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


                 COMBATING THE OPIOID CRISIS: HELPING 
                  COMMUNITIES BALANCE ENFORCEMENT AND
                             PATIENT SAFETY

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED FIFTEENTH CONGRESS

                             SECOND SESSION

                               __________

                           FEBRUARY 28, 2018

                               __________

                           Serial No. 115-103
                           
                           
 [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                          


      Printed for the use of the Committee on Energy and Commerce

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                    COMMITTEE ON ENERGY AND COMMERCE

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


                       MICHAEL C. BURGESS, Texas
                                 Chairman
BRETT GUTHRIE, Kentucky              GENE GREEN, Texas
  Vice Chairman                        Ranking Member
JOE BARTON, Texas                    ELIOT L. ENGEL, New York
FRED UPTON, Michigan                 JANICE D. SCHAKOWSKY, Illinois
JOHN SHIMKUS, Illinois               G.K. BUTTERFIELD, North Carolina
MARSHA BLACKBURN, Tennessee          DORIS O. MATSUI, California
ROBERT E. LATTA, Ohio                KATHY CASTOR, Florida
CATHY McMORRIS RODGERS, Washington   JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey            BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia         KURT SCHRADER, Oregon
GUS M. BILIRAKIS, Florida            JOSEPH P. KENNEDY, III, 
BILLY LONG, Missouri                     Massachusetts
LARRY BUCSHON, Indiana               TONY CARDENAS, California
SUSAN W. BROOKS, Indiana             ANNA G. ESHOO, California
MARKWAYNE MULLIN, Oklahoma           DIANA DeGETTE, Colorado
RICHARD HUDSON, North Carolina       FRANK PALLONE, Jr., New Jersey (ex 
CHRIS COLLINS, New York                  officio)
EARL L. ``BUDDY'' CARTER, Georgia
GREG WALDEN, Oregon (ex officio)
  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     1
    Prepared statement...........................................     3
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     4
    Prepared statement...........................................     5
Hon. Doris O. Matsui, a Representative in Congress from the State 
  of California, prepared statement..............................     6
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................     7
    Prepared statement...........................................     9
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................    10
    Prepared statement...........................................    12

                               Witnesses

Susan A. Gibson, Deputy Assistant Attorney, Diversion Control 
  Division, Drug Enforcement Administration......................    13
    Prepared statement...........................................    16
    Answers to submitted questions...............................   246
Frank L. Fowler, Chief of Police, Syracuse Police Department.....    62
    Prepared statement...........................................    64
Patrick M. Beardsley, Ph.D., Professor, Department of 
  Pharmacology and Toxicology, Virginia Commonwealth University..    67
    Prepared statement...........................................    69
John Mulder, M.D., FAAHPM, HMDC, Director, Trillium Institute....    80
    Prepared statement...........................................    81
Ponni Subbiah, M.D., Chief Medical Officer, Indivior PLC.........    89
    Prepared statement...........................................    91
David Y. Kan, M.D., President, California Society of Addiction 
  Medicine.......................................................    95
    Prepared statement...........................................    97
    Answers to submitted questions...............................   254
Richard J. Nance, LCSW, Director, Utah County Department of Drug 
  and Alcohol Prevention and Treatment...........................   109
    Prepared statement...........................................   111
Thomas J. Cosgrove, Partner, Covington and Burling LLP...........   136
    Prepared statement...........................................   138
    Answers to submitted questions \1\...........................   259
Andrew Kolodny, M.D., Codirector, Opioid Policy Research, 
  Brandeis University............................................   141
    Prepared statement...........................................   143
    Answers to submitted questions...............................   261
Richard N. Logan, Jr., Pharm.D., Owner, L&S Pharmacy.............   145
    Prepared statement...........................................   147

                           Submitted Material

Statement of Dr. Halberstadt, of the University of California, 
  San Diego, submitted by Mr. Green..............................   178
Statement of the College on Problems of Drug Dependence, 
  submitted by Mr. Green.........................................   180
Statement of Hon. Brad Schneider, a Representative in Congress 
  from the State of Illinois, submitted by Mr. Green.............   182
Statement of a public health group, submitted by Mr. Green.......   184
Statement of the American Society of Addiction Medicine, 
  submitted by Mr. Green.........................................   186
Statement of the Center for Lawful Access and Abuse Deterrence, 
  submitted by Mr. Green.........................................   188
Statement of Catalent, submitted by Mr. Green....................   189
Statement of the Pharma & Biopharma Outsourcing Association, 
  submitted by Mr. Green.........................................   191
Statement of the College on Problems of Drug Dependence, 
  submitted by Mr. Green.........................................   194
Report from the Center for Budget and Policy Priorities, 
  submitted by Mr. Green.........................................   196
Article entitled, ``The Opioid Epidemic: A Crisis Years in the 
  Making,'' The New York Times, October 26, 2017, submitted by 
  Mr. Lujan......................................................   204
Article entitled, ``Inside the Story of America's 19th-Century 
  Opiate Addiction,'' Smithsonian, January 4, 2018, submitted by 
  Mr. Lujan......................................................   213
Questions for the record from Representative David Kustoff, 
  submitted by Mr. Burgess.......................................   216
Statement of Prime Therapeutics, submitted by Mr. Burgess........   218
Statement of the National Association of Chain Drug Stores, 
  submitted by Mr. Burgess.......................................   220
Statement of the University of Texas Health Science Center, 
  submitted by Mr. Burgess.......................................   226
Statement of Catherine M. Davis, Ph.D., Hopkins Bayview Medical 
  Center, submitted by Mr. Burgess...............................   227
Statement of CVS Health, submitted by Mr. Burgess................   229
Statement of Braeburn, submitted by Mr. Burgess..................   231
Statement of the American Hospital Association, submitted by Mr. 
  Burgess........................................................   232
Statement of the Drug Policy Alliance, submitted by Mr. Burgess..   238
Statement of Andrew C. Kruegel of Columbia University, submitted 
  by Mr. Burgess.................................................   240
Statement of Hon. Mark DeSaulnier, a Representative in Congress 
  from the State of California, submitted by Mr. Carter..........   245

----------
\1\ The committee did not receive a response to Mr. Cosgrove's 
  submitted questions for the record by the time of printing.

 
 COMBATING THE OPIOID CRISIS: HELPING COMMUNITIES BALANCE ENFORCEMENT 
                           AND PATIENT SAFETY

                              ----------                              


                      WEDNESDAY, FEBRUARY 28, 2018

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 1:04 p.m., in 
room 2123, Rayburn House Office Building, Hon. Michael Burgess, 
M.D. (chairman of the subcommittee) presiding.
    Present: Representatives Burgess, Guthrie, Upton, Shimkus, 
Blackburn, Latta, Lance, Griffith, Long, Bucshon, Brooks, 
Mullin, Hudson, Carter, Walden (ex officio), Green, Matsui, 
Castor, Sarbanes, Lujan, Schrader, Degette, and Pallone (ex 
officio).
    Also Present: Representative Walberg.
    Staff Present: Jennifer Barblan, Chief Counsel, O&I Mike 
Bloomquist, Staff Director; Adam Buckalew, Professional Staff 
Member, Health; Daniel Butler, Staff Assistant; Kelly Collins, 
Staff Assistant; Zachary Dareshori, Legislative Clerk, Health; 
Jordan Davis, Director of Policy and External Affairs; Paul 
Edattel, Chief Counsel, Health; Margaret Tucker Fogarty, Staff 
Assistant; Adam Fromm, Director of Outreach and Coalitions; Ali 
Fulling, Legislative Clerk, O&I, DCCP; Jay Gulshen, Legislative 
Associate, Health; Zach Hunter, Director of Communications; Ed 
Kim, Policy Coordinator, Health; Mark Ratner, Policy 
Coordinator; Kristen Shatynski, Professional Staff Member, 
Health; Jennifer Sherman, Press Secretary; Austin Stonebraker, 
Press Assistant; Hamlin Wade, Special Advisor, External 
Affairs; Waverly Gordon, Minority Health Counsel; Tiffany 
Guarascio, Minority Deputy Staff Director and Chief Health 
Advisor; Jourdan Lewis, Minority Staff Assistant; Samantha 
Satchell, Minority Policy Analyst; Andrew Souvall, Minority 
Director of Communications, Outreach, and Member Services; and 
Kimberlee Trzeciak, Minority Senior Health Policy Advisor.

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

    Mr. Burgess. The Subcommittee on Health will now come to 
order. I will recognize myself for 5 minutes for the purpose of 
an opening statement.
    On the average, 115 Americans die every single day from an 
overdose of an opiate. Our nation remains in the grip of a 
frightening epidemic. The latest report from the Centers for 
Disease Control and Prevention list West Virginia, Ohio, New 
Hampshire, Pennsylvania, and Kentucky, as the five States 
hardest hit, but we all know the crisis has ravaged every one 
of our States. The statistics are heartbreaking. Five people 
every hour on the hour die from an opioid overdose. It has been 
said before; it bears repeating: Now more than ever we must 
come together and strengthen our commitment to fight this. It 
requires an all-hands-on-deck approach. Today's hearing is the 
first of three legislative hearings on combating this crisis.
    This hearing is the product of the Member Day the Health 
Subcommittee held last October where over 50 Members of 
Congress, bipartisan Members of Congress, both on and off the 
Energy and Commerce Committee, came to us and shared with us 
their personal stories of how the epidemic has devastated their 
communities, and they also offered potential legislative 
solutions. Since then, our teams have been hard at work 
examining these policies and engaging the relevant 
stakeholders.
    There are two panels of witnesses before our subcommittee 
today. First, I do want to welcome Susan Gibson, the Deputy 
Assistant Attorney in the Diversion Control Division at the 
Drug Enforcement Administration. Ms. Gibson, we look forward to 
hearing your thoughts and the progress the DEA has made to stem 
the flow of opiates through our neighborhood, and how these 
legislative proposals would strengthen the agency's efforts in 
what is now a public health emergency in our country. On the 
next panel, we will hear from a cross section of stakeholders 
representing local law enforcement, physicians, pharmacists, 
hospice, on one hand, and to the anti-opioid researchers, 
manufacturers, and policy groups on the other. We will look 
forward to learning their insights on one or more of the bills 
being considered today and anticipate a robust debate on the 
merits of these policies, as the title of our hearing 
indicates. We are seeking help from the communities to balance 
enforcement and patient safety.
    Today, we will focus our attention specifically on the 
Controlled Substances Act. Over the last several months, the 
committee has come to realize that some areas of this law 
require an update or clarification. For example, synthetic 
opioids, like fentanyl, have flooded the United States cities 
and towns and pushed drug overdose deaths to levels never 
previously seen. H.R. 2851, the Stop the Importation and 
Trafficking of Synthetic Analogues Act, offered by 
Representative John Katko, will better equip law enforcement to 
get illicit synthetic drugs off of our streets while 
modernizing scheduling guidelines for these drugs.
    Another issue of critical importance is the growing risk of 
the misuse and diversion of controlled substances. 
Representatives Tim Walberg and Debbie Dingell introduced 
legislation, H.R. 5041, the Safe Disposal of Unused Medication 
Act, that would reduce the number of unused controlled 
substances at risk of diversion or misuse by allowing hospice 
workers to safely dispose of these drugs in patients' homes. 
Another bill currently in discussion form, authored by 
Representatives Ryan Costello and Rick Nolan, will improve 
dispensing of implantable and injectable therapies that were 
developed to make misuse and diversion more difficult.
    We will examine two telemedicine bills that will improve 
access for patients. The Special Registration for Telemedicine 
Clarification Act, written by Representatives Buddy Carter and 
Cheri Bustos, would clarify telemedicine waivers, and direct 
the Attorney General to issue regulations for healthcare 
providers to prescribe controlled substances through 
telemedicine in legitimate emergency situations. The Improving 
Access to Remote Behavioral Health Treatment Act, written by 
Representative Gregg Harper and Doris Matsui, would expand 
access for patients in rural and underserved areas to their 
closest community mental health or addiction treatment centers 
by allowing these facilities to be obtain a DEA registration 
and qualify for the telemedicine exception under the Ryan 
Haight Act.
    Lastly, the subcommittee will consider two provider 
education bills, the first bill, H.R. 4275, the Empowering 
Pharmacists in the Fight Against Opioid Abuse, authored by 
Representatives Mark DeSaulnier and Buddy Carter, would help 
pharmacists detect fraudulent prescriptions through new 
education materials. Another bill aims to improve doctors' 
understanding of pain management and treatment guidelines and 
best practices, among other things, by mandating 12 hours of 
continuous medical education on the subject every 3 years. This 
policy contained in H.R. 2063, the Opioid Preventing Abuse 
through Continuing Education Act, authorized by Representative 
Brad Schneider, does concern me because it seems to suggest 
that doctors are primarily at fault for this epidemic, but as 
we consider solutions critical to blunting this crisis, we must 
strike a careful balance prior to casting blame.
    As I said earlier, an important aspect of today's hearing 
is to think through the debate that all of these policies have 
before us. I believe what we accomplish here today will set the 
tone for the next two hearings in this subcommittee.
    With that, again, I want to welcome our witnesses, and 
thank you for being here. And I will recognize Mr. Green of 
Texas 5 minutes for an opening statement, please.
    [The prepared statement of Mr. Burgess follows:]

             Prepared statement of Hon. Michael C. Burgess

    Our nation remains in the unrelenting grip of the opioid 
epidemic. While the latest report from the Centers for Disease 
Control and Prevention lists West Virginia, Ohio, New 
Hampshire, Pennsylvania, and Kentucky as the five States 
hardest hit, all of us know this crisis has ravaged other 
States, too. The statistics are heartbreaking: on average 115 
Americans die every day from an opioid overdose--that is nearly 
5 people per hour. I said it before and will say it again. Now 
more than ever, we must come together and strengthen our 
commitment to fight this scourge--it requires an all-hands-on-
deck approach.
    Today's hearing is the first of three legislative hearings 
on combating the opioid crisis. It is the product of the Member 
Day the Health Subcommittee held last October, where over 50 
bipartisan Members of Congress--both on and off the Energy and 
Commerce Committee--shared their personal stories on how the 
opioid epidemic has devastated their communities while also 
offering potential legislative solutions. Since then, our teams 
have been hard at work examining these policies and engaging 
the relevant stakeholders.
    There are two panels of witnesses before our subcommittee 
today. First, I would like to welcome Susan Gibson, Deputy 
Assistant Attorney in the Diversion Control Division at the 
Drug Enforcement Administration (DEA). Ms. Gibson, we look 
forward to hearing your thoughts on the progress DEA has made 
to stem the flow of opioids through our neighborhoods and how 
these legislative proposals would strengthen the agency's 
efforts in what is now a public health emergency for the 
country. On the next panel, we will hear from a cross-section 
of stakeholders representing local law enforcement, physicians, 
pharmacists, and hospices on one hand to anti-opioid 
researchers, manufacturers, and policy groups on the other. We 
also look forward to learning their insights on one or more of 
the bills being considered today and anticipate a robust debate 
on the merits of these policies that, as the title of our 
hearing indicates, seek help communities balance enforcement 
and patient safety.
    Today, we will focus our attention specifically on the 
Controlled Substance Act. Over the last several months, the 
committee came to realize that some areas of this law required 
an update or clarification. For example, synthetic opioids, 
like fentanyl, has flooded U.S. cities and towns and pushed 
drug overdose deaths to levels never seen before. H.R. 2851, 
the Stop the Importation and Trafficking of Synthetic Analogues 
(SITSA) Act, authored by Rep. John Katko, will better equip law 
enforcement to get illicit synthetic drugs off our streets 
while modernizing scheduling guidelines for these drugs.
    Another issue of critical importance is the growing risk of 
misuse and diversion of controlled substances. Reps. Tim 
Walberg and Debbie Dingell introduced legislation, H.R. 5041, 
the Safe Disposal of Unused Medication Act, that would reduce 
the number of unused controlled substances at risk of diversion 
or misuse by allowing hospice workers to safely dispose these 
drugs in patients' homes. Another bill, currently in discussion 
draft form, authored by Reps. Ryan Costello and Rick Nolan, 
will improve dispensing of implantable and injectable therapies 
that were developed to make misuse and diversion more 
difficult.
    Next, we will examine two telemedicine bills that will 
improve access for patients. The Special Registration for 
Telemedicine Clarification Act, written by Reps. Buddy Carter 
and Cheri Bustos, would clarify telemedicine waivers and direct 
the Attorney General to issue regulations for health care 
providers to prescribe controlled substances through 
telemedicine in legitimate emergency situations. The Improving 
Access to Remote Behavioral Health Treatment Act, written by 
Rep. Gregg Harper and Doris Matsui, would expand access for 
patients in rural and underserved areas to their closest 
community mental health or addiction treatment centers by 
allowing these facilities to obtain a DEA registration and 
qualify for the telemedicine exception under the Ryan Haight 
Act.
    Lastly, the subcommittee will discuss two provider 
education bills. The first bill, H.R. 4275, the Empowering 
Pharmacists in the Fight Against Opioid Abuse Act, authored by 
Reps. Mark DeSaulnier and Buddy Carter, would help pharmacists 
detect fraudulent prescriptions through new educational 
materials. Another bill aims to improve doctors' understanding 
of pain management treatment guidelines and best practices, 
among other things, by mandating 12 hours of continuous medical 
education on these subjects every three years. This policy 
contained in H.R. 2063, the Opioid Preventing Abuse through 
Continuing Education (PACE) Act, authored by Rep. Brad 
Schneider, concerns me greatly because it seems to suggest that 
doctors are primarily at fault for the opioid epidemic. As we 
consider solutions critical to blunting this crisis, we must 
strike a careful balance before casting blame.
    As I said earlier, an important aspect of today's hearing 
is to think through and debate the policies within these pieces 
of legislation. I believe what we accomplish here will set the 
tone for the next two hearings in our subcommittee.
    With that, I again want to welcome our witnesses and thank 
you for being here. I look forward to your testimony.

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

    Mr. Green. Thank you, Mr. Chairman.
    I want to thank you for the work on addressing the opioid 
epidemic that has impacted countless families and communities 
in our country. And as you said, according to the National 
Institute of Health, 115 Americans die every day after 
overdosing on opioids.
    The misuse and addiction that opioids, including 
prescription pain relievers, heroin, synthetic opioids, such as 
fentanyl, is a serious national crisis that affects public 
health as well as our social and economic welfare. The patterns 
of lives ruined and lost due to the opioid epidemic must be 
reversed. The opioid epidemic is complex and multifaceted, as 
you said. However, there are no simple or quick solutions.
    Ending the crisis will require better coordination of care, 
community involvement, and finding solutions, and more 
consistent use of improved pain control options. A 
comprehensive response to this crisis must address the limited 
resources currently available, the societal ills that fuel 
addiction, and the stigma attached to drug use.
    In recent years, Congress has expanded in this space. The 
Affordable Care Act expanded healthcare coverage to 20 million 
non-elderly Americans, giving access to the medical and 
behavioral attention opioid victims need to overcome their 
addiction. Any honest efforts to address the opioid epidemic 
must include measures to stabilize and strengthen the 
exchanges, make coverage accessible for Americans who currently 
do not have health coverage, including the 3 million Americans 
who lost their health insurance in 2017.
    Last Congress, I was proud to support the passage of the 
21st Century Cures Act and Comprehensive Addiction and Recovery 
Act, CARA. CARA authorized several grant programs to help 
prevent overdose, expand access to treatment, and help 
individuals recover. Unfortunately, some of the grants created 
under CARA have yet to receive funding through the 
appropriations process. I hope our committee will work with our 
colleagues on the Appropriations Committee to secure these 
necessary funds.
    Speaking with local stakeholders at home about the opioid 
crisis, I can share that more Federal assistance is needed to 
properly combat this epidemic. The committee needs to seriously 
consider authorizing the necessary resources, and our State and 
local partners need to help Americans struggling with opioid 
addiction and recovery.
    I look forward to hearing from our witnesses today, and 
continuing our committee's examination at this nationwide 
problem in the weeks and months to come.
    Now, I would like to yield a minute and a half to my friend 
and colleague, Congresswoman Matsui, from California.
    [The prepared statement of Mr. Green follows:]

                 Prepared statement of Hon. Gene Green

    Thank you, Mr. Chairman. I want to thank you for your work 
on addressing the opioid epidemic that has impacted countless 
families and communities in our country.
    According to the National Institutes of Health, 115 
Americans die every day after overdosing on opioids. The misuse 
and addiction to opioids, including prescription pain 
relievers, heroin, and synthetic opioids, such as fentanyl, is 
a serious national crisis that affects public health, as well 
as our social and economic welfare.
    The pattern of lives ruined and lost due to the opioids 
epidemic must be reversed. The opioids epidemic is complex and 
multifaceted, however. There are no simple and quick fixes.
    Ending this crisis will require better coordination of 
care, community involvement in finding solutions, and more 
consistent use of improved pain-control options. A 
comprehensive response to this crisis must address the limited 
resources currently available, the societal ills that fuel 
addiction and the stigma attached to drug abuse.
    In recent years, Congress has acted in this space. The 
Affordable Care Act expanded health care coverage to 20 million 
non-elderly Americans, giving access to the medical and 
behavioral attention opioid victims need to overcome addiction.
    Any honest effort by Congress to address the opioids 
epidemic must include measures to stabilize and strengthen the 
exchanges, and make coverage accessible for Americans who 
currently do not have health coverage, including the three 
million Americans who lost their health insurance in 2017.
    Last Congress, I was proud to support the passage of the 
21st Century Cures Act and the Comprehensive Addiction and 
Recovery Act (CARA). CARA authorized several grant programs to 
help prevent overdose, expand access to treatment, and help 
individuals recover. Unfortunately, some of the grants created 
under CARA have yet to receive funding through the 
appropriations process. I hope our committee will work with our 
colleagues on the Appropriations Committee and secure these 
necessary funds.
    Speaking with local stakeholders at home about the opioids 
crisis, I can share that more federal assistance is needed to 
properly combat this epidemic. Our committee needs to seriously 
consider authorizing the necessary resources that our State and 
local partners need to help Americans struggling with opioids 
addiction and recovery.
    I look forward to hearing from our witnesses today and 
continuing our committee's examination of this nationwide 
problem in the weeks and months ahead.
    Now, I would like to yield one-and-a-half minutes to my 
friend and colleague, Congresswoman Matsui of California.

    Ms. Matsui. Thank you very much.
    Thank you for yielding.
    Mr. Chairman, I appreciate very much this hearing. As we 
continue this discussion, I look forward to working together in 
a bipartisan manner to effectively confront issues of access 
and affordability for addiction treatment.
    I am encouraged by the steps taken today, but want to 
emphasize that this is just the beginning of what must be an 
iterative and comprehensive approach to combating the opioid 
crisis.
    We can all acknowledge that, while controlled substances 
should be carefully regulated, they also play a vital role in 
the effective addiction treatment. Accessing treatment 
continues to be a major hurdle in many communities. Today, we 
are examining a discussion draft that I am working on with my 
colleagues on the committee, Representative Gregg Harper, that 
looks at ways that we can use telehealth to increase access to 
substance use treatment.
    We are also examining a bill authored by my colleague 
Representative Brad Schneider that requires providers to 
prescribe opioids for pain to undergo training on pain 
management. These are targeted strategies, among many that we 
must consider. It will also be imperative that we support 
Medicaid funding, which has already played a crucial role in 
reducing the treatment gap.
    I look forward to continuing discussions here. This 
conversation must be paired with the significant resources to 
help patients and families who are suffering.
    Thank you, and I yield back to the ranking member.
    [The prepared statement of Mrs. Matsui follows:]

               Prepared statement of Hon. Doris O. Matsui

    Thank you for yielding. Mr. Chairman, as we continue this 
discussion, I hope we can work together in a bipartisan manner 
to effectively confront issues of access and affordability for 
addiction treatment.
    I'm encouraged by the steps being taken today, but want to 
emphasize that this is just the beginning of what must be an 
iterative and comprehensive approach to combatting the opioid 
crisis.
    We can all acknowledge that. while Controlled Substances 
should be carefully regulated, they also play a vital role in 
effective addiction treatment.
    Accessing treatment continues to be a major hurdle in many 
communities. Today we're examining a discussion draft that I am 
working on with my colleague on the Committee, Rep. Gregg 
Harper, that looks at ways we can use telehealth to increase 
access to substance use treatment.
    We are also examining a bill authored by my colleague, Rep. 
Brad Schneider that would require providers that prescribe 
opioids for pain to undergo training on pain management.
    These are targeted strategies among many that we must 
consider. It will also be imperative that we support Medicaid 
funding. and the ACA. both of which have already played a 
crucial role in reducing the treatment gap. I look forward to 
continued discussions here. This conversation must be paired 
with significant resources to help patients and families who 
are suffering.
    Thank you, I yield back.

    Mr. Green. Thank you.
    Mr. Chairman, I have a number of statements that I would 
like to ask unanimous consent to place into the record. 
Documents: H.R. 2851, a letter from Dr. Halberstadt, of UC San 
Diego; a letter from College on Problems of Drug Dependence; 
H.R. 2063, a statement on support of the bill from 
Representative Brad Schneider; for Ensuring Patient Access to 
Substance Use Disorder Treatment Act, a Public Health Group 
letter regarding support for the Senate companion; a letter 
from ASAM and CLAAD, expressing the support for the Senate 
companion for Tableting and Encapsulating Machine Regulation 
Act; a letter from Catalent and PBOA. Plus I have a Center for 
Budget and Policy Priorities that was just released today on 
the Medicaid expansion drastically increased coverage for 
people with opioid use disorders. The latest data from the 
Federal Agency on Healthcare Research and Quality highlight the 
importance of the Affordable Care Act, the Medicaid expansion, 
and increasing insurance among people with opioid use 
disorders. Our analysis of these data will offer a 
comprehensive picture of opioid-related hospitalization around 
the country, finds that the share of hospitalization in which 
patients were uninsured failed dramatically in States that 
expanded Medicaid from 13.4 percent in 2013, the year before 
the expansion, to 2.9 percent 2 years later. This steep decline 
indicates that many uninsured people are coping with OUDs have 
gained covered through the Medicaid expansion.
    And I ask unanimous consent to place this in the record.
    Mr. Burgess. OK. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Green. Thank you. I yield back my time.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentleman from Oregon, the 
chairman of the full committee, Mr. Walden, for 5 minutes for 
an opening statement.

