 
Without Federal support we would not have been so successful.
    Regarding infectious disease, the opportunity to prevent is 
now. In my county we have been able to decrease new Hepatitis C 
cases by 60 percent, using harm reduction strategies and 
training from CDC. And CDC assistance in surveillance has 
allowed us to identify and implement specific strategic 
measures to prevent an HIV outbreak. The Eliminating Opioid-
Related Infectious Diseases Act of 2018 authored by 
Representative Leonard Lance of this committee would provide an 
additional $40 million to CDC, money needed for Hepatitis C and 
HIV surveillance activities that help local health departments 
stop outbreaks before they occur, especially infections 
associated with injection drug use.
    On behalf of NACCHO I would like to suggest the bill be 
expanded to include surveillance of Hepatitis B. Opioid 
overdose from prescription and illicit drugs require special 
surveillance and rapid intervention to address emerging drug 
threats.
    Fentanyl, a particularly deadly opioid due to its potency, 
struck my city and other parts of our Nation especially hard in 
2016. It remains the drug most frequently found in overdose 
autopsies from my county. Any street drug product might contain 
fentanyl, and neither users, police officers nor public health 
officers know if it is there or not. A bill to improve fentanyl 
testing and surveillance authored by Representative Ann Kuster 
addresses this threat with assistance to public health 
laboratories in detecting fentanyl and its many analogues.
    NACCHO recommends that in addition to agencies named in 
this bill, CDC should be included in these efforts. I also 
support the pilot program authorized in this bill which would 
allow point-of-use testing that could save lives and modify 
drug use behavior. Local health departments like mine are 
working 24/7 to save lives and reduce the risk of opioid 
overdose and the risk of life-threatening infections.
    In closing, I hope that Congress will make an increased 
investment in funding for CDC and other public health agencies 
engaged in this fight. We have seized our opportunity in 
Huntington and we are succeeding. NACCHO represents nearly 
3,000 other local health departments, big and small, ready to 
fight this opioid epidemic and we need your ongoing help. Thank 
you.
    [The prepared statement of Dr. Kilkenny follows:]
    
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    Mr. Burgess. Thank you, Dr. Kilkenny.
    Again, the chair observes we do have a vote on the floor. 
So we are going to take a recess so members can go and be 
recorded on a procedural vote on the floor of the House and we 
will reconvene immediately after votes where we will start the 
member questions. So thank you all for your testimony. We stand 
in recess.
    [Whereupon, at 10:30 a.m., the subcommittee recessed, to 
reconvene at 11:12 a.m., the same day.]
    Mr. Burgess. I call the subcommittee back to order. Again I 
want to thank our witnesses for their testimony. We are going 
to move into the question portion of the hearing, but I do want 
to recognize the gentleman from Texas for his unanimous consent 
request.
    Mr. Green. Thank you, Mr. Chairman. I request unanimous 
consent to enter into the record a statement from 
Representative Ann Kuster who actually sat through some of our 
hearing yesterday in support of her draft under consideration 
to improve fentanyl surveillance and testing as well as bills 
featured as part of the Bipartisan Heroin Task Force 
legislative agenda for 2018. I ask unanimous consent the 
statement will go in the record.
    Mr. Burgess. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Burgess. And the chair will recognize himself 5 minutes 
for questions.
    Dr. Banner, in your testimony you referenced the difficulty 
of treating fentanyl with naloxone. Could you elaborate on that 
just a little bit?
    Dr. Banner. That is a pharmacologic and toxicologic 
problem. As you, I am sure, recognize fentanyl's potency means 
that naloxone may at times be required to give increased doses 
to reverse it because it is binding to the mu receptors. And I 
know I am not talking to most of the people in the room, but--
--
    Mr. Burgess. Just talk to me. It is OK.
    Dr. Banner. The mu receptor affinities are so high----
    Mr. Burgess. That is why I am sitting in this chair.
    [Laughter.]
    Dr. Banner [continuing]. With that affinity it takes a lot 
of naloxone sometimes to reverse them. Plus, if they are 
chronically using fentanyl and they get their body burden 
increases then the apparent duration of action of fentanyl can 
exceed the duration of naloxone and you may have to give a 
repetitive dose. And the third issue is that there are pretty 
good case reports where reversing fentanyl produces such a 
surge in adrenalin that you actually can get noncardiogenic 
pulmonary edema, or a flooding of the lungs with fluid, and 
that of course can convert a life-threatening situation into a 
life-threatening situation. So, we feel like that has upped the 
ante quite a bit.
    Heroin reverses pretty easily and it has, the duration of 
action of heroin itself is 7 to 8 minutes so it is a rapid 
high. If you get in trouble you reverse it and then the 
naloxone usually covers it. But drugs like methadone when they 
are involved or some of these fentanyl derivatives can really 
prolong the toxicity and therefore the need for repetitive 
doses and it makes it more complex.
    Mr. Burgess. All right, thank you. The way you are in your 
testimony that administration of naloxone is far more complex 
and dangerous for emergency responders to administer, I 
misinterpreted it. I thought for some reason it would be 
dangerous to the ER doc, but you are saying it is dangerous to 
the patient----
    Dr. Banner. Yes.
    Mr. Burgess [continuing]. During the administration 
episode. Very good. Thank you for clearing that up.
    And, Dr. Kilkenny, let me just ask you. We started this 
week in another subcommittee, the Oversight and Investigation 
Subcommittee, with the acting administrator of the Drug 
Enforcement Administration and focusing more on the enforcement 
side of this equation. And your State obviously came up for 
some discussion because of the delivery of pharmaceutical 
product to locations that seemed far in excess of the 
population that would be making itself available to that retail 
establishment, and I am trying to say that as carefully as I 
can.
    But then in your testimony you talked about in 2016 
fentanyl sort of bumped up. Were you aware in your communities 
that this problem of the excess delivery was occurring? Was 
that something that was novel when it was discovered? Just let 
us know what you saw on the ground as those years were 
unfolding.
    Dr. Kilkenny. Because I live there and I have seen the pill 
mills operating and I knew when I was practicing how that 
worked, I was not surprised to know that there was an 
overabundance of supply to very small towns that were servicing 
certainly the vehicles parked in those parking lots had license 
plates from all over the country. So I was aware of that 
practice, but I wasn't aware of the staggering numbers until 
they came in later.
    That distribution I think temporally occurred before the 
big switch to injection drug use that we saw using heroin. And 
there was always fentanyl around, but in 2016 something 
appeared to us to happen in the supply chain. And we saw----
    Mr. Burgess. Let me just interrupt you. The supply chain of 
fentanyl is not coming through the supply chain, right?
    Dr. Kilkenny. We are talking about the illicit supply 
chain.
    Mr. Burgess. Illicit, OK.
    Dr. Kilkenny. The illicit supply chain of fentanyl seemed 
to change really remarkably in the second half of 2016 and the 
entry of the fentanyl analogues really picked up then. That is 
when we started seeing a massive increase in overdoses and 
overdose death.
    Mr. Burgess. That seems to have been catalyzed by the 
initial excess distribution phenomenon that was happening in 
your neighborhoods.
    Dr. Kilkenny. I certainly do not argue with that iatrogenic 
component that this started with prescription drugs.
    Mr. Burgess. And I guess our frustration when we talked to 
the DEA on Monday was it seems like there was a blinking red 
light on the dashboard, why didn't anybody check the engine, 
you know what I mean? I always lived in fear of the DEA when I 
was in practice. I thought they knew everything about me, every 
prescription that I wrote, every patient that I treated. Then 
it turns out on Monday we hear that they really weren't paying 
that much attention and it was startling information to me.
    Dr. Kilkenny. Apparently not, but I don't think we as 
physicians were as red-flagged as we should have been while we 
were prescribing under the pain as the fifth vital sign rule.
    Mr. Burgess. Sure.
    Let me recognize Mr. Green from Texas 5 minutes for 
questions. I have some additional questions that I may try to 
get to at the end. But, Mr. Green, you are recognized for 5 
minutes.
    Mr. Green. Thank you, Mr. Chairman, and I want to welcome 
our panel here today. I want to thank all our witnesses for 
joining us.
    We agree that the opioid epidemic is a multisided problem 
and will require a multipart solution. As part of the solution 
it is essential that we expand access to treatment. We must 
also identify strategies that encourage individuals with 
substance use disorders to seek and remain in treatment. I am 
concerned that the proposed proposal to roll back protections 
under code federal regulations titled 42 Part 2, commonly known 
as Part 2, would do the opposite.
    Dr. Martz, in your testimony you state that if patients 
with substance use disorders are afraid their treatment records 
will be used against them they will not enter treatment. Could 
you explain the important role of confidentiality plays for 
individuals with substance use disorders in retaining and 
entering treatment and working towards recovery?
    Mr. Martz. Thank you. It plays a critical role. If you are 
working to decide whether or not I am going to enter treatment, 
whether or not I am going to deal with the issues that are most 
relevant in treatment that is a critical protection to have. We 
know that folks will not come to treatment if they are afraid 
of what the impacts will be.
    So, for example, I worked with parole and probation for 
quite some time and there would be some question of, someone 
goes and they are having a holiday party, and they go and they 
show up and there is drinking there, not a surprise. But then 
they start to have cravings.
    So the work of treatment has to do with having a safe space 
to be able to discuss these issues clearly and directly 
without, rather, having to say oh no, I didn't have any 
problems and nothing was going on here, so that for fear that I 
would disclose it to somebody else. You know, it is a role 
like, more like a priest/penitent relationship than just other 
roles.
    Mr. Green. Why are the heightened protections provided 
under Part 2 critical to creating the safe environment for 
treatment for individuals with substance use disorder that you 
describe in your testimony?
    Mr. Martz. It is critical for the safety. One of the key 
elements in terms of treatment is that there is a therapeutic 
alliance and sometimes it takes weeks or months to build a 
relationship. I have had clients that were with me for 6 months 
before they suddenly say all right, now I am going to tell you 
the truth about what is really behind this, so it takes time to 
build a relationship. It takes time to have that safety and 
anything that is going to damage that safety such as fear that 
this will be disclosed, it will impact that and prevent them 
from entering or staying in treatment or working on the 
critical elements within it.
    Mr. Green. According to a letter submitted to the Committee 
from the Campaign to Protect Patient Privacy Rights, rolling 
back the Part 2 protections to the HIPAA standard will 
contribute to the existing level of discrimination and harm to 
people living with substance use disorder and will only result 
in more people who need substance use disorder treatment being 
discouraged and afraid to seek the health care they need during 
the nation's worst opioid crisis.
    Dr. Martz, will you discuss how rolling back Part 2 
protections to HIPAA standard harms efforts to create a safe 
treatment environment and potentially leads individuals with 
substance use disorder not to enter or remain in treatment?
    Mr. Martz. Thank you. Many of our folks have dealt with 
trauma, for example, and so one of the things that is a really 
critical difference between HIPAA and 42 CFR is that with 42 
CFR when I disclose to my clinician I know that it is private 
unless I sign and get information that it will be shared with 
somebody else. When I share with my clinician about the sexual 
trauma and assault that I faced previously that is a private 
conversation and before that gets shared with multiple other 
people without my knowledge, which is what the standard would 
be under HIPAA, that is a problem.
    So when information comes back to me from some other 
clinician that gets the information from the clinical record 
rather than having that conversation with me directly when I am 
not ready to share it, it is a severe damage to the trust that 
is needed for a relationship for treatment.
    Mr. Green. Thank you. I support strongly the efforts to 
expand access to treatment, encourage individuals to seek and 
remain in treatment. I am concerned the proposed changes to 42 
CFR Part 2 misses the mark.
    And in my last few seconds, in my earlier life I did 
probate work and in Houston, Texas the probate judges are also 
the mental health judges. And I was honored, I think, when the 
judge decided he wanted to appoint me to be on the mental 
health docket for about 3 weeks, and this is before HIPAA. It 
was in the '80s and we still had that protection, though I 
don't know if it was under state law or federal law at that 
time that even the lawyers we had to destroy all our 
information.
    And believe me it would have been really difficult to get 
people in treatment if they knew that would be available to 
potential employers and that. Now, if there is a danger we all 
have a responsibility to that whether you are a medical 
professional or what. But just that average letting people know 
someone is under care, it really bothers me.
    Thank you, Mr. Chairman. I know I have run out of time.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman. The chair recognizes the gentleman from 
Kentucky, the vice chairman of the subcommittee, Mr. Guthrie, 
for 5 minutes.
    Mr. Guthrie. Thank you, Mr. Chairman. I appreciate the 
opportunity to be here and all the witnesses being here. I am 
going to focus my questions to direct them to Mr. Bauer who is 
from back home. We have had several Kentucky witnesses over 
yesterday and today and have been fantastic witnesses, but only 
says that we have a big issue in our State like surrounding 
States and then it is spreading. So that is why what we are 
doing here is so important to make sure that we move forward.
    But I am going to focus on the Prescription Drug Monitoring 
Program. So when providers check their PDMPs or Prescription 
Drug Monitoring Program, to Mr. Bauer, what is the evidence 
that this actually changes their prescribing or dispensing 
behavior resulting in improved patient outcomes and lives 
saved?
    Mr. Bauer. I thank you, Vice Chairman, for the question. 
Today with the PDMP programs one most impactful issue with the 
program is integration of that information into workflow. And 
we are finding that that really helps to enable efficient 
access to the PDMPs, so the PDMPs are checking. There are 40 
States that have mandated use laws in place today which mandate 
the checking of the PDMP in one way, shape, or form.
    So we have seen the use of the PDMPs having an impact on 
the overall volume of opioids prescribed. We think that is in 
conjunction with policy at a State level as well. From an 
outcomes perspective there are current studies that are 
underway, one of which is Appriss Health has a study underway 
to understand the actual outcome of checking the PDP on opioid 
death, the death curve. So that study is not completed yet. We 
are about 3 to 4 months into that study.
    Mr. Guthrie. Thank you. And also you mentioned that some 
States are turning the PDMP into a substance use disorder 
platform. Can you elaborate on what that means and how it would 
help someone who might be at risk of addiction or substance 
misuse?
    Mr. Bauer. Sure. When PDPs were first formed many years ago 
they were more of a diversionary tool that was used to 
understand drug diversion. The programs have since morphed into 
more of a public safety tool.
    So, today, information in the form of data, prescription 
data, is sent to the prescriber or pharmacist for review. 
States are now moving past that what they call the phone book 
of data trying to understand within that information what is 
the issue with this patient or what is the risk that this 
patient represents from an overdose perspective. And we are 
moving that into more of a substance use disorder platform to 
provide the clinicians, the prescribers, and pharmacists more 
clinical information so they engage with their patient while 
that patient is right there in front of them versus trying to 
read through a phone book of data in the 20 or 30 seconds that 
they have.
    So, adding additional datasets such as nonfatal overdose, 
providing for referral of treatment while they are in their 
PDMP, a peer-to-peer communication, et cetera, are all clinical 
tools that are designed to truly engage that patient before 
they go to an illicit drug event.
    Mr. Guthrie. OK, thank you. And I have a final question for 
you. PDMPs are not only critical to prescribers for identifying 
beneficiaries that are high users, but also in avoiding 
potentially dangerous drug interactions. It is my understanding 
that for the most part PDMPs are not allowed to have data or 
are prevented from having data on patients receiving methadone. 
On the other hand, buprenorphine prescribed in an office space 
setting is typically filled at a pharmacy which is then 
submitted to PDMPs. So why are methadone and buprenorphine 
treated unequally when it comes to PDMPs, and can we do 
anything to include this information but still protect patient 
privacy?
    Mr. Bauer. Thank you for that question. What we find today 
from the PDMPs as far as collecting that data such as methadone 
or buprenorphine prescriptions, buprenorphine, for example, is 
a prescription that is actually prescribed and typically picked 
up at a retail pharmacy therefore reported to the PDMP. 
Methadone on the other hand is typically administered within a 
substance use, a clinic and therefore by law not reported to 
the PDMP.
    So that is the difference as far as----
    Mr. Guthrie. Well, could somebody get methadone at a 
methadone clinic and also have a prescription for 
buprenorphine, or are they interactive?
    Mr. Bauer. The short answer is it is possible.
    Mr. Guthrie. I guess just to the question because I am 
about out of time, I know the idea for the methadone is patient 
privacy. Can we address that?
    Mr. Bauer. Yes. Obviously we want to take privacy into 
consideration from a PDMP perspective obtaining that methadone 
administration, administered methadone is critical to 
understanding the overall risk of that patient.
    Mr. Guthrie. OK, thank you. And I have 5 seconds, I yield 
them all back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back. The chair recognizes the gentlelady from 
California, Ms. Matsui, 5 minutes for your questions, please.
    Ms. Matsui. Thank you. Thank you, Mr. Chairman. And I want 
to thank the witnesses for being here today.
    Dr. Martz, thank you for your testimony. I have been a 
champion of building greater education and awareness about 
HIPAA privacy regulations particularly as it applies to tricky 
mental health situations, because I recognize the necessary 
balance between patient privacy and access to information for 
purposes of quality treatment. I appreciated your nuanced 
understanding of the importance of confidentiality for patients 
suffering from a substance use disorder and the different ways 
a stigma plays into the situation.
    I am also sympathetic to the caregivers and doctors who are 
trying to better serve patients and to stories of patients who 
are harmed because the provider didn't have the right 
information to make the right clinical decision. I am hopeful 
that working together we can find the appropriate path forward 
on this issue. From your perspective, how well do you think 
patients know their rights under HIPAA and specifically under 
42 CFR Part 2 and the recent SAMHSA update?
    Mr. Martz. Thank you for the question. Patients are pretty 
widely available and it is usually one of the very questions 
that will be asked, who is going to get this information? And 
even if they don't ask that up front, it is our responsibility 
as clinicians to immediately give them that information about 
what you are going to be sharing, what are the limits of 
confidentiality and what are the conditions under which is 
would be released or excluded.
    One of the challenges with the multiple changes we have had 
in the last year now from SAMHSA is that every time it comes 
out of the change we have to identify the regulation, we have 
to update our forms, we have to retrain the field, and re-have 
that conversation with the client which is very damaging to the 
relationship that has been built.
    Ms. Matsui. Right. So the familiarity among the doctors and 
caregivers need to be updated. So do you think it would be 
meaningful for HHS to conduct more education and awareness?
    Mr. Martz. Absolutely, across the field not only treating 
clinicians but also physicians and other allied professionals 
that are interacting so that we better coordinate the care. 
Very often, the problems that are found from confidentiality 
are really training issues rather than actual burdens.
    Ms. Matsui. Sure. Well, do you think there are certain 
situations or circumstances under which sharing a patient's 
substance use records would be beneficial to their coordinated 
care? So, for example, in the case of accountable care 
organizations that are specifically targeting comprehensive 
services for those with multiple conditions such as substance 
use disorder co-occurring with something like diabetes or 
depression?
    Mr. Martz. Yes. And it is very common to coordinate care 
and it is actually an expectation of myself and all the 
clinicians that I have worked with that we are to coordinate 
substance use, mental health, medical conditions. The 
difference is that there is a protected element for them to 
discuss the private areas and it is a clinical issue to engage 
them to have that trust to open the relationship and dialogue 
with the other clinicians to maintain that constant 
communication.
    Ms. Matsui. OK. Well, thank you.
    Dr. Strain, thank you for your testimony. As I mentioned 
previously, I am committed to advancing coordinated patient 
care without sacrificing patient privacy, especially around a 
sensitive and stigmatized disease. Recently, SAMHSA released 
some regulations that broadened rules about re-disclosure and 
42 CFR Part 2. Do you think that it has been helpful to 
providers;. Alternatively, did it go far enough?
    Dr. Strain. So I thank you for that question, 
Representative. I think that we haven't gone far enough. I 
think that we need to provide a mechanism whereby information 
can be more seamlessly shared between providers who are not in 
a substance abuse treatment program and those who are in a 
substance abuse treatment program. I think that at the end of 
the day, I am interested in seeing us do better in terms of 
coordinating care across those two foci, and the current 
barriers make that difficult.
    Ms. Matsui. Yes. So in your testimony you provided some 
very compelling examples particularly if a patient is 
incapacitated. For things like asking patients about history of 
substance use, what type of training do doctors currently 
receive about best practices?
     Dr. Strain. So training by physicians is variable by 
medical school. There is not a national standard for training, 
a Federal standard, but there is increasing amounts of training 
in medical schools and by, for physicians in terms of substance 
abuse and education and it is a critical part. It has become a 
critical part especially in the current climate.
    Ms. Matsui. I can see that we need more, probably, 
continuing education about this. Generally, if a patient is 
incapacitated or unconscious your testimony implies there is no 
way for a doctor to know if a patient has a history of a 
substance use disorder. Is that absolutely true? For example, 
can a doctor make inquiries of next of kin?
    Dr. Strain. I am sorry?
    Ms. Matsui. Can the doctor make inquiries of next of kin?
    Dr. Strain. Certainly the doctor can make inquiries of next 
of kin to attempt to determine that if they are available.
    Mr. Guthrie [presiding]. Thanks. I know we are pushing up 
against votes for another round of votes----
    Ms. Matsui. OK, thank you.
    Mr. Guthrie. Thank you. The gentlelady yields back. I now 
recognize the gentleman from Virginia, Mr. Griffith, 5 minutes 
for questions.
    Mr. Griffith. Thank you very much, Mr. Chairman.
    Over here, and I am going to continue, Dr. Strain.
    Doctor, you were just talking about what the doctor can 
find out by asking the next of kin. And one of the issues that 
we dealt with, not opioid directly related but dealing with 
violent tendencies and violence that we were trying to deal 
with in CURES and in some other things, was trying to figure 
out how we keep privacy for individuals but at the same time 
have some family involvement where the family is actually 
involved in a person's life, because if they have a significant 
mental illness and maybe also a drug addiction on top of that 
it is sometimes very difficult for the family to get 
information because of the HIPAA laws.
    So Dr. Martz raises good points, but how do we reach that 
balance where particularly if you are living in the home with 
parents or a sibling that they can have enough information to 
know whether, A, they are in danger, or B, how they can be of 
most assistance to their beloved family member? Any ideas for 
us?
    Dr. Strain. Thanks. It is a critical question, 
Representative Griffith. And it really comes down to, I think, 
the provider-patient relationship and that judgment that occurs 
in that relationship in terms of where do I treat patients, and 
where do I go in terms of when I have information that I 
believe has reached a critical point where I need to bring in a 
family member and inform them that? And there can be instances 
where I may do that even if the patient is saying I don't want 
you to do that.
    So obviously, for example, if there are issues of abuse of 
a child or a parent or things like that I may be compelled to 
do so, or if somebody is reporting that they are suicidal or 
homicidal. But at the end of the day, it does distill down to I 
think that relationship and the provider having determination 
of where do they need to go with the information that they are 
receiving. I think that trying to create a systematic answer to 
that may be challenging.
    Mr. Griffith. Well, we found it to be a challenge but we 
are still working on it, because obviously with the number of 
violent situations we have had in our country, these tragedies 
that have occurred, we are trying to figure out what is both 
right for the patient and right for society as a whole.
    Switching gears and continuing to talk about the opioid 
tragedies that are afflicting us, Dr. Kilkenny, you work in 
Huntington and Cabell County. Do you find that, because in O&I 
we had an earlier hearing this week on pill dumping and 
particularly into a couple of towns in West Virginia, do you 
find that those drugs coming into the small towns outside of 
your community--about 56 miles away was one of them, Kermit, 
and the reason I know that is because it is only about 53 miles 
from my district in western Virginia.
    Do you find that that has a spillover with the patients 
that you are seeing that some of those folks are coming from 
those rural areas where all these drugs were dumped?
    Dr. Kilkenny. I think the evidence in West Virginia 
indicates that the current injection drug use, the illicit 
trade was spawned by an overprescribing and then a more 
responsible set of prescribing.
    Mr. Griffith. So it would be reasonable to conclude that 
your testimony would also affect my district, which is about an 
equal distance although it takes longer to get through the 
mountains to get to mine from Kermit or from the other towns, 
that the problems would be very similar. It would be reasonable 
to make that conclusion, would it not?
    Dr. Kilkenny. I think that Virginia, West Virginia, 
Kentucky, Tennessee, any of the Appalachian districts in those 
states are going to be affected the same as we are.
    Mr. Griffith. Yes. That is pretty much my district.
    Mr. Bauer, thank you for being here as well and thank you 
for saying some nice things about our draft legislation on 
PDMPs. I was really pleased to see the graph that showed that 
just a few years ago there were only a couple of States, one of 
which was my State in Virginia in 2011, but that now we have 
more than 40 States and all of the States continuous to my 
district are now there, because at one point Martinsville had 
the highest per capita use of--and there is a formula that you 
would know, the morphine----
    Mr. Bauer. Equivalents.
    Mr. Griffith [continuing]. Equivalents of any place in the 
country and North Carolina was not a part of it. So hopefully 
that will be of some help. Can you explain further what we need 
to do to get all the States on the same page so that we are 
able to compare apples to apples, because I understand in some 
of the PDMPs that there is a difference in the data. Can you 
give us a few seconds on that?
    Mr. Bauer. Yes, I can. Thank you for that question. So 
today as you know there are 45 States that do share data 
securely and efficiently with each other. It is up to the 
States' purview as to what State they wish to share data with. 
Typically it is the surrounding States and then another 
concentric circle.
    The States that are not sharing data today it is truly a 
policy issue. The example I mentioned in Florida, Florida just 
recently passed legislation that will enable them to share, 
effective July 1st of 2018, California is the same way. So 
these are certainly policy issues that are involved in not 
being able to share data right now.
    Mr. Griffith. And I am out of time so I have got to yield 
back, but I would love to know if we can get everybody on the 
same page. I appreciate it, thank you.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman. The chair recognizes the gentleman from New 
Jersey, the ranking member of the full committee, Mr. Pallone, 
5 minutes for your questions, please.
    Mr. Pallone. Thank you, Mr. Chairman. I have some questions 
of Dr. Martz. I would like to thank all the witnesses for 
joining us today. I stated in my opening statement yesterday 
that I was concerned that H.R. 3545, the Overdose Prevention 
and Patient Safety Act could dangerously erect a barrier to 
patients seeking and remaining in treatment and therefore harm 
our efforts to respond to the opioid crisis.
    According to the Substance Abuse and Mental Health Services 
Administration, the disclosure of records of individuals' 
substance use disorders has the potential to lead to a host of 
negative consequences including loss of employment, loss of 
housing, loss of child custody, discrimination by medical 