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

    Mr. Walden. I thank the chairman for his leadership on this 
and many other healthcare-related issues, and I want to welcome 
our witnesses, and we look forward to your testimony.
    No community is immune from the opioid epidemic. It is 
ripping apart the very fabric of our neighborhoods, from Oregon 
to Ohio, from one coast to the other, from Connecticut to 
California. Our friends and our neighbors are experiencing this 
epic tragedy neighborhood after neighborhood, one that is 
claiming the lives of more than 100 Americans each and every 
single day.
    Working together, we can and we must continue to help. 
Congress must learn from the past. The Comprehensive Addiction 
and Recovery Act, or CARA, was an important milestone in 
helping States. The breakthrough 21st Century Cures Act struck 
a fair balance of speeding up the availability of innovative 
new drugs while maintaining patient safety, and it is already 
delivering. Those two, in fact, put more money into the opioid 
epidemic effort than Congress has ever put forward, and then we 
doubled down with a budget agreement that was just passed and 
signed into law by President Trump.
    Lawmakers must acknowledge the present. In 2016, opioid 
overdose deaths from both prescription and illicit drugs were 
five times higher than 1999. And as public officials 
representing our communities, we must plan for the future, and 
that is why we are here today, to work toward our shared goal 
of combating the opioid crisis.
    Each statistic is disturbing in and of itself. Even more 
tragic, every number has a name, a name like Mike. At a 
roundtable that I held in southern Oregon a year or two ago, a 
man named Mike simply showed up, sat in the chair next to the 
wall. Didn't know who he was. And when we were done going 
around the room, he wanted to talk about his situation.
    You see, Mike's son was injured in a high school sporting 
accident, and he became addicted to the prescription 
painkillers provided by his doctor to aid in his recovery. 
Eventually, Mike's son made the all-too-familiar transition to 
the cheaper opioid source: heroin. And to this day, Mike's son 
still struggles with his addiction that all began with opioid 
prescriptions.
    Mike then went on to talk about his sister, who also 
suffered from addiction. She was a nurse. He commented that she 
found herself with easier access to pills as a nurse, and when 
coworkers and others caught on, she moved and continued to 
procure pills elsewhere. Sadly, Mike's sister died as a result 
of her addiction. So Mike came to the meeting, a roundtable of 
law enforcement and medical professionals, to share his story 
about what he had faced, what he had lost, and what he was 
coping with.
    His, tragically, is not a unique story; it is the story 
that is ripping apart families all across our country. So we 
have to act. And, as people know, this committee has had a very 
aggressive, ongoing, diligent, deep investigation through the 
Oversight and Investigations Committee on how we got to this 
place in this country, and we will hold people responsible from 
one end to the other.
    The second track, however, is about the legislative 
initiatives we can all wrap ourselves around in a bipartisan 
way and move forward to get illicit synthetic drugs off the 
streets. To safely dispose of unused controlled substances, to 
improve patient access to substance use disorder treatments and 
remote services, to help providers and pharmacists to better 
prevent addiction, these are among just a few of the bills 
today. And this is but one of three upcoming hearings on this 
subject, with legislation we hope to be able to move to the 
floor routinely and regularly between now and Memorial Day.
    So it is important to acknowledge that this legislative 
hearing is the appropriate venue to ask tough questions and to 
make constructive suggestions on how we can improve these 
bills. That is what the hearing is all about. Many of these are 
discussion drafts because they are admittedly in need of 
discussion.
    So I look forward to the feedback from our witnesses and 
our members. In the coming weeks, we will continue this hard 
work, and we will continue the legislature hearings, and we 
will get our job done. People like Mike and Mike's son and his 
sister's family are depending on us, and we have a big job to 
do here.
    So I thank the members who have been so active in 
participating. Together, we are going to get this job done, and 
we need your help. So I would like to thank our two panels of 
witnesses for being here today, and I look forward to your 
feedback on these important issues.
    I would also like to thank my colleagues for staying in 
town to have this vital discussion. When others went home to 
their districts, these Members said, ``This matters,'' and they 
stayed. So combating the opioid crisis requires an all-hands-
on-deck approach, and I appreciate everyone's shared commitment 
to that effort today and in the weeks and months ahead.
    With that, Mr. Chairman, I appear to have run out of time, 
and I will stop.
    [The prepared statement of Mr. Walden follows:]

                 Prepared statement of Hon. Greg Walden

    No community is immune to the opioid epidemic. It's ripping 
apart the very fabric of our neighborhoods. From Oregon to 
Ohio. From Connecticut to California. Our friends and our 
families are experiencing an epic tragedy--one that's claiming 
the lives of more than 100 Americans each and every single day.
    Working together, we can help.
    Congress must learn from the past. The Comprehensive 
Addiction and Recovery Act, or CARA, was an important milestone 
in helping States. The breakthrough 21st Century Cures Act--
striking a fair balance of speeding up the availability 
innovative treatments and safeguarding necessary public health 
protections--is already delivering.
    Lawmakers must acknowledge the present. In 2016, opioid 
overdose deaths--from both prescription and illicit drugs--were 
five times higher than in 1999. And as public officials 
representing our communities, we must plan for the future. This 
is why we're here today--to work towards our shared goal of 
combating the opioid crisis.
    Each statistic is disturbing. Even more tragic, every 
number has a name. Like Mike.
    At a roundtable I held in Oregon, a man named `Mike' showed 
up. Literally, he just showed up. Mike didn't know anyone in 
the room. He'd heard of our meeting to discuss opioid abuse on 
the news and wanted to share his story.
    Mike's son was injured in a school sporting accident, and 
he became addicted to the prescription painkillers provided by 
his doctor to aid in his recovery. Eventually, Mike's son made 
the all-too-familiar transition to a cheaper opioid source: 
heroin. To this day, Mike's son still struggles with his 
addiction that began with opioid abuse.
    Mike went on to speak about his sister who also suffered 
from addiction. A nurse, Mike commented that she found herself 
with easier access to the pills. When coworkers and others 
caught on, she moved and continued to procure pills elsewhere.
    Sadly, Mike's sister died as a result of her addiction. 
Mike came to the meeting--a roundtable I held with law 
enforcement and medical professionals--in hopes that sharing 
his stories could help ensure it doesn't happen to other 
families.
    Mike, and the countless other folks who have fallen victim 
to this crisis, is the reason we're here today.
    Today marks our first of three legislative hearings this 
Congress. We'll focus on equipping law enforcement with the 
necessary tools to fight the opioid epidemic with careful 
attention to not compromising important public health 
protections.
    Getting illicit synthetic drugs off the streets, safely 
disposing of unused controlled substances, improving patient 
access to substance use disorder treatments and remote 
services, and helping providers and pharmacists better prevent 
addiction are among the handful of bills we'll review today.
    It's important to acknowledge that this legislative hearing 
is the appropriate venue to ask tough questions and make 
constructive suggestions on how to improve these bills. Many of 
these bills are discussion drafts because they are admittedly 
in need of discussion. I look forward to feedback from each of 
our witnesses as well as both the Democratic and Republican 
members of this subcommittee.
    In the coming weeks, this subcommittee will continue its 
hard work with legislative hearings related to public health 
and prevention efforts, as well as issues pertaining to 
insurance coverage. This is just the beginning and represents 
only a fraction of the ideas members from across the country 
have formulated to overcome this epidemic.
    I'd like to thank our two panels of witnesses for being 
here today, and I look forward to your feedback on these 
important issues. I'd also like to thank my colleagues for 
staying in town to have this vital discussion. Combating the 
opioid crisis requires all-hands-on-deck, and I appreciate 
everyone's shared commitment in this effort.

    Mr. Burgess. Do you yield to the gentlelady from Tennessee?
    Mr. Walden. I would be happy to yield to the gentlelady 
from Tennessee.
    Mrs. Blackburn. Thank you, Mr. Chairman.
    And I appreciate so much the hearing and our panels for 
being here today to work with us on this issue. Tennessee has 
seen a 10-percent increase in opioid deaths in 2015 and 2016. 
And while we have worked for years on this issue, first 
correspondence going back to 2012, on how we deal with this 
epidemic, we are pleased to have this--Representative Katko's 
bill, SITSA.
    We are interested in your perspective on that. Dealing with 
the synthetics is going to be important. Looking at the 
scheduling of this, we know it needs to be a focus, because 
much of the increase in the deaths deals with the synthetics 
and the analogues. And thank you for being here. Thanks for the 
perspective that you bring. And, as the chairman said, we have 
got three hearings that are going to be on bills going forward. 
We want to do our part at the Federal level to work with our 
State and local responsibilities so that they have the ability 
to address this crisis.
    I yield back.
    Mr. Burgess. The chair thanks the gentlelady.
    The gentlelady yields back.
    The chair recognizes the gentleman from New Jersey, Mr. 
Pallone, the ranking member of the full committee, 5 minutes 
for an opening statement, please.

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

    Mr. Pallone. Thank you, Mr. Chairman.
    Today is the first in a series of hearings meant to address 
the opioid and substance abuse crisis that is ravaging 
communities across the country. In my home State of New Jersey, 
more than 2,200 people died from opioids in 2016 alone, but 
obviously, this is a national crisis that is devastating 
families every day, and, simply put, a lot more needs to be 
done.
    Now I must say that I am utterly confused as to why the 
Republican leadership has chosen to hold this hearing on a day 
when Congress is not in session, because these are serious 
issues that deserve serious consideration. I know Chairman 
Walden was thanking those who didn't go home and stayed, but, 
frankly, no Member, in my opinion, should have to choose 
between staying in Washington when we are not voting or going 
home. And I think it is unfair to all the witnesses who have 
flown here today and will likely end up with less engagement by 
the time the panel ends.
    I get the feeling that the Republican leadership is just 
checking the box instead of giving members, staff, and 
stakeholders the time to carefully consider the important 
issues like the opioid crisis.
    But last Congress, we took bipartisan action to pass CARA 
and 21st Century Cures, both of which provided initial 
investments and steps to address this crisis. These laws are 
expanding access to treatments and providing recovery support 
services, financial resources to help States take action to 
prevent the misuse and abuse of opioids, and support the 
reduction of controlled substances in circulation. And I look 
forward to working to build on those efforts from both CARA and 
21st Century Cures.
    The legislative proposals we are examining today strive to 
address a number of discreet policy problems under the 
Controlled Substances Act that healthcare practitioners and law 
enforcement officials face in combating the opioid and 
substance abuse crisis. For example, we are considering 
legislation from Congressman Walberg and Dingell that would 
empower hospice employees to dispose of unneeded controlled 
substances after a patient has passed away.
    Another proposal from Congressmen Costello and Nolan would 
allow pharmacies to dispense implantable and injectable 
controlled substances directly to a practitioner, reducing the 
ability for misuse or diversion. And we are also considering 
legislation from Congressman Schneider, who I note is here, 
that would require mandatory prescriber education as a 
condition of DEA licensure. This would ensure that all 
providers who treat patients for pain with opiates have 
training on the best practices for prescribing opioids, early 
detection of opioid addiction, and treatment and management of 
opioid dependent patients.
    I know that Chairman Burgess--I don't know if he was being 
very critical--seemed to suggest that he didn't like the fact 
that many of us consider doctors a part of the problem. I think 
doctors are part of the problem. Now, that doesn't mean to say 
that they are intentionally trying to overprescribe or do 
anything bad.
    But my experience, Chairman Burgess, is that oftentimes 
doctors feel that they have to prescribe things and address 
pain problems. That comes from their education, that that is 
sort of their obligation. And so I think a lot of times we do 
get doctors overprescribing, not because they are intentionally 
trying to do anything abusive or criminal, but just because 
they have learned in medical school that they need to do this, 
they need to take care of pain if people are in pain.
    So I do think that we need more education. I think that 
many of the older doctors are not necessarily aware of the 
dangers of overprescribing. So I am not trying to be difficult 
with you, but I do think that is something that needs to be 
addressed and that Congressman Schneider's bill does address 
effectively.
    We also will discuss how we can employ telemedicine in 
treating those suffering from substance abuse and mental health 
disorders, including individual practitioners and community 
mental health centers and addiction treatment facilities. While 
this policy holds the potential to expand treatment options for 
those suffering, we must carefully consider how we can 
safeguard against further abuse or misuse of controlled 
substances.
    And, finally, we will consider two proposals that I 
continue to have strong concerns about. One is H.R. 2851, which 
attempts to address the problem of illicit synthetic analogues. 
And the second is the discussion draft that would propose 
scheduling tableting and encapsulating machine-like controlled 
substances.
    I recognize the importance of addressing illicit synthetics 
drugs and illegal importation, but both of these proposals 
would give the Attorney General broad and unprecedented new 
authority, including criminal penalties, as a way to deter 
traffickers that fuel our opioid crisis.
    I just want to say, Mr. Chairman, I do look forward to 
hearing more from DEA and our witnesses today on these issues, 
and I hope to work with all of us on a bipartisan basis to 
address these concerns. Thank you.
    [The prepared statement of Mr. Pallone follows:]

             Prepared statement of Hon. Frank Pallone, Jr.

    Today is the first in a series of hearings meant to address 
the opioid and substance abuse crisis that is ravaging 
communities across the country. In my home State of New Jersey, 
more than 2,200 people died from opioids in 2016 alone. This is 
a national crisis that is devastating families every day. 
Simply put, a lot more must be done.
    That is why I am utterly confused as to why the Republican 
leadership has chosen to hold this hearing on a day when 
Congress is not in session. These are serious issues that 
deserve serious consideration. I know Chairman Walden was 
thanking those who didn't go home and stayed, but frankly in my 
opinion no Member should have to choose to stay in Washington 
when we are not voting or go home. It is also completely unfair 
to all the witnesses who have flown here and will likely end up 
with less engagement by the time their panel ends. I get the 
feeling that the Republican leadership is just checking the box 
instead of giving members, staff and stakeholders the time to 
consider important issues like the opioid crisis.
    Last Congress, we took bipartisan action to pass CARA and 
21st Century Cures, both of which provided initial investments 
and steps to addressing this crisis. These laws are expanding 
access to treatment and providing recovery support services, 
financial resources to help States take action to prevent the 
misuse and abuse of opioids, and support the reduction of 
controlled substances in circulation. I look forward to working 
to build on these efforts.
    The legislative proposals we are examining today strive to 
address a number of discrete policy problems under the 
Controlled Substances Act that health care practitioners and 
law enforcement officials face in combatting the opioid and 
substance abuse crisis. For example, we are considering 
legislation from Congressmen Walberg and Dingell that would 
empower hospice employees to dispose of unneeded controlled 
substances after a patient has passed away. Another proposal 
from Congressmen Costello and Nolan would allow pharmacies to 
dispense implantable and injectable controlled substances 
directly to a practitioner reducing the ability for misuse or 
diversion. We also are considering legislation from Congressman 
Schneider that would require mandatory prescriber education as 
a condition of DEA licensure. This would ensure that all 
providers who treat patients for pain with opioids have 
training on the best practices for prescribing opioids, early 
detection of opioid addiction, and treatment and management of 
opioid-dependent patients.
    We will also discuss how we can employ telemedicine in 
treating those suffering from substance use and mental health 
disorders, including individual practitioners and community 
mental health centers and addiction treatment facilities. While 
this policy holds the potential to expand treatment options for 
those suffering, we must carefully consider how we can 
safeguard against further abuse or misuse of controlled 
substances.
    Finally we will consider two proposals that I continue to 
have strong concerns about. The first is H.R. 2851, which 
attempts to address the problem of illicit synthetic analogues. 
The second is a discussion draft that would propose scheduling 
tableting and encapsulating machines like controlled 
substances. While I recognize the importance of addressing 
illicit synthetic drugs and illegal importation of industrial 
pill presses, both of these proposals would give the Attorney 
General broad and unprecedented new authority, including 
criminal penalties, as a way to deter traffickers that fuel our 
opioid crisis.
    I look forward to hearing more from DEA and our witnesses 
today on these issues, and hope to work with my colleagues to 
address these concerns so that we can all support legislation 
that will help to address the opioid crisis.
    Thank you, I yield back.

    Mr. Burgess. The chair reluctantly thanks the gentleman. 
The gentlemen yields back.
    The chair now is pleased to--well, that will conclude 
members' opening statements.
    I would remind members, pursuant to committee rules, all 
members' opening statements will be part of the record.
    And we, again, want to thank our witnesses for being here 
today and taking the time to testify before the subcommittee.
    We do have two panels, and each witness will have the 
opportunity to give an opening statement followed by rounds of 
questions from members. Our first panel today, we are hearing 
from Ms. Susan Gibson, the Deputy Assistant Attorney, Diversion 
Control Division of the Drug Enforcement Administration.
    We do appreciate you being here with us today, Ms. Gibson.
    You are recognized for 5 minutes for an opening statement, 
please.

   STATEMENT OF SUSAN A. GIBSON, DEPUTY ASSISTANT ATTORNEY, 
  DIVERSION CONTROL DIVISION, DRUG ENFORCEMENT ADMINISTRATION

    Ms. Gibson. Chairman Walden, Subcommittee Chairman Burgess, 
Ranking Members Pallone and Green, and distinguished members of 
the Health Subcommittee, thank you for holding this legislative 
hearing today on several bills impacting the Controlled 
Substances Act aimed at combating the opioid epidemic.
    Let me say from the outset, the opioid crisis has been--and 
will unfortunately continue to be--the top threat facing our 
Nation. This epidemic includes not only prescription opioid 
medications but also the proliferation of heroin, illicit 
fentanyl, and fentanyl analogues.
    Despite record numbers of overdose deaths, 64,000 in 2016 
alone, we are making progress on the prescription drug front. 
However, I fear that we are witnessing a fundamental shift 
toward cheaper, easier to obtain illicit fentanyl produced in 
foreign countries. This is where the opioid epidemic converges 
with the synthetic drug threat.
    Data has shown that the increase in opioid-related deaths 
is largely attributed to illicit fentanyl. Synthetic opioids, 
cannabinoids, stimulants are produced by rogue chemists who 
create new drugs with unknown pharmacological effects in 
humans. Because synthetic drugs are made in the lab, the profit 
potential is enormous, and the ability to stay ahead of the law 
only requires a small tweak in a molecular structure.
    One kilogram of fentanyl purchased in China for roughly 
$5,000 can generate up to $1.5 million in drug proceeds. All 
the while, unsuspecting users of synthetics drugs are playing 
Russian roulette every time they use these deadly substances. 
The questionable legal status of these synthetics and their 
ever-changing chemical composition makes it difficult for our 
Federal, State, and local law enforcement counterparts to 
intercept these deadly substances before they hit our streets.
    This is not a U.S. problem. It is an international problem 
that is growing in scope. According to the United Nations, more 
than 100 countries have reported the presence of synthetic 
drugs, and as of March 2017, approximately 750 substances have 
been reported to the U.N.'s early warning advisory.
    So what is the DEA doing about it? We are moving 
aggressively to place temporary Schedule I controls on new and 
emerging synthetic drugs. Since March 2011, DEA has utilized 
this authority on 19 occasions to place 56 synthetic drugs in 
Schedule I on an emergency basis, including 17 fentanyl 
analogues. This process is unfortunately reactive and means 
that we first observe the deadly consequences of synthetic drug 
abuse before initiating control.
    On February 6, 2018, DEA temporarily placed emergency 
controls on the entire class of fentanyl-related substances in 
an unprecedented effort to curb the disturbing trend in 
fentanyl-related overdose death. Of course, we are continuing 
to conduct criminal investigations. For example, last year, DEA 
played a major role in helping take down AlphaBay, the largest 
criminal marketplace on the internet and a key source of 
illicit synthetics, including fentanyl, being shipped into the 
United States.
    Additionally, we have worked productively with China to try 
and stem the flow of synthetics to our shores, resulting in the 
scheduling of nearly 130 new psychoactive substances since 
October 2015. Last month, domestic controls became effective in 
China for two essential fentanyl precursors: NPP and ANPP.
    Beyond the deadly synthetics threat, DEA is committed to 
combating the epidemic through several different avenues, 
including expansion, disposal, and treatment options, new pill 
press regulations, and outreach to practitioners regarding the 
prescription of opioids. The implementation of telemedicine 
regulations pursuant to the Ryan Haight Act of 2008 to the 
recent publishing of a final rule that help increase access to 
opioid addiction treatment, DEA believes that this is important 
to ensure access to opioid treatment options while mitigating 
the risk of diversion.
    In July 2017, DEA implemented a final rule pertaining to 
domestic and international transactions involving tableting and 
encapsulating machines. Overall, this rule will give DEA 
greater visibility of transactions involving tableting and 
encapsulating machines.
    Finally, DEA recognizes the importance of opioid 
prescription training for prescribers and has begun to ask 
whether they have received training regarding prescribing or 
dispensing of opioids. While this information is voluntary, it 
will provide better data to show how many prescribers are 
taking training.
    Thank you for the committee's focus on the opioid crisis, 
and I look forward to answering any questions you may have.
    [The prepared statement of Ms. Gibson follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Burgess. We thank you for your testimony.
    We will now move on to the portion of the hearing where 
Members will be recognized to ask questions, and I am going to 
begin the questioning by recognizing myself for 5 minutes for 
questions.
    On the proposed legislation offered by Mr. Katko on the 
creating a new level of scheduling on the fentanyl analogues, I 
guess, primarily, but I guess it could include other compounds 
as well. Now, we are going to hear some testimony from our 
stakeholders on the second panel about how that will perhaps 
increase the bureaucratic load on people who are involved in 
the research on these compounds.
    Do you see the potential for any difficulty there or any 
conflict there?
    Ms. Gibson. Sir, I understand your concern for research, 
and it is our concern, too. DEA supports research. We have 
never denied a valid FDA research application, especially on 
synthetic drugs. We welcome research on synthetic drugs. Right 
now, we have 600 Schedule I researchers that are approved. We 
have 420 that are approved regarding THC extract. And then we 
have another 120 that are approved on an additional CBD 
extract. So DEA is fully behind research.
    Mr. Burgess. So, again, one of the observations that will 
likely be made by a witness in the second panel is concerning 
compounds that are put on a scheduling list, that once they get 
on, it is almost impossible to get off. And I believe the point 
is going to be made that the difference, the molecular 
difference, between agonist and an antagonist can be quite 
small. And if we restrict the access to molecules of a certain 
class, that we may in fact be limiting the ability to research 
drugs or compounds that would be helpful as antagonists.
    Is that something that your agency is looking at or 
concerned about?
    Ms. Gibson. Sir, I understand your concern about the 
analogues and the quick-changing nature of it, and I believe 
with the bill that we are trying to pass here, it could be more 
proactive in that arena. I think the biggest problem is exactly 
what you said. We have a substance that we get; we identify it 
as a problem. They change one atom on it, and then it is a 
whole new substance. It is labeled differently, and it is 
another problem to attack.
    We do believe that fentanyl analogues belong in Schedule I. 
We will look at every substance differently. And we work with 
our counterparts at HHS and make sure all the scientific data 
is there, and we make sure that we do it right as much as we 
can. But we look forward to working with the committee about 
any kind of concerns regarding that.
    Mr. Burgess. And that is, of course, the whole purpose in 
having the hearing, to explore some of these issues that are 
brought up. You all will work closely with the Food and Drug 
Administration as far as scheduling things in that class. Is 
that correct?
    Ms. Gibson. Sir, we work very closely with our counterparts 
at HHS, FDA, and we rely on them and their expertise, yes.
    Mr. Burgess. Let me just ask you a question. And you 
mentioned it. Mr. Pallone mentioned it, as far as the 
educational aspect. I am a physician, and I did receive 
training on the use and potential misuse of opiates. It was 
called medical school. I would just ask you, as far as the 
agency is concerned, you see legislation being proposed where 
you are going to be responsible for the oversight of an 
educational activity that will be administered to the Nation's 
physicians. I would just ask the question: Is the agency set up 
to do that? Is the agency set up to handle that?
    Ms. Gibson. Sir, I understand your concern for continuing 
medical education, and we think it is paramount. We think it is 
critical.
    Mr. Burgess. Let me just--I do, too. And, historically, 
that is an activity that has been regulated by the State. My 
state requires me to receive a certain number of hours of 
continuing education. Although I am not active and in practice, 
I do keep my license active. So, yes, I am required to do those 
things every year before that license can be renewed. So they 
are set up, and that is part of the process.
    Do you feel like your agency is ready to administer to the 
continuing educational needs on this front the same as, say, a 
State licensing agency is already doing?
    Ms. Gibson. Sir, we definitely work closely with the States 
regarding that, and that is a procedure that we would have to 
look extremely close at, and we would have to work with the 
committee to make sure that we would get that right. Again, we 
do believe in continuing medical education. I don't think we 
can dictate exactly what they take. It is----
    Mr. Burgess. And therein is the problem. I will just pledge 
to you that, yes, it is an issue that is important to me, and 
we will work closely on that.
    Ms. Gibson. I look forward to working with you.
    Mr. Burgess. I will yield back my time.
    I am pleased to recognize the ranking member of the 
subcommittee, Mr. Green, 5 minutes for questions, please.
    Mr. Green. Thank you, Mr. Chairman.
    And welcome, Deputy Assistant Administrator Gibson. Thank 
you for joining us today.
    I want to focus my questions on the impact of scheduling 
substances in Schedule I, which you mentioned in your 
testimony, or under the proposed Schedule A that H.R. 2851 
would have on research.
    We hear from Dr. Beardsley in our second panel about the 
difficulty associated with conducting research with Schedule I 
substances. He noted in his written testimony that it can take 
over a year to obtain a Schedule I registration. I heard from 
others that requirements associated with Schedule I substances, 
such as the storage and security requirements, can be very 
costly. The time and resource burdens have, in some instances, 
been a disincentive for young and promising researchers who 
examine these substances for their therapeutic value.
    My first question is, can you describe current requirements 
DEA imposes on researchers who wish to study Schedule I drugs? 
And I am particularly interested in whether you offer any 
accommodations today for researchers.
    Ms. Gibson. Sir, I appreciate your concerns for research, 
and it is critical. We do have a strict process regarding 
research as far as the application process. And the reason it 
is strict and it has to be FDA approved is because we have to 
prevent diversion. That is the bottom line. And we have to make 
sure that everything that a researcher receives as product has 
to be retained and secured.
    But as far as research, if somebody brings a valid FDA 
application to us, we will be approving it. In fact, if it is a 
synthetic analogue research application, I will expedite it 
because we need it done. We need it done.
    Mr. Green. One concern I have heard from the registration 
process today is confusing nature and how Federal and State 
registrations interact. Some States require Federal 
registration prior to application, yet the DEA advises a State 
registration is needed prior to Federal application.
    What guidance does DEA offer to researchers at States 
regarding their registration process?
    Ms. Gibson. Sir, I understand interaction with the States 
and your concern how that could be different between State and 
Federal. It is kind of shocking sometimes the difference 
between the State and Federal Government on various issues. 
However, when it comes to working in this arena, it is critical 
for the Federal Government and the State government to work 
together. And in order for the Federal Government to operate in 
a State, we need their compliance, we need their understanding.
    So we are more than happy to work with each State 
individually and make sure that we come up with a proper 
procedure, and we get it done right. Yes.
    Mr. Green. Yes, it is confusing if the State requires 
Federal and Federal also requires State, so I don't know if we 
could do it simultaneously. That might be much easier for the 
researchers. One of the bills before us today, H.R. 2851, 
attempts to streamline the research registration process. We 
heard from HHS, however, that this process could still 
constitute a burden or barrier to research and could have a 
negative impact on drug development.
    Can you share what discussions, if any, DEA is having with 
Health and Human Services regarding the registration process 
for researchers, and how such process could be streamlined?
    Ms. Gibson. Again, definitely research is a big concern for 
us, too. We work closely with HHS regarding applications for 
research. And, again, we do have 600 Schedule I researchers 
already that are ready to go. Again, we believe the new 
regulations could help streamline that process. So we look 
forward to any kind of tool that the Congress could provide to 
us to streamline that process, absolutely.
    Mr. Green. Well, Congress doesn't always provide the 
funding for a lot of agencies. We wish we were the 
Appropriations Committee sometimes.
    While I want to ensure that we are properly protecting 
against abuse, misuse, and diversion of synthetic substances, I 
also want to ensure that we are not unintentionally restricting 
the ability of researchers and drug developers to discover new 
and promising therapies.
    Would you work with us on legislation to ensure that we do 
not impede or inhibit or otherwise disincentivize research?
    Ms. Gibson. Sir, I would absolutely love to work with you.
    Mr. Green. Thank you.
    And I yield back my time, Mr. Chairman.
    Mr. Burgess. The gentleman yields back.
    The chair thanks the gentleman. The chair recognizes the 
gentleman from Oregon, the chairman of the full committee, Mr. 
Walden, for 5 minutes for your questions, please.
    Mr. Walden. Thank you, again, Dr. Burgess.
    And to our witness, thank you for being here today. So, in 
your testimony and in other people's comments this morning, we 
have heard a lot of statistics, so I want to repeat a line from 
your written comments that says, ``The sharpest increase in 
drug overdose deaths in 2015 to 2016 was fueled by a surge in 
overdoses involving fentanyl, fentanyl analogues, and synthetic 
opioids.'' This was reported by the National Institute of Drug 
Abuse or NIDA.
    You go on to build a compelling case to give DEA additional 
authority to get synthetics off of our streets. Under current 
law, the DEA Administrator acting on behalf of the Attorney 
General can temporarily schedule substances for a 2-year 
period, with a possible 1-year extension to avoid imminent 
hazard to public health.
    And on February 6, 2018, this administrative tool was 
utilized to place classwide Schedule I controls on fentanyl-
related substances.
    My question is this: What additional tools would SITSA give 
special agents to investigate and prosecute these substances 
that they do not have today?
    Ms. Gibson. Thank you, sir. I understand and I appreciate 
your efforts to give us any kind of tools that we can to get 
this job done because it is unprecedented, and it calls for 
unprecedented measures to get this done.
    Mr. Walden. Right.
    Ms. Gibson. I do believe that the SITSA law outlines 
sentencing, which makes it a lot easier to prosecute, even 
though the prosecution sentencing guidelines are that of 
Schedule III. But I think it streamlines the process, which 
helps us tremendously. I think also, too, the false labeling I 
truly support because they take a substance, they change the 
atoms, and then they relabel it something, and it is a whole 
new product. So----
    Mr. Walden. What happens in your world, the enforcement 
world, when that occurs?
    Ms. Gibson. Well, right now, that we did the class of the 
fentanyl, that helped us out tremendously. It was the first 
time we ever did anything like that, and we are proud of that. 
But it does make it very difficult. We have gone out to 
convenience stores, banks. We have reached out to many people 
regarding the purchasing of these synthetic fentanyls online, 
the selling of them at the local shops--they got to know what 
they are selling, and it is a difficult arena. And especially 
my biggest concern is working with our counterparts because 
they are on the front lines; they have to be armed with the 
information they need to do their job.
    And the dissemination of information, education to our 
counterparts, that is critical. And I think DEA is doing a 
pretty good job of that, as far as communicating with our task 
forces out there. We have expanded our tactical division 
squads, which I think can also provide a lot of expertise out 
there. And I think that is the wave of the future as far as 
tackling this subject.
    Mr. Walden. Congressman John Katko, who brought this issue 
to our attention, is a prosecutor and won a national award from 
the former U.S. attorney for his work going after narcotics and 
organized crime in the narcotics world, and brought us this 
measure. And we want to make sure that--because he has been on 
the front lines there. He has prosecuted these cases, and he 
says, they change one thing, and then there you are out there. 
It just bollocks-es up the whole process to go shut down.
    And he brought a woman to the State of the Union Address 
whose 19-year-old son, if I recall the story correctly, smoked 
something that he got at a head shop that I think had been 
sprayed with a synthetic fentanyl, and I remember his mother 
said--or her son said, ``What could be wrong with this? It is 
natural,'' even though it was labeled ``not for human 
consumption'' potpourri or something like that.
    It is the wink and nod behind the curtain. They think they 
are getting off on their liability when in fact they are 
poisoning a generation. Her son died. So that is--in this 
bill--one of the things we are trying to get at. Does this bill 
get to that?
    Ms. Gibson. It is a massive problem. And I think this bill 
can help us get there. And, again, it is such a serious topic 
right now because we have people out there, we have kids out 
there, purchasing this stuff thinking it is a legal alternative 
to the actual substance.
    Mr. Walden. Exactly. And ``because it is natural,'' that 
was the argument her son made.
    Ms. Gibson. Absolutely.
    We are facing cannibalism in certain States when they take 
some of these substances. There has been a couple incidents in 
Florida where the person took a cannabinoid or a cathinone and 
actually started eating somebody. That is how serious of a 
situation we have here.
    Taking these synthetic drugs is similar to taking meth and 
PCP at the same time. And the scientific term is excitable 
delirium. So imagine that: meth and PCP at the same time. These 
products are killing our kids out there. We have 750 substances 
right now that we have identified. We took 56; aggressively, we 
put them on the schedule. And out of that, what, I think my 
math is 696 that are still out there that can kill our kids--
696 different substances----
    Mr. Walden. Will this help get to that, or do we need more?
    Ms. Gibson. It is going to streamline it. But we have to 
look at the sentencing. We have to make sure that we are--these 
people are peddling death. It is not a victimless crime when 
you are dealing drugs.
    Mr. Walden. That is right.
    Ms. Gibson. And that is my biggest concern. I love to put 
handcuffs on people that violate the CSA. And this law can help 
us. And any other tool Congress can give us to tackle this 
problem, I will take.
    Mr. Walden. We want to be your partner in this effort. And 
just to make clear, this is the first of three legislative 
hearings we have announced. This one is focused more on the 
enforcement effort. We fully understand we need to do more on 
helping people who are addicted and treating--the treatment 
piece, the mental health piece. This is going to be across the 
whole spectrum. This begins the process to try and turn off the 
access to these illicit drugs.
    So thank you for your good work, and we look forward to an 
ever-improving partnership between the administration and this 
committee on this matter. And we are going to get this done.
    So, with that, Mr. Chairman, I yield back.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentleman from New Jersey for 5 
minutes for questions, please.
    Mr. Pallone. Thank you, Mr. Chairman.
    Ms. Gibson, in your testimony, you note that some 
traffickers of fentanyl and fentanyl analogues have had 
industrial pill presses shipped into the United States directly 
from China and have been operating fentanyl pill press mills 
domestically.
    Now, DEA has also acknowledged that industrial pill press 
machines are widely available on the open internet and that 
some vendors mislabel the equipment or ship it disassembled so 
as to evade regulatory oversight. And this is clearly one way 
traffickers have been able to further increase the production 
and availability of illicit fentanyl and other synthetic 
opioids.
    So my question is--I have several. Under current law, 
importers and exporters are required to notify DEA of the 
shipment of tableting and encapsulating machines. So how does 
DEA ensure compliance with those requirements?
    Ms. Gibson. Sir, I appreciate your concerns about those 
machines, and I am happy that DEA did take that measure and get 
up that regulation and get it in place. That requires any 
importation of a tabulating and encapsulating machine 15 days 
prior to it coming to the country.
    Obviously, you are going to have the legal people out there 
that abide by the laws, and they are going to be telling us 
they are bringing it in. But we, as DEA, I have to worry about 
the ones that aren't playing fair.
    Mr. Pallone. The bad actors.
    Ms. Gibson. Exactly. As an agent in New York City, I know 
the criminals are very industrious. They are very creative; 
that is their job. So they make their own kilo presses; I am 
sure they can figure out a way to make their own pill presses. 
And that is something else we can address in the sentencing 
guidelines with SITSA. However, some organizations also 
piecemeal it into the country, too. And then from different 
sources, different shippers, they get one part of the machine, 
and another part of the machine coming in separately. So that 
is the problem.
    But we are excited at least to see how the regulation works 
and to see how many actually are coming into the country and go 
from there. So it is really fairly new; it is July 2017 that we 
started that.
    Mr. Pallone. Do you think that DEA needs additional 
authority over tableting and encapsulating machines?
    Ms. Gibson. Sir, any kind of control regarding those 
machines getting into the wrong hands, we would love a tool, 
any kind of mechanism to prevent that from happening, yes. We 
also have to understand that there are some people out there 
that bring them in for legitimate business purposes, like 
vitamins and different things like that.
    So it is, again, a balance. And that is what I feel like, 
since I took this position, you got to have that balance. And 
making sure that people can do their job in the personal arena 
and the business arena, that is important.
    Mr. Pallone. Yes.
    Ms. Gibson. But also to keep these machines out of the 
hands of the people that don't need them is a problem.
    Mr. Pallone. Well, let me go to the bill that we have, this 
Tableting and Encapsulating Machine Regulation Act that we are 
considering, that would define in statute tableting machine and 
encapsulating machine. In addition, it would also propose a 
schedule of such machines in a to-be-determined schedule.
    Is there a precedent under the Controlled Substance Act for 
scheduling machines or other devices?
    Ms. Gibson. Sir, again, this is an unprecedented time. So I 
can understand thinking outside the box. We never at DEA have 
ever scheduled a machine. So that would be a new arena for us, 
and that would be something that we would have to work closely 
with you regarding.
    Mr. Pallone. Let me just ask this because I know we are 
going to run out of time. Can you describe for us the types of 
requirements that tableting and encapsulating machine owners 
would be subject to if they were placed into Schedule I? And 
then I will ask also, what would be the penalties an owner 
could potentially be subject to if they were not in compliance 
with those requirements?
    Ms. Gibson. Well, again, if you put a machine under a 
schedule, they would have to obtain a DEA registration to 
obtain that machine. So they would have to go through the DEA 
registration process. Again, that is something we would have to 
discuss with you further. We can definitely talk to our 
counterparts at DOJ to see if they have any kind of 
understanding of how we could go forward with a process like 
that, but we would definitely have to talk to you more about 
it.
    Mr. Pallone. What about penalties? You don't want to 
comment on what penalties an owner could potentially be subject 
to if they are not in compliance?
    Ms. Gibson. I think penalties could be addressed in SITSA 
as far as sentencing, if you have a tableting machine or 
encapsulating machine in your possession and you are not using 
for it a legitimate purpose, I think that could be a sentencing 
guideline that we could use, and that could be an option.
    Mr. Pallone. Thank you, Mr. Chairman.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman from Michigan, Mr. 
Upton, 5 minutes for questions, please.
    Mr. Upton. Thank you, Mr. Chairman.
    And I really appreciate your remarks and the full committee 
chairman's as well. This is something that we need to deal 
with, and I am glad to say that it is, for the most part, it 
has been bipartisan from the get-go. We want to provide you all 
the tools that you need. I dare say that every one of us knows 
someone that it has impacted, and with the budget agreement 
that we passed and the President signed--when we did 
sequestration a number of years ago, no one ever heard of 
opioids for the most the part in terms of where things are 
today. No one would have thought that we would lose 65,000 
people a year 8 to 10 years ago on this thing.
    So I am glad to say that the budget agreement did increase 
money versus what otherwise would have been a cut, and 
specifically earmarked opioid abuse as one of the increases 
that I know that the appropriators are going to come back with 
us for before that March 23 deadline. And, of course, all of us 
here on this committee supported 21st Century Cures, 51 to 
nothing. And in that bill, we included a billion dollars for 
opioids, and we know that that was only a 2-year bill, so it 
expires. So that is one of the reasons this budget agreement is 
so important where we focus on opioid abuse.
    Last year, I met with a number of my law enforcement 
officers undercover, and we talked--I met with a good number of 
folks in southwest Michigan, but I wanted to spend some time 
with my law enforcement folks to find out how easy is it to get 
fentanyl and some of these other products like heroin and 
others into west Michigan. They said it is real easy, because 
it comes in oftentimes through the postal center. And Grand 
Rapids is sort of the postal distribution center. They have one 
postal inspector for all of west Michigan.
    And it comes in in counterfeit labeling, and it changes. 
They felt that they had good cooperation with FedEx and UPS, 
but in fact, they know that it comes in there, too. And 
particularly for the drug dealers, the folks that are getting 
it, they can track it. They can find if it is delayed even 1 
day, they are not going to be there to pick it up, go someplace 
else. It is a huge enormous problem.
    So I cosponsored a bill that would require the Postal 
Service to provide package level detail, information for 
packages imported from overseas to Customs and Border Patrol as 
private carriers like UPS and FedEx are already required to do. 
Because of that--and I applaud the President, he had a number 
of us, on a bipartisan basis, down to the White House last 
summer--I raised this issue with him and how we needed more 
resources. And, frankly, when you think about trying to 
identify some of these drugs coming in and we have seen cases 
where just, you know, because of its potency, just any contact 
at all can actually kill, whether it is dogs or people, so 
there is an enormous problem.
    Can you tell us how are you interacting with where--as we 
know, when the President went to China a few months ago, I 
signed a letter with a number of my colleagues to raise the 
fentanyl issue to see what China can actually do to stop some 
of this junk coming here.
    But how is your frustration level with the law enforcement, 
or with the shippers, and what can we do to help you there as 
well?
    Ms. Gibson. I understand your concern about tackling this 
problem, and it is daunting. And that is one of the reasons why 
I am proud of DEA, because we never give up. And drug work is 
the most labor-intensive, frustrating entity that you can 
encounter in law enforcement.
    I know, when I was an agent in New York City, we routinely 
worked with the postal inspectors. We have worked with 
different shipping companies in various capacities, and we have 
had a lot of success with them. Sometimes you strike out, but 
you just got to keep on getting up to the plate and taking 
another swing.
    It is too important of a problem to just give up on. But we 
definitely will take any kind of resources, any extra resources 
that can be given to us. Specifically, if you have one major 
concern, please let me know.
    Mr. Upton. Let me ask you one quick question. Disposal of 
pharmaceutical waste in the hospital requires strict adherence 
to necessary protocols to avoid diversion of opioid waste, 
primarily administrated doses that are medically necessary for 
most surgical procedures from being improperly disposed of.
    So to render those opioid nonretrievable and unusable 
products for DEA regs at a much lower compliance burden than 
what many providers currently experience, what are you doing to 
help being able to dispose some of these that people may 
voluntarily bring in that they can then rest assured they are 
not going to be abused by someone later on?
    Ms. Gibson. Sir, I understand your concern because I think 
we have all been there where we had a loved one that passed and 
we had all this medication that we didn't know what to do with 
it. DEA prides itself on the National Take Back Initiative, 
where we actually have one coming up April 28. Through the 
beginning and the inception of that program, we have taken 9 
million pounds of prescription drugs off the street--9 million 
pounds. And, unfortunately, four out of five heroin users right 
now start with taking the pills out of the medicine cabinet and 
going ahead, using them, and developing a horrible habit.
    So it is incumbent for us to get those pills. And we do a 
lot with operation prevention. We get information out to 
parents, students, teachers. Operation 360 right now. We are 
working with communities to get the information out there. DEA 
wears many hats, and I think a lot of times people think we are 
just kicking in doors and arresting bad guys, but our Diversion 
Control Unit, we tackle those problems as far as making sure we 
get the information out there.
    Mr. Upton. I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentlelady from California, Ms. 
Matsui, for 5 minutes for your questioning, please.
    Ms. Matsui. Thank you, Mr. Chairman, and I want to thank 
all the witnesses who are yet to testify yet for being here 
today and also you, too. My priority here is to improve access 
to care. And, as mentioned before, I am working on improving 
access to remote behavioral health treatment. It is a 
discussion draft, which is what it means: It is a discussion 
draft. And we are still working on it, but I think it is 
important to lay it out there so we can have a conversation as 
to how we might improve it.
    This is with Representative Harper. And both of us believe 
that telemedicine has the potential to improve access, 
especially in the midst of this opioid epidemic. However, I am 
looking forward to hearing from stakeholders--all the 
stakeholders--about how best to improve access via telemedicine 
without creating new problems.
    The last thing we want to do is to make it easier for 
unscrupulous actors to prescribe controlled substances. And I 
think you mentioned before that the bad actors are always the 
ones who, I don't know, that is their job to figure out how to 
mess up things, right?
    Ms. Gibson. Yes.
    Ms. Matsui. So we are going to have to try to figure out 
what to do to prevent that. But I do though believe that many 
people in our communities are receiving high-quality 
comprehensive care in their local community behavioral health 
clinics. And access to medication can be a part to treating 
patients suffering from opioid use disorder and other mental 
illnesses.
    Ms. Gibson, according to DEA's interpretation of the Ryan 
Haight Act, a hospital or clinic must first be licensed by the 
State before registering with the DEA. Can you provide us with 
some insight into the reasoning for DEA's narrow 