professionals and insurers, arrests, prosecution, and even 
incarceration.
    So, Dr. Martz, I am hoping you can help us better 
understand these consequences. The first question, I understand 
from your testimony that you have worked in a number of States 
in a range of settings and served a diverse mix of patients. 
Based on that experience, can you provide some context on the 
issues facing individuals with substance use disorder that make 
Part 2 heightened confidentiality protections important?
    Mr. Martz. Thank you. Thank you. I think, and in response 
to your question I may have to respond with a brief note from 
the last listening session of SAMHSA, some notes that were 
submitted regarding 42 CFR from the folks that are affected 
here.
    ``Dear Administrator Hyde, I have a criminal record and 
attending recovery. I don't want my history to become a burden. 
I realize individuals have discussed good medical care for me 
will be compromised if all medical professionals cannot see my 
treatment records, but available to ones who must see them. I 
don't want to risk losing my family or my job or my housing due 
to someone knowing or finding out I have been treated with 
addiction. I don't want my past to jeopardize my future because 
I am doing the right thing. I am writing to ask privacy 
protections for patient records be maintained. I do not wish 
for this to be a lifelong burden. My privacy records are very 
important. I am soon applying for a job and I fear I will never 
have the chance to better myself in society otherwise. Thank 
you so much for even considering. We know we are but little 
value to society, but even if we were to become trash men one 
day it would be the best for us and for free men.''
    There are a stack of these letters coming from these 
individuals. I also worked in the Pathways to Pardons project 
in Pennsylvania where we worked with folks seeking clemency, 
and there were many folks who were seeking clemency because 
they couldn't get jobs, they couldn't become nurses, they 
couldn't get promoted. They had various challenges that they 
couldn't work with. So even many, many, many years later there 
is a lifelong stigma attached.
    Mr. Pallone. All right. Now a recent study published in the 
Journal of Addiction Medicine found that a significant portion 
of the study population of ED physicians at Johns Hopkins had 
low regard for patients with substance abuse. For example, 54 
percent of survey responders indicated that they agreed that 
they, ``prefer not to work with patients with substance use who 
have pain,'' and 54 percent agreed that patients like that 
irritate me.
    So, Doctor, is this unique to the physicians in the survey 
or do individuals with substance use disorders sometimes face 
stigma and discrimination from medical providers?
    Mr. Martz. Absolutely. There is an old term for, in the 
profession in some areas what is called a GOMER, Get Out Of My 
ER. There is just such an absolute disdain. And even in recent 
weeks and months as I mentioned, there were a couple quotes 
just out there from recent providers some of which I mentioned 
before, for example, ``Jail, the best way to beat addiction.''
    ``Why is this a problem? Opioids are eliminating the bad 
folks in our communities--smiley face.''
    ``If they would stop reviving them there would be less 
usage.''
    The level of stigma and vitriol out there is widespread and 
which is what we are trying to protect our folks from, because 
some of the discrimination will be overt but some will be 
covert and use other reasons to say you are fired and we are 
not going to use you, but rather than saying oh, it is because 
you have a history of this.
    Mr. Pallone. And then my last question deals with the 
dramatic increase, the presence of substance use treatment 
records in electronic health records and health information 
exchanges a lot of these records will be increasingly 
vulnerable to cyber attacks and breaches. One of my Republican 
colleagues noted in reference to our committee inquiry to the 
healthcare cybersecurity that as technology becomes 
increasingly integrated with all levels of health care, cyber 
threats pose a challenge to the entire sector.
    You want to just explain the impact of such risk? There was 
a recent Ponemon Institute survey that found that half of HIPAA 
organizations expose patient data at some point and improper 
disclosures on patients with substance use disorder. I know we 
are almost out of time so quickly if you could.
    Mr. Martz. Absolutely. Cybersecurity has been a growing 
threat. We know, for example, in February 2015, an Anthem Blue 
Cross Blue Shield organization had 37.5 million records stolen. 
Russell Branzell, president and CEO of College of Healthcare 
Information Management, has said that health care is ground 
zero for cyber attacks. According to the Department of Health 
and Human Services, while all industries face this growing 
threat, the size and scope of the attacks on the healthcare 
industry have accelerated rapidly in the past few years. This 
is valuable information that can be bought and sold. And so 
cyber attacks are a serious risk and have been growing rapidly.
    Mr. Pallone. Thank you. Thank you, Mr. Chairman.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman. The chair recognizes the gentleman from Indiana, 
Dr. Bucshon, 5 minutes for your questions, please.
    Mr. Bucshon. Thank you, Mr. Chairman. First of all, I just 
want to respond a little bit to this study about ER doctors. 
There are people who come to the ER legitimately drug seeking 
trying to get legal ways to get drugs. This is nothing to 
people who are drug addicted. They are treated just like 
everybody else. But if you have ever spent any time in an 
emergency room, and I have because I was a heart surgeon, there 
are legitimately large numbers of people trying to get legal 
prescriptions or legal narcotics through coming to the 
emergency room.
    And it is honestly insulting for studies to try to show 
that the ER physicians are in some way not treating patients in 
an ethical and moral way. It is just not right. And let me just 
also comment on what it is like to be a physician--and my wife 
is an anesthesiologist by the way also--and have patients 
taking unknown medications or have an unknown medication 
history. This is a really serious problem. If you as a surgeon 
you don't know if they are on opioids, benzodiazepines, and in 
many cases certain dietary supplements.
    I have had myself, personally, two patients who almost bled 
to death after heart surgery because they were taking 
supplements for vascular health. And my wife tells me every 
day, she is still in practice, she still has patients that have 
unexplained difficulty in being anesthetized with narcotic or 
benzodiazepine-based anesthetic agents, and looking at the 
medical record there should be no reason for that and the 
reason is is because it is undisclosed.
    So, look, there is a balance here and Dr. Martz makes some 
great points. But I just wanted to point that out that it is a 
difficult problem for medical providers and we need to find a 
balance.
    Dr. Strain, I know there are concerns that if we amended 
the statute to allow substance use disorder treatment 
information to be disclosed it could be used in criminal 
proceedings, cause someone to lose their housing, employment, 
or even child custody. Does the amendment to H.R. 3545 include 
safeguards to prevent this from happening?
    Dr. Strain. Thank you, thank you for those comments and 
thank you for the question. Absolutely, my understanding is 
that there are safeguards within the Mullin amendment that does 
prevent those sorts of concerns.
    Mr. Bucshon. Yes. And many people with substance abuse 
disorder also struggle with mental illness or have comorbid 
conditions such as diabetes or hypertension. How does 42 CFR 
Part 2 prevent quality care coordination?
    Dr. Strain. So it is a great question. And the dilemma as 
you actually illustrated earlier is that the provider may be 
seeing a patient who is in substance abuse treatment and not 
know about that and then can't coordinate their care in terms 
of infectious illnesses or other medical problems that have 
arisen related to their substance abuse. And the patient may 
not be telling them about that or may not be fully disclosing, 
for example, what medications they are on through their 
substance abuse treatment program.
    We want to be holistic about treating people. That is at 
the end of day that is what we should be striving to do and 
right now we are segmenting out this part.
    Mr. Bucshon. Yes. I also want to point out that, again as a 
physician, family members may not know the medical history of 
their loved one and I think Congressman Griffith was talking 
about that. And we tried to, in a mental health bill a year or 
two ago we tried to change HIPAA a little bit to allow parents 
who have adult children who have severe mental illness to have 
some minimal access and we couldn't get that done because of 
the privacy issues. In fact, in your State I think had a State 
senator whose son had an episode and tried to kill him and then 
subsequently killed himself and so the system failed both of 
them, really.
    But if you look at, for example, the directed donor 
program, say you are going to have your hip or your knee done 
and you want family members to donate blood and put it in the 
blood bank for you, there is a pretty substantial instance of 
that blood being rejected by the blood bank because of a blood-
borne problem, usually hepatitis history, and family members 
don't necessarily know that their family member has had that 
history and they don't want that disclosed and I understand 
that.
    I think we should look back to what happened in the '80s 
and the '90s with HIV and the critical issue we had there with 
privacy. And we have worked through that I think and maybe this 
is where we are going with drug addiction also. We clearly 
don't want people discriminated against for any reason, but we 
also want to be able to have holistic medical care that 
includes knowledge of a patient's addiction history. I yield 
back.
    Mr. Carter [presiding]. The gentleman yields. The chair 
recognizes the gentlelady from California, Representative 
Eshoo.
    Ms. Eshoo. Thank you very much, Mr. Chairman, and thank you 
to all of the witnesses. It is good to have you here on a 
subject that is really wrecking communities and wrecking 
people's lives and there is enormous loss of life surrounding 
this issue. Over the last at least month or 5 weeks, I have had 
five friends and my sister, so six individuals that have shared 
with me the following:
    They had hip replacement surgery. And I am directing this 
to Dr. Strain. They were sent home with a bottle of 100 tablets 
of either Oxycontin or Percocet. Now a hundred tablets of 
either is, I think, over the top. I am not a physician but that 
is a lot of pills. Why is that the case? Why is so much being 
prescribed?
    Dr. Strain. So----
    Ms. Eshoo. I would think, excuse me, that if you are not an 
addict you may have a new hip, but by the time you are finished 
with your recovery you will be an addict. So is there a 
kickback on these drugs? Can you enlighten us as to why so much 
is being prescribed? And this is the second most common surgery 
in the country. Number one is cataract surgery; number two, hip 
surgery.
    Dr. Strain. So certainly if we were having this 
conversation even 5 years ago I would have said the reason that 
there is large numbers of pain pills being prescribed is 
because the medical profession has had it drummed into its head 
that we need to be more aggressive about treating pain. And 
that is something that goes back 15 years and 20 years.
    Ms. Eshoo. Well, I think it is important to stay ahead of 
pain, but a hundred?
    Dr. Strain. I agree. I think that that----
    Ms. Eshoo. And these were all, they were different 
hospitals that they were discharged from.
    Dr. Strain. The current CDC guidelines do not recommend 
doing that. The current thinking by other professional 
organizations is not to be prescribing those sorts of amounts 
of pain medications. I don't know the particulars of these 
situations, but it is alarming to hear. And I think that the 
medical profession hopefully is----
    Ms. Eshoo. But what would you suggest? What would you 
prescribe?
    Dr. Strain. Well, first of all----
    Ms. Eshoo. I am not asking you what prescription you would 
write and how many pills you would prescribe, I am speaking in 
terms of policy.
    Dr. Strain. In terms of policy I would say that there 
should be a much lower of medicines prescribed whether it is 
oxycodone or whatever. I would follow things like the CDC 
guidelines for a week, reevaluating the patient, using non-
opioid medications for the treatment of pain. I should 
parenthetically note I am not a pain treatment doctor. I am a 
psychiatrist by training. But I think a lot about this because 
of this issue and my recommendations would be along those 
lines. Did I answer your question?
    Ms. Eshoo. Well, does CDC have guidelines now on this?
    Dr. Strain. Yes.
    Ms. Eshoo. They do.
    Dr. Strain. Yes. They issued guidelines about a year ago.
    Ms. Eshoo. It seems to me they are not being, they either 
don't know about it or that they are just not paying any 
attention to it.
    Dr. Strain. Well, I think that----
    Ms. Eshoo. Do you have any suggestions that have, excuse 
the expression, more teeth in it?
    Dr. Strain. Well, I think that from a systems level what we 
could do, I think that we need to continue to be aggressive in 
our education of all healthcare providers about this, but I 
don't----
    Ms. Eshoo. We really have a crisis obviously on our hands, 
but it seems to me that in the system itself, professionally, 
we are creating a whole other wave of it.
    Dr. Strain. I think though I like to hope that we are 
turning the corner on that and not doing that.
    Ms. Eshoo. Well, let me just switch gears because I don't 
have very much time left. I am an original cosponsor of 
Congressman Lance and Kennedy's bill which makes investments in 
CDC's surveillance of injection drug related infections. What 
barriers currently exist to states implementing drug related 
infection surveillance systems today?
    Dr. Strain. Are you asking me that question or----
    Ms. Eshoo. Well, whomever wants to answer.
    Dr. Strain. I think you were commenting on this bill.
    Dr. Kilkenny. Thank you. I think I can speak to that. The 
barriers are probably mostly manpower. We need more people to 
do the adequate case tracking and we need more communication 
amongst the agencies to not the same level of communication 
that this end of the table is talking about, but communication 
in the public health sectors to basically identify the risk, 
the risky individuals, and case-track them and work that 
epidemic with the methods that we use. It is a labor-intensive 
method.
    Ms. Eshoo. I am not so sure I understand the answer, but I 
know we are going to have the opportunity, Mr. Chairman, to 
submit questions to the witnesses and I will do that.
    Mr. Carter. Sure. Thank you.
    Ms. Eshoo. I will yield back. Thank you everyone.
     Mr. Carter. The gentlelady yields. The chair recognizes 
the gentleman from Florida, Mr. Bilirakis.
    Mr. Bilirakis. Thank you. Thank you, Mr. Chairman, I 
appreciate it. I thank the panel for their testimony.
    Mr. Bauer, Florida law as of January 1st, 2018 requires 
that all controlled substances dispensed to an individual be 
reported as soon as possible, but no later than the close of 
the next business day to afford its PDMP the electronic Florida 
online reporting of controlled substances evaluation. If the 
controlled substance is dispensed on a Saturday and the 
pharmacy is closed on Sundays it could result in a 48-hour 
latency. Does typical notification latency range from 2 hours 
to 7 days depending on the State?
    Mr. Bauer. Thank you for that question. Today there are 43 
States that require submission of controlled substance 
prescriptions no later than 24 hours. There is one State that 
is real time, Oklahoma, and there are, the remaining States are 
either on a 7-day to 8-day cycle.
    Mr. Bilirakis. OK, thank you. And yes, elaborate a little 
bit, as far as how important that is.
    Mr. Bauer. Absolutely. The timely submission of information 
is extremely important. The 43 States that do submit the 
information no later than 24 hours, there are typically 
multiple submissions that are made of the dispensation when it 
leaves the pharmacy. For example, when it comes into our system 
we append that information. We provide our logic as far as 
appending that to the right patient and make that information 
available within about 5 minutes' time. So it is very much near 
real time that once that information is received by the PDMP, 
in the case of Florida that information is made readily 
available within about 5 minutes' time.
    Mr. Bilirakis. Very good. I know it is critical. I 
understood that many States are able to share PDMP data across 
State lines. However, even if States are connected to an 
information hub, isn't it true that those States do not 
necessarily have across State line information for all other 
States connected to the hub? Is that true?
    Mr. Bauer. Yes. Today the 45 States that do participate in 
PMP Interconnect, for example, can share with all 45 States 
should they wish. It is up to the discretion of the actual 
state as to what States they wish to share information with. 
Again most States, in fact all States share data with at least 
their border states. Most draw another concentric circle and 
others look at different migration paths as far as the I-95 
corridor or the I-65 corridor or the Northeast states as far as 
sharing information.
    Mr. Bilirakis. OK. I think I know the answer to this 
question but I am going to ask it. Can any State PDMP actually 
stop the fraudulent prescriptions from leaving the pharmacy if 
the patient obtained multiple prescriptions within the same 
day, potentially, across State lines?
    Mr. Bauer. Yes. That is a great question. Built into 
today's PDMPs there are very efficient and effective ways where 
the States are actually proactively sending alerts based on 
various thresholds of the data both within their State and 
combined with multi-state data.
    So, for example, understanding if a patient is traveling 
from State to State to State accumulating prescriptions from 
multiple providers or multiple dispensers, that information can 
be made available via an alert is what we call based on 
specific thresholds that states set so those alerts are sent 
out proactively to the actual prescriber or pharmacist that is 
checking on that patient.
    Mr. Bilirakis. What are we doing to call out those five 
States that aren't participating?
    Mr. Bauer. Yes. That is a great question. Again it is more 
of a policy issue. California and Florida are addressing those 
issues as we speak. Florida will be online hopefully by July 
1st, California later this year. The remaining States actually 
are in process, meaning the actual MOU, the memorandum of 
understanding that is required to share data among States is in 
review. The only States that are an exception to that are 
Nebraska and Hawaii. Those States have not yet engaged on the 
MOU process. But Washington State and Wyoming have.
    Mr. Bilirakis. Very good, thank you. I yield back, Mr. 
Chairman, appreciate it.
    Mr. Burgess. Will the gentleman yield to the chair for just 
a second?
    Mr. Bilirakis. Yes, I will. Yes, I yield.
    Mr. Burgess. I wanted to make the gentleman aware that in 
the appropriations bill that will be on the floor of the House, 
the NASPER language in the fiscal year 2018 omnibus bill, just 
to draw attention to the fact that it will promote these 
Prescription Drug Monitoring Programs including implementation 
of activities described in the National All Schedules 
Prescription Electronic Reporting Act of 2005 that was this 
committee's product, and include, as amended, by the 
Comprehensive Addiction and Recovery Act of 2016 and this shall 
include efforts continuing to expand and enhance the utility of 
PDMPs in States and communities making them more interconnected 
real time and usable for public health surveillance and 
clinical decision making. The CDC shall use $10 million of the 
funds provided to conduct an opioid nationwide awareness and 
education campaign.
    So that is a little bit different now we have actually got 
NASPER, which we have worked on in this committee as long as I 
have been on this subcommittee, is actually receiving funding 
in this appropriations bill should it pass in a little while.
    So I now recognize the gentleman from New Mexico for 5 
minutes for questions.
    Mr. Lujan. Thank you, Mr. Chairman.
    Mr. Martz, I would like to thank you for being here today, 
sir, all the witnesses who are with us today. My questions 
today will specifically be for Dr. Martz.
    Yesterday I was taken aback by the conversation about how 
providing individuals who continue to face stigma and 
discrimination with heightened Part 2 protections, which 
include the right to decide with whom to share their substance 
abuse treatment records, stigmatizes individuals with substance 
use disorder. I was surprised to hear SAMHSA echo this 
accusation in the final rules modernizing Part 2 regulations. 
Those rules explicitly acknowledge the stigma and 
discrimination faced by individuals with substance use 
disorder.
    All of America's antidiscrimination laws from Civil Rights 
Act to Americans with Disabilities Act to the Fair Housing Act 
provide heightened protections for populations like individuals 
with substance use disorder who face stigma and/or 
discrimination because of who they are. And, frankly, I am 
having a hard time understanding the argument that these 
protections stigmatize these individuals.
    So, Dr. Martz, please describe the stigma and 
discrimination that individuals with opioid use disorder face.
    Mr. Martz. Thank you. It is an excellent question and a 
critical area because and to the points earlier this is not 
limited to the ERs. This is stigma that goes across the way. 
One in four families has someone in the family now with 
substance use disorder, and so very often my experience of 
substance use disorder is cousin Joey who has been stealing 
from us. And so stigma runs deep and it is very different from 
the aspects of other medical conditions which are very unique 
to the substance use disorder which, for example, there are 
still crimes associated.
    So you don't get thrown in jail for having depression. You 
don't have your kids taken away for your acne. You don't have a 
loss of your job because you have a heart attack. So, medical 
conditions are not all the same and so there are reasons why 
there may be some segregation even though there are ways to 
coordinate that care effectively. These stigma issues are 
critical and to suggest that the stigma is caused by these laws 
is a little bit of a misunderstanding.
    For example, we don't have laws protecting 
antidiscrimination in the workforce because we are creating 
stigma in the workforce, we have laws protecting things like 
gender and race and ethnicity and religion because these things 
have been discriminated against in the past. And so even if we 
have come a long way as we have with HIV, we have not yet come 
that far with substance use disorder and so it still maintains 
a critical protection.
    Hopefully some day in the future we will understand that 
these are brothers and mothers and sisters and children that we 
are talking about here and can move beyond that discrimination, 
but we are just not there yet. We need that protection 
desperately.
    Mr. Lujan. So a yes or no question, is that stigma and 
discrimination the result of heightened protections provided by 
the Part 2 protections?
    Mr. Martz. No.
    Mr. Lujan. I was also taken aback by something in Dr. 
Strain's testimony. In his discussion of rolling back Part 2 
for payment purposes he states that, ``patients could retain 
the ability to keep their substance use disorder treatment from 
their health plans by choosing to pay out-of-pocket for 
services which is a right guaranteed under HIPAA.'' To me this 
means that a person's ability to protect the privacy of their 
substance abuse treatment record would be based on their 
income, their ability to pay out-of-pocket for treatment. If 
you are rich you can keep it private.
    Dr. Martz, is it appropriate to make a person's ability to 
keep their substance use information private based on a 
person's ability to pay cash for treatment?
    Mr. Martz. Thank you. My gosh, that is such a fundamental 
civil right to be able to be private, have my own and disclose 
at my own pace when I am ready and when I am able. That 
shouldn't be something that is only available to the rich who 
can afford it. Many folks that we deal with are police officers 
and teachers and students and all walks of life so should have 
these opportunities should they choose to use that option.
    Mr. Lujan. One thing that I was struck with as well is I 
learned that it was estimated that 20 million people in the 
U.S. have some form of substance use disorder. Currently, four 
million people are seeking treatment as has been reported, but 
the fear of not being provided confidentiality is one of the 
primary reasons people do not seek treatment.
    So, Mr. Chairman, I know that this is an important part of 
the legislative package that we have, and I certainly hope that 
we take this into consideration as we try to make things better 
versus taking protections away from individuals. And I yield 
back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back. I am sure ICD-10 has not one but fifteen different 
codes. The chair now recognizes the gentleman from Illinois, 
Mr. Shimkus, 5 minutes for questions.
    Mr. Shimkus. Thank you, Mr. Chairman. And it is great to 
have you here. We have had 2 days of hearings and as I 
mentioned yesterday it is just not, I mean we are focused on 
opioids but there are a lot of other addictive drugs out there 
and challenges.
    So I am going to be brief because I want to focus on what 
Gus Bilirakis was saying and to, really, Mr. Bauer on the 
Prescription Drug Monitoring Programs. One way we can shame the 
five States is to call them out, and we can do it ourselves and 
we use the bully pulpit to say, you guys need to start sharing 
information. We have got to stop the easy access especially 
across State lines or in other areas.
    A good example, so I really live in the St. Louis 
metropolitan area, I am from Illinois. Illinois has one, 
Missouri does not. St. Louis County has one which really makes 
it very difficult to make sure we have the procedures in place 
to be able to access them when a State doesn't allow the States 
to have the memorandum of understanding and work through those 
processes.
    We have seen these type of things when they can communicate 
in the meth challenges. We have seen that be successful. We 
need your help in figuring out how to really force this 
national communication across state lines to address this. I am 
curious if you can expand on ways we can help ensure that these 
multiple systems are working together as opposed to creating 
new burdens and confusions.
    Mr. Bauer. Sure, another excellent question around 
interoperability and states being able to share data among 
themselves. I think today with the current PMP Interconnect 
system, for example, that is facilitating about 18 million 
transactions a month with 45 sStates, again I stated earlier it 
is more a matter of policy and I think we are making some 
significant progress with Florida coming on board and the 
remaining States are making, I think, measurable progress 
towards that.
    So I think it is not out of the question that all remaining 
States that are not currently sharing data can share data. 
There is a very effective means to do that today with a single 
MOU in place to accommodate for different state laws and 
security concerns as well.
    Mr. Shimkus. When someone has been prescribed legally and 
they go to the pharmacist, they should be able to get that 
dispensed but they shouldn't be able to go across the state 
lines and there should be a red flag saying, hey, it has 
already been filled. And that is what we need to work on and 
that would be helpful.
    Mr. Chairman, in lieu of time and other colleagues, I am 
going to yield back so you can give them a chance to ask.
    Mr. Burgess. The chair appreciates the gentleman. The chair 
recognizes the gentlelady from Indiana for 5 minutes for your 
questions, please.
    Mrs. Brooks. Thank you, Mr. Chairman. And thank you to our 
colleague from Illinois for yielding.
    I want to ask you, Dr. Banner, I am the lead sponsor on 
H.R. 5329, a bipartisan bill to enhance our poison control 
centers in the country of which there are 55, I understand, 
across the country. But most people probably don't realize that 
the poison control centers field about three million calls, but 
more recently about 192 calls a day on average on the opioid 
misuse and abuse, and I really want to talk about the 
importance of not only the hotline but what the service that 
poison control centers provide.
    How can poison control centers work with the educators, 
caregivers, people who call, children, others, what is poison 
control center's role? I think it is one of those you know the 
number and you rush there, and I have had to use it once or 
twice when my kids were young as well. I hate to admit it, but 