interpretation?
    Ms. Gibson. Ma'am, DEA agrees with any kind of efforts that 
we can do to get somebody on the right path forward, and to get 
them help. So I understand your concern, and I would love to 
work with you.
    It is incumbent that DEA works with the State government 
regarding registrations. A lot of times, active investigations, 
whether criminal or administrative in nature, we work hand-in-
hand with our State. So if there is a problem going forward 
with having registrations, and if State is the problem, we can 
figure that out and get you information that you need.
    Ms. Matsui. So are there circumstances, then, under which 
DEA could modify, work with this requirement to be more 
inclusive at clinics that may be authorized by the State or 
county but not licensed by the State?
    Ms. Gibson. Again, this is where I have to put my DEA hat 
on as though we were enforcement and regulation, because it is 
so important to make sure that these clinics are abiding by 
Federal and State laws.
    Ms. Matsui. Right.
    Ms. Gibson. So if a clinic wants to move forward with 
obtaining registration for a narcotic treatment program and to 
dispense MAT, medical assistance treatment, we would be more 
than happy to work with them, because we want to make sure that 
people have access to those types of treatment centers.
    Ms. Matsui. Right. I am looking at it from a drug 
enforcement perspective, and you are looking at certain 
guardrails that must be put in place to assure appropriate 
prescribing of controlled substances for a medication-assisted 
treatment via telemedicine. That is the aspect of it here that 
we are trying to address.
    And it is a little bit different, but on the other hand, is 
there a situation, I am trying to get to where we can narrow 
this in a way, not so widely but not so narrowly as it is today 
so that we might be able to have this remote telemedicine ways 
of treatment in this crisis.
    Ms. Gibson. Well, ma'am, as it stands right now, 
telemedicine is authorized.
    If we can get the patient to either a registered hospital 
or clinic, with DEA, or a registered physician, physician 
assistant, nurse practitioner, they use appropriate audio-
visual equipment, to their prescription and data-waived 
physician, it can happen.
    Ms. Matsui. The only problem, though, is that in a 
situation, you would want the person to be in place and we are 
looking at community clinics where that is not necessarily a 
hospital or something that is licensed by the State. And that 
would take away the efficiency of the telemedicine then. And we 
are trying to get to that place where we can get the community 
health clinics to be able to be participants in this with the 
patient without having to move them somewhere, if you know what 
I mean.
    So anyway, it is something that we are trying to figure 
out, Congressman Harper and I, to figure out how to get the 
guardrails in place but have it flexible enough so we can do 
this.
    So thank you very much. We are going to be working with 
you, I believe.
    Ms. Gibson. Absolutely. I want to work with you and see how 
we can figure that problem out.
    Ms. Matsui. Thank you. I yield back.
    Mr. Burgess. The chair thanks the gentlelady. The 
gentlelady yields back. The chair recognizes the gentleman from 
Illinois, Mr. Shimkus, 5 minutes for questions.
    Mr. Shimkus. Thank you, Mr. Chairman. Thanks for being 
here. I want to applaud my colleagues on both sides who--it is 
easy for us to try to run home when we are not voting and they 
are here working. And so hats off to both sides, because it is 
such a national issue and a national concern. And we have got a 
long way to go. This is a plethora of options and bills. There 
is a lot of ideas out there, and a lot of them sponsored by my 
colleagues on this committee and some outside the committee.
    So I want to focus on this issue of FDA and DEA and this 
pseudo, not a conflict, but the scheduling and the FDAs 
approval for scientific safety and efficacy, and then the 
listing. Where on this what we need to do is try to keep people 
from taking the first dose and getting hooked, and that is a 
whole set of problems, but then the other side is the 
treatment. And some of this treatment has opioid-type events. 
And so it is a total ban when you got to use that on the 
treatment end, there is also a concern.
    So I want to make sure the FDA's role in the scheduling 
process is strong and solid. I think both sides talked highly 
about the strength of FDA and its record, but it seems like 
there is certain factors within the current eight-step process 
to bring new drugs under the Controlled Substances Act such as 
the state of the current scientific knowledge about the 
substance or its risk to public health, are better suited for 
the FDA and agency focused on scientific safety and efficacies 
of drugs than the DEA, which enforces the criminal and civil 
justice on controlled substances.
    Does the DEA believe that in order to strike the balance 
between addressing the risk posed by illicit use and allowing 
the scientific research needed to develop new therapies that 
the FDA should continue to have some role in the temporary and 
permanent scheduling of controlled substances?
    Ms. Gibson. Sir, I appreciate your concern about scheduling 
substances and getting them out of the hands of our kids as 
quickly as possible, too. It is critical to work with our 
counterparts at FDA and HHS. I have the utmost respect for them 
and I look forward to working with them in the future.
    The only way we can tackle this problem is together. I came 
from a task force in New York City comprised of DEA, NYPD, and 
New York State Police, and the only way that we were as 
successful as we were is because we worked together. So I 
promise you that any kind of scientific data, anything that 
FDA, HHS can bring to the table, I will be more than happy to 
work with.
    Mr. Shimkus. Yes, because the concern is to make sure that 
you all make reasonable technical accommodations for research, 
which is critical, and that FDA should continue to have some 
role in the scheduling process. I appreciate your comments. 
What we had hope was that you all, the DEA, would help provide 
some technical comments to, in essence, the Katko bill, which 
is the H.R. 2851, which I scribbled--I don't like to use 
acronyms, so I try to scribble down, but then I can't read my 
writing, so Stop the Importation and Trafficking----
    Ms. Gibson. Synthetic Analogues----
    Mr. Shimkus. Yes, you got it. So if you could provide us 
some feedback on how we can address this concern about making 
sure that the FDA can be involved in this process and what your 
concerns will be as this bill--my guess would be this bill 
would get a fair hearing and will move through the process. And 
we would like to have your input on that.
    Ms. Gibson. Again, sir, I understand all your concerns. And 
especially being that I just came to this position, I have been 
here a month-and-a-half.
    Mr. Shimkus. Welcome. What a time.
    Ms. Gibson. Thank you. But you know what, I think it is a 
great time to be a part of it because it is such a massive 
problems that it takes all hands on deck, and it takes 
everybody to get on the same page and figure this out.
    So I promise you, that is my motto. I need to work with 
people. We need to bring people into this conversation. Because 
I can talk about regulation all day long and making sure the 
stuff stays out of the bad guys' hands, but I need to rely on 
my scientific counterparts to understand everything going on.
    Mr. Shimkus. We just don't want the two agencies to trip 
over--we have the same objective. We just don't want the two 
agencies to trip over each other. And so we need help 
clarifying the language, that suits both sides, that would be 
helpful.
    And with that, I yield back. Mr. Chairman, thank you.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman. The chair recognizes the gentlelady from 
Florida, Ms. Castor. 5 minutes for your questions, please.
    Ms. Castor. Thank you, Mr. Chairman. Welcome, Ms. Gibson.
    A U.S. District Court judge in Ohio, who is overseeing 
hundreds of lawsuits that have now been consolidated into one, 
these are lawsuits filed against opioid manufacturers and 
distributors. The judge has directed DEA to release data about 
the national distribution of opioids. The judge ordered the DEA 
to inform him very soon that it will consent to releasing data 
from the automation of reports and consolidated order systems, 
ARCOS. ARCOS data, which drug companies must provide to the 
government under the Controlled Substances Act shows 
transactions made by opioid manufacturers and distributors.
    The database shows how many pills were sold, where in the 
U.S. they were sent, and what pharmacies bought them. The 
database, as you know, is often used by agents conducting 
criminal investigations into trafficking of prescription 
opioids.
    The judge proposed that the DEA give a list of drug 
companies that manufacture and distribute 95 percent of the 
opioids in each State broken down by each State for each year 
between 2006 and 2014. The judge also would like the data to 
include the total number of pills sold in every State each year 
and how much market share each company enjoys.
    Will the DEA comply with the judge's request?
    Ms. Gibson. Ma'am, I understand what you are discussing 
right now, because it has been a big part of my time since I 
have been here in this position. I know personally, and I have 
been part of the meetings, that we are working as much as we 
can with the coalitions. We understand their goals. We have, 
though, a right--well, not a right, but we have to protect 
business proprietary information. We are working with them 
right now to come up with the mechanism.
    Ms. Castor. That is the business information of drug 
manufacturers and distributors?
    Ms. Gibson. Proprietary information, yes. And that is 
statute. That is not something that I can chose to do. It is 
statute.
    Ms. Castor. But the DEA said you would provide a couple of 
years of information. What is the difference?
    Ms. Gibson. Ma'am, there are multiple lawsuits going on 
right now, so I have to clarify actually which one, if you are 
specifically talking about Ohio.
    Ms. Castor. Yes.
    Ms. Gibson. I know we have moved forward with several 
States as far as giving them information. Some States we have 
already. Some States we are still trying to work that out. So I 
would have to get back with you regarding exactly Ohio.
    Ms. Castor. I know the DEA will have to get back to the 
Federal District Court judge.
    Ms. Gibson. We have. We absolutely have.
    Ms. Castor. --shortly.
    Ms. Gibson. We absolutely have.
    Ms. Castor. I would just encourage the DEA to be as 
responsive as possible.
    If there is a law that is preventing you from sharing 
certain data, the Congress needs to understand that. And I know 
there has been a lot of press reports about what has happened 
with drug laws and things, but we need some honest brokers in 
this business to help us combat it.
    And you said you are committed to combating the epidemic. 
And I would think DEA's full compliance with the District Court 
judge's request for information would go a long way to doing 
that.
    Now, the Controlled Substances Act requires drug companies 
to report the unusually large or suspicious orders, and if they 
fail to do so, they are fined or they are suspended, or they 
lose their registration. Then DEA has the ability, if they are 
not complying, to issue orders to show cause or immediately 
suspend them.
    I am wondering, in this physical year, how many enforcement 
actions have been taken by DEA, and can you characterize that? 
Do you have those statistics in front of you?
    Ms. Gibson. As far as enforcement action, we have taken 
approximately 900 registrations per year in the past 7 years. 
In the past 7 years, I believe we opened, what 10,000 cases, 
about a couple thousand cases a year. So we are aggressively 
going after people and we are opening up cases, and we are 
using every tool that we have----
    Ms. Castor. Could you provide those specific statistics to 
the committee, up-to-date? Because looking on the website, the 
data only goes through 2016, and it would be very helpful.
    Also, there has been a lot of criticism about the DEA and 
the revolving door between the DEA and drug companies and 
manufacturers. What regulations are in place right now that--
just like Congress, we are prevented from lobbying for a couple 
of years--what is in place right now, in ethics and government 
that prevents an employee from the DEA leaving and going to 
work for a drug manufacturer or a law firm that represents them 
or a drug distributor right now currently in law or in agency 
regulation?
    Ms. Gibson. Ma'am, I wish I was close enough to retirement 
to have to worry about something like that, but unfortunately 
you are stuck with me for several years. I would have to get 
back to you with specific information regarding that. We do 
have an ethics committee and counsel back at DEA, and he can 
provide exactly what you need regarding that.
    Ms. Castor. Do you know of any restriction that is 
currently operative at the agency?
    Ms. Gibson. Again, I wish I had the opportunity to know. 
That meant I was closer to retirement. But I----
    Ms. Castor. Please get us that information.
    Ms. Gibson. Absolutely.
    Ms. Castor. Thank you very much. I yield back.
    Mr. Burgess. The gentlelady yields back. The chair thanks 
the gentlelady. The chair recognizes the gentleman from Ohio, 
Mr. Latta for 5 minutes for your questions, please.
    Mr. Latta. Thank you, Mr. Chairman, and thank you very much 
for being with us today on this panel. Being from Ohio, we are, 
unfortunately, right in the middle of this. We have seen some 
sobering statistics that we had from overdose deaths. We go 
back to 2015, we had 3,050 people lose their lives. In 2016, 
that number went up by 1,000 to 4,050 people. And just in the 
period ending from the physical year from the end of June of 
2016 to 2017, that number went to 5,232. So we are seeing this 
horrible increase in the State of Ohio. And also, a lot of this 
is being caused because of fentanyl.
    And when you look at in 2016, we saw about 58.2 percent of 
all the overdose deaths because of something involving 
fentanyl. So, our topic today is on the opioid crisis, but for 
us in Ohio, we are going through an epidemic because of how bad 
it is out there.
    And if I could, because it is important for you, and I know 
there is a little bit of discussion that you have had already 
talking about drug take-back days and things like that. We have 
participated in two within Lucas County with the sheriff. I was 
absolutely astounded at how much came in that day. And then I 
was with the Findlay Police Department, just south of there in 
my district on another drug take-back day, and the amount of 
drugs that were taken back that day.
    So, there are things happening out there, and it is 
important, but I am also working with legislation on getting 
the information out for my communities. And it is the Info Act. 
Because one of the things I have heard from my communities, 
because I represent a lot of small areas. And the problem is 
that they don't have the grant writers, they don't have the 
information. They need to have some place they can go to get 
the information, what is happening on the Federal side. And 
also, just as importantly, where the money is to help. So, we 
have been working on that because it is very, very important.
    But let me ask you, because in your testimony, again, just 
this data information back and forth, but in your testimony you 
talk about the heroin-fentanyl task force which is the 
intergovernmental working group, and you have a lot of law 
enforcement, Homeland Security, investigative Postal, even 
Defense and Intelligence Agency. Is it an oversight or is HHS 
not part of that working group?
    Ms. Gibson. Sir, which working group?
    Mr. Latta. OK. This is the heroin-fentanyl task force that 
you mentioned in your testimony. I see that HHS is not in that 
group.
    Ms. Gibson. Sir, I would have to get back with you exactly 
what the role would be. But I know for a fact anything that 
comes across my desk, I reach out for HHS immediately because 
they provide the scientific expertise that I need to get this 
job done. I have a lot of experts at DEA also, but we work 
hand-in-hand with them. So even if it is not listed, we would 
be more than happy to partner with anybody----
    Mr. Latta. OK. Well, if you could just tell me if they are 
in that working group, that would be important. Let me go on. 
Because, again, when you are talking about fentanyl, and when 
you are talking about the importation, especially from China, 
and, again, I have had meetings with my 14 county sheriffs in 
conference calls and meeting with them personally, and also 
with my police chiefs across the districts.
    One of the concerns out there, what is happening is, we are 
seeing that fentanyl is now being laced with marijuana. And not 
specifically in this case, but a young individual died in my 
district recently from fentanyl about the size of three grains 
of salt that took that person's life.
    And what is DEA trying to do right now, trying to stop the 
importation? I know a lot of it is coming across from there. 
You brought up the fact it is $3,000-$4,000 and how much you 
can get on the street level, out there on the street with it 
over $1 million. But what is the active role DEA right now is 
taking on stopping the fentanyl from coming into the country, 
especially from China or if it is being sent to Mexico or into 
Canada and somehow getting brought back in the United States. 
But what exactly are we doing at DEA?
    Ms. Gibson. Sir, I appreciate your question, because I am 
really proud to be sitting here saying that our DEA Beijing 
country office works closely with the Chinese Government.
    China has been a very good friend to us. And the fact that 
they have put I think 138 new psychoactive substances. They 
regulated them over in China for us, and they are not even a 
problem over there. And statistics have shown if they regulate 
a substance over there, it has a direct impact on law 
enforcement encounters. It dramatically declines.
    So DEA, we are very present in a lot of foreign countries 
that I am very proud of, and I think our job starts thousands 
and thousands of miles away from the United States borders, and 
I think that is just one example of it. And we are really 
appreciative for anything that the Chinese government can do 
regarding regulating those substances.
    Mr. Latta. Mr. Chairman, my time has expired.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentleman from Maryland, Mr. 
Sarbanes, 5 minutes for your questions, please.
    Mr. Sarbanes. Thank you, Mr. Chairman. Thank you, Ms. 
Gibson, for being here. I appreciate it.
    I was looking at the website of the Diversion Control 
Division and some frequently asked questions on there. And I 
was focusing on a part of it that talks about how while DEA 
doesn't directly regulate the marketing of control substances, 
it is in keeping with your mandate to ensure appropriate 
safeguards against diversion, and you do have concerns when 
marketing and advertising tactics appear to create increased 
possibility for diversion or misuse.
    And if you see such tactics leading to oversupply or 
minimizing risk of abuse, you make every effort to work with 
pharmaceutical companies and the FDA to find appropriate 
solutions to these problems.
    And I am really curious about the history of OxyContin and 
the extent to which the Diversion Control Division had its wits 
about it when it came to the marketing practices of Purdue 
Pharmaceuticals and anybody else who was using unscrupulous 
marketing techniques and what kind of lens that the vision that 
you head up brought to that and continues to bring to that 
since it is something that appears to fall within the mission 
of the agency.
    Ms. Gibson. Sir, I appreciate your concern.
    The bottom line is the prescriber. One of our goals for 
2018 is to have conferences regarding prescribers. Our goal is 
to get as much information out there to prevent a physician 
falling for those ads, and to make sure that opioid 
prescription is done correctly.
    Just recently over our website we added the link to the CDC 
opioid prescription guidelines. So right now when it comes----
    Mr. Sarbanes. So let me just interrupt. So your focus is on 
the prescriber but let's say you see a pattern of prescribers 
being bombarded with marketing tactics, false and misleading 
information, broad campaigns to stretch the facts on what a 
particular drug can and cannot do, the harm it may present, and 
so forth. Presumably, if you see a pattern of that among the 
prescribers that you are focused on, you would say you are, in 
effect, trying to protect from some of those marketing tactics, 
you then turn your attention, at least in part or in concert 
with other agencies that have jurisdiction, to the source of 
the marketing and bring some attention to that.
    So that is what I am interested in right now. What is that 
kind of focus? What are the questions you bring to those doing 
the marketing? What is the inquiry, and investigation, and 
pressure you bring to bear so that these marketing practices 
aren't bombarding these physicians, or pulling them in to a 
large disinformation enterprise?
    Ms. Gibson. Sir, I appreciate your question because I have 
to say, that is something that I have not encountered and or 
really addressed since I have been here. So that would be a 
learning curve for me, too. I would definitely want to sit down 
with you and get you information regarding that because that is 
information, too, the marketing tactics I think would have to 
go a few years back for what your scenario is that you are 
giving to me. And I would love to find out myself exactly what 
we do.
    Mr. Sarbanes. Well, I hope you get interested and it does 
seem to fall squarely within the mission to pay attention to 
these marketing practices. And there is a lot of history to 
look at with how OxyContin was marketed, how Purdue managed to 
overcome well-founded concerns and anxieties in the medical 
community about the addictive nature of that particular 
medication.
    And the reason to study the history of it is because from 
what I can tell, those kinds of marketing practices continue in 
force. They may have, you know, altered them slightly to 
respond to pressure in the public and from some agencies, but I 
think the practices continue and we need you all to cooperate 
with any agency that has relevant jurisdiction on this to make 
sure we shut those kind of practices, marketing practices down 
to protect people out there in the country. So I hope you will 
bring attention to it.
    Thank you. And I yield back.
    Mr. Burgess. The gentleman yields back. The Chair thanks 
the gentleman. The Chair recognizes the gentleman from Indiana, 
Dr.Bucshon. 5 minutes for your question, please.
    Mr. Bucshon. Thank you, Mr. Chairman.
    I was a practicing cardiothoracic surgeon for 15 years 
prior to coming to Congress. I have known about this opioid 
situation for probably 25, 20-25 years. This is not a new 
problem, but it kind of reached the tipping point, and it has 
gotten dramatically worse, but the tipping point where it is 
become a public health issue, specifically.
    And a little background from a physician perspective. Back 
in the 1990s there was a big push to control pain, both chronic 
and acute pain. And that came really from everywhere. It came 
from accrediting agencies for hospitals, it came from inpatient 
advocacy groups, it came from nursing groups, doctor groups. 
The little smiley face, frowny face on the patient's chart. 
Your pain from 1-to-10 type of thing.
    And so what happened is--and I am going to be quick here 
because I have a question--what happened is that we somewhat as 
a society started to create a culture of, in my view, of 
prescribing opioid-type pain medicine, probably in many cases, 
inappropriately when there were non-opioid alternatives that 
could have been used for both chronic and acute pain.
    And then it started to get linked to payment, where patient 
satisfaction scores, hospitals, and others were worried about 
getting their payment cut because of patient satisfaction 
scores. And that included the ``fifth vital sign,'' which was 
pain.
    That is not a defense of practitioners, but it also is the 
truth. And I think our society has created a culture that it is 
going to take a while to turn the Titanic, right? We are not 
turning the speedboat here. We are going to have to change our 
medical culture to fix some of that.
    So a couple questions: What percentage, approximately, do 
you think of heroin being abused in the United States comes 
across the southern border of the United States?
    Ms. Gibson. I don't know if I can give you a specific 
number, but I would think a fair majority of it would be 
coming----
    Mr. Bucshon. The majority comes across there. So, we have 
some, not only in areas where we have the international 
shipping, that is a huge issue, but my parents stayed down in 
the Brownsville area for 20 years over the summer. And almost 
weekly they would catch a semi-load full of either cocaine or 
heroin, or something, right? And that is the ones they caught. 
So, I think we do have an issue down there.
    So in Indiana served the 8th district. It is very rural. 
And this is going to change, we are going to change to a 
different direction here a little bit. And we have a problem 
with access to medication assisted treatment and I support the 
use of telemedicine.
    In your testimony, you mentioned that there is confusion 
over whether a doctor is authorized to treat opioid-use 
disorder using MAT, medication assisted treatment, can perform 
the services via telemedicine, and the DEA is in drafting 
process to implement regulations regarding special registration 
for telemedicine.
    Do you have a timeline of when you expect to promulgate 
these types of regulations?
    Ms. Gibson. Sir, I understand your concern about the 
special registration. Upon my arrival here, I met with my 
drafting unit, and I realize that that has been pending a 
while, and it has been put on our unified agenda. And we are 
going to make it a priority right now. But I really think it is 
important for me to get out to 1.7 million registrants that it 
can be done.
    Mr. Bucshon. Yes.
    Ms. Gibson. In certain circumstances it can be done. So the 
special registration has nothing to do with telemedicine being 
done now.
    Mr. Bucshon. Right. Yes, just do your best to tell 
everybody what the rules are. I think that is the bottom line, 
right?
    With that, Mr. Chairman, I yield back.
    Mr. Burgess. The gentleman yields back. The Chair thanks 
the gentleman. The Chair recognizes the gentlelady from 
Colorado for 5 minutes for your questions, please.
    Ms. DeGette. Thank you so much, Mr. Chairman. Before I ask 
my questions, I just want to take a moment of personal 
privilege and thank my wonderful healthcare staffer, Polly 
Webster, whose last day is today, as a matter of fact. Polly 
was instrumental in helping--Fred Upton is sitting here, and he 
will tell you, she was instrumental in getting 21st Century 
Cures over the finish line. And we are going to really miss 
her. So thanks for all your good work, Polly. I appreciate it.
    I also want to just make an observation, Mr. Chairman, 
which is I am hoping, I know there was some disappointment that 
a lot of the members left, but we had a very good showing on 
both sides of the aisle today for this hearing. And when the 
hearing was originally scheduled, it was scheduled for a day 
when we thought we would be having votes. But having said that, 
and listening to Ms. Gibson's testimony here, unfortunately, I 
am going to have to miss the second panel because I am going to 
have to go home--but I think there are so many issues around 
this opioid issue, and certainly the scheduling of fentanyl and 
other compounds is one issue. Some of the other members have 
raised other issues. I believe that you are intending to have a 
whole series of these hearings. And I think that it really will 
be worth it.
    Some of you know, everybody on the committee knows, I am 
the ranking Democrat on the Oversight Subcommittee. And over 
the last few years, we have had a number of hearings on the 
Oversight Subcommittee around the opioid issue, so if there is 
anything we can do to assist this committee, we could have some 
joint hearings, or whatever.
    Someone said it has reached a tipping point, and it really 
has in every community in this country. And we need to take 
aggressive action. Ms. Gibson, when I hear you talking about 
the struggles with telemedicine and how are we listing these 
substances and so on, it is just really clear there are a lot 
of facets to this and a lot of things that can be tightened up. 
So consider us to be your partners in this.
    I did want to ask you about something that hasn't really 
been discussed today. As tempting as it is to go very deep into 
the issue of synthetic opioids, I want to ask you about drug 
take-back programs. As you know there is a lot of unused 
prescription drugs lying around in homes. And so Congress 
passed the Secure and Responsible Drug Disposal Act in 2010. 
What that says is it allows DEA registered entities like 
pharmacies and hospitals to collect prescription drugs for 
disposal.
    Now in Colorado, my home State, the Consortium For 
Prescription Drug Abuse Prevention has piloted a number of 
successful drug take-back programs that have helped remove 
these unused opioids. But unfortunately, as I understand it, 
the Colorado Consortium is the exception not the rule.
    Last October, the GAO released a report that said 
nationally just 3 percent of DEA-registered facilities are 
operating take-back programs. So I am wondering, Ms. Gibson, if 
you know what the primary challenges that DEA registered 
facilities face when they are trying to operate this program? 
Is there something that you can do or we can help you do to 
make this program more robust?
    Ms. Gibson. Ma'am, I appreciate your endeavors to expand 
upon this process because it is so critical getting this stuff 
off the streets for our kids. I know what keeps me going during 
the day is thinking about diversion and making sure that 
anything that is taken from our citizens out there, get it out 
of the hands of the kids to take is paramount to me. But I have 
to make sure that it goes to the right person and that it is 
not being diverted from that person and it goes to an entity 
where it is secured and it is not going to be stolen. So there 
is a lot of----
    Ms. DeGette. Well, you are totally right, but those are 
called DEA-registered facilities, and they are supposed to be 
implementing this program. But only 3 percent of them are. I am 
not talking about getting people who aren't registered to do 
it. I am talking about people who are OK to do it, to do it. Do 
you know if DEA has programs to bolster up these facilities 
doing the take-back programs?
    Ms. Gibson. I am going to have to look at that. I know we 
have one coming up in April. And if I can address that and take 
that back to my counterparts----
    Ms. DeGette. That would be great, because if----
    Ms. Gibson. Right.
    Ms. DeGette. We are all committed to it.
    Ms. Gibson. Yes.
    Ms. DeGette. We just need to make it happen.
    Ms. Gibson. Thank you.
    Ms. DeGette. We have to make that happen.
    Ms. Gibson. All right.
    Mr. Burgess. The gentlelady yields back. The chair thanks 
the gentlelady. The chair recognizes the gentleman from 
Missouri, Mr. Long. 5 minutes for your questions, please.
    Mr. Long. Thank you, Mr. Chairman. And Ms. Gibson, you 
mentioned in your testimony that the drug control process under 
the Controlled Substances Act is reactive, and that it requires 
an extensive interagency collection and evaluation of data and 
an arduous and time-consuming process. Is this current process 
satisfactory?
    Ms. Gibson. Sir, I appreciate your question. And I have to 
say, and I am just not saying this, since my time at Diversion 
Control Division, I am so impressed with the people that work 
there, primarily because we were able to do the class of 
fentanyls within 2 months. It may not sound quick to some 
people, but to get that done and get those substances scheduled 
in 2 months, a whole class, I think that was pretty darn good. 
So you know, SITSA can help streamline that process a little 
bit, but I think we are also doing our job just because of the 
diligent efforts of the people in Diversion.
    Mr. Long. So even though it is an arduous and time-
consuming process, according to your testimony, they are doing 
it quick?
    Ms. Gibson. We got it done in 2 months, and that is because 
people, they went above and beyond.
    Mr. Long. You also mentioned the difficulty of preventing 
the distribution and abuse of controlled substances analogue, 
designer drug, and you state the Analogue Act is cumbersome and 
resource-intensive. Can you discuss what is and is not working 
with the current structure?
    Ms. Gibson. There is a process. And a lot of times the 
process takes a little bit longer than what we want. Look, I 
have 696 substances that I wish tomorrow I could put on a 
schedule and get them dealt with and get them regulated. But 
there is a process. And I have to adhere to that process. And, 
again, it is up to the valiant people that work for me that do 
their job above and beyond and get the process done.
    Mr. Long. Well, speaking of the process, what can we do to 
make it less cumbersome, or can we, so the DEA can use its 
resources more effectively? If you had your druthers, what 
would you rather them do?
    Ms. Gibson. If I had my what?
    Mr. Long. If you had your druthers. If you would rather do 
something, what would you rather them do?
    Ms. Gibson. If I had a choice, what I could do to make 
this----
    Mr. Long. That is English, yes. Choice, yes.
    Ms. Gibson. OK. Sorry, I am a simple girl from 
Pennsylvania. Again, I think that is one of the neat things, 
that I come from an enforcement background. I was an agent in 
New York City for 20 years, and now I have this hat to put on 
under Diversion. And it is exciting because now I get to ask 
those questions, and in a perfect world, what can I do, what 
can I make better. And I ask that question a lot.
    And so I am still formulating exactly what I can do to 
think outside the box, but I know one thing I am definitely 
believing in is getting information out there. I just recently 
visited a methadone clinic. It was Dr.Hoffman's methadone 
clinic here in D.C., PDARC, and I learned a lot of invaluable 
tools from that and dissemination of information to get people 
help, to get local law enforcement, help to tackle dealing with 
this issue.
    So, yes, sir, I can get back with you. Give me a month and 
maybe I can have a lot more ideas. I have ideas brewing. I just 
got to make sure that I take them into the right arena and move 
forward with them. But I promise you, I am thinking outside the 
box as much as I can.
    Mr. Long. OK. Thank you. And thanks for being here. And 
Diana had my other question there, so we got that answered when 
she was asking her questions. So now that I have introduced 
your druthers to the committee, I yield back.
    Ms. Gibson. Thank you.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back. The chair recognizes the gentleman from New 
Mexico, Mr. Lujan for 5 minutes for questions, please.
    Mr. Lujan. Thank you, Mr. Chairman. Ms. Gibson, thank you 
so much for joining us today. According to the CDC, in 2013 
providers wrote almost 250 million opioid prescriptions in the 
U.S. Enough for every American adult to have their own bottle 
of pills.
    Can you briefly explain how the high volume of opioids 
prescribed in the U.S. contributes to the misuse of 
prescription drugs?
    Ms. Gibson. Sir, I appreciate your question. And from what 
I am experiencing and what I am learning here, regarding 
prescription of pills, we have a lot of doctors out there that 
do God's work. They do the right thing. But we have some people 
out there that have overprescribed. And it is incumbent upon 
DEA to make sure that we get the education out there and maybe 
provide guidance and correct some behavior, and go after the 
people that are stockpiling currency at their house because 
they are writing too many prescriptions, and they are doing 
nefarious things. And that is actually happening. So that is my 
concern, are those doctors. And I want to make sure I get the 
education out there to streamline prescriptions.
    Mr. Lujan. And so I think what you are referring to, Ms. 
Gibson, is that the DEA recently started asking if new or 
renewal of registrants for a DEA license have received training 
on safety prescribing, prescription drugs.
    Can you explain why the DEA took the action, and how the 
DEA will utilize data on prescriber opioid training?
    Ms. Gibson. We did it on a voluntary basis right now, so 
any registrant that renews the registration or its initial 
application for registration, they voluntarily check a box to 
let us know that they received CME, continuing medical 
education. Again, we have a great website. I have got 1.7 
million registrants. And the best way of me communicating with 
them is through that website so, and that is what I am 
intending to do.
    Mr. Lujan. So in the future, will the DEA increase 
supplement prescriber training on the dangers of opioid and 
safe prescribing practices for opioid medications?
    Ms. Gibson. Absolutely, sir.
    Mr. Lujan. I appreciate your testimony in that space, Ms. 
Gibson. One thing I wanted to, I think, just bring up to the 
committee: Ms. Gibson, how long has this opioid crisis been 
affecting America?
    Ms. Gibson. Sir, way too long.
    Mr. Lujan. Do you know when it started?
    Ms. Gibson. According to another physician that was here, 
he has been a physician for 25 years, and he saw it. So I think 
prescribing of opioids have happened well before we actually 
recognized it as an epidemic.
    Mr. Lujan. Would it surprise you if I said that the opioid 
epidemic has been affecting America since before we were a 
country?
    Ms. Gibson. It wouldn't surprise me because I believe that 
methadone was actually a World War II development, if I 
remember correctly.
    Mr. Lujan. Well, let's go back to the 1800s, at the very 
least. So as we talk about the 19th century. The reason I bring 
this up--and I am going to ask an article be submitted into the 
record----
    [The information appears at the conclusion of the hearing.]
    Mr. Lujan. Is just so that we don't lose sight that this 
problem is at least a couple hundred years old, if not over 300 
years old, from where we are today, and what I hope that we 
realize is that while we are talking now about pills, that some 
of these drugs and strains that have hit the streets, these 
were developed by companies to deal with opioid addiction. They 
say, you are addicted to an opioid, so we are going to come up 
with another opioid to treat that opioid addiction, and we are 
going to warn about this one to treat that one.
    And so the reason I ask that question, and I see some 
giggling in the audience, which alarms me, this is a serious 
epidemic, I think earlier someone said this was maybe 8 to 10 
years old. People have been getting killed in all parts of 
America for too long. And I know that in my district, we have 
had problems in this space that whether they are prescription 
drugs or heroin, as we have seen grow across the America.
    I am real interested in going after all parts of the 
problem that we see. I think earlier you said that you never 
give up, ``we never give up at the DEA.'' Are there current 
investigations pending with companies that were recently fined 
to see if they have corrected their behavior about distributing 
large amounts of pills in our communities?
    Ms. Gibson. Yes, sir.
    Mr. Lujan. I believe that Mr. McKinley joined our chairman 
and our ranking member of this committee to inquire about some 
of these questions to these manufacturers and distributors, and 
it is something that we need to get to the bottom of, and that 
we look forward to working with you.
    And with that, Mr. Chairman, I would like to submit two 
articles into the record, one titled, The Opioid Epidemic, a 
Crisis Years in the Making, from the New York Times, October 
26th, 2017, and from Smithsonian.com, inside the story of 
America's 19th Century opioid addiction.
    Mr. Burgess. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Lujan. Thank you, Mr. Chairman.
    Mr. Burgess. The gentleman's time is expired. The gentleman 
yields back. The chair recognizes the lady from Indiana, Mrs. 
Brooks. 5 minutes for questions, please.
    Mrs. Brooks. Thank you, Mr. Chairman, and thank you so 
much, Ms. Gibson, for being here.
    I have worked with the DEA. I was U.S. attorney in the 
southern district of Indiana from 2001 to 2007, worked very, 
very closely with the DEA during that time. Not only 
prosecuting large drug trafficking organizations and know the 
incredible dedication that agents have, but also worked with 
Diversion at that time, because we did a very significant case 
involving significant diversion of OxyContin by a physician.
    And so I know that DEA has been involved in the 
prescription, then-heroin problem for a long time, to my 
colleagues on both sides of the aisle. But what I think has 
changed over time is that we now know, because of the 
incredible epidemic, I think in large part fueled by far too 
many people being on opioids as a prescription initially, and I 
think the research has shown that, that about 80 percent or so, 
started with prescription drugs, moved to heroin, moved to 
fentanyl, and that is where our overdose deaths are.
    But I think we do have a lot of prescribers, not just 
physicians but nurse practitioners, dentists, podiatrists, lots 
of others that maybe have not had sufficient medical education 
or continuing medical education.
    And so in the spirit, in some ways, of Representative 
Schneider's bill, I have been working on a bill as well, but in 
a bit different format, because you mentioned there has to be 
that interaction, DEA--and I was looking at your Diversion 
website--between the States and the Federal Government on 
regulation and on licensing.
    Can you please talk with us about how DEA, DEA for anyone 
to be a prescriber, they have to get what is called the magical 
DEA number. Is that correct?
    Ms. Gibson. Yes, ma'am.
    Mrs. Brooks. And that is what it is called, isn't it?
    Ms. Gibson. Yes, the DEA registration number.
    Mrs. Brooks. The DEA registration number. And am I missing 
categories of prescribers, besides physicians? We all know 
physicians. But who is eligible to get a DEA number?
    Ms. Gibson. As far as prescribers?
    Mrs. Brooks. Yes.
    Ms. Gibson. Well, right now anyone that dispenses, that can 
write a prescription, needs a DEA number. Since I have been 
there at Diversion, I have definitely been made aware of data-
waived prescribers, and that is for drug treatment.
    Mrs. Brooks. And how long have you been there, in 
Diversion? I know you have been an agent in the field for a 
long time.
    Ms. Gibson. A month and a half, ma'am.
    Mrs. Brooks. OK. Well, welcome.
    Ms. Gibson. Thank you.
    Mrs. Brooks [continuing]. To leading the effort, because I 
really do believe you are and need to be the person leading the 
effort for DEA because we have to do a lot of things 
differently than what we have been doing.
    What we have been doing isn't working. We haven't turned 
the corner yet. We are not just at the tipping point. We are 
beyond the tipping point. We are losing far too many people. I 
attended a funeral of a family friend in December, far too many 
funerals last year. And we have not changed it.
    And yet, I know that our prescribers do not want to be a 
part of the problem, but I think we need more education. And I 
think in Indiana, our State medical association, as well as a 
number of the groups we have talked to are willing and want to 
be a part of the problem and get more education. And in fact, 
have done it in Indiana. Some States do. Some States don't.
    And what I am asking is whether or not what we are working 
on is 3 hours of continuing medical education over the period 
which is every 3 years, is that correct? Do you know?
    Ms. Gibson. According to your bill, I think it was 3 hours 
every 3 years.
    Mrs. Brooks. Correct. And that the States would then have 
jurisdiction over determining what is the appropriate training. 
And how do you feel about that? That the State medical 
associations and the State medical licensing boards would be 
the ones that would be in charge of working, of course, and 
looking for the best practices of training from HHS?
    Ms. Gibson. Ma'am, we rely on our State counterparts. We 
need them. Hands down, we need them.
    Mrs. Brooks. Well, in fact a prescriber can't get a DEA 
license unless they show they have a valid medical----
    Ms. Gibson. Yes.
    Mrs. Brooks [continuing]. Or a valid license----
    Ms. Gibson. Yes.
    Mrs. Brooks [continuing]. In the State, is that correct.
    Ms. Gibson. Yes. And oftentimes we work with the States 
regarding, if a State can easily take away a registration, then 
if they don't have that State registration, we are able to 
revoke their Federal registration.
    Mrs. Brooks. Is there enough coordination between all 50 
States and DEA, or are there some problem States? I won't ask 
you to name them.
    Ms. Gibson. I have to say, again, I am proud of Diversion 
investigators because they're imbedded in these communities, 
and they all work closely with their States regarding those 
issues. So I haven't heard of any issues, but obviously, if 
there are, I will make sure that they are addressed.
    Mrs. Brooks. I have a number of other questions but will 
submit in writing. Thank you so much for your efforts.
    Ms. Gibson. Thank you.
    Mr. Burgess. The chair thanks the gentlelady.
    Mrs. Brooks. I yield back.
    Mr. Burgess. The gentlelady yields back. The chair 
recognizes the gentleman from North Carolina, Mr. Hudson. 5 
minutes for questions, please.
    Mr. Hudson. Thank you, Mr. Chairman. Ms. Gibson, thank you 
for being here today.
    As you know, the opioid epidemic is arguably one of the 
worst public health crises we have ever faced in this country. 
In North Carolina, we have 4 of the top 25 worst cities for 
abuse in the country, including Fayetteville, North Carolina, 
in my district. I don't believe there is one silver-bullet 
solution, but I have homed in one area that I do believe we can 
make a big difference, and that is the proper disposal of 
opioids.
    As I examined disposal, I have found that almost every one 
I talked to back home, a light bulb goes off when we start 
talking about it, and they say, I have a bottle of pills in my 
medicine cabinet. I talked to one woman who for 5 years moved 
her bottle of opioids with her as she moved from apartment to 
apartment.
    And just a few statistics to provide: There are as many as 
200 million opioids prescriptions written each year. As many as 
92 percent of patients don't complete that. In other words, 
have pills left over. Less than 10 percent of those folks 
properly dispose of them. So we are talking about a huge 
amount. And according to the National Institutes of Drug Abuse, 
70 percent of heroin addictions start by a product found in a 
home medicine cabinet.
    I went on the DEA website last night, and the 
recommendations for disposal of unused medications, including 
DEA take-back programs--which I participated in--flush them 
down the toilet, mix them up with something undesirable, such 
as kitty litter or coffee grounds or dirt in a resealable bag 
and throw them in the trash. These are recommendations updated 
as of October 25 of 2017.
    Given all the statistics I have just listed and the scope 
of the opioid epidemic we are facing, do you think these 
recommendations are effective? Just yes or no.
    Ms. Gibson. Yes.
    Mr. Hudson. OK. And then would you agree that we might, 
though, need to explore some new ways to help patients dispose 
of unused prescription drugs, in particular opioids?
    Ms. Gibson. Absolutely.
    Mr. Hudson. Great. Would you be willing to work with me on 
some solutions we have been working on and taking a look at to 
try to bring more options for consumers?
    Ms. Gibson. Absolutely.
    Mr. Hudson. Great. Well, I appreciate your testimony and 
your time here today, and look forward to working with you on 
this.
    Ms. Gibson. Thank you.
    Mr. Hudson. OK. And with that, Mr. Chairman, I will yield 
back.
    Mr. Burgess. The Chair thanks the gentleman. The gentleman 
yields back. The Chair recognizes the gentleman from Virginia, 
Mr. Griffith, for 5 minutes for questions, please.
    Mr. Griffith. Thank you, Mr. Chairman. I appreciate it very 
much. I appreciate you being here with us today.
    So I have heard a lot of comments from my colleagues on 
both sides of the aisle about concerns about doing research 
with different--and I don't know what the right word is--but 
when you change the formula a little bit on fentanyl, and they 
are concerned about, we don't want this stuff on the street, 
but what about research because it may be helpful, the drug 
might, if you change it a little bit, it might actually have 
some positive impacts. And you responded that you have 600 
folks working on THC and cannabidiol.
    My concern is, and I think probably where this concern has 
come from other folks is, is that this has been a long standing 
complaint with the DEA on substances that are either 
unscheduled or Schedule I, such as marijuana. You mentioned THC 
and cannabidiol. Virginia had the first medical marijuana law 
in the United States passed in 1979 by former Congressman Rick 
Boucher when he was in the State Senate, and member of the 
House of Delegates, the late Chip Woodrum.
    And from 1979 to 1998, there wasn't a whole lot going on, 
because in 1998, somebody tried to take that law off the books. 
That is when I got involved in this issue. And what we heard at 
that time in Virginia was, yes, they say they are doing 
research at the DEA, but we have a hard time getting approval.
    And I note with some interest that in our next panel, we 
have a witness, Dr.Beardsley, who in his written testimony, 
tells us that in one instance, it took over 4 months to get 
cannabidiol added to my Schedule I registration. And this drug 
has no abuse potential and no street value, so I think it is 
pretty much accurate.
    So I want to work with you to get the language right. I 
don't want this stuff on the street. But I also want to make 
sure that we don't have a repeat of the past, and then once it 
gets put into a Schedule I or Schedule A, as the Katko bill 
would have it do, that we not just immediately take all those 
substances off the table for research. Because if we don't 
continue to look at all the possibilities for all kinds of 
treatments, we may not know what we are missing, and we may 
have some value in that.
    Will you agree to work with me on that and others to get 
this language right so that we can do the research while trying 
to give you the power to get the nasty stuff off of the streets 
that we don't want our kids using, but knowing that sometimes a 
little poison can be a medicine?
    Ms. Gibson. Sir, I appreciate your concern about research, 
and it is my concern, too. And I will be more than happy to 
work with you regarding research. If we can streamline the 
process, if we can get the right people to do----
    Mr. Griffith. What I want is not just the research. I want 
your folks and your legal team to help our legal team come up 
with language that allows us to do both. To make it improper to 
have it on the streets, but still to allow our research 
universities and our folks and our doctors and our medical 
community who are doing research, to look for those miracle 
cures, even if one of those may have some component that is a 
fentanyl derivative.
    Ms. Gibson. Sir, I will be more than happy to work with 
you.
    Mr. Griffith. On getting that language down?
    Ms. Gibson. Yes, sir.
    Mr. Griffith. Excellent. Thank you.
    Also, Mr. Beardsley's written testimony mentions a policy 
change made a few years ago that now requires a researcher to 
have a separate control substance registrations for each 
building that they conduct research in.
    So he goes through a system, and he says, I used to have 
one person who could be in charge of it, now I have to have 20 
people. And some of those people have to have four different 
registrations because they work in four different buildings. 
And he is at MCV, Medical College in Virginia, VCUs medical 
school. And it is in downtown Richmond, and they do stuff in 
lots of different buildings, four for research, apparently.
    I am just wondering why that policy change was made and if 
we couldn't change it back?
    Ms. Gibson. Sir, again----
    Mr. Griffith. You have been here a month-and-a-half and you 
don't know the answer to that one. Can you research that and 
get it for me?
    Ms. Gibson. But I want to find the answer for you.
    Mr. Griffith. Yes, ma'am.
    Ms. Gibson. I am sitting here and I want to find the answer 
for you. And I definitely want to work with you regarding this, 
because I believe research is very important.
    Mr. Griffith. Yes. And I understand that. That is a 
reasonable answer in light of the fact you have been there 6 
weeks.
    Have you all released any updated regulations or guidance 
to pharmacists or other healthcare professionals and/or 
patients regarding the implementation of Section 702 of CARA, 
which allows prescribers and patients to request a partial fill 
of Schedule II control substances. And if yes, where can that 
information be found. And if not, why?
    Ms. Gibson. Sir, I believe that is still in my regulations 
department, still being drafted. And we are trying to get that 
language right, but is it definitely part of the CARA bill, and 
we are definitely working on it.
    Mr. Griffith. Well, and I would hope that, and I appreciate 
that you all worked hard to get the fentanyls rescheduled or 
scheduled in 2 months, but this would cut down on supply out 
there on the street and would really appreciate if your 
department that handles that could get that done expeditiously.
    With that, I have to yield back because my time is up and I 
thank you much.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back. The chair recognizes the gentleman from Georgia, 
Mr. Carter, 5 minutes for questions, please.
    Mr. Carter. Thank you, Mr. Chairman. Thank you, Ms. Gibson, 
for being here. I appreciate it very much. We talked earlier 
today, you had a question from another member about a bill that 
I am cosponsoring along with one of my Democratic colleagues, 
the Special Registration For Telemedicine Clarification Act of 
2018.
    And you mentioned that it is available now that through 
telemedicine you can get a waiver in order to write a 
prescription for an opioid for pain medication without seeing 
the patient but seeing them through telehealth. Is that right?
    Ms. Gibson. It is not a special waiver, from what I 
understand. Telemedicine under the Ryan Haight Act----
    Mr. Carter. Right.
    Ms. Gibson [continuing]. Has been outlined as far as there 
are certain situations that you can follow and you can engage 
in telemedicine.
    Mr. Carter. But the Ryan Haight Act limits that. 
Nevertheless, the intent of this bill that we are cosponsoring, 
Representative Bustos and myself, is to allow or to direct the 
agency to come up with and to promulgate the rules so that we 
can do this, so that it can happen. Because this is extremely 
important, particularly in rural areas where telemedicine is 
vital, and particularly for patients who need that pain 
medication who may not have access to a professional at that 
time.
    Ms. Gibson. I agree that telemedicine is definitely needed. 
But, again, when I put my regulatory hat on and my main concern 
is diversion.
    Mr. Carter. I understand. Do you feel like this is 
something that you can do? Because what we say in this 
legislation is to direct the agency to come up to DEA to 
promulgate the rules within 30 days of the passage of the law.
    Ms. Gibson. I understand.
    Mr. Carter. OK. Well, I just want to make sure. And 
certainly, we are concerned about the fraudulent use of it as 
well. So another bill that I am cosponsoring, again, along with 
one of my Democrat colleagues Representative Mark DeSaulnier, 
is Empowering Pharmacists in the Fight Against Opioid Abuse 
Act. And that, of course, is for the DEA to help pharmacists to 
identify fraudulent prescriptions. And that is something that 
is very important. For your information, currently I am the 
only pharmacist serving in Congress. I practiced for over 30 
years. And I have to tell you that this is something we do need 
help with, and we welcome this help. We want to have the 
ability to identify fraudulent prescriptions.
    However, you have to keep in mind that we are not law 
enforcement officers. The only thing worse, I think, for myself 
as a practicing pharmacist, the only thing worse than 
dispensing medication that would be opioids, in particular, 
that would be for abuse and for diversion, would have been to 
deny a prescription to a person who truly needed it. That is 
very difficult.
    I don't want to have to profile. It is unfair for you to 
expect me to have a patient come in and for me to make a 
decision by looking at that patient and saying that they don't 
look like they need this, that I am supposed to keep them from 
having it. That is simply not right. And something that I am 
not trained in. So I hope you will keep that in mind during the 
time that you are looking at it.
    Another thing I wanted to touch on was what we did in CARA, 
the Comprehensive Addiction Recovery Act, to allow 3 
prescriptions for a 30-day supply to be written. One of the 
things that has been suggested, and it was just mentioned, was 
the fact that possibly allowing physicians to have a refill on 
a prescription, in a smaller amount.
    All of us in pharmacy have experienced getting a 
prescription for simply a dental procedure for 30 oxycodone. 
And that is something we hate to see.
    So I hope that the Department will look at possibly 
allowing for a smaller quantity with perhaps just one refill 
that has to be filled within a certain time period. That is 
something that I had hope you will look at as well.
    Mr. Carter. One of the things that concerns me is--look, 
there are rogue practitioners in every profession, every 
profession, including the medical profession, and 
practitioners. And one of the things that concerns me is that I 
have never had a doctor who said: I didn't know opioids were 
addictive.
    Physicians are smart people. They are intelligent people. 
They have gone through intensive training. They understand it. 
They do need to have continuing education with it.
    But it does concern me, and it concerns me how long it 
takes for the DEA to respond to some of these rogue doctors. 
Sometime I hope you will look at that.
    The last think I wanted to touch on is, when I was a member 
of the Georgia State legislature, every year, we have a 
dangerous drug act, and we include drugs into the Schedule I 
classifications in our State. I did that on numerous occasions. 
It is very difficult. It is going to be very difficult with you 
with the synthetic drugs. I know how they get around it.
    I just want to ask you. After it becomes a Schedule I drug, 
a state can't overrule you and say that that could be legal, 
can they? You know where I am going.
    Ms. Gibson. I know where you are going.
    Mr. Carter. OK. Yes or no.
    Ms. Gibson. And if Federal law identifies a substance to be 
Schedule I, it is Schedule I.
    Mr. Carter. Can I ask you one question?
    Ms. Gibson. Yes, sir.
    Mr. Carter. What is marijuana?
    Ms. Gibson. Schedule I.
    Mr. Carter. Thank you very much.
    Mr. Chairman, I yield.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman from Kentucky, Mr. 
Guthrie, the vice chairman of the subcommittee. You are 
recognized for 5 minutes for questions.
    Mr. Guthrie. Thank you for being here today. In your 
testimony, you mentioned AlphaBay, a criminal marketplace 
website operated for over 2 years. I understand it took a lot 
of national and even international resources to take them down.
    Can you please tell me if there is now a timely process in 
place should another AlphaBay surface again?
    Ms. Gibson. Sir, I appreciate your questioning because 
these cases are difficult. These cases are labor intensive to 
include diversion cases. Going after physicians, it is 
incumbent that we use every tool in our toolbox to go after 
them, to include working with our state. So, yes, they are 
labor intensive, but we get it done, and that is why I am proud 
of the DEA, because no matter what the task is in front of us, 
we figure it out, how to do it, and we get it done.
    Mr. Guthrie. I understand that, and I agree. But if there 
is something unique like website--this new website that came on 
board, you went through a 2-year process, and you did, there 
had to be lessons learned, to say, well, this is something that 
we could have done differently, done better that would have 
sped up the process again or sped up the process, and hopefully 
that is more adopted into plans?
    Ms. Gibson. Sir, I am a fairly aggressive human being, and 
I believe that we learn from anything that we do, and we make 
it better. And that being said, anything that we can improve 
upon to get these bad actors out there in handcuffs, I am all 
for. Anybody who violates the CSA intentionally, they will be 
in handcuffs, if it is up to me.
    If it is a distributor and if I have a criminal case that I 
can make against them, they will be in handcuffs, I promise 
you.
    Mr. Guthrie. Thank you, I appreciate that. And also, 
yesterday, Attorney General Sessions announced the formation of 
the new Prescription Interdiction & Litigation Task Force at 
DOJ. I was very pleased to hear about this. And can you please 
speak to the DEA's role in this task force and how the DOJ task 
force will work with the DEA Special Operations Division on 
heroin/fentanyl task force.
    Ms. Gibson. Sir, I appreciate your question, and that is a 
new endeavor. And we are working with our counterparts at the 
Department of Justice right now to understand our role. So I 
would have to get back with you regarding your answer.
    Mr. Guthrie. OK. Thank you.
    Also, I know several people, Ms. DeGette and Mr. Hudson and 
others, have mentioned the National Drug Take Back Initiative. 
I think several of us have asked about that. It has been 
effective, but we can do more. I know that Mr. Walberg, who is 
probably going to go in a couple of minutes, has a bill 
addressing unused opioid disposal for hospice. I won't get into 
his area, but I know he is going to talk about that.
    But would you just kind of speak to safe disposal and what 
options do we have, and what you would like to see Congress do 
in that respect?
    Ms. Gibson. Sir, I appreciate that concern because it is a 
concern of mine, because once we can get these drugs off the 
street in the prescription pill form, we have to make sure that 
they are not diverted again. So that requires guidelines. That 
requires policy. And we would be more than happy to work with 
any entity out there to come up with a game plan so that when 
we get those pills off the street and we can get them into a 
safe location and they remain in custody to be disposed of, 
that is our ultimate goal.
    Mr. Guthrie. OK. Thank you. And that finishes my questions. 
I yield back a minute 26.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman. I think we have accommodated all the members of 
the subcommittee, and I am now pleased to recognize Mr. 
Walberg, who is a member of the full committee, 5 minutes for 
your questions.
    Mr. Walberg. I thank the chairman for your hospitality and 
allowing me to sit with this panel today.
    And, Ms. Gibson, thank you for the work that you do, and 
thank you for being here.
    In Mr. Mulder's testimony to come, it expresses support for 
H.R. 5041, a bill that I have sponsored along with a couple of 
other members of our committee. He expressed the support of it 
being expanded to authorize hospice personnel to dispose of 
unused medication when a living patient undergoes a medication 
change. Would the DEA have concerns with that proposal?
    Ms. Gibson. Sir, we definitely want to work with you and 
the committee to make sure that we get the language right and 
we get the process right, because we want to make sure that we 
get those drugs into the hands of an entity that can secure 
them and prevent them from being diverted.
    Mr. Walberg. Well, I think that would be the concern of the 
hospice personnel as well at this point, plus making sure that 
there isn't a temptation by leaving those in the medicine 
cabinets or--we look forward to working on that.
    Would the DEA be supportive of language being included in 
the bill to add additional reporting requirements? For example, 
a notation on the patient's record that state the date the 
medication was destroyed, the dosage, and who destroyed the 
medication, could that alleviate concerns?
    Ms. Gibson. That is definitely language that we can talk 
about and add. Absolutely, it would be a mechanism that would 
we could use.
    Mr. Walberg. Thank you. I won't wear out my welcome. Those 
were two questions I had. I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back. I believe that has accommodated everyone who had 
questions.
    Mr. Green, do you have a followup?
    Mr. Green. No.
    Mr. Burgess. Neither do I. We are going to take the 
briefest of recesses while we transition the panel.
    Ms. Gibson, I want to thank you for your participation 
today. I expect we will have an opportunity to talk about all 
of these things in more detail as your tenure in the agency 
increases. So thank you for being here today.
    Ms. Gibson. I look forward to it. Thank you.
    [Recess.]
    Mr. Burgess. I think we have almost successfully 
transitioned. We still have a couple of vacant chairs. There we 
go. Well, I think we have transitioned to our second panel 
today, and we want to thank our witnesses for being here and 
taking the time to testify before the subcommittee.
    Once again, each witness will have the opportunity to give 
an opening statement, and that will be followed by rounds of 
questions from members. So, today, this afternoon, in the 
second panel, we are going to hear from Mr. Frank Fowler, Chief 
of Police, Syracuse Police Department; Dr. Patrick Beardsley, 
Professor, Department of Pharmacology and Toxicology, Virginia 
Commonwealth University; Dr. John Mulder--I have got you out of 
order--Dr. Mulder, John Mulder, Director, Trillium Institute; 
Dr. Ponni Subbiah, Chief Medical Officer, Indivior; Dr. David 
Kan, President, California Society of Addiction Medicine; 
Richard Nance, Director, Utah County Department of Drug and 
Alcohol Prevention and Treatment; Thomas Cosgrove, Partner, 
Covington and Burling, LLP; Dr. Andrew Kolodny, Codirector, 
Opioid Policy Research, Brandeis University; and Richard Logan, 
owner of L&S Pharmacy.
    We appreciate each of you being here today and, again, are 
grateful for your forbearance in what has been a long 
afternoon. Chief Fowler, you are recognized for 5 minutes to 
give a summary of your opening statement.
    And, chief, make sure your microphone is on.