we all do at some point. And, but what is the role of the 
poison control centers with education?
    Dr. Banner. We so very much appreciate your sponsorship and 
involvement in this. If we have a couple of hours I could 
really explain this to you. We have a very multifaceted 
approach to education. Personally, I have emergency medicine 
residents rotating with me at all times in the poison center 
and in the ICU and we are educating them. I am teaching in the 
College of Pharmacy as part of my responsibilities at the 
poison center and I think the other 54 centers are similar. We 
are actively engaged in that level of education.
    The certification requirements for a center is to have an 
educator who is principally pointed at the public and, too, the 
National Poison Prevention Week is one of their big times, but 
they are engaging kids at the elementary and early-on levels 
about the dangers of things. And as we have evolved, they have 
incorporated more about substance abuse into those educational 
packages and teaching teachers, et cetera.
    Did you have something else to add?
    Mrs. Brooks. Well, I want to just, in your written 
testimony you actually mention that actually a quarter of calls 
to our poison control centers come from healthcare facilities. 
And so, and just your testimony now about rotating residents in 
and so forth, there is a significant need, is there not, to 
continue to increase the education of poison issues leading 
injury cause, by the CDC in this country, of death with our 
medical professionals?
    Dr. Banner. This was a simple job back in the '90s. The 
explosion that has occurred with bath salt drugs, synthetic 
cannabinoids, synthetic opioids has just changed the landscape. 
And I would agree with you, the reason we get about 25 percent 
of our calls from other healthcare professionals is because the 
level of training of the medical toxicologists and the people 
working in the poison centers is very, very unique.
    And the other issue is Oklahoma has a lot of rural 
hospitals as do many of the poison centers, and my ability to 
reach out to a physician in a very rural hospital who has never 
seen this before, and I have, is very helpful. Plus, I am a 
critical care doctor. The vast majority of the doctors that are 
medical toxicologists are trained in emergency medicine or 
critical care and we are reaching out to rural areas with high 
level, intensive care, emergency medicine, and toxicology all 
at the same time and providing that and educating them at the 
same time.
    Mrs. Brooks. In fact, in our bill we are directing HHS to 
implement call routing based on a caller's actual location 
because that is not necessarily how you receive that 
information now. Is that correct?
    Dr. Banner. That is correct. When this was initially funded 
back in 2000 it was reasonable to have where your area code. 
And since then, area codes, now people are taking their phones, 
particularly the military they are moving all over the country. 
And one of the benefits of a regional poison center is I am 
speaking to a doctor that I know in that area and if I am 
suddenly faced with a caller who happens to have the Oklahoma 
area code and they are in California, I can't really say you 
need to go down to Dr. Such-and-Such at this hospital, because 
I don't know them.
    So the geo-routing, it sounds fairly simple. It is a little 
more technically complicated, but it is something we really 
need because we have got to, we have the regional resources to 
help people and it is where they are at right now, not where 
they used to live.
    Mrs. Brooks. Thank you for your leadership in this area. 
And on behalf of citizens in Indiana and across the country and 
my colleague from Oklahoma, we really appreciate your advocacy 
for poison control centers.
    Dr. Banner. Thank you.
    Mrs. Brooks. I yield back.
    Mr. Burgess. The chair thanks the gentlelady. The 
gentlelady yields back. The chair recognizes the gentleman from 
Texas for a unanimous consent request.
    Mr. Green. Thank you, Mr. Chairman. I would like to ask 
unanimous consent to enter in the following letters from NAMA 
Recovery-the Campaign to Protect Patient Privacy Rights and the 
Pennsylvania Recovery Organizations Alliance, into the official 
record.
    Mr. Burgess. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Burgess. The chair recognizes the gentleman from 
Oklahoma, 5 minutes for your questions, please.
    Mr. Mullin. Thank you, Mr. Chairman.
    Dr. Banner, good to see you here. We were taking little 
friendly wagers up here to see if you had your boots on or not. 
I said yes and you probably got your cowboy hat outside too. So 
I do appreciate the knowledge that you bring and thank you so 
much for coming up here. I know it is hard to leave our 
beautiful state especially where we live, right?
    Dr. Banner. That is right.
    Mr. Mullin. Dr. Martz, I want to dig in a little bit on 
some stuff that you have been saying. And I respect your 
opinion, but I have a problem with the fact that you are trying 
to push it off as facts. When we start talking about privacy--I 
just want a yes or no here because you kept referring back to 
this--is it legal for treatment to be shared with an employer 
right now? The answer to that is no, so is it legal? Yes or no.
    Mr. Martz. There are conditions with which you can really 
make a release.
    Mr. Mullin. Only if the individual has consent. Don't mix 
words with me, yes or no. Is it legal or no?
    Mr. Martz. In that condition, no.
    Mr. Mullin. Right. I am an employer. I have several hundred 
employees. It is completely illegal. Second, I am also a 
landlord. Is it legal for treatment information to be shared 
with a landlord? Yes or no.
    Mr. Martz. No.
    Mr. Mullin. No. It is absolutely not. Is it legal for 
information to be shared in a criminal case or a divorce 
hearing?
    Mr. Martz. No.
    Mr. Mullin. No. So what you are saying about privacy is 
completely irrelevant to what we are trying to do here. This is 
about patients. It is not about opinion or maybes. It already 
is illegal and under this legislation it stays illegal.
    So when you are testifying with us, please be a little bit 
more factual on what you are saying instead of making a broad 
statement like that and drawing fears into people. We bring you 
here because you are considered an expert. Please be that 
expert. I know you have a wealth of knowledge up here, but you 
are misleading us and the panel when you don't put facts with 
it.
    Second of all, you start talking about the stigma that is 
put in place and you referred back to SAMHSA several times. I 
sent out a letter to the assistant secretary asking for their 
information on our bill and what their thoughts were. Let me 
read you a quote that came out of it. This is my favorite 
letter that when they sent it back they said, ``The practice of 
requiring substance use disorder information to be any more 
private than information regarding chronic illness such as 
cancer or heart disease may itself be stigmatizing.`` That is 
from SAMHSA. Pretty plain and simple there that they think, 
itself, it shouldn't be treated any differently.
    Now let's talk about the fines, because you brought up 
fines about this. How many, underneath Part 2, how many 
penalties have been issued underneath Part 2 for violation of 
Part 2?
    Mr. Martz. On Federal or State level, because there will be 
sanctions against licenses on the local level.
    Mr. Mullin. Federal.
    Mr. Martz. Federal, not that I am aware of.
    Mr. Mullin. Two. How many has been brought up underneath 
HIPAA?
    Mr. Martz. That is outside of my scope.
    Mr. Mullin. Let me just kind of put this out there, 173,426 
since 2003. Now why is that?
    Mr. Martz. There are----
    Mr. Mullin. Because you talked about this in your opening 
testimony and I just want to make sure that we are factual here 
so you understand what we are talking about. A lot of people 
want to talk about privacy and about not providing or not 
separating or why Part 2 and HIPAA needs to be separated, but 
underneath Part 2 the penalty is $50 if that information is 
mishandled with the patient, $50. It is not worth the court's 
time to deal with it. It is only two cases. Underneath HIPAA it 
ranges between $150,000 per violation and a maximum of $1.5 
million per year.
    This is about patients. What we are trying to do here is 
treat the patient. But how can he treat the patient when the 
doctor can't see all the medical information? How can he do it? 
And the reason why I am so passionate about it because it 
touches my family, we are currently dealing with it. I 
currently dealt with this situation yesterday over the phone 
because we have a family member that has a disorder of being 
addicted to drugs because it started with an elective surgery 
and now her life is completely ruined and she keeps going to 
doctors and they keep prescribing her stuff.
    And they can't see her complete record and how many times 
she has been in treatment, so every time she goes in they start 
diagnosing, or prescribing her more pain medicine because she 
is in pain. Well, what is the difference between pain and a 
withdrawal? Because at some point you start coming off of it 
and you start having withdrawals and guess what, that is 
painful too and so we are talking about combining those two.
    Are you following me on this? So what is wrong with my 
legislation that allows a patient to be treated completely? And 
don't tell me about the stigma because it is not about stigma. 
It is about treatment. It is about getting the patient back to 
who the person they were before.
    Mr. Martz. Thank you for your passion and information. I 
fully agree with the points that you are making. I would add 
respectfully a couple of points in addition to that. In good 
clinical care and for the treatment of the use disorder, OK, 
for the----
    Mr. Mullin. Make it short because I didn't know I was 
already over time.
    Mr. Martz. Sorry. Thank you, that it is critical to have 
that patient be involved in that collaboration so that there 
can be the best collaborations. And even in----
    Mr. Mullin. They are seeking more treatments because they 
are addicted to drugs.
    Mr. Martz. Which will all be noted in the PDMP where they 
will all have access to that already, information.
    Mr. Mullin. Which is important for the doctor to have the 
same information. That is why we are trying to see, or trying 
to compare the two and make sure that both of them are combined 
so the doctor can give the patient the treatment they need. 
That they need, they are professionals just like you are a 
professional. I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back. The chair recognizes the gentleman from Georgia, 
Mr. Carter, 5 minutes for your questions, please.
    Mr. Carter. Thank you, Mr. Chairman, and thank all of you 
for being here. And this is a great panel and I appreciate your 
participation here.
    Mr. Bauer, in 2009, as a member of the Georgia State Senate 
I sponsored the legislation creating the Prescription Drug 
Monitoring Program in the State of Georgia, so I am very 
interested in it. I appreciate you throughout your testimony 
clearing up the fact that when States are sharing information 
they are not sharing it with all States, they are only sharing 
it with certain states. And initially that was a little 
confusing, so I hope my colleagues understand that just because 
you are sharing information you are not sharing it with all 
States. You are only sharing it with States that you choose to 
share it with and I just wanted to make sure we got that 
straight.
    Mr. Guthrie asked you a question, Mr. Bauer, about who is 
mandated to see this information that is on the PDMPs and you 
answered him and said 40 states mandate. Mandate who to see it, 
pharmacists or doctors?
    Mr. Bauer. Predominantly prescribers. So the 40 States that 
have a mandated use law or statute, typically that is a 
prescriber. In a handful of states it also includes the 
dispenser which would include the pharmacist.
    Mr. Carter. I am not sure I agree with that but I will take 
your word on that. In fact, in the State of Georgia when we 
created it, it was the pharmacist who had to look at it. 
Starting July 1st, the doctors will have to look at it and I 
think in most cases it is for the pharmacists and not for the 
doctors. But anyway will you clarify that for me and follow up 
in my office on that?
    Mr. Bauer. Yes, sir.
    Mr. Carter. I appreciate that very much. Also I wanted to 
ask you, I have had a number of companies come into my office 
who are showing me how they can incorporate the PDMPs with the 
electronic health records so that we are not disrupting 
workflow, and that is certainly something that is important and 
certainly something that we have experienced in the pharmacies 
when we are trying to incorporate the PDMPs with our workflow. 
It is a disruption and the more we can incorporate it into our 
workflow the better the program will work, and I am sure that 
is the case with physicians as well and I know it is the case 
with pharmacists.
    Also I wanted to ask you, cash prescriptions, are they 
being included in your PDMPs?
    Mr. Bauer. Yes sir, all prescriptions, controlled 
substances, typically Schedules II through V, including cash, 
are required.
    Mr. Carter. OK. And let's talk about Schedule V 
prescriptions because sometimes that can cause a problem 
particularly with patients who are getting medications that are 
Schedule V and not necessarily medications of abuse. For 
instance, epilepsy patients may get some Schedule V 
prescriptions and sometimes this can cause a disruption in 
their therapy as well.
    Have you experienced anything with that? Is that something 
that you are looking at to make sure that we don't disrupt that 
therapy?
    Mr. Bauer. That is a great question. From a PDMP 
perspective that is not something that we weigh in on. That is 
typically a state policy decision that is made. Our 
responsibility is to collect the information.
    Mr. Carter. OK. All right, one last question, you talked 
about methadone with I believe it was Representative Guthrie 
again. You said the methadone clinics were not required to 
report to the PDMPs?
    Mr. Bauer. Any methadone administered in a clinic.
    Mr. Carter. What about in pharmacies? I am required in 
Georgia to----
    Mr. Bauer. If it is filled by a pharmacy that is reported 
to the PDMP.
    Mr. Carter. If it is filled by a pharmacy, but if it is 
filled by a clinic it is not?
    Mr. Bauer. Correct.
    Mr. Carter. There we have it. For a while we didn't have 
the VA reporting and that was a problem, now hopefully they are 
online as well.
    I want to go to you, Mr. Banner, because one thing that has 
concerned me and I just wanted to get your opinion on it was 
the use of naloxone and the dependency that it seems to be 
getting. I know we have had some situations where some of the 
ambulances have been carrying so much of it and actually had to 
administer so much that it is bankrupting, literally, some of 
their budgets and that they have had to stop and only carry a 
certain amount on that. Do you see that sometimes happening?
    Dr. Banner. We definitely have areas where there are spikes 
that are concentrated activities and that is concerning in and 
of itself. But yes, for a lot of reasons there are a lot of 
shortages of a lot of drugs and that pushes prices up and that 
is a problem. I think it is going through a this-should-work-
for-everything phase and we know it only works for the opiate 
receptor interaction drugs.
    Mr. Carter. Right. But I think one of the problems too is 
that users are getting dependent on it knowing that oh, if I 
OD, they are going to come rescue me and I will be OK.
    Dr. Banner. Yes. I think it does encourage people in some 
ways to push the envelope.
    Mr. Carter. Exactly, exactly. Thank you. And also thank 
you, you mentioned something that throughout these hearings I 
have not heard anyone mention: synthetic marijuana. That has 
been a big problem in Georgia. Thank you for mentioning that 
because we want to continue that as well. And I know I am out 
of time and I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back. The chair recognizes the gentleman from New 
Jersey, Mr. Lance, 5 minutes for your questions, please.
    Mr. Lance. Thank you very much, Mr. Chairman, and my thanks 
to the distinguished panel. We have been back and forth in 
several hearings today, several of the subcommittees and of 
course votes on the floor. I want you to know this is an 
incredibly important topic to the entire nation and you are 
among the great experts on it.
    Dr. Kilkenny, could you speak briefly about the opioid 
crisis and the rise of infectious disease rates and how the two 
issues are linked?
    Dr. Kilkenny. Yes sir. Blood-borne pathogens are spread by 
sharing blood and injection drug use. When people who are 
engaged in injection drug use are sharing syringes or other 
materials of injection they are often sharing blood. So there 
is a clear correlation between those blood-borne pathogens that 
would be Hepatitis B, Hepatitis C, and HIV, and injection drug 
use.
    Mr. Lance. How have your efforts been successful in 
bringing together community partners in Huntington to address 
infectious diseases associated with the opiate epidemic?
    Dr. Kilkenny. The city of Huntington has a remarkable 
history of working together against common threats. And with 
the opioid epidemic reaching a level that it impacts every 
family, we have no problem getting every entity aligned in a 
strategy against it. So we have brought in virtually every 
other entity in the community into the strategic plan.
    Mr. Lance. Thank you. I have introduced legislation 
regarding the opiate issue and infectious diseases and my 
cosponsors are Congressman Kennedy on the other side of the 
dais. This is completely bipartisan and I hope that you as the 
experts might have the opportunity to review the legislation.
    I think there is a growing awareness among the various 
avenues we have to pursue that there is a significant 
correlation between the opiate crisis and infectious disease 
rates. And we are in this battle together and I am sure we will 
overcome and conquer based upon our joint efforts both 
bipartisan and bicameral in nature here on Capitol Hill, but 
also with leading experts across the country including this 
distinguished panel.
    Thank you, Mr. Chairman. I yield back the balance of my 
time.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman. The chair would recognize Mr. Walberg of 
Michigan, not a member of the subcommittee but my understanding 
is you want to waive on for questions. Is that correct?
    Mr. Walberg. That is correct.
    Mr. Burgess. The gentleman is recognized for 5 minutes for 
questions.
    Mr. Walberg. I appreciate, Mr. Chairman, the opportunity to 
join the August subcommittee. I have a great interest in this 
and a personal interest and I appreciated hearing what I have 
been able to listen to today about the fuller subject that we 
are addressing. And of course there has to be compassion. There 
has to be a willingness of a patient to seek help, first and 
foremost, but there also has to be certainly a willingness of 
the medical profession and society in general to reach out and 
solve the problem as well.
    Earlier this Congress, I introduced Jessie's Law with 
Congresswoman Debbie Dingell in an effort to try to find a 
solution to something that tragically took place in Michigan 
with Jessie Grubb, a resident who had been doing very well in 
beating her addiction and growing was involved in a sports 
accident injury in preparation for a marathon and had a 
surgery. Her family as well as Jessie herself notified the 
attending physician, the surgeon, of her problem with 
addiction, but it didn't reach the attention for some reason of 
the discharging physician and so she was sent home from the 
hospital with a prescription of oxycodone which she ultimately 
overdosed on the next day and lost her life.
    So we want to find a solution to that. And, Dr. Strain, we 
are currently examining both Jessie's Law and H.R. 3545, the 
Overdose Prevention and Patient Safety Act. Can you elaborate 
on the major differences between the bills and, if so, why it 
would be helpful to have both?
    Dr. Strain. First, I am sorry for that loss and for the 
family, for you and how you have had it impact you as well. It 
is a tragedy. I think both bills have value. I want to just be 
clear, I think that both have great value. I think that both 
illustrate the fact that as a physician I teach my residents 
and interns when in doubt get more data, and that is something 
that we are in a situation now where we may not know about how 
to get more data.
    So I could, for example, have seen Jessie and not known 
about her addiction history if she didn't tell me about that. I 
think that as I understand Jessie's bill, I think bringing 
together stakeholders who can look at how could something like 
this not happen in a medical record again is a worthwhile thing 
to do and to see if there is some way that that can be 
codified. I don't think it is enough. I think that we have a 
situation right now where we have got a whole treatment system, 
substance abuse programs that could be taking care of somebody 
and I may not know about that.
    And it is artificial at this point if I could say, if I 
could take a moment to say it is artificial. I could know 
somebody has got a substance abuse treatment, substance abuse 
problem documented in the record, but it is only if they are in 
a particular program that I may not know about what is going on 
in that program.
    So I have plenty of patients with substance abuse problems. 
I have asked them, they have told me. I have it documented in 
my records. Those records can be accessed by obstetricians, by 
orthopedic surgeons, by whoever. They can get access to that 
information in my record but they can't get access to the 
treatment records, which is artificial.
    Mr. Walberg. So what will give that access? What are the 
additional things we need to do?
    Dr. Strain. I think the Mullin amendment does that. I think 
the Mullin amendment, 3545, does that.
    Mr. Walberg. It is mandatory and automatically shared with 
any and all who need to know that?
    Dr. Strain. Well, with the proper protections in place as 
they are required, yes, which Representative Mullin pointed out 
in his questions, I think.
    Mr. Walberg. OK. Thanks for the opportunity to ask those 
questions. I see my time is about expired. I will yield back.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman. The chair recognizes the gentleman from New 
York, Mr. Engel, 5 minutes for your questions, please. And the 
chair would observe that was the vote being called. So we will, 
after Mr. Engel we will recess and reconvene with the next 
panel.
    But, Mr. Engel, you are recognized.
    Mr. Engel. Thank you. Thank you, Mr. Chairman. This week, 
Congresswoman Brooks and I introduced the Poison Center Network 
Enhancement Act, a bill that will reauthorize the Nation's 
poison center programs for an additional 5 years. Speedy access 
to poison centers through the national toll-free number, again 
800-222-1222, is an essential resource for all Americans, 
especially parents who can take solace in the fact that there 
are 55 poison centers across the U.S. available 24 hours a day, 
7 days a week, 365 days a year.
    These centers are a smart public health investment. They 
offer real time, lifesaving assistance while at the same time 
saving hundreds of millions in federal dollars by helping to 
avoid the unnecessary use of medical services and shortening 
the amount of time a person spends in the hospital if 
hospitalization due to poisoning is necessary. Most of us 
already know about much of the work poison centers do thanks to 
a magnet on the refrigerator displaying the poison center phone 
number. But many may not know about the critical role poison 
centers are playing in the fight to end the opioid crisis.
    Since 2011, our Nation's poison centers have handled nearly 
200 cases per day involving opioid misuse. Data from poison 
centers has helped detect trends in the epidemic and experts 
have helped educate Americans about the crisis in ways they 
could potentially save the lives of their loved ones. For 
example, the Upstate New York poison center used the New York 
State Fair to educate New Yorkers about proper use of naloxone, 
the overdose reversal drug. This bill would ensure that these 
important activities continue.
    I was proud to co-author the last poison center 
reauthorization in 2014 and I am proud to be part of this 
legislation. I want to thank Congresswoman Brooks for working 
with me for this important bill as well as Congresswoman 
DeGette and Congressman Barton for being the original 
cosponsors.
    Dr. Banner, let me ask you this in light of what I have 
said. Thank you for your being here and for sharing your 
expertise. This bill would authorize additional funding for the 
poison control center grant program. Would you talk about how 
this funding will help build capacity at poison centers and 
enhance their ability to respond to the opioid crisis?
    Dr. Banner. I appreciate everything that you have done, 
Congressman, and you know on behalf of the poison centers I 
really appreciate you. We hope to continue this fight. We hope 
to expand our educational activities as we go forward. We have 
a big state, so do you, and getting reaching out, particularly 
rural areas where education is critical, is difficult and 
expensive and so having extra funding and improving our funding 
base helps us in those outreach activities.
    We are also actively seeking the first responders to get a 
hold of the poison control center as part of naloxone 
administration. As the good gentleman from Georgia pointed out, 
it could be misused or overused and we want to actively 
supervise and help in that program and our ability to continue 
that activity is very critical. So we see a lot of 
opportunities reaching out to minority communities where these 
are problems as well is an important issue for us. So we thank 
you.
    Mr. Engel. Well, thank you, Dr. Banner. You mentioned in 
your testimony that poison centers have helped identify trends 
in the opioid epidemic. How do you think that this information 
in poison centers could help us as policymakers respond to the 
crisis more effectively?
    Dr. Banner. Well, I think it already has in a lot of ways. 
This is the kind of data when you see it, it may be coming from 
the CDC and we work closely with them. Every 8 minutes we 
upload from all 55 centers into a central database. Plus, 
conversations, we have our listservs and there is a lot of 
human intelligence going on where we are identifying things 
very early.
    The increasing Oxycontin, a lot of our recognition of those 
came from the NPDS database which is that contributory public 
health surveillance activity that we do. So we are constantly 
updating that database so that the FDA, the CDC, can be 
monitoring activities. We do that in real time for some acute 
events, but we also are looking over long terms. Every year we 
publish and people rely upon it heavily to look at trends in 
what drugs are becoming more prevalent and identifying new 
substances.
    So I think you do rely upon us. You might not know it came 
from a poison center, but our data is there and it is I hope 
really helpful in guiding you to see where the future lies.
    Mr. Engel. Well, thank you very much and thank you for your 
good work. And thank you, Mr. Chairman. I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back. The chair recognizes the gentleman from Virginia 
for a unanimous consent request.
    Mr. Griffith. Mr. Chairman, I would request that we 
introduce into the record a letter from the President and CEO 
of Titan Pharmaceuticals, Inc., related to the therapeutics for 
select chronic diseases and related to opioids.
    Mr. Burgess. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Burgess. And the chair wishes to thank this panel. You 
have been very informative. It has been a lively morning and 
that is what we wanted and so we appreciate your expertise and 
your sharing it with us. We are going to take a recess. This 
panel may be excused and we will reconvene 10 minutes after the 
vote series on the floor with our fourth and final panel. So 
the subcommittee stands in recess.
    [Whereupon, at 12:44 p.m., the subcommittee recessed, to 
reconvene at 1:24 p.m., the same day.]
    Mr. Burgess. We do want to thank all of our witnesses for 
being here this afternoon and for taking the time to testify 
before the subcommittee. Each witness will have the opportunity 
to summarize their opening statement followed by rounds of 
questions from the members.
    And this afternoon, for our fourth and final panel of this 
2-day hearing, we are going to hear from Ms. Jessica Hulsey 
Nickel, Founder, President, and CEO, Addiction Policy Forum; 
Ms. Carlene Deal-Smith, Peer Support Specialist at Presbyterian 
Medical Services; Mr. Ryan Hampton, Recovery Advocate, Facing 
Addiction; Dr. Mark Rosenberg, Chairman of Emergency Medicine 
and Chief Innovation Officer, St. Joseph's Healthcare System, 
Board of Directors in the American College of Emergency 
Physicians; Ms. Stacy Bohlen, CEO of the National Indian Health 
Board; and Ms. Alexis Horan, Vice President of Government 
Relations, CleanSlate Centers.
    Again thank you all for being with us today. Ms. Hulsey 
Nickel you are recognized for 5 minutes.