STATEMENTS OF FRANK L. FOWLER, CHIEF OF POLICE, SYRACUSE POLICE 
DEPARTMENT; PATRICK M. BEARDSLEY, PH.D., PROFESSOR, DEPARTMENT 
     OF PHARMACOLOGY AND TOXICOLOGY, VIRGINIA COMMONWEALTH 
UNIVERSITY; JOHN MULDER, M.D., FAAHPM, HMDC, DIRECTOR, TRILLIUM 
INSTITUTE; PONNI SUBBIAH, M.D., CHIEF MEDICAL OFFICER, INDIVIOR 
   PLC; DAVID Y. KAN, M.D., PRESIDENT, CALIFORNIA SOCIETY OF 
  ADDICTION MEDICINE; RICHARD J. NANCE, LCSW, DIRECTOR, UTAH 
COUNTY DEPARTMENT OF DRUG AND ALCOHOL PREVENTION AND TREATMENT; 
THOMAS J. COSGROVE, PARTNER, COVINGTON AND BURLING LLP; ANDREW 
  KOLODNY, M.D., CODIRECTOR, OPIOID POLICY RESEARCH, BRANDEIS 
  UNIVERSITY; AND RICHARD N. LOGAN, JR., PHARM.D., OWNER, L&S 
                           PHARMACY.

                  STATEMENT OF FRANK L. FOWLER

    Chief Fowler. Thank you. Thank you, Chairman Burgess, 
Ranking Member Green, and the distinguished members of the 
Committee on Energy and Commerce. I am here today to make an 
effort to paint a picture of a community that has been ravaged 
by synthetic drug abuse. Beginning in 2013, the Syracuse Police 
Department responded to an increase in the use and subsequent 
overdose of synthetic marijuana known as Spike. The Syracuse 
Police Department implemented various means of tracking the 
problem in addition to our law enforcement efforts.
    In 2015, the Syracuse Police Department saw its largest 
number of overdoses from the use of synthetic marijuana, the 
largest number of overall cause for services related to overall 
overdoses and persons down, and also made the largest number of 
arrests related to this substance. While the department took 
steps to get these drugs off the streets, new chemical 
formations of Spike were beginning to be put into circulation.
    In addition to all of the Syracuse Police Department's 
efforts, the only thing that we could charge a person with was 
a local law violation, issuing them an appearance ticket and 
releasing them. This is just one example of the dangerous 
synthetic compounds that are flooding our streets. Toxic 
synthetic drugs are designed to mimic drugs like marijuana, 
LSD, cocaine, ecstasy, and other hard drugs. They could be more 
potent than the real thing, and oftentimes are more deadly.
    In addition, these drugs are not simply affecting the 
users, my officers and other first responders are put in harm's 
way simply by coming in contact with these often lethal 
substances.
    As a local law enforcement official, we need H.R. 2851, the 
SITSA Act, which was introduced by Congressman Katko. This bill 
takes a big step towards eradicating these harmful substances 
and protecting our community. SITSA will give my officers the 
tools they need to target synthetic substance and the criminals 
who distribute and traffic them.
    Under this bill, a drug such as Spike could be temporarily 
or permanently added to the new schedule under the Controlled 
Substances Act in as little as 30 days after the chemical 
compound has been identified. The abusers of these synthetic 
drugs are not simply confined to my jurisdiction. Colleagues of 
mine from across the country are dealing with the same issues 
and have expressed a need for a solution. H.R. 2851 is that 
solution.
    I urge this committee to pass this bill and to give us the 
tools we need to combat this deadly epidemic. Thank you again 
for this opportunity and I welcome your questions.
    [The prepared statement of Chief Fowler follows:]
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    Mr. Burgess. Thank you, Chief Fowler.
    Dr. Beardsley, you are recognized for 5 minutes, please.

            STATEMENT OF PATRICK M. BEARDSLEY, PH.D.

    Mr. Beardsley. I am Dr. Patrick Beardsley, a professor of 
pharmacology and toxicology at the Virginia Commonwealth 
University. In addition to my faculty appointment, I am a 
member of the Expert Committee on Drug Dependence for the World 
Health Organization, a committee that is the first step for 
processing drugs for their international control.
    Thank you for the opportunity to be here today to discuss 
SITSA, H.R. 2851. We are all dedicated to finding paths to take 
us away from our present opioid crisis. I believe one path will 
be through research. There is a perpetual need to strike a 
balance between regulatory control of drugs to ensure public 
safely and the necessity for researchers to have access to 
controlled drugs to further science.
    The Controlled Substances Act, the CSA, explicitly 
recognizes both those needs, and I am personally sympathetic to 
both needs. As a researcher of the drugs of abuse, however, I 
have concerns that SITSA upsets that balance. I would like to 
take the next few minutes of your time to identify my concerns.
    It is my opinion that the Attorney General has already been 
able to effectively regulate all synthetic opioids that are 
known to be a current problem via the present CSA. Effective 
February 6 of this month, the DEA issued a scheduling order 
that included all fentanyl-related substances that are not 
currently scheduled to be included in Schedule I.
    Fentanyls constitute the greatest portion of all synthetic 
opioids abused. A few non-fentanyl synthetic opioids that have 
been identified as abused have previously been scheduled. 
Because most, if not all, currently abused synthetic opioids 
are currently scheduled under the CSA, it is unclear of the 
introduction of Schedule A by SITSA to help address the current 
problems with abused synthetic opioids.
    Considering 13 fentanyls are exclusively identified in 
SITSA to be included in Schedule A, it is likely all will 
eventually be transferred. How public health would be enhanced 
transferring these compounds from Schedule I to Schedule A 
conditions is also unclear. The addition of another category of 
drugs by SITSA to the CSA is problematic. In so doing, it adds 
another level of costly bureaucracy to researchers who work 
with drugs of abuse.
    Registrants with only a Schedule II to V registration will 
have to obtain a Schedule A registration. All registrants, 
whether they hold a Schedule I or a Schedule A registration, 
will have to submit protocols to the Attorney General for his 
approval to justify the use of each drug in Schedule A. 
Functionally, this arrangement is very similar to how research 
with Schedule I drugs are now handled. It can take a year or 
longer to obtain a Schedule I registration, and it can require 
many months to have a new drug added to one's existing Schedule 
I registration. With similar delays that are now impeding 
research with Schedule I drugs transferred to Schedule A drugs, 
SITSA will provide nothing to the research that will has hasten 
our understanding of synthetic opioids through science and will 
likely only impede that progress. This problem is compounded by 
an absence of a mechanism in SITSA for removing a drug from 
Schedule A once it is scheduled.
    Under SITSA, the Attorney General has the power to place a 
compound in Schedule A based upon a drug structure. And in the 
absence of additional scientific information, commonly provided 
by HHS and NIDA, the National Institute of Drug Abuse, this can 
result in misclassifications of drugs and missed opportunities 
for discovering medications we need to confront the opioid 
crisis with.
    Determining scheduling driven by chemical structure can be 
misleading. For example, the chemical structures of morphine 
and naloxone are very similar, yet one is highly abused and the 
other is an antagonist that is an antidote to the effects of 
the other. Adding a compound just based upon structural 
similarity to an abused compound may inadvertently ban an 
antidote to the abused compound.
    In addition to my concerns regarding SITSA, I do have 
suggestions that would make conducting research with synthetic 
opioids and controlled substances in general more efficient, 
far less costly, and bring much relief from the bureaucratic 
burden of conducting research with them. My statement time 
doesn't permit me to enumerate them, but my suggestions can be 
found in my written statement, and I would be happy to discuss 
them later, if asked.
    I have tried to identify a few concerns I have with SITSA 
as a researcher, and I welcome any questions you may have. 
Thank you.
    [The prepared statement of Mr. Beardsley follows:]
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    Mr. Burgess. Thank you, Dr. Beardsley.
    Dr. Mulder, you are recognized for 5 minutes, please.

          STATEMENT OF JOHN MULDER, M.D., FAAHPM, HMDC

    Dr. Mulder. Thank you, Chairman Burgess and members of the 
committee. We appreciate the opportunity to just share a few 
moments with you this afternoon. I am John Mulder. I am a 
physician who has been practicing in the field of hospice and 
palliative medicine for over 30 years and have cared for a lot 
of folks, thousands over that period of time.
    I am here in support of House bill 5041 and appreciate 
Representative Walberg, as well as Representative Dingell and 
Representative Hudson, for crafting and advancing this bill. It 
is pretty straightforward. This bill would allow licensed 
hospice personnel to destroy medication in the home that is 
left over after a patient dies, or in cases where someone is 
still living, but the medication has been changed, leaving 
excess medication in the house. It would allow for them to 
properly dispose of that.
    Every year in America, we care for between 1 \1/2\ and 2 
million hospice patients, which means that those are the 
numbers of patients that are dying. And I would submit that 
virtually everyone has medication left over. We can't predict 
when someone is going to die. Therefore, we prescribe 
medications, typically in small amounts, but they die, and 
medications are left over.
    So the mathematical extrapolation is pretty 
straightforward. We end up with tens of millions of doses of 
controlled substances that are left in the homes of our hospice 
patients every year. And at this point in time, our hospice 
personnel are not legally allowed to handle that. They can make 
recommendations, but as we have already heard in earlier 
testimony, the availability of take-back programs, the process 
of using the mail-in envelopes and other processes that are in 
place legally are sometimes onerous, and families typically 
don't take advantage of that. That just leaves too many 
medications left on the shelf and ultimately potentially to be 
sometimes innocently, but sometimes nefariously, abused by 
family members or diverted.
    So, when we are talking about a quick and easy way to get 
rid of millions of doses of controlled substances off the 
streets--potentially off the streets--this is a very simple, 
and I would note, bipartisan effort that has--that to me makes 
an awful lot of sense. And that is it. That is it.
    The only thing I would add is--just the one thing I have 
noticed in a lot of legislation, both Federal as well as State, 
is that in the effort to push forward legislation, a lot of 
times the role of hospice in the care of the patients and the 
unique and special plight of hospice patients is sometimes 
overlooked, and sometimes the legislative burdens and barriers 
could have the potential of introducing preventable suffering 
for our hospice patients.
    So I would just ask that the committee and members be 
mindful of the unique nature of hospice concerns and to take 
advantage of the resources of the National Association of Home 
Care and Hospice as a resource for additional input. I as well 
am available to answer any questions or concerns that someone 
might have about this issue.
    [The prepared statement of Dr. Mulder follows:]
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    Mr. Burgess. Thank you, Dr. Mulder. We appreciate your 
testimony.
    Dr. Subbiah, you are recognized for 5 minutes, please.

                STATEMENT OF PONNI SUBBIAH, M.D.

    Dr. Subbiah. Good afternoon. I am Dr. Ponni Subbiah. I am a 
neurologist and chief medical officer at Indivior, global 
specialty pharmaceutical company with a core focus on addiction 
medicine. We have a 20-year commitment to the vision that all 
patients have access to evidence-based treatments. We developed 
the first buprenorphine-based medication for treatment of 
opioid dependence in the U.S.
    Today, we have a portfolio of treatments for opioid 
addiction, as well as a pipeline of product candidates to 
address unmet patient needs for this and other disorders, 
including alcohol use disorder and schizophrenia. To address 
the opioid epidemic, it is important to understand the patient 
journey. It is complex and often misunderstood.
    Addiction is a brain disease and not a moral failure. 
However, social stigma, prejudice, and misconceptions about 
addiction coupled with feelings of guilt and shame often 
prevent people from seeking help. Even when people want help, 
cravings and withdrawal symptoms can be so intense that there 
is generally only a small window of time when a person can 
emotionally and physically pursue treatment.
    The healthcare system, however, does not always encourage 
treatment during that window due to structural barriers to 
care. This is one reason that many of those who need help go 
untreated. Any patient in need of treatment for opioid use 
disorder should have access to the medication-assisted 
treatment prescribed by their healthcare professional.
    Indivior's focus on patient needs to drive decisions 
inspired the R&D team to develop Sublocade, which received FDA 
approval on November 30 of last year. Sublocade is the first 
once-monthly Schedule III buprenorphine extended release 
injection for subcutaneous use. In the face of this growing 
addiction crisis, FDA granted the product fast-track approval 
and priority review designation.
    Now, it is indicated for the treatment of moderate to 
severe opioid use disorder in patients as part of a complete 
treatment plan that includes counseling and psychosocial 
support. Sublocade uses the Atrigel delivery system, which 
allows for once-monthly dosing and is intended to be 
administered only by healthcare providers. Sublocade will be 
distributed through a restricted distribution system, which is 
part of a risk evaluation and mitigation strategy program. The 
goal of this program is to mitigate serious harm or death that 
could be result from intravenous administration, self-
administration, by the patient.
    All healthcare settings and pharmacies that order and 
dispense Sublocade must be certified and establish procedures 
to verify that the medication is dispensed directly to a 
healthcare provider for administration by a healthcare provider 
only. As every patient's journey toward recovery is different, 
access to all evidence-based treatment options is critical. 
Sublocade represents one such option.
    Government policies impacting these treatments must adapt 
to ensure patients to have access to new innovative medical 
technologies. Historically, buprenorphine treatments have been 
daily oral medication, and the Controlled Substances Act allows 
for dispensing this medication directly to patients. However, 
Sublocade, as required by our FDA approved REMS can only be 
administered directly by the healthcare provider and cannot be 
dispensed directly to the patient.
    In recent years, the distribution of injectable products 
have evolved from a transitional buy and bill system where 
physician practices purchase drugs directly from a distributor 
to one that allows specialty pharmacies to ship a patient's 
prescription directly to administering provider. For example, 
current long-acting injectable treatments used for 
schizophrenia utilized both these distribution methods to 
ensure optimal patient access to these medications.
    Current law, however, is ambiguous and could impede patient 
access to new treatment innovations. We agree with 
Representatives Costello and Nolan that the law needs to be 
clarified so that these next-generation buprenorphine products 
can be accessed directly by healthcare providers through a 
specialty pharmacy restricted delivery system, as well as a 
traditional buy-and-bill system.
    We support the proposed legislation to remove ambiguity in 
the current law to ensure that patients of opioid use disorder 
and their providers have the same level of access to these 
innovative treatments as they do to other injectable products. 
This technical clarification will ensure the safest 
distribution channels for these new medical technologies.
    Thank you again for the opportunity to address the 
committee. Together, we can transform addiction from a human 
crisis to a recognized treatable disease. Thank you.
    [The prepared statement of Dr. Subbiah follows:]
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    Mr. Burgess. Thank you for your testimony.
    Dr. Kan, you are recognized for 5 minutes, please.

                STATEMENT OF DAVID Y. KAN, M.D.

    Dr. Kan. Chairman Burgess and Ranking Member Green, thank 
you for inviting me to participate in this hearing. Thank you 
to the subcommittee for your leadership in addressing our 
country's opioid epidemic.
    My name is Dr. David Kan, and I am the president of the 
California Society of Addiction Medicine, a chapter of the 
American Society of Addiction Medicine, also known as ASAM. 
This testimony is offered on behalf of ASAM. Established in 
1954, ASAM is a national medical specialty society of more than 
5,000 physicians and allied health professionals whose mission 
is to increase access to high-quality addiction treatment. I am 
board certified in addiction medicine and psychiatry. I served 
10 years in Federal service at a VA methadone program within 
the San Francisco VA Medical Center as medical director. I am 
the current medical director at Bright Heart Health, which 
provides telemedicine services in 21 states across the United 
States.
    My testimony today will focus on three facts. Number one, 
addiction involving opioid use is effectively treated with a 
combination of medications and psychosocial interventions. And 
ASAM has published guidelines that detail best practices for 
the use of these medications.
    Number two, there are significant barriers to accessing 
medications for addiction involving opioid use and a nationwide 
treatment gap.
    Number three, changes to the Controlled Substances Act to 
facilitate the use of telemedicine and new medication 
formulations can expand access to medications for addiction 
involving opioid use to close the gap. There are currently 
three medications--methadone, naltrexone, and buprenorphine--
that are FDA approved and have substantial evidence for their 
effectiveness treating addiction involving opioid use.
    Given the bills being considered today, I will focus my 
remarks on the safely and effectiveness of buprenorphine. 
Compared to full opioid agonists like methadone, buprenorphine 
is much safer with significantly lowered overdose deaths and 
adverse events. The direct healthcare savings per treated 
opioid dependent patient per year exceed $20,000. ASAM has 
published clear standards of care for clinicians treating 
patients with addiction, as well as prescribing guidelines.
    Despite the strong evidence used for the use of 
buprenorphine, very few eligible patients are offered 
medications to help treat their disease. Studies have shown 
that 80 percent of patients with opioid addiction don't receive 
any treatment, and the majority of States don't have enough 
treatment providers to provide the capacity to meet the need.
    Other access barriers include transportation difficulties, 
limited hours of operation, and few prescribers who accept 
Medicaid or Medicare, often making access to treatment next to 
impossible. Making smart and targeted changes to the Controlled 
Substances Act to facilitate treatment of buprenorphine and for 
addiction involving opioid use via telemedicine and the use of 
new buprenorphine formulations are steps this Congress should 
take to expand addiction treatment access.
    Telemedicine provides significant opportunities to reach 
more patients. The Ryan Haight Act limits the expansion of 
treatment with buprenorphine for addiction involving opioid use 
via telemedicine by generally requiring an in-person medical 
evaluation or the presence of the patient in a DEA-registered 
hospital or clinic.
    Consistent with ASAM's standards of care and national 
practice guidelines, ASAM recommends that the requirement for 
an in-person physical exam by the prescribing clinician be 
revised to allow for a physical exam to be conducted by another 
appropriately licensed healthcare professional and documented 
in the patient's medical record.
    Additionally, ASAM recommends limiting this exception to 
the in-person physical exam requirement only to those 
physicians who hold additional certification or who practice in 
a qualified practice setting per the definitions in the 2016 
SAMHSA rule that raised the dated 2016 prescribing limit. These 
changes would increase access while ensuring high-quality care 
from competent healthcare providers and safety for the patients 
to reduce diversion.
    Secondly, ASAM encourages Congress to amend the Controlled 
Substances Act to allow for specialty pharmacies to deliver new 
injectable and implantable buprenorphine formulations directly 
to the administering clinician's practice rather than relying 
on the buy-and-bill method for obtaining and being reimbursed 
for the medications. Such a change is not a new pathway for 
medication delivery; it would allow for these controlled 
substances to be delivered as many noncontrolled substances are 
already. It is a technical, commonsense fix that will expand 
treatment access while potentially reducing buprenorphine 
diversion. And ASAM urges this subcommittee to advance the bill 
to approve it.
    Thank you again for the opportunity to present here today. 
I look toward to your questions.
    [The prepared statement of Dr. Kan follows:]
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    Mr. Burgess. Thank you, Dr. Kan.
    Mr. Nance, you are recognized for 5 minutes, please, for an 
opening statement.

                 STATEMENT OF RICHARD J. NANCE

    Mr. Nance. Thank you, Chairman Burgess, Ranking Member 
Green, and members of the committee, I appreciate the 
opportunity to testify on an issue that is impacting community-
based addiction and mental health centers across the country.
    Thanks to Representatives Carter, Bustos, Harper, and 
Matsui for their leadership on the two discussion draft bills 
focused on the Ryan Haight Act. We appreciate your work.
    I am honored to be here today on behalf of the National 
Council for Behavioral Health, a national group that represents 
2,900 member centers who serve more than 8 million adults and 
children living with behavioral health disorders in the United 
States. Since 1998, I have served as the director of Utah 
County's Department of Drug and Alcohol Prevention and 
Treatment. I am a member of the National Council. I am also a 
licensed clinical social worker in the State of Utah. My 
department provides a comprehensive range of drug and alcohol 
prevention and treatment services, including medication-
assisted treatment for opioid addiction and abuse.
    Over 40 percent of the people I have in treatment at my 
agency right now are there for an opiate issue, and over 30 
percent of them are receiving medication-assisted treatment. 
That is nearly 400 out of 850 clients I have in treatment 
today.
    I am here to discuss an issue that limits community 
addiction and mental health centers' ability to provide 
patients access to treatment using telemedicine. Medically 
appropriate treatment for behavioral health conditions 
sometimes involves controlled substances. Unfortunately, today, 
thousands of centers across the country are unable to utilize 
telemedicine that results in a prescription for a controlled 
substance due to the DEA's narrow interpretation of the Ryan 
Haight Act.
    In my remarks, I will explain why this is and why the 
Matsui-Harper bill provides the relief we need in order to be 
able to serve patients more effectively. Let me state upfront 
first, though, the National Council appreciates and affirms the 
importance of the Ryan Haight Act. As recent reports have 
shown, even with the act in place, it is still far too easy to 
go online and buy controlled substances without a valid 
prescription.
    In November of 2016, two junior high students in Park City, 
Utah, ordered a drug called U47700, a synthetic opiate 
analogue, sometimes referred to as Pink, took the drug and 
overdosed and died. These studies underscore the importance of 
the DEA's vigilance over the online ecosystem and the rogue 
actors that claim to be doing telemedicine and operating an 
online pharmacy but, instead, are functionally pill mills.
    Our goal is to allow licensed, DEA-regulated, community 
addiction and mental health centers staffed by regulated and 
licensed professionals to be able to comply with the Ryan 
Haight Act in order to improve patients' access to care. So 
what we are asking is that you regulate us. I don't know too 
many people who would come in here and ask you to regulate us.
    Here is how the situation plays out in Utah and illustrates 
the problem around the country. The act allows for a 
prescription of controlled substance without a prior in-person 
examination in limited circumstances, known as telemedicine 
exceptions. The most common way telemedicine is allowed is when 
the patient is located in a DEA-registered hospital or medical 
clinic and is being treated by a DEA-registered provider 
located offsite. The problem is DEA has interpreted the 
hospital and clinic exception so narrowly that it often does 
not apply to community-based addiction and mental health 
centers.
    For an example, one patient at one of the Utah's community 
addiction and mental health centers is in crisis. I am giving 
you an example here. The patient may need addiction treatment 
involving medication-assisted treatment with a controlled 
substance like Suboxone. The center is staffed with the social 
workers, nurses, counselors, and other licensed mental health 
professionals, sometimes including physicians. Due to shortages 
of providers in parts of Utah, the center where our patient is 
located rarely has a DEA-registered doctor onsite. But the 
center does have the ability to connect the patient to a DEA-
registered addictionologist using telemedicine technology. The 
problem is my center is licensed by the Utah Department of 
Human Services as a drug and alcohol treatment agency, not 
licensed as a hospital or medical clinic by the Utah Department 
of Health, as the DEA requires.
    As such, my licensed center is unable to register with the 
DEA and the hospital or clinic telemedicine exception in the 
Ryan Haight Act doesn't apply. Accordingly, we can't provide 
the needed care to patients using telemedicine. Instead, we 
must wait for a DEA-registered doctor to go on the road to do 
an in-person physical examination before the patient gets a 
prescription for Suboxone or another controlled substance to 
treat their opioid addiction. This is just one illustration of 
the problem.
    As discussed in my written statement, there are many other 
examples of how the DEA's narrow interpretation of hospital or 
clinic is keeping legitimate centers from treating patients 
utilizing telemedicine when controlled substances are needed. 
The Harper-Matsui bill aims to remedy this.
    Finally, although the opioid epidemic is the subject of 
today's hearing, it is critical that the DEA allow centers to 
use telemedicine to treat other mental health conditions, too. 
This is discussed also further in my written statements.
    Thank you very much. I appreciate the opportunity to be 
here, and I am also willing to take questions.
    [The prepared statement of Mr. Nance follows:]
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    Mr. Burgess. Thank you, Mr. Nance.
    Mr. Cosgrove, you are recognized for 5 minutes, please.

                STATEMENT OF THOMAS J. COSGROVE

    Mr. Cosgrove. Thank you, Chairman Burgess, Ranking Member 
Green, and members of the subcommittee, for the opportunity to 
testify today. My name is Tom Cosgrove. And until last year, I 
was an official at the Food and Drug Administration responsible 
for current good manufacturing practice enforcement and 
compliance within the Center for Drug Evaluation and Research, 
or CDER.
    In that role, I was responsible for ensuring manufacturing 
quality and compliance for the thousands of drug manufacturing 
facilities around the world that make medicines distributed in 
the United States. Since December of 2017, I have been a 
partner at the law firm of Covington & Burling here in 
Washington. Covington represents a number of clients in the 
food, drug, and cosmetics industries that use tableting and 
encapsulating machines. The subject of the draft bill under 
consideration, which is the Tableting and Encapsulating Machine 
Regulation Act of 2018, but the views expressed today here are 
my own.
    I share Congress' and the public's concern about the opioid 
abuse epidemic and am encouraged to see so much action in 
Congress and society at large aimed at ending the crisis. In my 
role at FDA, I was aware of the acute problem of the 
importation of illicit opioids, opioid analogues, and synthetic 
drugs from overseas from international mail facilities. This 
appears to be a different issue, however, than the use and 
regulation of tableting and encapsulating machines in the 
United States.
    Virtually all manufacturers of solid oral drugs in the 
United States use tableting or encapsulating machines in some 
form, at least as those terms are defined under the draft bill. 
This includes prescription, nonprescription, and many animal 
drugs covering everything from innovative new drugs to OTC 
products that people use daily. In addition, dietary supplement 
manufacturers commonly use tableting and encapsulating machines 
as part of their manufacturing processes.
    One need only walk down the health and wellness aisle of 
the local supermarket to get a sense of the ubiquity of 
products manufactured using tableting and encapsulating 
machines. Furthermore, tableting machines are often used in the 
manufacture of candy, cosmetics, and certain household products 
such as cleaning agents.
    Were the draft bill to be enacted as now written, lawful 
domestic manufacturers using tableting and encapsulating 
machines to produce legally marketed, noncontrolled products, 
including nondrug products, they would be subject to the CSA's 
strict requirements for controlled substances.
    A straightforward reading of the draft bill at hand would 
appear to require manufacturers to register with the DEA and 
with state authorities in each location that they hold or 
operate a machine. Manufacturers apparently would need to store 
tableting and encapsulating machines in secured areas, such as 
the ones used to safeguard controlled substances themselves. 
This includes things like electronically-monitored safes, steel 
cages, or vaults that meet certain specifications.
    Manufacturers hoping to dispose or replace malfunctioning 
machines could need to transfer machines to companies 
specifically registered by DEA to render those machines 
nonretrievable. In addition, manufacturers might need to comply 
with additional recordkeeping and paperwork requirements each 
time they move a machine. Such requirements, if enacted, could 
cause domestic manufacturers to incur direct costs of machine 
registration, recordkeeping, security, and disposal, and 
indirect costs from training, education, and audits to ensure 
compliance.
    We live in a time also where there is enormous pressure on 
drug manufacturers to move their operations overseas for cost 
reasons. In fact, one of FDA's main challenges today is keeping 
up with the pace and explosion of drugs being manufactured 
overseas in places like India and China.
    Ironically, the draft bill would burden most of the 
companies that have nothing to do with opioids or other 
controlled substances because these companies would need to 
establish CSA compliance systems from scratch. Furthermore, 
Congress has already amended the CSA to give DEA special 
authority to regulate tableting and encapsulating machines.
    In 1988, Congress passed the Chemical Diversion and 
Trafficking Act, or the CDTA. That act is described in the 
written testimony of Ms. Gibson, who testified earlier today, 
and I won't recap that here.
    If Congress decides that enhanced regulation of tableting 
and encapsulating machines is needed. I would encourage a more 
tailored approach that builds on existing authorities. First, I 
would want to better understand why DEA's existing CDTA 
authorities are not sufficient. One potential further approach 
would be to consider amending the CDTA, such that companies 
would also register equipment with DEA beyond only reporting 
transactions. This could be tethered with an appropriately 
crafted exemption for firms regulated by FDA. This way, DEA 
could develop a more robust database of tableting and 
encapsulating machines so that perhaps thousands of companies 
around the United States would not suddenly be regulated as if 
they were holding controlled substances.
    If Congress decides to move forward on this or any similar 
proposal, I would be happy to serve as a resource in 
deliberations going forward. Thank you for the opportunity to 
testify today. I would be happy to take any questions.
    [The prepared statement of Mr. Cosgrove follows:]
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    Mr. Burgess. Thank you, Mr. Cosgrove.
    Dr. Kolodny, you are recognized for 5 minutes, please.

               STATEMENT OF ANDREW KOLODNY, M.D.

    Dr. Kolodny. Thank you, Chairman Burgess, Ranking Member 
Green, and members of the Health Subcommittee, for the 
opportunity to testify today. And my name is Dr. Andrew 
Kolodny, and I am the Codirector of Opioid Policy Research at 
Brandeis University. I am also the Director of Physicians for 
Responsible Opioid Prescribing. My testimony today is on behalf 
of PROP, Physicians for Responsible Opioid Prescribing.
    As you all think about solutions to the opioid crisis, I 
think it is very important to frame the problem and to frame it 
the right way. I believe that the correct way to frame the 
opioid crisis is as an epidemic of opioid addiction. Not 
everyone who dies of an opioid overdose was suffering from 
opioid addiction, but the studies tell us that the vast 
majority of the people dying are opioid addicted.
    If we frame the problem the right way, as an epidemic of 
opioid addiction, the strategies, the big picture strategies, 
for bringing it under control become much more clearer. We 
really have to accomplish two things. We have to prevent more 
people from becoming opioid addicted, and we have to see that 
the people who are addicted are accessing effective treatment.
    When I say ``epidemic,'' I am not exaggerating. From 1997 
to 2011, there was a 900-percent increase in the number of 
people suffering from opioid addiction, and it is that increase 
in the number of Americans with opioid addiction that explains 
why we are experiencing record high levels of overdose deaths, 
why we are seeing a soaring increase in infants born opioid 
dependent, outbreaks of injection-related infectious diseases, 
and a flood of heroin and fentanyl into our communities.
    To bring the epidemic under control, we have to prevent new 
cases of the disease. That primarily is going to be through 
cautious prescribing. And I am going to focus the remainder of 
my statement on H.R. 2063, a bill to mandate prescriber 
education.
    Although I do not support the bill in its current form, I 
am strongly in favor of mandatory education for DEA registrants 
who intend to prescribe more than a 3-day supply of opioid 
analgesics. And I commend Representative Schneider and his 
cosponsors for introducing this legislation. The need for this 
law becomes clear when we look at the cause of our opioid 
addiction epidemic. And the CDC has been perfectly clear about 
why we are experiencing this epidemic.
    What the CDC has shown us--and we have got a slide up here. 
If you look at the slide, the green line at the top represents 
opioid consumption or prescribing in the United States. The red 
line represents deaths involving prescription opioids, and the 
blue line represents addiction involving prescription opioids. 
The CDC has really been saying that, as that green line went 
up, addiction and overdose deaths went up right along with it. 
As the prescribing increased, it has led to the epidemic that 
we have got today.
    The reason that that green line began to go up so rapidly, 
the reason the medical community began prescribing so 
aggressively is because we doctors were responding to a 
brilliant multifaceted marketing campaign that changed the 
culture of opioid prescribing in the United States. Starting in 
the nineties, we began hearing that patients were suffering 
because we were too stingy with opioids. We began hearing that 
we should stop worrying about addiction, that even with long-
term use, the risk of addiction was much less than 1 percent.
    We began hearing that opioids were safe and effective for 
conditions like low back pain, where the leading experts tell 
us they are neither safe nor effective. We would have been less 
gullible if we had just heard these messages directly from drug 
companies. But as we heard earlier, these messages came to the 
medical community from every different direction. In 
particular, we were hearing these messages from professional 
societies.
    The American Academy of Pain Medicine and the American Pain 
Society in 1997 put out a consensus statement calling for much 
greater use of opioids and claiming that the risk of addiction 
had been overblown, even that the risk of overdose deaths had 
been overblown.
    My greatest concern with H.R. 2063 is that it relies on 
these organizations and other professional groups with industry 
ties to provide the government-mandated prescriber education. 
One of the most important lessons from the crisis is the need 
for strict firewalls between pharmaceutical company marketing 
and medical education. Had marketing not been so cleverly 
disguised as education, we might not have an opioid addiction 
epidemic today.
    If we learn from our past mistakes, we will not rely on the 
same industry-funded professional societies that got us into 
this mess to provide the education we need to get out of it. It 
may be hard for you to believe that, in the midst of our opioid 
addiction epidemic, that doctors are still overprescribing, but 
we are. The United States continues to prescribe more opioids 
than any other country on Earth.
    Millions of dollars were spent misinforming the American 
medical community about opioids, but very little has been done 
to correct the record. That is why prescriber education must be 
made mandatory, and that is why the content for the education 
must be developed and administered by individuals and 
organizations who do not accept payments from pharmaceutical 
companies. Thank you.
    [The prepared statement of Dr. Kolodny follows:]
  [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
  
    Mr. Burgess. Thank you.
    Mr. Logan, you are recognized for 5 minutes, please.

               STATEMENT OF RICHARD N. LOGAN, JR.