  STATEMENTS OF JESSICA HULSEY NICKEL, FOUNDER, PRESIDENT AND 
 CEO, ADDICTION POLICY FORUM; RYAN HAMPTON, RECOVERY ADVOCATE, 
FACING ADDICTION; CARLENE DEAL-SMITH, PEER SUPPORT SPECIALIST, 
PRESBYTERIAN MEDICAL SERVICES; MARK ROSENBERG, DO, MBA, FACEP, 
  FAAHPM, CHAIRMAN OF EMERGENCY MEDICINE AND CHIEF INNOVATION 
OFFICER, ST. JOSEPH'S HEALTHCARE SYSTEM AND BOARD OF DIRECTORS, 
 AMERICAN COLLEGE OF EMERGENCY PHYSICIANS; STACY BOHLEN, CEO, 
NATIONAL INDIAN HEALTH BOARD; AND, ALEXIS HORAN, VICE PRESIDENT 
          OF GOVERNMENT RELATIONS, CLEANSLATE CENTERS

               STATEMENT OF JESSICA HULSEY NICKEL

    Ms. Hulsey Nickel. Thank you so much, Chairman Burgess and 
Ranking Member Green.
    [Disturbance in hearing room.]
    Mr. Burgess. Ms. Hulsey Nickel, you are recognized for 5 
minutes, please.
    Ms. Hulsey Nickel. Thank you so much, Mr. Chairman, for 
your leadership on this important issue that is facing so many 
families and communities nationwide. My name is Jessica Hulsey 
Nickel and I am the President of the Addiction Policy Forum. I 
started the Addiction Policy Forum to bring patients, families, 
stakeholders across the country together to advocate for a 
comprehensive response to addiction including prevention, 
treatment, recovery support, overdose reversal, criminal 
justice reform and law enforcement, and also bring a voice for 
families. We have one goal, to help create a world where fewer 
lives are lost to addiction and help exists for the millions of 
Americans who need it.
    I am grateful to be with you today to discuss key 
legislation and how it will help address the addiction crisis. 
I know firsthand the devastating impact that substance use 
disorders has on families and communities. I lost both of my 
parents to addiction, and their substance use disorders meant 
for me and my little sister homelessness and foster care and 
being wards of the state until I was 10, and then being placed 
with our grandparents, and I lost both of my parents far, far 
too young.
    Every day we lose 174 people to drug overdoses in our 
country. One hundred seventy four--that is like a plane crash 
every day. It is important to put real faces to the scope of 
this crisis and the real families and communities that are at 
the epicenter, so we wanted to share with you some of the 
stories from our families.
    First up is Doug and Pam who lost their daughter Courtney 
when she was just 20 years old. He describes Courtney as a 
shining star. The room lit up when she walked in and everyone 
loved her. Doug writes, we were told that because it is not a 
matter of life or death there would be no coverage for 
treatment. On the advice of our local authorities we asked her 
to leave our home and canceled her insurance. By doing this she 
would be homeless and then could be eligible to receive 
treatment. Courtney died alone, away from our home, and the day 
before she was scheduled to go into a treatment facility.
    Lorraine describes her twin brother Larry as amazing, 
charming, funny, popular, and the most talented drummer you 
have ever heard. Larry died from a drug overdose leaving behind 
his 1-year-old son and Lorraine became a single parent 
overnight.
    Jennifer lost her son Dylan when he was just 19 years old. 
She says to us, every day when I walk into my house I see 
Dylan's shoes sitting on the floor where he kicked them off and 
his jacket draped over the bannister where he left it. He will 
never have the chance to get married, to have kids, to travel, 
to do all the things that a 19 year old should have 
experiences.
    And then Amy who runs our Massachusetts chapter, she lost 
her son Emmett when he was just 20 years old. In college 
studying computer science, Emmett had six overdoses reversed at 
his local hospital, but treatment was not initiated and the 
family was not notified. Each of these overdoses was an 
opportunity to engage him in the help that he needed.
    As a community of families, patients, and key stakeholders, 
we are so pleased to see the comprehensive approach that this 
committee is pursuing with the legislative proposals that are 
being considered. I would like to address three pieces of 
legislation in particular that will help us respond to this 
crisis.
    First off, the Comprehensive Opioid Recovery Centers Act of 
2018, we have an enormous treatment gap in this country. Of the 
21 million people that need treatment for a substance use 
disorder, only about ten percent will receive it. Can you 
imagine if ten percent of Alzheimer's or ten percent of cancer 
or ten percent of diabetes patients received treatment?
    Our current healthcare system has many systemic issues that 
continue to limit the effective and sustainable implementation 
of evidence-based practices to treat substance use disorders. 
For example, there is a lack of integration between general and 
specialty care. There is a lack of screening for substance use 
disorder in health care. There is inconsistency providing all 
three FDA-approved medications for opioid use disorder.
    The Comprehensive Opioid Recovery Centers Act will help 
address these barriers through the development and promotion of 
integrated care models based on best practices which will build 
a pathway toward a comprehensive healthcare infrastructure that 
must be achieved to ensure that everyone suffering with a 
substance use disorder has access to quality treatment. This is 
a preventable and a treatable illness.
    The Addiction Policy Forum supports the quick enactment of 
CORC, the Comprehensive Opioid Recovery Centers Act which will 
help fill the need for coordinated, comprehensive care for 
patients. Many thanks to Congressman Guthrie and Congressman 
Green, for their leadership on this bill.
    I would also like to address the TEACH Act--Treatment, 
Education, and Community Help Act to Combat Addiction. There is 
an alarming lack of substance use disorder education in medical 
school curriculums and among current physicians. According to 
the 2016 Surgeon General's report, only eight percent of U.S. 
medical schools have a separate required course on addiction 
and only a handful of medical schools have robust curriculum on 
the diagnosis and treatment of substance use disorders.
    Often, healthcare providers do not feel prepared to deal 
with what is commonly perceived as a difficult patient 
population, and because of the lack of education for students 
and experienced practitioners patients can be denied access to 
a large portion of evidence-based treatment options. Physicians 
around the country also report not having enough training on 
the prescribing of pain medications and alternative treatments 
for chronic pain. This particular gap in physician education in 
the midst of a worsening opioid epidemic must be addressed.
    The TEACH Act incentivizes the development of evidence-
based education and curricula. The legislation would fund 
educational institutions be centers of excellence and substance 
use disorder education and require such institutions to 
collaborate with the stakeholders in their community who are 
really on the front lines of this crisis. We are supportive of 
the TEACH Act and I thank Congressman Bill Johnson and Paul 
Tonko for their work on this legislation.
    And, finally, just very briefly, we are also very pleased 
to see the Preventing Overdoses While in Emergency Rooms, the 
POWER Act. This makes me think of Emmett and his mom, Amy, and 
how we can do a better job of equipping our emergency room 
physicians and all of our providers and emergency room 
departments to address nonfatal overdoses and to use this as an 
intervening moment. This is a high priority for the Addiction 
Policy Forum and we are in support of the POWER Act and 
grateful for this committee and your commitment to these 
issues.
    And I just wanted to express on behalf of all of the 
families that your focus on this issue in such a comprehensive 
manner that includes all six of the key components--prevention, 
treatment, recovery, support, overdose, reversal--the focus 
means the world to us. We have millions of families that are 
struggling, some alone, some trying to come together and really 
fight for better responses. And so I am here to also transmit 
that heartfelt thank you for your leadership and focus on these 
issues.
    So thank you so much for having me today.
    [The prepared statement of Ms. Hulsey Nickel follows:]
    
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    Mr. Burgess. We appreciate your testimony. Of course we 
also focused on enforcement during one of our first panels and 
as well as scientific discoveries to try to expand the universe 
of medications to treat pain.
    Ms. Deal-Smith, you are recognized for 5 minutes, please.

                STATEMENT OF CARLENE DEAL-SMITH

    Ms. Deal-Smith. Good afternoon, ladies and gentlemen. My 
name is Carlene Deal-Smith. I am a Native American of the 
Navajo tribe from Farmington, New Mexico. I am employed with 
Presbyterian Medical Services Totah Behavioral Health 
Authority. I work with homeless individuals who have substance 
abuse problems.
    Due to my own struggles with alcoholism I am able to assist 
with what they are struggling with. I understand the impact 
substance abuse has on their lives, understand them when they 
say nobody cares, the low self-esteem, and the unemployment 
they suffer with. The relatives, we call our clients relatives 
because that is how we relate to them, totah has a program that 
helps them get their life back.
    It takes months, maybe sometimes years for them to achieve 
sobriety, and being their peer support you have to be 
consistent with being available to them. Each day is a new day. 
It doesn't matter if they had a bad day yesterday. Being a peer 
support you have to model being healthy by your own recovery. A 
hard day in sobriety can be achieved when you model you are 
taking care of yourself. Being healthy is the key to help the 
relatives that still suffer.
    I come to you today to show my support for peer support 
programs. These programs offer more than just support, they 
offer jobs and independence. Thank you.
    [The prepared statement of Ms. Deal-Smith follows:]
    
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    Mr. Burgess. The chair thanks the gentlelady for her 
testimony.
    Mr. Hampton, you are recognized for 5 minutes, please.

                   STATEMENT OF RYAN HAMPTON

    Mr. Hampton. Thank you, Mr. Chairman. Mr. Chairman, Ranking 
Member Green, and members of the committee, my name is Ryan 
Hampton. I would like to thank the committee for inviting me to 
speak on the Ensuring Access to Quality Sober Living Act on 
behalf of Facing Addiction with NCADD, which represents over 
800 community organizations and 75 regional affiliates across 
the United States, a network now reaching over 35 million 
Americans.
    As a person in sustained recovery and a member of the 
recovery community, it is an honor to speak about the impact 
that H.R. 4684 will have on Americans with substance use 
disorder. I spent a decade struggling with an addiction to 
heroin. Addiction is not the result of bad decisions, but 
rather a health condition that is exacerbated by drug use. I am 
one of millions of Americans affected by it.
    Addiction affects people from all backgrounds, 
constituencies, races, classes, religions, and party 
affiliations. It does not discriminate. However, unlike other 
chronic illnesses like cancer and diabetes, we do have a 
solution. We are not struggling to find a cure. This issue is 
one that we can address together and prevent further loss of 
life. One of the ways we can do this is by supporting ethical 
guidelines for recovery housing.
    The person you see sitting in front of you today is in 
remission from the potentially fatal illness of addiction in 
spite of the broken system that we have in place. Long waiting 
lists, abstinence requirements for housing, unscrupulous 
operators, and unethical treatment practices all undermined my 
recovery. Some facilities discriminate against harm reduction 
measures and medication assisted treatment. That is a barrier 
to access and it kills.
    I went through multiple treatment centers, detoxes, and 
sober living homes before I was finally able to sustain my 
recovery. Not everyone has been so lucky. I am here today 
because my friend Tyler died of a heroin overdose in a sober 
living home. Because there was no naloxone on site and because 
the home staff weren't trained to deal with overdoses, my 
friend lost his life.
    Not having naloxone in a sober living home is like refusing 
to put lifeboats on an ocean liner. It doesn't mean that you 
are planning on a shipwreck. It means that in case of a 
disaster the passengers will make it safely to land. When I 
heard how Tyler had died I was outraged and I approached my 
congresswoman, Judy Chu. Thanks to her help, the support of 
Facing Addiction and the National Alliance of Recovery 
Residences, I stand before you today asking for bipartisan 
support of H.R. 4684 as a solution. I know it is not a silver 
bullet, but it will help get best practices in recovery housing 
implemented across the country.
    Tyler's death was 100 percent preventable and H.R. 4684 
addresses the changes we need in order to ensure that recovery 
homes are doing what they are supposed to do, saving lives and 
not endangering Americans. Recovery should never be about luck 
and it shouldn't be a guessing game for people who are in 
desperate need of help. H.R. 4684 is a step in the right 
direction that will for the first time allow SAMHSA to develop 
best practices that can be disseminated to states and help 
people and prevent more tragic overdoses like the one that 
killed my friend.
    Quality, access, care, and choice are key parts of the 
existing NARR standards for recovery residences. Quality means 
defining the essential elements of a properly operated recovery 
residence. Access means providing a road map for developing the 
full spectrum of recovery housing to better match needs and a 
blueprint for housing providers to rise to the occasion. Care 
means evaluating the peer support components of a residences 
recovery environment. Choice means empowering informed recovery 
housing choices with regard to placement and resource 
allocation.
    Everyone should have equal access to recovery support 
services. Not just prevention and treatment, but continuing 
care that includes peer support and housing. The 2016 Surgeon 
General's Report on Alcohol, Drugs, and Health, and the White 
House Commission on Opioids final report both recommend the use 
of peer recovery supports and recovery housing. Providing 
ethical and safe housing and support post clinical services is 
linked to higher rates of recovery.
    Without these measures in place we will continue to lose 
people like Tyler. Millions of Americans who access treatment 
and continuing care ask for help in good faith. We must ensure 
that their safety net is strong, safe, and ready to catch them.
    And, Mr. Chairman, on a personal note, to close I would 
like to say that not a single day goes by where I do not think 
about the friends that I have lost and the people that I have 
loved that are gone from this crisis, and I showed up to 
testify today for them, because of them, and in memory of them. 
Thank you.
    [The prepared statement of Mr. Hampton follows:]
    
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    Mr. Burgess. And the committee thanks you for your 
testimony.
    Dr. Rosenberg, you are recognized for 5 minutes, please.

                  STATEMENT OF MARK ROSENBERG

    Dr. Rosenberg. Thank you, Mr. Chairman. My name is Dr. Mark 
Rosenberg and I am the chairman of Emergency Medicine at St. 
Joseph's University Medical Center in Paterson, New Jersey. I 
serve on the board of directors of the American College of 
Emergency Physicians.
    So on behalf of St. Joseph's University Medical Center and 
its 170,000 visits in the emergency department per year, the 
38,000 members of the American College of Emergency Physicians, 
and the great State of New Jersey, I would like to thank the 
committee for this opportunity to provide testimony in support 
of two bills: ALTO, the Alternative to Opioids in the Emergency 
Department Act; and POWER, Preventing Overdose While in the 
Emergency Room Act.
    There are two cornerstones to ending the opioid epidemic, 
prevention and treatment, and they are represented by these two 
bills that I am supporting today. The prevention program is 
Alternative to Opioids, or ALTO, and the treatment program is 
MAT or the POWER Act, and both are necessary to stop the 
continued opioid misuse, abuse, and overdose.
    Prevention, H.R. 5197 ALTO, was developed by my team at St. 
Joseph's University Medical Center in New Jersey in 2016 to 
address the variation in prescribing habits and to decrease the 
reliance on opioids by emergency physicians. We started the 
program with a very simple premise, the best way to avoid 
opioid misuse and addiction is to never start a patient on 
opioids. The ALTO program is evidence-based protocols using 
nonaddicting and therapies that target receptor sites and 
enzymes that mediate the pain. An example is a patient with 
back pain. Instead of giving them opioids I give them a layered 
treatment of therapies that include nonaddicting medication and 
trigger point injections resulting in better pain management 
and improved patient experience of care.
    I am proud to say that after 2 years of implementation at 
St. Joseph's, the ALTO program has witnessed tremendous 
success. In the first year there was a 57 percent reduction of 
opioid use and by the end of the second year there was over an 
80 percent reduction of opioid use. These statistics reveal 
that education, evidence-based clinical treatment protocols, 
can have a dramatic impact on the fight against opioid 
addiction and overdose. More importantly, ALTO program can save 
lives and already there are emergency physician acceptance 
across the country to use ALTO protocols.
    Emergency Department-initiated MAT, or medical assisted 
treatment, represents the treatment arm of the equation. Let me 
give you a moment to tell you about every single patient 
addicted or dependent on opioids or heroin fears going into 
withdrawal. Patient in withdrawal experiences a feeling of 
being sick with chills, sweats, GI symptoms, and agitations. 
These patients either have to do another dose of opioids to 
stop the withdrawal or they need medical assisted treatment to 
stop feeling sick and stop the withdrawal.
    ED-initiated medical assisted treatment alone has shown 
positive results in getting patients with substance use 
disorders into addiction treatment. But MAT, plus a warm hand-
off, yields the best opportunity for success in getting 
patients into addiction treatment as well as decreasing the 
need for inpatient addiction treatment services.
    H.R. 5176 requires that healthcare sites have two essential 
ingredients that emergency physicians would like: Providers 
that are trained and licensed to provide MAT, and number two, 
agreements with community providers and facilities to continue 
services--the warm hand-off.
    We appreciate what Congress has done to help the opioid 
epidemic. The $6 billion included in the Bipartisan Budget Act 
of 2018 will be very helpful in turning the tide against opioid 
misuse. We urge you and your colleagues to not only authorize 
H.R. 5197 and H.R. 5176, but to support full funding of these 
programs as well. This is one of the biggest healthcare 
challenges of our generation. It took many years to get to this 
crisis point and unfortunately it will take some time to 
resolve the epidemic.
    But we are on the right track. Provide us with ALTO and MAT 
tools and funding and emergency physicians will be able to 
provide a better future for our patients as well as society. 
Thank you.
    [The prepared statement of Dr. Rosenberg follows:]
    
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    Mr. Burgess. Thank you, Dr. Rosenberg.
    Ms. Bohlen, you are recognized for 5 minutes, please.

                   STATEMENT OF STACY BOHLEN

    Ms. Bohlen. Thank you, Chairman. Chairman Burgess and 
Ranking Member Green, members of the subcommittee, on behalf of 
the National Indian Health Board and the 573 federally 
recognized tribal nations we serve, thank you for holding this 
important hearing. And in my native language I say, miigwech. I 
am Stacy Bohlen. I am the chief executive officer of the 
National Indian Health Board and an enrolled member of the 
Sault Ste. Marie Tribe of Chippewa Indians in Michigan.
    The current opioid epidemic represents one of the most 
pressing public health crises affecting tribal communities. 
While this epidemic is impacting many communities throughout 
America, it has disproportionately impacted tribes and has 
further strained the limited public health and healthcare 
resources that are available to the tribes. American Indians 
and Alaskan natives had the highest rate of drug overdose 
deaths every year from 2008 through 2015. A 519 percent 
increase in drug overdose deaths from 1999 to 2015 is also one 
of our statistics.
    These demonstrate the critical need for more comprehensive 
interventions in tribal communities to improve prevention and 
treatment measures. The epidemic is so bad that several tribes 
throughout the country have declared a state of emergency to 
tackle the crisis. Historical and intergenerational trauma 
including trauma across the life span, lack of funding at the 
Indian Health Service, and a failure by states to include 
tribes in state level prevention and public health programs all 
contribute to this crisis.
    In Minnesota, pregnant American Indian women were 8.7 times 
more likely to be diagnosed with maternal opioid dependency and 
American Indian infants were 7.4 times more likely to be born 
with neonatal abstinence syndrome, meaning that the 
repercussions of the trauma and this crisis are 
intergenerational.
    But the lack of funding for the Indian health system 
overall is one of the greatest systemic contributors to this 
crisis. Deferral of needed care due to lack of funding, 
physician workforce shortages at IHS, has created greater 
dependence on opioids. Limited funding means denial of needed 
care nearly 80,000 times in 2016 alone. Instead of being 
referred for surgeries or simpler treatments, patients are 
offered and simply placed on prescription opioid medications to 
address their pain as they wait for treatment and sometimes 
they wait for years.
    Policy solutions should focus on allowing tribes access to 
long-term, sustained resources improving data and disease 
surveillance, and traditional healing approaches. What would we 
like Congress to do? Well, number one, allow tribes access to 
the state targeted response to opioid epidemic grants. National 
Indian Health Board supports the provisions of H.R. 5140 that 
address this.
    We also request that the legislation include a ten percent 
set-aside for tribes. Direct funding of tribes reinforces the 
tribal sovereignty and the government-to-government 
relationship between the federal government and the tribes. It 
also will ensure that tribal communities are directing the 
programming so it can be most effective.
    Number two, establish tribally-specific funding streams 
such as behavioral health program for Indians modeled after the 
Special Diabetes Program for Indians. That is outlined in H.R. 
3704, the Native Health Access Improvement Act.
    Number three, ensure parity between states and tribes in 
any opioid related legislation advanced by this Congress. This 
means specifically including tribes as eligible entities and 
requiring tribal consultation information, data sharing, and 
funding set-asides at the state level.
    Number four, ensure that cultural and traditional healing 
practices are able to be utilized with Federal resources that 
includes Medicaid funding. Tribal communities have been healing 
our own people for thousands of years and these practices are 
highly effective in the communities where they are used. And 
five, establish trauma-informed interventions in coordination 
with tribes to reduce the burden of substance use disorders 
including those involving opioids.
    And we just learned that tribes received a $50 million set-
aside in the fiscal year 2018 omnibus for the state opioid 
response grant and 5 million was set aside for tribal 
medication assisted treatments. This is very important to us. 
We know that members of this committee were activists in 
getting this effort to happen and we say a big thank you, chi-
miigwech, and this is an excellent start.
    Health information technology and data also represents a 
serious challenge when it comes to the opioid crisis. I 
understand that my time is expired and I want to be respectful 
of the other witnesses, so the rest of my remarks appear in our 
written testimony. Thank you, Chairman.
    [The prepared statement of Ms. Bohlen follows:]
    
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    Mr. Burgess. Thank you for your testimony. Without 
objection, your full remarks will be made a part of the record.
    Ms. Horan, you are recognized for 5 minutes.

                   STATEMENT OF ALEXIS HORAN

    Ms. Horan. Thank you. Chairman Burgess, Ranking Member 
Green, and subcommittee members, my name is Alexis Horan, Vice 
President of Government Relations for CleanSlate Addiction 
Treatment Centers. CleanSlate is grateful for the opportunity 
to testify on H.R. 3692, the Addiction Treatment Access 
Improvement Act, and H.R. 5102, the Substance Use Disorder 
Workforce Loan Repayment Act, two bills that will expand access 
to high quality treatment and promote the growth of a stable, 
high quality, substance use disorder workforce capable of 
meeting the growing demand for evidence-based treatment for 
opioid use disorder.
    CleanSlate is an office-based opioid treatment program. 
That means we help patients overcome their addictions using 
pharmacotherapies including buprenorphine and naltrexone, more 
commonly known as Suboxone and Vivitrol, in combination with 
supportive counseling and clinical and social care coordination 
services. Our treatment centers are physician practices staffed 
by a combination of physicians, nurse practitioners, physician 
assistants, care coordinators, and support staff each of whom 
play a critical role in delivering pharmacotherapy-based 
treatment for opioid and alcohol use disorders.
    CleanSlate operates 41 centers across eight states, 
including Massachusetts, Indiana, Pennsylvania, Texas, Florida, 
Arizona, Wisconsin, and Connecticut, with 8,000 patients 
currently under our active care. Since our inception in 2009, 
we have treated nearly 28,000 patients which we believe gives 
us a keen understanding of the role medical treatment for 
opioid addiction can play in ending the opioid epidemic.
    We plan to open our first centers in Ohio and Kentucky this 
spring. Our decision to open a new center sets in motion an 
intensive recruiting, contracting, and community outreach 
effort. Sadly, there is no shortage of demand for our treatment 
services, but providing treatment to meet demand is 
increasingly difficult primarily due to the challenges we face 
in finding willing, experienced prescribers with sufficient 
buprenorphine waiver slots to support our program.
    Fully 20 percent of CleanSlate prescribers are at or near 
their prescription limits. Despite our own internal workforce 
building efforts and the addition of advanced practice 
clinicians to the pool of eligible prescribers, we are not 
always able to fully meet the demand for treatment in the 
communities we serve. The Comprehensive Addiction and Recovery 
Act of 2016 took important steps toward helping close this 
treatment gap. However, demand for opioid use disorder 
treatment continues to grow while the workforce does not grow 
commensurately.
    To give a sense of the dynamic we face, in 2017 CleanSlate 
hired and trained 85 providers for medication assisted 
treatment through our internal program, 58 of the 85 providers 
did not have their prescribing waiver before they came to 
CleanSlate. Even with these additions we constantly face 
capacity challenges. H.R. 3692, the Addiction Treatment Access 
Improvement Act, and H.R. 5102, the Substance Use Disorder 
Workforce Loan Repayment Act, will meaningfully close key parts 
of the treatment gap that exist in our country and we 
appreciate that these measures are under active consideration 
by the committee today.
    Broadening the pool of eligible prescribers and their 
capacity for highly qualified providers to treat larger panels 
of patients, simply stated, would enable CleanSlate clinicians 
and others around the country to treat more patients 
immediately. Allow me to share the experiences of some of our 
centers to illustrate this point.
    Our Anderson, Indiana treatment center currently employs 
four prescribers who are authorized to prescribe MAT for a 
combined total of 190 patients. Still, we have 60 patients on a 
waiting list at Anderson. As a result, some patients are 
driving over an hour away to another CleanSlate program in 
Indianapolis to access treatment.
    Alternately, our Scranton, Pennsylvania center has nine 
prescribers who currently treat 570 patients with 100 treatment 
slots still available. That may sound like a lot of capacity, 
but in January 85 new patients joined that center and in 
February 66 joined. At that rate, our capacity to treat more 
people could and likely will be filled by the end of April.
    H.R. 3692, the Addiction Treatment Access Improvement Act, 
introduced by Representative Paul Tonko, addresses and 
alleviates these challenges by allowing a larger pool of 
advanced practice clinicians to prescribe MAT by making that 
prescriptive authority permanent instead of sunsetting the 
authority as it is under CARA, and by allowing highly 
credentialed prescribers or those working in qualified practice 
settings like CleanSlate to treat up to 100 patients at the 
outset instead of just 30 as is under current law.
    As stated before, prescription limitations are not the only 
barrier to expanding access to treatment. There remains a 
dearth of providers who are willing to work in this field due 
in part to the complex medical, behavioral, and social needs of 
patients with opioid use disorder as well as the stigma 
associated with the patient population. These factors make 
provider recruiting a challenge.
    Retaining a high quality, compassionate workforce is also a 
challenge. H.R. 502, the Substance Use Disorder Workforce Loan 
Repayment Act, introduced by Representative Katherine Clark, 
authorizes a robust loan repayment program for a wide range of 
full-time substance use disorder professionals who provide 
treatment in underserved areas. Not only will this legislation 
incentivize newly minted providers to begin careers that 
involve treating substance use disorders, the bill will also 
help stabilize the workforce by meting out payments over 6 
years which should counter attrition that is all too common in 
this field.
    CleanSlate strongly supports these important bills and 
thanks Representatives Tonko and Clark for their thoughtful 
contributions toward addressing an opioid epidemic that affects 
us all. Together, H.R. 3692 and H.R. 5102 directly address 
barriers that preclude providers from adequately providing 
effective treatment for opioid and other addictions.
    Thank you, Chairman Burgess, Ranking Member Green, and 
members of the subcommittee once again for the opportunity to 
speak in support of these bills and on behalf of my 
organization and the addiction treatment field at large. The 
hearings you are holding are tremendously important to 
increasing awareness and building support for the policy 
changes needed in our field and we look forward to assisting 
you in any way. Thank you.
    [The prepared statement of Ms. Horan follows:]
    
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    Mr. Burgess. And we thank you for your testimony. We thank 
all of you for your testimony this afternoon and thank you for 
bearing with us through what has been a pretty long day. At 
this time we will move into the question portion where members 
are each recognized for 5 minutes for a series of questions.
    And if he is ready, I will yield to the gentleman from 
Virginia, Mr. Griffith, 5 minutes.
    Dr. Bucshon, Mr. Griffith requests that I recognize you.
    Mr. Bucshon. I would be happy to do that. Thanks, Mr. 
Chairman.
    Since you were the last one to talk, I think maybe I will 
ask you a question. First, I have, it is a little opening kind 
of statement, then I will ask the other members of the panel.
    So, doctors do not prescribe insulin to a diabetic without 
education, support, or routine follow-up care. That said, 
prescribing buprenorphine without wraparound services, I would 
argue, is substandard care. I am fully supportive of doing 
everything we can to combat the opioid crisis ravaging the 
country. That includes expanding access to medication assisted 
treatment, Section 303 of CARA I helped author, for example. 
However, it is important that we do so in a thoughtful way.
    I was a heart surgeon before, so I am a medical person. A 
health professional with no expertise in addiction medicine, 
for example, can now prescribe ultimately buprenorphine to 275 
patients. That is about 14 patients per day. These patients are 
seen just once per month. Do you think that a provider seeing 
14 patients a day is consistently able to provide the 
comprehensive, therapeutic services that best fits the clinical 
needs of his or her patients?
    Ms. Horan. Well, thank you for that question. To the 
training part, and I can only speak on behalf of CleanSlate and 
how we train and educate our physicians, our physicians do come 
from a wide range of backgrounds. Regardless of their 
background, however, they are all put through about a 4-week 
training program, internally with us, which includes a 
combination of didactic and onsite learning and training.
    In terms of the wraparound services we provide as an 
organization, all of our clinicians are trained in supportive 
counseling. We staff care coordinators at most of our centers 
to make sure that the patient has at least access to, and not 
just access to in terms of here is a business card, good luck 
finding it in the community, but a warm connection to the 
referrals that we have made. That is part of the community 
outreach in terms of how we set up in a new community.
    So our providers are, we believe, providing extensive 
supportive counseling and then relying on the expertise that is 
in the community to fill their primary care, dental care, OB-
GYN care, additional behavioral healthcare needs.
    Mr. Bucshon. So I guess if you hired someone new and they 
go through their training, would you think that they should be 
able to see 14 patients a day, all month, right off the bat? 
Because I think that is in your testimony and based on the 
legislation is what you are implying that they should be able 
to go right to the full amount right off the bat.
    Ms. Horan. I do. We do, because we believe that we have 
established programs that provide the administrative care 
coordination and clinical support necessary to enable that 
physician or that nurse practitioner or physician assistant to 
really attend to the patient's addiction treatment needs.
    Mr. Bucshon. Because I think, in CARA we were trying to 
expand the scope of who can do this with a 3-year, with a 
pilot, expanding the type of practitioner. But do you think we 
should really lock in this big of an increase in the number of 
patients, really, before we have seen a single piece of data 
from HHS as was part of CARA to see if these practices are 
successfully treating patients in adhering to the evidence-
based guidelines and ensuring that buprenorphine or methadone 
or whatever, buprenorphine, which is one of the most diverted 
medications, is not being further diverted? Because the whole 
point was if we expanded this we wanted to get data to see if 
that was successful.
    Ms. Horan. Right, right. Again I am going to speak on 
behalf of CleanSlate here and I will answer it in two parts. 
One, we feel like we have some data that shows that our 
treatment programs are successful. We worked with one of our 
payers to look at our patient outcomes and we showed patients 
who had been in treatment with us for 6 months had shown, as 
compared to the treatment they had for 6 months prior, showed a 
35 percent reduction in use of ERs, a 25 percent reduction in 
any in-hospital stay, and reduced their conversion to Hepatitis 
C by about 80 percent.
    So we feel that at least again in our program, a program 
that really wraps not just the patients around with services, 
but the providers that work with them, the tools that they need 
to do their job well, we believe that MAT can be successful. We 
have worked now for almost a year with advanced practice 
clinicians, thanks in part to the CARA bill, and they are 
incredible additions to our team. There is no way we would be 
able to meet the demand for treatment in the communities 
without them and they work in collaboration with our physicians 
in almost every scope of practice.
    Mr. Bucshon. Yes. I would just say this, and some of my 
personal views is sometimes the ends doesn't always justify the 
means. I get that there are a lot of people out there on 
waiting lists, but as a healthcare provider I think we also 
want to be cautious. Your program is excellent, but there are 
others out there that probably are not.
    And so when we try to put public policy in place we want to 
make sure, I do at least, we think about the patient at the end 
of the day and across the country what is going to work. So I 
would argue against immediately expanding to 275 without some 
sort of a ramp-up and that is my personal view. I yield back, 
Mr. Chairman.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back. The chair recognizes the gentleman from Texas, Mr. 
Green, 5 minutes for your questions, please.
    Mr. Green. Thank you, Mr. Chairman. I want to thank all our 
panelists for joining us today, and I will start my questions 
with Ms. Nickel.
    Ms. Nickel, you note in your testimony that I have been 
working with Congressmen Guthrie, Lujan, and Bucshon to 
introduce the Comprehensive Opioid Recovery Centers Act. In 
your testimony you highlighted that of the 21 million Americans 
who need treatment for a substance use disorder like opioids, 
only ten percent receive such treatment.
    This almost begs the question, why aren't more Americans in 
need receiving that treatment?
    Ms. Hulsey Nickel. Our treatment system has a lot of gaps 
that we need to fill and there are lots of silos and 
fragmentation. And I believe the CORC Act will help us to fill 
in some of those gaps and make sure that for example, going to 
three different places to receive a medication if you have an 
opioid use disorder can be very difficult and we need to make 
sure we are streamlining how to have patient-centered care so 
the right medication is identified and given to that patient 
based on a doctor's advice and not just who you happen to find 
near you or on a Google search or by calling someone off of a 
commercial.
    We need to make sure that this is led by health care and 
have better provision of evidence-based service.
    Mr. Green. What are the most common barriers to receiving 
that treatment?
    Ms. Hulsey Nickel. I think we have some pair issues with 
finding coverage and how do you pay for this. We have a lot of 
navigation problems that when this hits your family you usually 
are thinking about like how do I Google someplace and empty out 
my savings account, rather than how do I go find the right 
physician or a counselor to help me build a treatment plan for 
myself or for my loved one?
    So I think the externalization from health care of removing 
this out of our healthcare system is one of the biggest 
barriers to making sure that we get the treatments to all the 
patients that need it.
    Mr. Green. One of the unique requirements of our 
legislation is the need for treatment centers to have trained 
personnel responsible for outreach to the key community 
stakeholders such as institutions of higher education and the 
criminal justice system. Can you speak to the importance of 
this community integration as part of the treatment and 
recovery?
    Ms. Hulsey Nickel. Absolutely. Addiction is an illness that 
begins mostly in adolescence or young adulthood. Ninety percent 
of those that have a substance use disorder it began in those 
ages. So that component with higher education or even earlier, 
very important to make sure that you are initiating treatment 
and intervening early. Right now this is the only disease that 
we wait for it to worsen before we treat it. Can you imagine 
like waiting for an amputation before you would treat diabetes?
    So when you have those community outreach functions out of 
your legislation and make sure that we are getting the help 
that we need into the places where you can intervene earlier 
and have better outcomes for that patient.
    Mr. Green. OK. Through your work with the Addiction Policy 
Forum do you have experience with treatment that have included 
outreach to these key community stakeholders? If so, can you 
share how community outreach has and has not improved the 
treatment outcomes?
    Ms. Hulsey Nickel. I think any opportunity you have for 
community outreach is going to improve your outcomes and your 
access to care. We need to vastly expand that type of service 
and coordination. We need to go into younger ages and also 
figure out new ways to get into families and communities so 
that they know how to ask for help and where to go for 
evidence-based care.
    High schools, through employers and through the workplace, 
through colleges, through our churches, it doesn't really 
matter how they come in the door, but you need to make sure 
that they find the right help so they don't get taken advantage 
of directed to nonevidence-based care that is going to have 
poor outcomes.
    Mr. Green. In your work with your family members, people 
who unfortunately have lost their battle with addiction as a 
result of the opioid overdose, how common is it their loved 
ones completed treatment without being offered a range of 
treatment options and the necessary support services?
    Ms. Hulsey Nickel. Unfortunately, of all of our families a 
very large majority could not find evidence-based care. They 
were denied care. They were offered very short periods of 
treatment, 14 days or 21 days, instead of the long-term 
wraparound care that they are needed. As I mentioned, trouble 
accessing medications to treat addiction, not providing MAT for 
someone who has an opioid use disorder, you are going to have a 
very, very difficult time having a positive outcome. So this is 
common in the stories we hear over and over again of not having 
that quality care.
    Mr. Green. OK. Well, Ms. Hulsey Nickel, thank you. Last 
month, the CDC published troubling new data showing that 
between July 2016 and September 2017 opioid overdoses visits to 
emergency room departments increased by 30 percent. In 
addition, opioid overdoses are increasing among men and women 
of all ages from all parts of the country. This data highlights 
the increasing severity of the opioid epidemic and the critical 
role emergency departments must play in response to this.
    And I will yield back what little time, I don't have any 
time left.
    Mr. Burgess. No, you don't. The gentleman's time is 
expired. The chair recognizes the gentleman from Oklahoma, 5 
minutes for your questions, please.
    Mr. Mullin. Thank you, Mr. Chairman, and thank you once 
again for your continued effort on holding these hearings. It 
means a lot to me and so many other families. Thank you to the 
panel for being here too and sticking with us. It has been a 
long day and so I do appreciate it.
    Stacy, thank you for working with us on the IHS Task Force, 
coming in and talking to the staff, just Monday, and educating 
us and working with us trying to figure out how we can help 
better serve Indian country as a whole, and as you said in your 
testimony that it is disproportionately high of accidental 
overdoses inside of Indian country.
    I represent the great State of Oklahoma. I am Cherokee 
myself and, I have the highest Native American population of 
any district and so this hits home really tough. And part of 
what we are trying to do is make sure that it is not 
overlooked.
    Tribes are unique because we are considered sovereign 
nations and so by getting funding to Indian country is vitally 
important because most health care for Native Americans are 
done within the IHS system. That was the Federal Government 
obligation through the treaties to which they were signed. And 
I understand most people don't understand that but it is where 
I grew up my whole life. I am still living in Indian country. I 
still live at the same place I was raised and my family was 
raised. We are generational there.
    I have got a question for you though. What are the benefits 
to direct funding the tribes throughout this program?
    Ms. Bohlen. Thank you, Congressman.
    Mr. Mullin. No, thank you.
    Ms. Bohlen. Well, first of all, directly funding the tribes 
upholds the Federal Government trust responsibility and as you 
so eloquently expressed the promises that were made in the 
treaties to the tribes. The trust relationship that is 
established through the Constitution, Federal law, and so 
forth, is a relationship between the Federal Government and the 
tribes.
    When funding for programs is sent to the states with the 
hope or maybe even the intention that the state will share that 
funding with the tribes, there is no legal obligation and there 
is no accountability whatsoever on whether any of that money 
will reach the tribes and that is largely because the trust 
responsibility cannot be delegated to the states.
    Mr. Mullin. Right.
    Ms. Bohlen. It has to be honored at the federal level. So 
the benefits are tremendous. If I may, Special Diabetes Program 
for Indians, it is not a large investment from the government 
to the tribes, but it is a public health program that is taking 
the best of Western medicine and the best of tribal traditional 
practices and implementing a preventive treatment program that 
is probably, after immunizations, the most successful public 
health program in the country. The tribes know how to do this.
    Mr. Mullin. Right. And I want to elaborate just a second on 
what you said it is not their obligation. It is not the State's 
obligation. The treaty was made with the Federal Government and 
it is not a handout. It is payment from land that was taken 
from the tribes for years and years ago and that obligation and 
that payment still stays in place.
    And for tribes to be able to ask the State for it, the 
State does look at it as it is not our obligation and which it 
is not, it is not any fault to the State. Oklahoma deals with 
this in a very unique way. I have 19 different tribes just in 
my district and we have a unique relationship with the States. 
But we do have to realize that through the grant programs they 
need to be available to the Indian country also.
    So, one more question for you. Can you discuss the 
technical challenges that we have that is hampering Indian 
country with getting the data and the information that they 
need?
    Ms. Bohlen. Yes, I can talk about that briefly. The health 
IT system in Indian country, it does not have great 
interoperability among the various electronic health records 
and so forth, that the tribes who are self-governing may choose 
to use an application that is different from what the Indian 
Health Service uses which is the RPMS system. And RPMS system 
is very cumbersome in terms of trying to extract data and 
trying to make the picture that you actually want to make out 
of the disparate ways that data is collected.
    There needs to be an investment in Indian country to 
advance electronic medical records. The agency, I believe, 
States it would require $3 billion over 10 years to bring that 
system into par with what the rest of America is experiencing.
    Mr. Mullin. Thank you so much. My time is out. Thank you, 
Stacy, again for working with us. Thank you, Chairman. I yield 
back.
    Mr. Burgess. The chair thanks the gentleman. The chair 
recognizes the gentleman from Maryland, Mr. Sarbanes, 5 minutes 
for your questions, please.
    Mr. Sarbanes. Thank you very much, Mr. Chairman. I want to 
thank the panel for very compelling testimony. I wanted to 
focus particularly on H.R. 5102 which has been mentioned. This 
is a bill that I am very proud to be cosponsoring with Mr. 
Guthrie on this committee, but the prime sponsors are Katherine 
Clark of Massachusetts and Congressman Hal Rogers who have 
really taken the lead on this issue of trying to respond to 
shortages in the workforce.
    And it has been touched on by Ms. Horan, but I wanted to 
again go over some of the statistics and information we have 
that call upon us to have an aggressive and, I think, creative 
response to the provider shortage. We know that there are 
workforce shortages for all of the various substance use 
disorder healthcare professional categories across the United 
States. According to SAMHSA in 2012, in addition, the turnover 
rates in the addiction services workforce ranged from 18.5 
percent to over 50 percent. And in a recent survey, nearly half 
of the clinical directors and agencies that specialize in 
providing a substance use disorder treatment acknowledge real 
difficulty in trying to fill these open positions and then keep 
them filled, dealing with the lack of qualified applicants on 
the one hand and the inability to keep folks in place on the 
other hand.
    In Maryland, where we are certainly facing as every State 
in the country is a severe crisis in terms of substance use 
disorder and the effects of the opioid addiction epidemic, I 
have been hearing this as well. Recently I met with the head of 
Baltimore Medical System, which is one of our federally 
qualified health centers in Maryland, and she told me about her 
own difficulty in finding and keeping healthcare professionals 
that specialize in this arena.
    So the bill that has been introduced by Congresswoman Clark 
and Congressman Rogers and is being cosponsored in this 
committee by Mr. Guthrie and myself, we create a pretty 
creative loan repayment program for substance use disorder 
treatment providers. Participants in this program could receive 
up to $250,000 in loan forgiveness if they agree to work as a 
substance use disorder treatment professional in an area that 
is most in need of their services. So that could be a mental 
health professional shortage area or in a county or 
municipality that has overdose death rates above the national 
average. That would be one qualifying category.
    Participants can work in a wide range of facilities, which 
is important. Community health centers, I alluded to that. 
Hospitals, recovery programs, correctional facilities, et 
cetera, wherever the need exists in a significant way. And it 
will be available to a broad range of direct care providers 
including physicians, registered nurses, social workers, other 
behavioral health providers.
    So we are hoping that this will allow us to attract new 
providers into this very, very important field and it has 
received strong endorsements from the American Society of 
Addiction Medicine, the National Council for Behavioral Health, 
the Addiction Policy Forum, and so forth. So again I am very 
proud to be part of this.
    I did want to ask you, Ms. Horan, just to speak, if you 
could, with a little more detail to what you have seen and 
gathered by way of data and otherwise about this shortage in 
these particular areas of practice and what it would mean to 
have this kind of an incentive program in place to address it.
    Ms. Horan. Sure. Thank you for the opportunity. Again I am 
going to speak from CleanSlate's perspective on this because I 
think it is a slice of, I think, reality that might reflect 
what other programs like ours are facing.
    Recruitment is an ongoing challenge. There are not a lot of 
highly trained physicians or advanced practice clinicians with 
a lot of addiction medicine background or addiction psychiatry 
background. Many of those that are out there are working in the 
field already. So we are always looking for new, compassionate, 
committed talent to try and help us both grow our programs 
across the country, but just try and keep the programs that we 
have running.
    As you mentioned, turnover is very high for various reasons 
in the field. And turnover, while it might be a bear for us in 
terms of, the administrative side of it, the biggest problem is 
the danger to patient continuity of care. And so any effort, 
particularly this one, I think, will really help us bring, and 
probably newer, younger talent to the field, the folks that are 
really carrying the highest debt burden at this point and that 
is a good thing.
    I think these are probably folks who are graduating within 
the last couple of years who may have had a little bit more of 
the addiction and pain education in medical school, we hope, 
but also who might not have some of the biases about addiction 
treatment that exist in other parts of the treatment. So 
certainly for us it is just another wonderful tool that we have 
in our toolbox to try and recruit the best, just so that we can 
provide our patients with the best care. Thank you.
    Mr. Sarbanes. Well, thank you for your testimony. I yield 
back. And hopefully we will get this through and help will be 
on the way. Thank you. I yield back.
    Mr. Burgess. The chair thanks the gentleman. The chair 
recognizes the gentleman from Georgia, 5 minutes for your 
questions, please.
    Mr. Carter. Thank you, Mr. Chairman, and thank all of you 
for being here. I have described the opioid epidemic in our 
country as being twofold. First of all, we have that part that 
is somewhat tangible that we can somewhat put our arms around, 
that is, how do you control these numerous prescriptions that 
are being written, limiting the number of prescriptions, 
limiting the pills, those things are somewhat tangible.
    But then we talk about all those millions of people who are 
addicted now and how do you deal with that? That is a whole 
different subject, if you will, and a whole different 
situation. That is why I am so glad to see all of you here and 
I appreciate it very well, very much.
    And, Dr. Rosenberg, I want to start with you, because as 
the only pharmacist currently serving in Congress I find it 
fascinating that--I feel like there is a big void that exists 
right now in medicine. And I have preached this to the 
pharmaceutical manufacturers that we have opioids and once you 
get past opioids we really don't have anything else to 
prescribe.
    You have ibuprofen and tramadol and then you go to opioids 
and there is a big gap there. And I have been on the 
pharmaceutical manufacturers. We need to fill in that gap. And 
over my career I have witnessed miracles come out of research 
and development, but I still haven't seen them fill in that 
gap. That is why I am so interested in your program. And I want 
to tell you that until this hearing I was not familiar with it, 
but I commit to you that I am going to study it. I do think 
there is value in this. There are alternatives that can be used 
that we need to use as opposed to just putting people on the 
opioids.
    I can remember practicing my pharmacy across from a dental 
clinic and they would always give them three prescriptions--
ibuprofen, the pain pill, and the antibiotic. And they would 
come in and say oh, I don't need the antibiotic, I just need 
the pain pill. Yes, right. Well, we finally passed a self-
imposed rule, you had to get the antibiotic if you are going to 
get the pain pill.
    But, really, I am going to study more, so I want to 
acknowledge you. Now, I want to go to Ms. Nickel.
    I found your testimony to be fascinating and I want you to 
know how much I appreciate what you are doing. I had the 
opportunity along with Chairman Burgess and Mr. Green to attend 
a conference a couple of weeks ago and we heard from a retired 
sheriff from West Virginia who told the story about a young 
man, a boy who was always late for school and who was in a 
family of opioid addicts.
    And instead of the police officer just simply turning him 
into juvenile detention he decided to mentor him and when he 
was mentoring him he had a birthday. And he asked him, he said, 
what do you want for your birthday? And he said I want a clock. 
And the policeman said why would an 8-year-old want a clock? 
And he said, because I don't want to be late. I want to be on 
time. He didn't even have a clock.
    And that is why I find your story so fascinating. How do 
you break that cycle? What was different? What broke it for 
you? How can we mentor people? We know particularly us in 
Congress that, you know, it is just cyclical and the 
generations it is hard to break those cycles like that.
    Ms. Hulsey Nickel. Thank you. You know, when I get asked 
this question I sort of come back to it is all about science. 
We need to use evidence-based and science programs and 
interventions for kids that are impacted by this epidemic, kids 
like me, and we need to find them early and we need to give 
them the services right away.
    And I love that you mentioned mentoring because that was 
one of the key components for me as well. The mental health 
department in our county assigned me a big sister when I was 11 
years old and it was the first person I had ever met that had 
gone to college and was professional and a mentor and a real 
guide for me. But I also had mandated mental health. There were 
loving family members that I was put with in kinship care, 
living with my grandma, my grandparents. And we know to 
identify children that are impacted. And there is trauma. There 
is adverse child events.
    Mr. Carter. Right.
    Ms. Hulsey Nickel. You are susceptible to lots of things. 
So we need to identify all these kids early and then get them 
the services that they need.
    Mr. Carter. I am sure probably many of you read the book, 
Hillbilly Elegy, and, you know, J.D. Vance and that story, what 
a fascinating story. And it is just what you are saying, same 
scenario.
    Mr. Hampton, I also found your testimony to be fascinating. 
Thank you for being here and thank you for what you are doing. 
I wanted to ask you, and I really want to ask all of you, what 
works? That is something I am struggling with because so many 
of my colleagues think all we have got to do is throw money at 
it and we know it has got to be more than that. What programs 
work?
    Mr. Hampton. Thank you for that question, Congressman. It 
is a matter of throwing money at things, but I think it is a 
matter of throwing money at the right things, first of all.
    Mr. Carter. OK, fair enough.
    Mr. Hampton. So the Surgeon General's 2016 report, and then 
I will go into my own personal experience, said that after year 
1 people like myself we are considered in remission after year 
1 of recovery. After 5 years we have an 85 percent chance at 
maintaining long-term recovery. So the question becomes why are 
we not supporting people beyond that in that first critical 
first year, but also up to those 5 years? For me----
    Mr. Carter. Because this is a lifelong challenge.
    Mr. Hampton. It is a lifelong challenge. For me, I had been 
through treatment multiple times, detox multiple times. I will 
say treatment works. Treatment saved my life. But my 18 friends 
who have died in the last 2 years all had been through 
treatment, all had been through detox. Where we, I believe the 
system is failing is we are not spending enough time and money 
on recovery and recovery support services and we are 
constantly, you know, we are bunching up treatment with 
recovery. Treatment is not recovery. Recovery happens when you 
leave treatment.
    Mr. Carter. I am way over my time but I have to ask and I 
am going to ask, do programs with a spiritual component work 
better than others?
    Mr. Hampton. Congressman, there are multiple pathways to 
recovery. Personally, me, I am a member of a 12-step fellowship 
and that is what works for me, but I have seen programs for all 
sorts of different people, faith-based, folks who are agnostic. 
It works and there are many different ways that people do this.
    Mr. Carter. That is the big challenge for us that we find. 
We want to fund the programs that work, but it is just a 
struggle.
    Mr. Hampton. I will add to that, every year SAMHSA--I went 
this year in September, they release all the numbers. We know, 
the Federal Government knows how many people are addicted to 
heroin, how many people are using cocaine, all the different 
drugs, the age groups, State by State data. There are 23 
million people that are living in long-term recovery in the 
United States and I don't believe that the Federal Government 
has spent time studying us and how we achieved it. So maybe 
that would be a good first step.
    Mr. Carter. Again I want to thank all of you for being here 
and I yield back, Mr. Chairman.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman. The chair would inquire of the gentleman of 
Oregon, do you wish to--pass on questions.
    So the chair will recognize the gentleman from Virginia, 5 
minutes for your questions, please.
    Mr. Griffith. Thank you very much, Mr. Chairman. And I 
appreciate all of you being here. As I think one of the 
previous members said, it has been a long day for you all. We 
know that and we appreciate you being here.
    Ms. Nickel, I am going to address most of my questioning to 
you. I represent 22 counties, mostly rural, and seven 
independent small cities. The biggest one is about 25,000. The 
smallest of my cities is 3,500. We are all in an area that is 
underserved for drug abuse and mental health so we have 
problems there.
    So that is where I am coming from when I ask these 
questions because we don't have enough treatment centers. In 
fact, in a huge number of my counties they just don't have 
anywhere to go. And I had some folks who are recovering and 
trying to do what they can, but there is no long-term treatment 
there. So that is where my questions are coming from and keep 
that in mind, if you would, with the answers to them.
    So part of that is it is obviously important to build a 
pipeline of qualified healthcare providers that have been 
trained in substance use disorder treatment and pain management 
education, and as I understand it, the TEACH Act will help 
highlight curricula from centers of excellence and disseminate 
these best practices widely. What types of healthcare workers 
will the bill educate and how will the TEACH Act take into 
consideration the smaller institutions that are educating 
healthcare workers with limited resources, because if you are 
just doing the big ones you are not going to reach all of my 
counties.
    Ms. Hulsey Nickel. Absolutely. Thank you so much for that, 
Congressman. The TEACH Act will help to make sure that we get 
the right curriculum and training to all different kinds of 
healthcare providers, from specialty physicians, emergency 
departments, primary care, pediatricians, nurse practitioners. 
We need to move this to a chronic disease model, chronic care, 
and make sure that we have qualified and trained healthcare 
providers in all different types of settings, hospitals, in 
your regular doctor's office or your pediatrician's office so 
they can identify and assess and treat substance use disorders 
more early.
    This is particularly important for rural communities where 
you are not going to find as much specialty treatment. Very 
long distances, we are doing work on the ground in a few places 
like Ohio in rural communities, very difficult to find 
medication-assisted treatment, providers that can prescribe the 
medicines that you need to treat opioid use disorder that can 
do that long care follow up. And it also is true we need to 
have long-term care plans--12 months, 3 years, 5 years--
depending on the severity of that substance use disorders, and 
TEACH Act will give healthcare providers the tools that they 
need to assess, identify, and make sure we build those 
treatment plans.
    Mr. Griffith. I appreciate that. Also, the Comprehensive 
Opioid Recovery Centers Act will identify some of the best 
centers in America providing care for addiction and recovery. 
And from what I understand, these centers deliver the full 
complement of addiction services. Congress will direct funding 
to support those centers and they in turn will provide 
documentation and data on their effectiveness, their models of 
care, and their collaboration with their communities.
    Is the goal of the bill to scale up and spread so that 
there are more centers of excellence across the U.S. or is the 
goal to lift all boats with the rising tide so that any 
facility can improve even if they are not able to reach the 
centers of excellence level? And obviously when you don't have 
any you may need to start with something. Even if it doesn't 
meet the gold standard, we would like to have something that 
meets at least the silver standard.
    But what do you think? Will the bill help with that?
    Ms. Hulsey Nickel. I believe so. I think it could help 
actually with both. I think creating these centers of 
excellence so we can really advance what patient-centered care 
looks like, to take down these silos to have better coordinated 
care, and then the lessons learned from these centers to be 
applied throughout our healthcare systems and to all of the 
components that we need to treat this illness. So I think it 
will actually have both effects.
    We have a lot of rural communities that are struggling with 
this illness and we need to have more evidence and more new 
programs and protocols in place that we get to them quickly. 
And I believe that the Comprehensive Opioid Recovery Centers 
bill will help to do that.
    Mr. Griffith. I appreciate that. And for those folks who 
came in to see me, I hope this helps them know that we are 
trying to find something and several of those folks as I said 
were in recovery. Complement all, it is not easy.
    I appreciate you, Mr. Hampton. But all those that we have 
had testify over the last couple of days, there have been a 
number of people that have had issues who are now in recovery 
and I compliment you all. And look, we have to realize there is 
a lot of talent out there that we are wasting if we don't use 
those people who are in recovery. And I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back. Does the gentleman from Oregon seek recognition?
    Mr. Schrader. Yes, just briefly, Mr. Chairman. I want to 
thank the panelists for coming and sharing their stories. That 
will help us craft hopefully a better solution at the end of 
the day. I am in a listening mode right now and appreciate it 
very much, but a colleague of mine I would like to yield to, 
the Ranking Member Mr. Green, for some salient questions, 
please.
    Mr. Green. I want to thank my colleague for yielding to me.
    I have got a question for you, Ms. Deal-Smith, but when I 
was practicing law and dealt with clients through the mental 
health process I saw so many times when people were--it was a 
revolving door and a lot of things that we don't understand 
that this is a lifelong illness.
    And I would see these patients, or clients of mine on a 
regular basis. I said, why weren't you, you left here, you had 
medication, you were doing fine. And a number of them said, 
well, I felt so good I didn't think I needed my medication. And 
I said, do you have anybody in your household that has heart 
trouble? I don't know if that is cured but you have to take the 
medication.
    And so, but this is a lifelong illness in some cases and we 
need to recognize that. But sure, we would like a cure, but we 
would like a cure for cancer too, but we are still trying to 
manage it, so. But, Ms. Deal-Smith, how much of are you 
comfortable sharing, can you tell us about the background and 
history with substance use disorder?
    Do you want to turn on your mike?
    Ms. Deal-Smith. So my addiction started at an early age. I 
was 12 years old when I had my first alcohol and it progressed 
as the years went by and when I was like 28 years old I got 
into trouble with my addiction. I got a DWI and I had to go to 
residential treatment for 28 days. And in that treatment center 
I was given the tools to learn about my addiction and how to 
help myself get through hard times when they would be coming up 
and when I got out of treatment I had a director where I worked 
that helped me through the process because he was in recovery 
himself.
    So I had a lot of support in my recovery and that is what I 
bring here is I am there for the people that are in recovery. I 
help them get along. I take them to the hospitals, the 
medications that are prescribed for them can they take this, 
can they not take it, so I talk to the therapists and the 
counselors, the substance abuse counselors and we find a good, 
a better way to treat them.
    And if it is an opioid that they are prescribed we have to 
say, OK, is this good for them? The person is in recovery, no, 
it is not good for them. Let's look for another alternative so 
we can assist with getting them through this hard time. So that 
is part of my job is to be there for the client when they need 
you most and that is in early recovery.
    Mr. Green. Congratulations. You were able to go from your 
history to be a peer support specialist. What do you think is 
the most important aspect of your job working with people in 
recovery, because if it works we would like to see how it works 
around the country, so.
    Ms. Deal-Smith. It works because people like me who is in 
recovery are there to help them guide through the hardest time 
of their life to educate them and say, no you can't do this, 
yes you can do this. I will help you. I will do this. They meet 
me halfway and I meet them halfway. So I am able to be there 
for them when they need me the most.
    I have people that are taking care of them at night and 
then they can call me when the clients, the relatives, need 
help, need assistance. I am there for them. I am there all the 
time.
    Mr. Green. Thank you.
    Thank you, Mr. Chairman. I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    Mr. Tonko, you are not on the subcommittee, but do you wish 
to be recognized for questions?
    Mr. Tonko. I do.
    Mr. Burgess. You are recognized for 5 minutes.
    Mr. Tonko. Thank you, Mr. Chair and Ranker Green. I thank 
you both for waiving me on to the subcommittee. I am grateful 
that the committee has decided to focus its attention on this 
life and death issue. It means a lot to the communities that I 
represent in the capital region to see Congress working 
together across the aisle to reduce the burden of this deadly 
opioid epidemic.
    In particular, I am pleased that we are considering two 
bipartisan bills that I have had a hand in authoring, the 
Addiction Treatment Access Improvement Act and the TEACH to 
Combat Addiction Act. Combined, these bills would expand access 
to medication assisted treatments for opioid use disorders and 
help to prepare our next generation medical workforce to tackle 
the disease of addiction.
    So, Ms. Horan, thank you for your testimony in support of 
the Addiction Treatment Access Improvement Act. In your written 
remarks you discuss the importance of including nurse 
practitioners and physician assistants as part of the addiction 
workforce. Can you go into a bit more detail about how NPs and 
PAs are integral to addiction care at CleanSlate and how 
integrating other high skilled nursing professions might 
enhance CleanSlate's ability to provide high quality substance 
use treatment?
    Ms. Horan. I would be happy to. Thank you for the question. 
I think, first and foremost, they help us meet the demand in 
the communities. As we have mentioned before we have talked 
about workforce shortages, some of the limitations around 
prescriptive authority, even if you can and are willing to do 
it, and the nurse practitioners and physician's assistants have 
been willing, wonderful, warm additions to our team.
    I would say more than that they work alongside in strong 
collaboration with our physicians to prescribe, rather to 
provide a whole host of clinical services from physical exams 
to the support of counseling to medication management. They are 
part of the backbone of our clinical program. In terms of 
adding additional highly trained, interested, invested 
prescribers, we welcome them all. It is not easy to find folks 
who are this eager and this willing to work in the space and if 
they want to be part of the solution and join our team, we more 
than welcome them.
    Mr. Tonko. Thank you. And I would think struggling with 
that illness, when you have the moment of clarity, treatment on 
demand is essential.
    Again, Ms. Horan, how do CleanSlate and other high quality 
treatment centers work to minimize the risk of diversion of 
medication assisted treatment and how would the Addiction 
Treatment Access Improvement Act specifically encourage 
expanded treatment capacity in high quality settings like 
CleanSlate?
    Ms. Horan. Again thank you for the question. So I am not 
sure I talked much about our treatment model aside from who 
staffs it. We are what we call a high touch model so the 
patients that come to our centers are seen with a high level of 
frequency. So the sicker you are, the more severe your illness 
is, the more frequently you will be seen. That would be about 
twice a week.
    And then as you progress in your recovery, we are looking 
for markers of recovery, a number of things that are telling us 
that you are getting better, you will be seen once a week. Even 
at your most stable you won't be seen less than once a month. 
So that is important for a number of reasons. One, it is a way 
to keep the patient and the provider accountable to the 
patient's goals. Two, it brings them into the office with 
enough frequency where and in each visit they are given urine 
drug screens and other things. So we are testing for not just 
the drugs of, you know, of misuse but to make sure that they 
are taking the medication properly.
    We also do more standard diversion control tactics. We do 
random pill, or patient recalls where they have to come in and 
bring their films and then we count films. And I think those 
things all combined we feel pretty secure that our patients are 
using the medications as prescribed.
    Should a patient for some reason be found to have diverted 
the medication for purposes other than why we prescribed it 
that would be a cold stop for us. That would be a reason why we 
would ask a patient to leave. Now having said that, it is not 
in the interest of the patient or in the interest of the 
community to not make sure that that patient is somewhere else. 
Typically they will be referred up to methadone or somewhere 
else in the community.
    So I just want to make clear that they are not being exited 
to nothing. And there will be instances when they can rejoin 
depending on the circumstances but, generally speaking, 
diversion, we take a pretty hard stance on that.
    Mr. Tonko. Thank you. In your testimony you described 
waiting lists to access treatment in your facility in Anderson, 
Indiana. Unfortunately this is not an isolated phenomena as I 
have spoken with individuals in my district who have had to 
wait a year or more for a treatment slot. When an individual 
who is struggling with addiction is faced with barriers to 
treatment like waiting lists, what does that do for their 
chances of recovery?
    Ms. Horan. Well, first and foremost, The data shows that if 
access to MAT is a relapse prevention tool it also greatly 
increases, or reduces the chances that our patients will 
overdose. So when patients come to our centers, we have talked 
about readiness for change. Readiness for change means we want 
to open the door and bring them in right away. To have to turn 
a patient away means that we feel like we have put them at risk 
for relapse or for overdose. Moreover, it is just demeaning and 
demoralizing to finally be ready for change, to be ready to 
enter treatment, and to not be able to access it when you are 
ready for it.
    We will do everything we can to ensure that that patient 
even if they can't be seen in our center is at least seen in a 
treatment program within the community or within, as in the 
case of the Anderson patients can access the next closest 
CleanSlate Center. But it is just, fundamentally it is a lost 
opportunity that really shouldn't exist.
    Mr. Tonko. Thank you, Mr. Chair. I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back. Does the gentleman from Texas have another 
request?
    Mr. Green. Mr. Chairman, I have a unanimous consent request 
to place into the record a statement from Congressman Bill 
Pascrell in support of H.R. 5197, the Alternative to Opioids in 
the Emergency Department Act, and also a statement from 
Congresswoman Katherine Clark and Congressman Hal Rogers in 
support of H.R. 5102, the Substance Use Disorder Workforce Loan 
Repayment Act of 2018. I ask unanimous consent to place those 
in the record.
    Mr. Burgess. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Burgess. The chair will recognize himself for 5 minutes 
for questions.
    Dr. Rosenberg, I was intrigued by your testimony and your 
alternatives that you use in your emergency department. There 
is an ancillary bill that is not directly related to what you 
are doing, but it seems to me that it has some connection. Dr. 
Gottlieb, yesterday, when he, the commissioner of the Food and 
Drug Administration, was talking to us talked about the 
difficulty of developing new treatments for pain and that the 
datasets are sometimes vague and indecipherable. And you seem 
to be doing though some work with what you described as 
alternative pathways. Is that correct?
    Dr. Rosenberg. That is correct.
    Mr. Burgess. So the bill that, actually it is only in draft 
form right now and it is one that is under development, but it 
is to encourage the Food and Drug Administration to develop 
draft guidance for alternative pain medicines and use and 
breakthrough designation along that development pathway. Again 
Dr. Gottlieb referenced how difficult that is in the research 
and regulatory environment, but you seem to have found a way to 
make that useful. Is that correct?
    Dr. Rosenberg. That is correct, Mr. Chairman.
    Mr. Burgess. What, if I may ask, if it is not proprietary, 
what is it? You reference enzymes in your testimony.
    Dr. Rosenberg. The principles behind the ALTO protocol is 
to really increase the number of tools in the physician's 
toolbox. As one of the congressmen suggested, there used to 
only be Tylenol, Motrin, and opioids, and if I wanted to 
guarantee the patient the best treatment we would give them 
opioids. Obviously that was a bad decision.
    The principles between ALTO and the development of the ALTO 
protocols was really to search the world literature for 
existing protocols that existed without the use of opioids. Let 
me just give a quick example. Renal colic, if anybody had 
kidney stones, is a tremendously painful condition. But there 
have been treatment protocols and treatment successes in the 
literature using IV lidocaine that we used to use commonly for 
cardiac issues, now that works tremendously well for people 
with renal colic. It does two things. One, it relieves the 
pain. And we have to do more study on this, but it seems like 
it passes the kidney stone more quickly.
    So the real secret behind ALTO is finding existing 
protocols, not going through an I or a B, not doing a lot of 
studies, at least that is how we created it by taking the 
protocols that are out there. We use medications like nitrous 
oxide and do nerve blocks and lidocaine and use patches, but it 
is a layering of different medications and protocols together 
to get the maximum benefit for the patient.
    Mr. Burgess. Well, I thank you for that. It is very 
intriguing. Of course I am old enough to remember when we had 
toradol and stadol as new medicines.
    Dr. Rosenberg. Yes, indeed.
    Mr. Burgess. We no longer have those in our toolbox.
    Mr. Hampton, thank you for being here. Your testimony, very 
compelling. We have heard and learned something around sober 
homes or sober living homes and I assume you are from 
California----
    Mr. Hampton. That is correct.
    Mr. Burgess [continuing]. Since your representative is 
Representative Chu. Now there was recently some news from 
California about, I think, new regulations at a state level 
that they were applying to sober living homes. Do I recall that 
correctly?
    Mr. Hampton. Actually, yes, Congressman. I have been 
working on that legislation also. Yes.
    Mr. Burgess. And so I wasn't sure what it was, so I Googled 
it and then what impressed me was the vast number of sober 
living homes that are available. Sober living homes California, 
and there is a lot of stuff that comes up on the little iPad. 
And we have had some hearings in the Oversight Subcommittee and 
I will say this as delicately as I can, but apparently all 
sober living homes are not created equal. Is that fair to say?
    Mr. Hampton. That is correct, yes.
    Mr. Burgess. And I don't know whether it was you or someone 
else who referenced that how you get to treatment may vary and 
it could be through an advertisement on the television. We have 
all seen the advertisements. I have wondered about the 
advertisements. Pretty hard for a patient to discern what is 
reasonable, what is not. They are in trouble, they know they 
need help, here is someone offering help.
    So take us through that a little bit how, from a patient's 
perspective how do you navigate that?
    Mr. Hampton. Currently, it is nearly impossible, I would 
say, to be able to find an ethical, stable home without having 
firsthand knowledge of the home or a referral from a trusted 
family or friend. As you know, there is a lot of claims-based 
marketing that is going on, false claims-based marketing that 
is going on with treatment centers and with sober homes.
    Luckily for me, my story happens that I, it is by sheer 
luck that I sit here today and that I found my way into a 
stable recovery residence. I had lived in Florida for some time 
also. That is where I am from. So I had been through multiple 
unscrupulous homes.
    Families have a very hard time navigating the system.And I 
think that there is a solution to, you referenced California so 
the outcome of my friend Tyler dying was not just going to 
Congresswoman Chu and looking at the federal level, but it was 
going to our state senator as well and assembly members and 
drawing up legislation.
    When we came up with SB-1228 there was no standard. There 
was no Federal standard. There were no best practices that the 
Federal Government was publishing saying here is what a 
recovery residence should look like. I believe that that is a 
solution. It would have helped us with crafting the California 
legislation and I do believe other states are looking for that 
as well and part of that should be a ban on claims-based 
marketing.
    There Re a lot of good places that people could find and we 
could draw them a road map, but unfortunately they don't have 
the types of budgets that some of these unscrupulous operators 
have because of the fraud they have committed and money that 
they have made off of the others' backs.
    Mr. Burgess. Well, perhaps you will be good enough to share 
with the subcommittee some of the data that you have collected 
over time and that is a much longer conversation, but we may 
ask, if you would, to submit that in writing.
    And I do recall during the previous Congress we worked on 
the CURES for the 21st Century bill and the mental health title 
in that and also the peer support that I think you described 
seemed at some times to be almost as effective as the 
medication assisted therapies. Is that a fair statement?
    Mr. Hampton. Yes. IThat is a fair statement. I think that 
again there are varying ways of recovery. I would say that peer 
support, in my opinion, medication assisted treatment does not 
work without the wraparound services as we have heard and the 
peer support. We need more MAT.
    I am a supporter of MAT in other but going back to the 
housing issue, MAT is not welcome in, I would say, the super 
majority of sober homes in the United States. There is a huge 
disparity in terms of the services that someone on MAT can 
receive. So that is something that the states, I believe, need 
to deal with as well.
    Mr. Burgess. Very well. Well, you have been a great panel. 
And seeing there are no further members wishing to ask 
questions, I again want to thank our witnesses for being here 
today. I do want to submit statements from the following for 
the record.
    Regarding H.R. 5102: the American Medicine Foundation, the 
Addiction Policy Forum, the American Academy of Addiction 
Psychiatry, the American Association of Colleges of Osteopathic 
Medicine, American Nurses Association, American Osteopathic 
Association and the Massachusetts Osteopathic Society, the 
American Society of Addiction Medicine, Association for 
Behavioral Healthcare, the Coalition to Stop Opioid Overdose, 
the International Certification & Reciprocity Consortium, 
Legacy Community Health, National Board of Certified 
Counselors, the National Council for Behavioral Health, the 
United States Representatives Clark and Rogers.
    Regarding the Mullin Amendment in the Nature of a 
Substitute to H.R. 3545, a Partnership to Amend Part 2, 
Confidentiality Coalition, Premier, America's Essential 
Hospitals, Congressman Patrick Kennedy, National Governors 
Association, President's Commission on Combating Drug Addiction 
and the Opioid Crisis.
    Articles from the following: The Journal of Accountable 
Care, American Journal on Addictions, New England Journal of 
Medicine, Journal of American Medicine, Ascension Michigan, 
Bloomberg Health Data Management.
    And further statements from the following: The American 
Academy of Neurology, the American College of Obstetricians and 
Gynecologists, the American Society of Addiction Medicine, the 
Electronic Health Record Association, Keith Pardieck, National 
Association of Chain Drugstores, National Coalition on Health 
Care, Ohio State University, United South & Eastern Tribes 
Sovereignty Protection Fund.
    And I would also like to submit Congressman Patrick 
Kennedy's statement for the record. He was unable to join us 
yesterday due to weather, but had planned on it.
    [The information appears at the conclusion of the hearing.]
    Pursuant to committee rules, I remind members they have 10 
business days to submit additional questions for the record. I 
ask the witnesses to submit their responses within 10 business 
days upon receipt of the questions. Without objection, the 
subcommittee then stands adjourned.
    [Whereupon, at 2:54 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]
    
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