    Mr. Logan. Chairman Burgess, Ranking Member Green, members 
of the subcommittee, thank you for holding this hearing on the 
opioid crisis. I am Dr. Richard Logan. I have been a community 
practice pharmacist since 1975 and currently own two pharmacies 
in southeastern Missouri. Oddly enough, in addition to my 
duties as a community practice pharmacist, I have spent the 
last 25 years as a Missouri certified police officer and am a 
recently retired prescription drug diversion investigator for 
the Mississippi County, Missouri, Sheriff's Department.
    I am here today on behalf of the National Community 
Pharmacists Association to present some of my experiences and 
viewpoints focusing on viable solutions to prevent drug abuse 
and diversion while maintaining legitimate access of patients 
to needed medication.
    NCPA represents America's community pharmacists, including 
owners of more than 22,000 independent community pharmacies 
just like mine. Our job as healthcare professionals is to help 
patients safely navigate medication-related treatment across 
multiple disease states. We are focused on positive outcomes 
and safe medication usage.
    Yet, as pharmacists, we struggle to meet these goals in the 
midst of an opioid epidemic that kills hundreds of people daily 
and over 200,000 Americans since 1999. My flagship pharmacy is 
in Missouri. It is the first pharmacy across the Mississippi 
River on I-57 and Highway 60 from Illinois, Tennessee, and 
Kentucky. My State has no adequate functioning PDMP and, as 
such, is a magnet for those who would abuse prescription 
opioids.
    It is not unusual for travelers to drive hundreds of miles 
from eastern Kentucky, Ohio, or other areas distant to me to 
visit a pill mill in Georgia or Florida and end up at my 
prescription counter with prescriptions for narcotics, lots of 
narcotics. Common sense tells me that somewhere between 
Kentucky, Florida, and Missouri, those folks have passed a 
pharmacy, but they end up at mine.
    I once investigated a traveler who had driven U.S. Highway 
60 across just southern Missouri, had seen eight physicians and 
visited 18 pharmacies in search of opioids. I served on many 
search warrant teams, made many arrests, some at my own 
prescription counter, had lots of convictions, dodged bullets 
in the line of duty, spent nearly 25 years fighting drug abuse, 
was responsible for putting together a bicounty prescription 
drug task force that led to many arrests, and still I feel like 
I have done nothing to stem the tide. It is just that 
overwhelming.
    All the while, as a practicing pharmacist, I go to bat for 
my legitimate patients who need opioid therapy so they can lead 
a productive life and not be denied therapy or declined therapy 
due to the stigma attached to opioid abuse. As the final 
checkpoint in the system of checks and balances, pharmacists 
play a vital role in ensuring all medications, including 
controlled substances, are appropriate for their patients.
    Pharmacists are often the last professional an opioid 
patient sees and the first professional to realize that a 
patient is slipping into an abusive pattern. Pharmacists must 
monitor their patients and work in collaboration with other 
healthcare providers, understand the risks and benefits of 
opioid therapy, and keep the best interest of the patient at 
the center of all decisions.
    There are promising policies that Congress or the 
administration could move forward that would have a positive 
impact on mitigating or preventing abuse. One such policy is 
included in H.R. 4275, the Empowering Pharmacists in the Fight 
Against Opioid Abuse Act, to provide for the development and 
dissemination of programs and materials for training 
pharmacists, healthcare providers, and patients on indicators 
that a prescription is fraudulent, forged, or otherwise 
indicative of abuse or diversion. This is not only a 
commonsense policy; it is one that fits in well with the DEA 
360 strategy to engage all of those involved with opioid 
treatment.
    NCPA supports such efforts to bring greater diversity and 
education to other healthcare providers and patients regarding 
a pharmacist declining to fill a controlled substance. NCPA 
offers itself as a resource, if necessary. Thank you.
    [The prepared statement of Mr. Logan follows:]
  [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Burgess. Thank you, Mr. Logan.
    And thanks to all of our witnesses for your testimony. It 
has certainly been insightful.
    At this time, I would like to yield to the gentleman from 
Oregon, the chairman of the full committee, for your questions.
    Mr. Walden. Thanks, again, Mr. Chairman, for your 
leadership on this issue and your subcommittee's good work.
    And to all our witnesses, thank you for your testimony, it 
is very, very helpful in our work.
    I want to ask Chief Fowler, you provided a crime analysis 
report as part of your written testimony. The primary focus of 
the report is overdoses related to Spike or synthetic 
marijuana. Have you seen other synthetic drugs on the streets 
in your community? What has been the impact of these 
substances? And is synthetic marijuana the worst analogue drug 
on the streets of Syracuse, or do you have data that fentanyl 
and other opioids are worst?
    Chief Fowler. So, currently, Spike, the one that I spoke 
about, is the one that we are having the most problem with. But 
fentanyl is certainly a tremendous problem, and it ranks 
second.
    Mr. Walden. Which is the most deadly?
    Chief Fowler. Fentanyl is indeed the most deadly. We see 
the most deaths associated with overdoses with fentanyl.
    Mr. Walden. What is the practical effect with Spike? What 
happens when you come on a scene?
    Chief Fowler. It is marketed as a synthetic marijuana, but 
it has a hallucinogenic effect. And what we see is people in 
what I could best term as psychosis. They are acting out in a 
very bizarre fashion, oftentimes violent, incoherent. And then 
they exhibit a number of medical issues in which they have to 
be addressed at the local hospital.
    Mr. Walden. Such as?
    Chief Fowler. Rapid breathing. Some even pass right out 
after they have exhausted themselves from running around and 
acting in a very bizarre way. Sweating profusely. And I am not 
a medical expert----
    Mr. Walden. Right.
    Chief Fowler. I would imagine that everything that a 
company--a person's heart rate rising, their blood pressure 
rising, I would imagine that that has some type of medical 
effects on a person, but I am not a medical expert, so I can't 
tell you what those are. But the bizarre behavior and the 
violent behavior, that is something that I can really identify 
with.
    Mr. Walden. What is the youngest age that you have seen 
either----
    Chief Fowler. Quite young.
    Mr. Walden. What is that?
    Chief Fowler. When this first came on the scene, what we 
discovered was that it was sitting right on the shelf in the 
local convenience stores.
    Mr. Walden. Now, wait a minute. It was what?
    Chief Fowler. When it first came on the scene, it was 
sitting right on the shelf of local convenience stores in these 
very colorful packages, and I personally overheard a couple of 
high school students talking about why it is that they would 
choose to use Spike over marijuana; it is because they happen 
to be on probation, and if they were to have to give a 
urinalysis test, that this substance would not appear. And so 
they were using this to get away with a probation violation.
    So our young people started to use this substance, and they 
were experiencing the same things that everyone else was, these 
episodes of psychosis there in the schools, on the streets. So 
we see all ages.
    Mr. Walden. So the legislation Mr. Katko brought to our 
attention and worked hard on is very focused on the fentanyl 
analogues?
    Mr. Nance. Sure.
    Mr. Walden. In your police department's experience, what 
other synthetic drugs do you think we should be addressing 
comprehensively by class? What else should we be looking at 
here?
    Chief Fowler. Well, I think that all of the synthetic drugs 
that we can identify, we need to take a look at them because 
what is happening is, is that they are all appearing on our 
streets. The minute that we bring one substance under control, 
a different or another substance will pop up. And we have a 
simultaneous problem with Spike and fentanyl right now.
    Mr. Walden. And so, broadly speaking, do you feel like your 
department has the tools you need when your team comes across 
illicit synthetic drugs? The goal here is we want to get this 
right when we put this legislation together. So what are we 
missing here that would be helpful in your efforts?
    Chief Fowler. Sure. Law enforcement is only as effective as 
the laws that we enforce.
    Mr. Walden. Right.
    Chief Fowler. Let's take Spike, for example, because that 
is what I have talked about the most. Right now, it is not 
scheduled. And the only thing that we can do is give people an 
appearance ticket for a local law violation for----
    Mr. Walden. What does that mean, a local law enforcement 
violation?
    Chief Fowler. Well, we went to our local legislators and 
had them enact a local ordinance to----
    Mr. Walden. Against Spike?
    Chief Fowler. Excuse me?
    Mr. Walden. Against Spike.
    Chief Fowler. Yes. To make the substance illegal. And that 
is the charge that we utilize.
    Mr. Walden. What is the penalty?
    Chief Fowler. It is a violation, so----
    Mr. Walden. Oh, it is a traffic ticket, in effect.
    Chief Fowler. Basically, sir.
    Mr. Walden. So it is not a deterrent, to speak of?
    Chief Fowler. Not at all. Not at all.
    Mr. Walden. Thank you.
    And thanks again to the whole panel. You all have been most 
helpful in our work, and we are going to continue down this 
path, and we are going to get it right, and we are going to 
pass new laws so you have the tools you need to stop this to 
the best of your ability. But we need your input, so thank you 
very much.
    Chief Fowler. Thank you, sir.
    Mr. Guthrie [presiding]. Thank you. The chairman yields 
back. And the chair will recognize Ms. Castor from Florida for 
5 minutes.
    Ms. Castor. Thank you very much, Mr. Chairman. And thank 
you to all the witnesses for being here this afternoon.
    Dr. Kan, in your testimony, you talk about the significant 
barriers to access for folks who are suffering from opioid 
addiction. And you call it, you say we have a significant 
addiction treatment gap in America. You cite the journal of the 
American Medical Association, a report in 2015 that says 80 
percent of Americans with opioid addiction do not receive 
treatment.
    And a lot of you here have recommended some ways to tackle 
the problem. It seems like it is so piecemeal, though. These 
recommendations are good, to do a little more in telemedicine 
and buprenorphine formulations and distribution, but this is a 
public health crisis. And what I am hearing at home from 
parents and others, there is just no capacity out there. There 
is just no, even in the Affordable Care Act now, we have new 
requirements that insurance cover essential health benefits, 
including mental health.
    Under Medicaid, yes, you have some treatment options, but 
it is just not happening on the ground. So what else can you 
recommend to us to help improve the long-term treatment that so 
many Americans are going to need to tackle their addiction?
    Dr. Kan. Thank you for that question. I think telemedicine 
is one piece of the entire puzzle. There is a much broader 
puzzle when it comes to reducing stigma around the illness, 
that is part of the effect in this telemedicine, in that people 
don't have to walk into a clinic and be publicly identified as 
being treated.
    In addition to that, we need to expand access to all forms 
of treatment, both different formulations and different avenues 
in which people can get that type of treatment. If I think 
about opioid use disorder as a physician, about 80 percent of 
the side effects is predicted by medications alone. Meaning 
that with medications, you can effectively reduce the risk for 
accidental overdose, and counseling is significant. It is 
incredibly important in changing people's lives, but we need to 
create expanded access. We need to keep people alive.
    This is a position that has been considered the American 
Society of Addiction Medicine, and it is certainly a position 
that ASAM has taken in that we need to reach out to patients 
that we do not see. I don't worry about the patient that is in 
my practice. I don't worry about the patient that I am treating 
because they are in front of me, and I can monitor them and 
give them appropriate treatment.
    However, the person who leaves my practice or they 
disappear from care, I worry about because I know they are not 
receiving care.
    Ms. Castor. So Mr. Nance, you are on the ground doing this. 
What is it going to take for us, really, to make sure that the 
folks who need long-term treatment, receive that long-term 
treatment.
    Mr. Nance. Well, Dr. Kan is right. The biggest problem we 
face is capacity. You mentioned this yourself, that was the 
beginning of your question. We have got the capacity in Utah to 
treat less than 20 percent of the people that need drug and 
alcohol treatment. So workforce is a huge factor. If we don't 
have the staff to deliver the services, we can't provide the 
treatment.
    Effective evidence-based treatments are important as well. 
And we strive very hard to identify those that we can afford, 
implement them, train our staff to implement them to fidelity--
--
    Ms. Castor. So you are recommending to offset, we need to 
do more in workforce training for doctors, nurses, counselors? 
Is that part of it?
    Mr. Nance. Yes, we need to provide more primary behavioral 
health staff, but other specialties that don't deal primarily 
with drug and alcohol prevention and treatment services need 
more training and education on how to identify and refer 
someone to treatment and provide some of those treatments 
themselves.
    Ms. Castor. And Dr.Kolodny, you have cited some very stark 
statistics that we are now-- what are your recommendations to 
really tackle the barriers to access for--JAMA says 80 percent 
of Americans with opioid addiction don't receive any treatment. 
How do we get to that?
    Dr. Kolodny. I very much appreciate that question. I think 
the only way we are going to get there is with a massive 
Federal investment in the billions. We have to create a 
treatment system that doesn't really exist yet.
    The majority of the State-licensed drug and alcohol 
treatment programs don't offer buprenorphine. Many of them 
don't even have enough physician time to be able to prescribe 
buprenorphine. Among people who are getting it right now, even 
people with good insurance often have to pay out of their own 
pocket for the doctor's visit, their Medicaid or their 
commercial insurance is only paying for the prescription.
    If we really want to see deaths start to come down, it has 
to be easier to get treatment than it is to get a bag of dope. 
If someone who is opioid-addicted when they wake up in the 
morning, they are going to need to use. Many people will have 
something by the bedside because they are going to be feeling 
very sick when they start to wake up. If they have got $20 in 
their pocket and they know where they can go get heroin, even 
if it has got fentanyl in it, that is what they are going to 
do. And if finding a doctor is more expensive and more 
difficult, we are not going to start to see overdose deaths 
start to come down.
    So we really have to build out a system that doesn't exist, 
and I don't see any other way other than investing billions for 
that system.
    Ms. Castor. Thank you very much. I yield back my time.
    Mr. Burgess [presiding]. The chair thanks the gentlelady. 
The gentlelady yields back. The chair recognizes the gentleman 
from Kentucky, Mr. Guthrie, 5 minutes for questions, please.
    Mr. Guthrie. Thank you very much, Mr. Chairman. And thank 
you all for being here. This is very informative.
    And, Dr. Kan, I have a question for you. Thank you for your 
insightful testimony. Knowing that you have firsthand 
experience treating patients with opioid addiction, as well as 
utilizing telemedicine builds your credibility both as a 
practitioner and a witness.
    My questions will be two. When using medication-assisted 
treatment, how common is it for you to pair this medicine with 
cognitive behavioral therapy? And is it important that any 
changes to the Ryan Haight that increases access to medicated-
assisted treatment not be so tailored that the result 
unintentionally cuts off behavioral therapy?
    Dr. Kan. Thank you for those questions. So the answer to 
your first question, how often do I combine treatment with 
therapy, and you mention cognitive behavioral therapy, which is 
a very specific type of therapy, but we use multi-modal 
therapies that we pick because of the patient assessment, what 
is it that they need? And within my practices, within the VA, 
within my company, it is 100 percent. One hundred percent of 
patients receive psychotherapeutic intervention.
    The second question--I am sorry, I forgot the second 
question at this point.
    Mr. Guthrie. The second question, is it important that any 
changes to Ryan Haight that increase access to medicated-
assisted treatment not be so tailored that the result 
unintentionally cuts off behavioral therapy?
    Dr. Kan. I think that the room for psychotherapeutic 
intervention should always be available. And when we talk about 
the qualified practice setting within the data--2016 amendment, 
it does cover those things that the people have the capacity to 
provide the therapy, if it is indicated.
    Mr. Guthrie. Thank you. And I have a question for 
Dr.Mulder. Thank you for your testimony and for the Michigan 
Home Care Hospice Association support for the Safe Disposal of 
Unused Medication Act.
    In your testimony, you note that roughly 98 percent of 
hospice care days are provided in a patient's residence. You go 
on to explain that at a moderate-sized hospice care with 2,000 
patients per year, approximately 1 million pills will be 
prescribed per year.
    So a series of questions: If 98 percent of these 
prescriptions, roughly 1 million pills are going into homes, 
isn't this statistic alone enough to validate the need for safe 
disposal? Is it your belief that safe disposal would reduce the 
likelihood of misuse or diversion? And are you able to give 
some examples of safe disposal that hospice workers have used 
in the past or currently use in States that allow this type 
of----
    Dr. Mulder. Yes. Yes. And I will give you some examples.
    Mr. Guthrie. Perfect.
    Dr. Mulder. So going back a few years, as I mentioned, I 
have had the privilege of working in the hospice industry for 
over 30 years. And so we have seen, it is very, very common in 
past years, a nurse would come out, she would declare the 
death, she would sit and work with the bereaved family. And 
then with a witness, she would either crush and flush the 
pills, or in case of liquid opioids, just put them down the 
sink and turn the faucet on. That is what they did.
    In later years, when they said, oh, maybe we shouldn't be 
doing the flush thing, that they would, most of the nurses 
would carry kitty litter in their trunk, and they would bring 
in some of that. They would crush the pills and the liquid and 
just mix them with kitty litter, take it back and dispose of it 
back at the office. I suppose it ended up in a landfill 
somewhere, but I don't really know.
    But that is how they did it in the past. Since I had----
    Mr. Burgess. Will the gentleman yield for 1 minute.
    Mr. Guthrie. Yes, I will yield.
    Mr. Burgess. We also have the EPA under our jurisdiction. 
Be careful. They might be watching.
    Dr. Mulder. I understand.
    Mr. Burgess. I yield back.
    Dr. Mulder. You didn't hear that from me.
    But, again, that is in the past. That is in the past. And I 
think some of the more recent strategies are simply because of 
that.
    They just didn't want opioids winding up in our water 
supply and our landfills. And so, more recently when the laws 
were amended and changed and introduced, that restricted the 
personnel, who could really take back medications, that really 
put the hands off. And I want to say that goes back to about 
2013 or 2014, 2013 or 2014. I don't remember the exact dates of 
the legislation, so that is how they did it in the past.
    I don't know how they are doing it in States that they 
currently allow that but now--and there has also been another 
trend that we saw developing, where patients families would 
say, oh, you can't touch that, that is mine now. He died, but I 
inherit everything that was his. And so those are my pills, and 
you may not touch them.
    Mr. Guthrie. Well, thank you for your testimony. And it is 
certainly an area, when you start looking at the volume, that 
we have to address. And so I appreciate my friends from 
Michigan for bringing this forward.
    Dr. Mulder. Thank you.
    Mr. Guthrie. And I yield back my time.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman. The chair recognizes the gentlelady from 
California, Ms. Matsui, 5 minutes for questions.
    Ms. Matsui. Thank you, Mr. Chairman. As I mentioned in my 
question to DEA, the purpose of the discussion draft I am 
working on with Representative Harper is to expand access to 
treatment where it is not currently available. We are seeking 
to do this within the current Ryan Haight telemedicine 
prescribing framework.
    Mr. Nance, you are familiar with the community behavior 
health clinic system in Utah and see a need for additional 
access to remote prescribing for the patients you serve. Can 
you expand upon the need that you see for more access to 
medication-assisted treatment and the challenges that clinics 
and their patients face?
    Mr. Nance. Sure. Here is a visual representation of one of 
the challenges. This is a pretty good shot of the road from 
Moab down to Blanding, Utah. From my office to Blanding is 
about a 300-mile drive. There are about 4,000 people that live 
in Blanding. If someone down there has an opioid addiction 
problem and rural and frontier areas have a higher rate than 
the rest of the country in general for opioid addiction 
problems, their access to treatment is very, very limited.
    So I kind of hang out with some farmers from time to time.
    Ms. Matsui. OK.
    Mr. Nance. And one of the funny things I have heard one of 
them say was, the darn beavers can irrigate better than I can, 
but the water has got to the end of the row. So we need to have 
access to telehealth treatment so that if a client shows up in 
the community behavioral health center in Blanding and needs 
opioid addiction treatment, that that can be provided for them 
through a physician that may be located in Provo or Salt Lake, 
or some other place along the Wasatch front where the majority 
of the population of the State lives.
    If we can't do that, we are going to have a higher death 
rate than we already do. We had 600 last year in the State of 
Utah, 187 of those were heroin, and all the rest were 
preparation opioids. So we need to be able to have qualified, 
certified license addiction medicine professionals to be able 
to provide services in those small outlying towns across the 
country, not just in Utah.
    Ms. Matsui. So you are dealing with putting doctors on the 
road to do in-person exams, is that right?
    Mr. Nance. Yes, I am sorry to interrupt you. If my 
addictionologist was to drive to Blanding, it would take her 2 
days away from the office to possibly see one patient, if that 
patient showed up. People with opioid disorders typically are 
sick and disorganized and cognitively impaired. They have a 
difficult time keeping appointments. That would take the 
ability away for her to see somewhere between 48 and 60 
patients in my own office and would cost us close to $2,000 in 
her time and travel time and overnight stay to be the able to 
see that one patient.
    Ms. Matsui. So you mentioned it is important for the 
committee to allow telemedicine to be used for mental health 
treatments as well, not just substance use disorder. Why is 
that?
    Mr. Nance. Same thing. In rural Utah, there aren't that 
many psychiatrists to go around. Right now we have been doing 
telehealth through Project Echo with the University of Utah as 
kind of a platform to do that. The same thing happens in New 
Mexico. And it is pretty easy for a child psychiatrist, for 
instance, and there are even fewer of those than there are 
addictionologists in the State, to be able to use telehealth 
technology to evaluate a patient at that remote site.
    But if they are going to write a prescription for a 
controlled substance, like a benzodiazapine for an anxiety 
disorder, or ADHD for attention deficit and hyperactivity 
disorder, that face-to-face issue still exists under the Ryan 
Haight Act.
    Ms. Matsui. OK. Could I just address some concerns that 
have been expressed?
    Now, you expressed strong support for preventing fraudulent 
remote prescribing. Obviously, they all do. There may be 
concerns that opening a new pathway to registration for non-
DEA-registered clinics may lead to fraudulent prescribing. We 
need to ensure that there are sufficient requirements on both 
the clinic with a patient present and a doctor doing the 
prescribing remotely. For clinics you represent, how are the 
authorized, and what is the regulatory oversight they undergo?
    Mr. Nance. That is a very good question, too. We are 
licensed by the Utah State Department of Human Services. We 
have a licensing inspection every year. We also get an 
inspection from the Utah Medicaid program. We also get a 
contract compliance audit from the Utah Department of Human 
Services, and a peer-review visit. We get at least 3 or 4 
oversight visits every year.
    So our centers are licensed, our staff are licensed. And 
what I am proposing we do is kind of an agency-to-agency 
practice model. It is very similar to the Vermont hub and spoke 
model. You may be familiar with that. If you are not, you ought 
to look that up.
    Ms. Matsui. OK.
    Mr. Nance. It is on addictionpolicy.org, I believe, 
website. And Vermont is kind of small. I think the furthest 
distance between one side and another might be 100 to 150 
miles. It is a lot further than states on the left.
    Ms. Matsui. Well, I have a lot of questions, but I also 
know we will be working on discussion drafts, so I will be 
hopefully conferring with you and others on the committee. So 
thank you very much for that.
    Mr. Nance. And the National Council staff will be happy to 
be a resource for you as well.
    Ms. Matsui. Thank you.
    Mr. Nance. It is just up on K street.
    Mr. Burgess. The gentlelady yields back. The chair would 
observe that Project Echo was a product of the Energy and 
Commerce Committee.
    The chair now recognizes Dr.Bucshon from Indiana, 5 minutes 
for questions, please.
    Mr. Bucshon. Thank you, Mr. Chairman. Dr.Kan, Section 303 
of CARA, the Comprehensive Addiction Recovery Act was something 
that meant to expand available treatment and give patients 
information basically on what their treatment options are. It 
also included requirements for individual treatment plans and 
other things. How is SAMHSA doing with implementing, you know, 
the new, some of the changes that were made in CARA?
    Dr. Kan. I probably couldn't comment on how SAMHSA is 
doing. I think Dr. McCants Kats could probably provide some of 
that testimony, but my understanding, is that they are making 
affirmative----
    Mr. Bucshon. I have already asked her so.
    Dr. Kan. OK. I would defer to her on the answer.
    Mr. Bucshon. All right. OK. I didn't like her answer, but 
that is OK.
    Mr. Nance.
    Mr. Nance. You want me to answer the same question?
    Mr. Bucshon. Yes.
    Mr. Nance. Well, this has been a great thing----
    Mr. Bucshon. I mean, are you getting good guidance from 
SAMHSA after CARA was----
    Mr. Nance. Yes, what SAMHSA has done is transmitted the 
guidance to the Utah State Department of Substance Abuse and 
Mental Health.
    We had several meetings back in the spring of 2017. The 
funding was made available to us. We had to write applications 
for that that complied with what the State guidance was.
    Mr. Bucshon. Yes.
    Mr. Nance. So it has been really helpful. I had 10 hours a 
week of physician prescriber prior to the CARA Act and the 21st 
Century Cures Act. Now I have her full time. The physician I 
had on contract with before would not prescribe buprenorphine 
for me. Now, I have a full-time physician that will prescribe 
buprenorphine and that we can make available to other parts of 
the State.
    Mr. Bucshon. OK. Now, HHS would increase the therapy--the 
number of people. Has that been implemented? I mean from 100 to 
any practice to HHS----
    Dr. Kan. Yes, that has. Both on an ongoing basis for people 
who are qualified but also in emergent circumstances when 
people reach 100 patient cap.
    Mr. Bucshon. OK. That is good to hear. Doctor--yes go 
ahead.
    Dr. Subbiah. I would just add something to that. I think 
the caps have been increased, but if you look at the physicians 
or healthcare providers who have been waivered, not many of 
them are prescribing up to capacity. Because it is not only 
stigma of disease, we have to overcome also stigma of 
treatment----
    Mr. Bucshon. Understood.
    Dr. Subbiah [continuing]. And taking care of these 
patients.
    Mr. Bucshon. Yes, I agree. In fact, this next question is 
for you. For long-acting buprenorphine, are insurance companies 
and CMS paying for this?
    Dr. Subbiah. This product, Sublocade, just got approved at 
the end of last year and it is going to be on the market in 
March.
    Mr. Bucshon. It got approved by FDA, right?
    Dr. Subbiah. FDA.
    Mr. Bucshon. Yes, that is different than CMS?
    Dr. Subbiah. Yes. So it is not, right now, in the market 
yet. It will be in the market starting in March.
    Mr. Bucshon. Yes, I am just asking, did CMS give a coverage 
decision on it?
    Dr. Subbiah. Not yet.
    Mr. Bucshon. Not yet. Because what we are finding in a lot 
of areas in healthcare right now as we get FDA-approved 
products, both drugs and devices, and then we get delayed 
payment decisions from CMS, which is preventing access to 
patients. So that is a big problem. If that is the case, I 
would appreciate knowing about that because we try to have some 
impact on that.
    Dr. Kolodny, I was interested in your testimony talking 
about continuing education for physicians. Is there anything 
the Federal Government can do to encourage, maybe, what I would 
call ground-level training, which is not after people who are 
already out of medical school and practicing, but I have been 
talking with the Association of American Medical Colleges, for 
example, about implementing more training programs for 
assessing pain and properly treating pain in medical schools, 
and then certainly residency programs.
    I mean, do you have any thoughts on that?
    Dr. Kolodny. You know, I think the bigger problem are the 
older doctors, not the docs coming out of training. Doctors who 
are in their 20s and 30s, they have come of age during our 
opioid addiction epidemic. Many have lost friends to opioid 
overdoses. They are much less likely to fall for the nonsense 
that you can prescribe long-term and a patient won't get 
addicted.
    The bigger problem are doctors my age and older----
    Mr. Bucshon [continuing]. Who had it drilled into them for 
15 years that we need to prescribe more and more.
    Mr. Bucshon. Right. And I commented on that during the 
testimony from the DEA. I am in that boat. I went into practice 
in 1995. We all understood that.
    Dr. Kan, last question real quick. The existing laws in-
person medical evaluation as well as allowable exemptions, you 
explained in your testimony that the in-person evaluation 
committee excepted if a patient is being treated by and 
physically located in a DEA-registered hospital or clinic or a 
patient is being treated by and in the physical presence of 
another DEA-registered practitioner, does this narrow exception 
cause geographic access problems--and you may have answered 
this in part--particularly for patients in rural areas that 
cannot physically get to a DEA-registered hospital or clinic or 
a DEA-registered practitioner?
    Dr. Kan. I am speaking on behalf of ASAM. So ASAM does not 
have a position on this specific issue. I will say in my 
practice, we lose 20 percent of our patients because we can't 
get a physician to them between the time that they call and our 
72 hours that we set out the goal to meet with them. And we 
send the physicians to the patients. We don't require the 
patients to travel to us.
    Mr. Bucshon. Understood. Thank you. I yield back, Mr. 
Chairman.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back. The chair recognizes the gentleman from Texas, Mr. 
Green, 5 minutes for questions, please.
    Mr. Green. Thank you, Mr. Chairman.
    Mr. Cosgrove, your testimony was basically not to make it 
harder to import these pieces of equipment that make pills is 
that correct?
    Mr. Cosgove. Well, I don't think it is necessarily that. I 
think my testimony really is focused on making sure that 
legitimate users of tableting and encapsulating machines are 
not suddenly stuck with the requirements of the CSA, the 
Controlled Substances Act.
    Mr. Green. OK.
    Mr. Cosgrove. I think there can be ways for importation to 
be monitored and blocked in appropriate circumstances, but what 
we don't want is thousands of facilities around the country to 
suddenly have controlled substances within their walls.
    Mr. Green. Well, for example, I assume some company in the 
United States actually produces these machines also?
    Mr. Cosgrove. I believe that is correct. I think some of 
them are also imported from Germany and other countries.
    Mr. Green. OK. Dr.Beardsley, I want to thank you for 
sharing your experience as a researcher because this is the 
Health Subcommittee, and we are proud of our efforts to try and 
plus up NIH funding.
    You noted in your testimony, it will take over a year to 
obtain a Schedule I registration. I heard from others that the 
requirements associated with Schedule I substances such as 
storage and security requirements can be cost prohibitive, in 
some instances, be a disincentive for researchers to examine 
these substances for their therapeutic value.
    You note in your testimony the confusion in the application 
process and delay in obtaining an approved registration 
inhibits researchers, especially young researchers, from 
commencing research with drugs of abuse and from dedicating 
their careers to study.
    To what extent does this confusion in the process and other 
hurdles you mentioned, protocols, registration, costs, 
obtaining institutional support, inhibit researchers and 
institutions from taking up projects with Schedule I 
substances?
    Mr. Beardsley. Well, thank you for that question. There is 
a huge hurdle in becoming a Schedule I registrant, for 
instance. The application process entails submitting security 
requirements, detailing how much drug you will be using in your 
protocol. In my case, I work with laboratory animals. I have to 
identify how many doses I will be giving each animal and what 
routes of administration. I have to estimate the amount of drug 
I will be administering to be approved with the protocol.
    And just that point is particularly difficult to estimate 
the amount of drug one needs to do research.
    Mr. Green. Well, I only have 5 minutes.
    Mr. Beardsley. Oh, I am sorry.
    Mr. Green. We heard from HHS, however, that H.R. 2851 
attempts to streamline the researcher registration process. But 
we heard from HHS that there may still be, constitute a barrier 
to research that may have negative impact on drug development.
    Could you reiterate why you think this and what steps we 
can to remove those hurdles, and clearly getting bumped between 
Virginia and the DEA on which one registration you get first. 
That seems pretty silly. We ought to be able to deal with that.
    Mr. Beardsley. Right. First off, with SITSA, a drug can be 
put into Schedule A only based upon structure. That is 
problematic because there are many drugs that have similar 
structures, some of which are drugs of abuse, some of which are 
antidotes to those drugs of abuse.
    So if a drug is scheduled, it is really a disincentive for 
a researcher to begin conducting research with that drug. If 
the drug is in the schedule for no other reasons than its 
structure, we will never know whether it is a drug of abuse or 
a breakthrough medication. So that is one instance in which 
scheduling a drug just based on structure can be a disincentive 
for conducting research with these drugs.
    And for younger researchers to go through the hurdles of 
obtaining the Schedule I registration, for instance, that is 
yet another hurdle.
    Mr. Green. Well, we don't want to do anything that would 
eliminate the potential for research, because that is the other 
thing that we want to do. But be that as it may, we will see 
what we can do.
    Dr. Kolodny, do you believe requiring 12 hours of 
continuing education every 3 years is a practical requirement 
for healthcare practitioners to prescribe opioids?
    Dr. Kolodny. I do think that we should be mandating 
prescriber education. I think that we should allow doctors who 
don't intend to prescribe more than a 3-day supply of opioids 
to opt out. If we had an opt out, then you are not making 
people take training irrelevant to their practice. Many doctors 
would opt out, because 3 days is more than enough. You would 
reduce the number of doctors able to prescribe aggressively. 
And for doctors who do major surgery or treat cancer, they 
would take the training.
    I think that is the way to go. I would like to point out 
that for buprenorphine, a medicine much safer than drugs like 
oxycodone, we have an 8-hour training requirement, and then we 
limit the number of patients the doctor can treat. Whereas, for 
the drugs that are causing addiction, causing overdose deaths, 
we have no training requirement and we have no caps on the 
number of patients that they can prescribe to.
    Mr. Green. OK. Thank you. I yield back, Mr. Chairman.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back. The chair recognizes the gentlelady from Indiana, 
Mrs. Brooks, 5 minutes for questions, please.
    Mrs. Brooks. Thank you, Mr. Chairman. Dr. Kolodny, I am 
going to follow up. And I assume you heard from the last panel, 
from DEA, that I, too, am working on a bill, but slightly 
different. While fewer hours, it comes in part from the 
President's Commission on Combating Drug Addiction Opioid 
Crisis, and it was top recommendation that all prescribers 
should be required to have some continuing medical education. I 
know you agree with that.
    Ours calls for 3 hours, but it is not just about preventing 
the overdose, it is also about education on physicians and 
other practitioners, learning how to detect of their own 
patient base that they already have, not just the prevention of 
the addiction, but also, how they can learn more about just 
addiction writ large.
    Do you believe that state licensing agencies are equipped 
to produce and manage education programs of this type? Because 
I know you are not in favor of other organizations producing 
that training. What about state licensing or agencies, possibly 
in conjunction with working with best practices from HHS?
    Dr. Kolodny. It took a while for policymakers on a State 
and Federal level to recognize that the opioid addiction 
epidemic was being fueled by very aggressive prescribing, that 
the medical community really needed to change course. And many 
State legislators have responded by passing laws mandating 
prescriber education on a State level. I don't believe those 
systems are working.
    The way they typically work is that every doctor in the 
State who has a registration, whether or not they ever intend 
to prescribe an opioid, has to take a course on pain treatment. 
It is usually online. The content for these courses is awful. 
In many cases, the courses are taught by the same doctors who 
were teaching the courses that really got us into this mess.
    I don't think that is the way to go. I think this should be 
done on a Federal level linked to DEA registration with an opt-
out for doctors who don't want to prescribe more than 3 days, 
let them opt out. But then they are not allowed to prescribe 
more than 3 days. That would overnight shrink the pool of 
doctors capable of prescribing aggressively. I like that you 
are thinking about addiction and we really do want to teach 
more than just how to prescribe these medicines. We need to 
also be teaching people who prescribe addictive drugs about 
addiction.
    Mrs. Brooks. And I will probably be submitting for the 
record, because I have a couple other questions for another 
panelist about other model programs or ideas you might have on 
the specific types of courses and so forth.
    Dr. Kan, my concern, and you have testified about the fact 
that so few people receive treatment but yet many people have 
medical professionals in their lives or they do see medical 
professionals. Would you say it is uncommon for primary care 
physicians or the physician that has prescribed the opioids to 
detect and to diagnose an addiction?
    Dr. Kan. I would say that it is quite common. Dr. Kolodny 
made a comment earlier that I agreed with, that the change in 
opioids is going to cost in the billions of dollars. But the 
changes that we can have now is we need to educate the 
prescribers on how to identify problematic use.
    For example, we know that anywhere from 15 to 45 percent of 
patients who are taking prescribed opioids for chronic pain 
demonstrate aberrant behavior, meaning that they have a urine 
drug screen that is negative for the opioid. They may have 
something else in the drug screen or there is other problems.
    I think that treating the opioid epidemic, one of the main 
emphases that we see is that primary care needs to be taught 
how to do it. I think of buprenorphine a lot like insulin. If 
you look at the Type 2 diabetes disease model, it is almost a 
perfect analogue for opioid use disorder. I think of opioid use 
disorder with chronic exposure, whether for recreation or 
medication, changes the brain. And for some patients they need 
buprenorphine, just as some people who suffer from diabetes 
need insulin.
    And I would argue to you that insulin is far more dangerous 
than buprenorphine.
    Mrs. Brooks. Would you please share with me, though, aside 
from continuing the medical education, which is what I have 
been focused on in crafting a bill, what else can we do to 
better equip physicians, primary care, who are not trained 
addiction specialists as to what they should be doing?
    Dr. Kan. I think what we need to equip them with is the 
access to the specialist. The greatest difficulty that a 
primary care provider sees, they don't know who to send the 
person to, because the addiction specialist they referred them 
to may be a cash practitioner or they may not have access to 
treatment.
    So we need to educate a workforce that once the primary 
care provider identifies the person, then they can be sent to 
the specialist. This is the Vermont hub and spoke model. 
Because they have hubs that are specially trained clinics, and 
when they stabilize, they go back to their primary care 
provider. It is a model that has been used in the city and 
county of San Francisco where I work part-time.
    I already had my DEA x-waiver, but I was required to get it 
because the model that they use is they have extensive 
treatment and then goes back to the primary care provider once 
somebody is stabilized. As they destabilize, go back to the 
hub.
    Mrs. Brooks. Thank you. My time is up. I yield back. Thank 
you all for your work.
    Mr. Burgess. The chair thanks the gentlelady. The 
gentlelady yields back. The chair recognizes the gentleman from 
Virginia, Mr. Griffith, 5 minutes for questions, please.
    Mr. Griffith. Thank you very much, Mr. Chairman. Mr. Nance, 
let me just say thank you for your testimony that you have 
given thus far on telemedicine. It is a very important field 
for us to get in and explore.
    My district is in the east, but it is a very rural 
district. And while we don't have the miles that you have, 
sometimes getting around the mountain, particularly when the 
weather is not the best or when people are having problems to 
begin with, as you pointed out, can be a problem. And so I 
agree with many of the things that you say and appreciate your 
testimony here today on that. I appreciate everybody's 
testimony today. It has been very informative.
    Dr. Beardsley, if I might just briefly. You talk about 
drugs and compounds may be structurally similar. And we heard 
some comments earlier today about the long history of opioids, 
and sometimes we treat one opioid with another opioid. And so I 
am just kind of curious, the naloxone, are you absolutely 
certain that that doesn't have an addictive problem down the 
road? Do you think that works for us no matter what?
    Mr. Beardsley. I am absolutely certain that naloxone does 
not have addictive properties.
    Mr. Griffith. Because it is the antidote, as you said 
earlier.
    Mr. Beardsley. It is an antagonist, right, to opioids that 
are abused. That is an antidote, more or less it reverses their 
effects.
    Mr. Griffith. Yes. I appreciate it. That takes me to you, 
Mr. Logan, if I might. One of your recommendations is to allow 
pharmacists to prescribe naloxone.
    Can you explain the differences you have seen in terms of 
access to reversal drugs in the States that currently allow 
this compared to those that do not. And how has increased 
access improved patient treatment?
    Mr. Logan. There is a long answer to that question.
    Mr. Griffith. Can I get a shorter one?
    Mr. Logan. You can.
    Mr. Griffith. You can send a longer written one, if you 
would like.
    Mr. Logan. Naloxone is a life-saving drug. When it is used, 
it is in a life or death situation. If it is not used there is 
no treatment thereafter. In that instance, the more we 
distribute the easier it is to get, whether provided by a 
healthcare professional, an EMS, or a family member. It doesn't 
matter. We have got to get it in the hands of the people who 
need it. And as of now, if I am not mistaken, naloxone is 
available through pharmacies in every State.
    Mr. Griffith. OK. You referenced a Virginia program, 
Virginia's Medicaid Addiction Recovering Treatment Services has 
a new benefit for Medicaid patients which includes coverage for 
SBRT (ph) provided by pharmacies. And I wrote that down. I am 
bad with all those names, too. But could you explain how that 
program works and specifically, how it has worked in Virginia 
and what good that does?
    Mr. Logan. I am going to defer to NCPA for that answer. I 
can tell you about what is happening in Missouri.
    Mr. Griffith. All right. Tell me what is happening in 
Missouri.
    Mr. Logan. Not much.
    Mr. Griffith. OK. But it seems like what they are looking 
for is giving the pharmacists the authority to--and they will 
send me a written response--but giving the pharmacists the 
authority to say, ``Hey, we think this person might have a 
problem.'' And instead of having law enforcement swoop in, have 
some education and try to get treatment for that individual 
first. Is that your understanding of the program?
    Mr. Logan. The whole goal of the program is to keep 
addiction addiction and not make addiction criminal. We don't 
want a person who is ill being treated in the legal system. 
From both sides of my life, my pharmacy healthcare side and my 
law enforcement side, we want those people properly assigned 
and properly treated.
    Mr. Griffith. Absolutely. And so do we. And I appreciate 
you on that.
    Dr. Beardsley, back to you. I know earlier you were 
scratching your head a little bit. That is what us lawyers call 
conditional relevancy. I was setting up his question but asking 
you something. And you were like, why is he asking me that.
    But now I am going to ask questions directly to you and 
that is, you talked about how adding a new drug to your 
existing Schedule I registration may take months. Now for the 
folks back home who are watching this in the middle of the 
night or right now, you have to get permission to do--you do 
Schedule I registration, to do research on some of the more 
dangerous drugs, or at least the ones that are on Schedule I, 
isn't that correct?
    Mr. Beardsley. That is correct.
    Mr. Griffith. And so could you tell us how, so we can all 
better understand, how taking months to get the Schedule I 
registration for a researcher can gum up the process.
    Mr. Beardsley. Well, it interrupts the research process if 
you have to wait for months in order to get approved for using 
a drug.
    The initial process for even applying to have a Schedule I 
drug added to your registration is lengthy for the researcher 
himself. It takes several hours to prepare a protocol. And that 
also has research costs in terms of downtime. In my case, I do 
research in four laboratories--buildings are very close 
together. And yet I have to have four Schedule I registrations, 
four Schedule II to V registrations, and four commonwealth of 
Virginia registrations to do that research. That all adds cost 
and hampers research.
    Mr. Griffith. Cost, time, and makes it harder to come up 
with good results, isn't that correct?
    Mr. Beardsley. Well, it ends up creating a bureaucratic 
morass that can almost make research untenable.
    Mr. Griffith. Well, I appreciate that. My time is up and I 
appreciate all of you. And I yield back.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman. The chair recognizes the gentleman from Georgia, 
Mr. Carter, 5 minutes for questions, please.
    Mr. Carter. Thank you, Mr. Chairman. Mr. Chairman, before I 
start, I want to compliment you and staff. This is an 
outstanding panel. Seriously, we got boots on the ground. So 
often, with all due respect, we only have people from academia. 
But this is truly boots on the ground. And I just can't tell 
you, I am so impressed. I am sorry I had to leave a little 
earlier to go meet with another group, but let me get started 
because I have a lot I want to go through.
    I am going to start with you, Dr. Kan. I want to ask you, 
because telemedicine--I have got a bill that we are considering 
with telemedicine--but specifically with the Ryan Haight Act, 
it limits expanded access to buprenorphine. And I am just 
wondering if you can speak to that, very quickly, about how we 
could do away with that so that we could be able to prescribe 
it, if we needed to, but because of this act, as I understand 
it, we are not able to?
    Dr. Kan. If we amend it to the recommendation that we can 
rely on another provider, that would be extremely helpful. With 
my company, we rely on emergency department physicians. We pair 
with emergency departments to identify, get them started on 
buprenorphine and quickly matriculate into care.
    The short version of it is that the drug dealers are open 
24/7.
    Mr. Carter. Right.
    Dr. Kan. We need to be ready to do the same.
    Mr. Carter. Right. Mr. Nance, you mentioned this also in 
your testimony, about the limitations that Ryan Haight Act is 
causing us on that. Can you comment on that very quickly?
    Mr. Nance. Can you ask me a more specific question?
    Mr. Carter. Particularly, as I understand it, it limits the 
expanded access to treatment with some of the drugs that we 
need to be treating this opioid addiction with, like 
buprenorphine.
    Mr. Nance. Yes, the whole point of my testimony is that, 
especially in rural and frontier areas----
    Mr. Carter. Absolutely.
    Mr. Nance [continuing]. You have very, very few licensed 
providers who will actually be willing to provide 
buprenorphine. My friend at the DEA in Utah says we have 503 
licensed trained buprenorphine prescribers. Only 125 of them 
are actually practicing and prescribing buprenorphine. But if 
you go on the buprenorphine treatment binder on their website, 
there are only about 70 listed.
    Mr. Carter. Right.
    Mr. Nance. So you have got a huge potential labor pool out 
there but they are just reluctant to do it because they are not 
familiar with----
    Mr. Carter. But specifically with telemedicine, if we were 
able to have the physician be able to prescribe it then, as I 
understand it, and they can't because of the Ryan Haight Act.
    Mr. Nance. Right. It is very, very difficult. You have to 
have that first face-to-face. If we can get the community 
behavioral health centers included as a kind of separate 
definition inside the Ryan Haight Act, then we can open up a 
lot of potential buprenorphine services to the patients in 
those extreme----
    Mr. Carter. OK. Let me move on. Mr. Logan, I wanted to ask 
you. Did you all ever get the PDMP in Missouri?
    Mr. Logan. I keep getting asked these questions with long 
answers.
    Mr. Carter. OK. I need you to make it real quick. Yes or 
no.
    Mr. Logan. We have an executive order signed that examines 
prescriptions written and adjudicated through a third-party 
insurance.
    Mr. Carter. OK.
    Mr. Logan. And prescribes blame to over-prescribers.
    Mr. Carter. OK. For a long time 49 out of 50 States had it. 
Missouri was the only one who didn't have it. And it needs to 
go across State lines. As you pointed out earlier in your 
testimony, you are right on the State line. And you are going 
to get prescriptions as I did, in my pharmacy from many States. 
So that is why it is so very important.
    I wanted to mention just a couple of other things. Mr. 
Cosgrove, you mentioned a number of companies, pharmaceutical 
manufacturers are moving overseas. Is that because of our tax 
laws? We changed that just recently, so I hope that we have 
resolved that.
    Mr. Cosgrove. Well, I am not an expert in tax law.
    Mr. Carter. Right.
    Mr. Cosgrove. I do know that the manufacturing costs 
overseas for a number of reasons----
    Mr. Carter. OK.
    Mr. Cosgrove [continuing]. Are dramatically lower than----
    Mr. Carter. Well, if it is because of manufacturing costs. 
But if it is because of the tax problems, then we have resolved 
that problem with the Tax Cuts and Jobs Act. So I want to make 
sure we understand that.
    Dr. Subbiah, you mentioned about the new drug that you had. 
I just wanted to ask you very quickly. You haven't used 
specialty pharmacies, only practitioners can be injected. Was 
that mandated by the FDA or did the company decide that is the 
way that you wanted to go? Because access is a big problem when 
we are talking about these kinds of drugs, and obviously, that 
is going to limit access there.
    Dr. Subbiah. So this was in discussion with the FDA. It is 
part of our risk evaluation mitigation strategy program.
    Mr. Carter. OK.
    Dr. Subbiah. Because a lot of doctors, some of them do not 
want to do the buy-in bill, and so there had to be another way 
in a restricted distribution system. So if a doctor in Utah 
wanted to prescribe Sublocade, they can contact one of the 
specialty pharmacists that we are working with.
    Mr. Carter. Right.
    Dr. Subbiah. And they will get a named patient for 
prescription that will be sent to that doctor for use only in 
that patient.
    Mr. Carter. OK. And one last thing. Dr. Mulder, thank you. 
I was a hospice consultant pharmacist for many years. And quite 
often in Congress, we have the tendency to overreact and overdo 
it. And you pointed out something that is very important. There 
are people out there who truly need these drugs. We need to 
make sure that they are going to be able to get them and have 
access to them. So thank you for pointing that out.
    Mr. Mulder. Amen.
    Mr. Carter. Yes. Thank you, Mr. Chairman. I yield back.
    Mr. Burgess. The gentleman yields back. The Chair thanks 
the gentleman. And does the gentleman from Michigan wish to be 
recognized for questions?
    Mr. Walberg. Yes, Mr. Chairman.
    Mr. Burgess. You are recognized for 5 minutes.
    Mr. Walberg. Thank you. Thanks again for letting me sit in 
this panel. And specifically, I would add to my colleagues' 
comments--and compliments to you, Dr. Mulder. It is a tough 
field that you are in. And it is a compassion field, and we 
want to make sure that we do things right. But I am delighted 
that you are also thinking along the lines of how do we carry 
on our impact with end-of-life issues, with human beings in 
need, but also make sure that what we use and use 
appropriately, doesn't end up causing problems for others down 
the road.
    In our home State of Michigan, Mr. Mulder, we have seen 
real challenges with diversion and misuse of leftover 
medications that have contributed to the opioid crisis. 
Hospices and hospice personnel could play a key role in helping 
ensure these drugs are properly disposed of, but current DEA 
regulations appear to pose an obstacle.
    Could you please describe the current challenge that 
hospice personnel face when an individual passes away and there 
is remaining unused medication? How does the current law 
specifically prevent hospice personnel from destroying this 
unused medication to ensure that it is not diverted to another 
purpose?
    Dr. Mulder. Well, it somewhat has to do with the take-back 
provisions in which, if they are going to receive these 
medications, whether for the purpose of distributing them 
somewhere else or to, of destroying them, it is a reverse 
distributor process. And they have to be licensed by the DEA as 
a reverse distributor to be able to take those medications in. 
I think I am using the right terminology. The pharmacists can 
correct me if I am not.
    But when that came into effect then, they, by law, can't 
take those medications. They really are not allowed to do 
anything with that. And that is the primary limitation.
    Mr. Walberg. Is that the same problem in an actual physical 
hospice facility?
    Mr. Mulder. No, it really isn't. And part of that has to do 
with how those facilities are licensed. And that may vary from 
State to State but that does not exist, for example, we have a, 
our hospice operates in a facility. We do not have that same 
restriction.
    Mr. Walberg. OK. In your opinion, what type of licensing 
should a hospice worker have to be able to destroy unused 
medication? Is that something that needs to be further 
clarified in my bill, H.R. 5041?
    Mr. Mulder. Yes. Well, for sure, physicians, physician 
assistants, nurse practitioners, and registered nurses, I would 
put at the top of my list as those who already have licensure 
and could, I think, very logically be certified to be able to 
manage that process.
    Mr. Walberg. So they have the background, they have the 
training, they have the certification. If indeed they are 
retired and volunteer services, would that carry over?
    Mr. Mulder. I probably would not extend that to volunteers. 
Volunteers, although they function in many capacities as a kind 
of a surrogate employee at the hospice, the relationship is 
different, the financial relationship is different, the 
regulatory relationship is different. And I probably would be 
reluctant to subscribe that particular task. That is my own 
personal view, though, to a volunteer.
    Mr. Walberg. OK. Well thank you. I appreciate the entire 
panel and sitting in, but appreciate, Dr. Mulder, your points. 
I yield back.
    Mr. Burgess. The gentleman yields back. The Chair thanks 
the gentleman. The Chair would observe that I had delayed my 
questioning to allow other members to pose their questions and 
then catch planes, or trains, or automobiles, whatever they 
needed to do.
    Dr. Mulder, I really was encouraged to hear you use the 
term, we are going to miss some episodes of preventable 
suffering. And it worries me, too.
    Mr. Mulder. Thank you.
    Mr. Burgess. One of my very first hearings in this 
committee, and it was a long time ago, but it is why doctors 
are not prescribing enough pain medicine to the point that some 
others have made on this panel. I have seen the pendulum swing 
both ways. And I do worry that we live in the land of 
unintended consequences here in the United States House of 
Representatives.
    So it worries me that some of the things that we are 
perhaps contemplating today are going to put more people into 
the realm of preventable suffering that is not prevented, and I 
worry about that. So thank you for what you do in bringing that 
to our attention as well.
    Mr. Mulder. Well, thank you for your comments and we will 
be looking forward to the diligence of this committee to make 
sure that doesn't happen.
    Mr. Burgess. Yes, ever hopeful.
    Mr. Logan, first off, I want you to know that in the 
appropriations bill for Labor, Health and Human Services that 
the House of Representatives passed in September--now, the 
Senate has never taken any action, so it hasn't become law--but 
the bill that we passed in September actually did carve up some 
dollars for people who don't have a PDMD available so that it 
would be available.
    I am a big believer in PDMPs. I think they are useful. I 
worry about burdening people with too many inputs that they 
have to put in their electronic health record but at the same 
time--or too many queries of a database, but still, this is one 
that I think can be very useful.
    But let me just ask you. You described a situation where 
your pharmacy is, and you are on a big highway, that is the 
crossroads of the Nation and people come from all over the 
country with prescriptions they have received somewhere else 
and then they present them to you. Did I understand that 
correctly?
    Mr. Logan. Yes, you did.
    Mr. Burgess. And I got the impression, I may have been 
overcalling it, but I got the impression that you felt that 
sometimes--I don't want to infer anything. Do you feel that 
sometimes the prescription perhaps is overly generous with the 
amount of medication that is dispensed?
    Mr. Logan. Any time I see multiple prescriptions for 
multiple people in one vehicle in quantities of excess of 180 
oxycodone, I think that is excessive, yes.
    Mr. Burgess. So with your keen powers of observation, you 
are able to deduce that that may be an overprescribing 
situation?
    Mr. Logan. Thank God it don't take no rocket scientist.
    Mr. Burgess. And that is the point. Our representative from 
the agency, from the DEA, I don't think is here any longer, but 
I was under the impression every time I wrote a triplicate 
prescription for a controlled substance that it goes into--
whether I had a PDMP or not--it goes into a database. Somebody 
is monitoring that. Maybe someone at my State level, maybe 
someone at the Federal level.
    So it is not a surprise that these prescriptions are going 
out the doors or the pills are going out the doors. I had this 
very conversation with Secretary Azar 2 weeks ago when he was 
here. CMS has a lot of data at its disposal. It knows who under 
their care, in Medicare or Medicaid, is receiving an untoward 
number of pills. And it also knows the pharmacies to which it 
is reimbursing payment where an untoward number of pills are 
going out. Is that not recently to assume?
    Mr. Logan. An inordinate number of these prescriptions are 
cash. There is no claim generated for them. So what you deal 
with at a payor level is paid claims. PDEs we call them. If 
there is no cash claim, if there is no PDMP, it never happened.
    Mr. Burgess. Well, back to the point of the PDMP, why I 
thought it was important to put the money forward on that. This 
committee actually authorized a bill, it was called NASPER well 
over 10 years ago, that was to provide that type of help. It 
got tied up in the appropriations process, and although it was 
authorized on several occasions, it was never funded. So I 
tried to correct that last September so that it would be 
funded.
    But I guess the point I am getting at is it is not a 
surprise that there are some people who are overprescribing, 
and you can know who they are. You have brought up a point that 
I had not actually considered, which was the cash transaction, 
but still, the pharmacy has a record of the pills that they--
are you not required to account for every controlled substance 
dose that comes through your shelves?
    Mr. Logan. Absolutely. The pharmacist's duty of care is to 
determine the legality of the prescription. Are all the numbers 
on it? Is it filled out correctly? But also the legitimacy of 
the prescription. Is there a valid prescriber-patient 
relationship? Have there been diagnostic tests done to justify 
what we are talking about? A lot of times, the pharmacist has 
to go on gut feeling on the legitimacy. And the independent 
pharmacist is in a unique position. We determine our own 
destiny.
    We can say yes, we will fill it. No, we won't. We are where 
the buck stops. There are people who work for companies that 
may not have the discretion to determine the legality and 
legitimacy and go strictly on the legality of the prescription.
    Mr. Burgess. And I guess the point I was getting at, at 
some level, that data is available, because whether it be an 
independent pharmacist or a chain pharmacy, all of those 
dosages of those controlled substances have to be accounted for 
somewhere.
    Mr. Logan. In either controlled substance inventory 
mandated by DEA or purchases through wholesalers.
    Mr. Burgess. Correct. So it is knowable if a location is 
receiving an unusual or an untoward amount of product, is 
that----
    Mr. Logan. Absolutely.
    Mr. Burgess. And Dr. Kolodny, obviously you and I do see 
things a little bit differently on some of the approaches, but 
I will say this: I look at our doctors as our allies in this, 
not our adversaries. I think if we treat our doctors as allies, 
they will be our allies. If we treat them as adversaries, they 
will be our adversaries.
    We, I think, sometimes unnecessarily complicate the lives 
of our physicians to the point where some of them will just 
give up and we will have preventable pain that doesn't get 
prevented or that doesn't get treated. So I just worry that 
putting the onus on a practicing physician to do some mandatory 
training, I don't know that that is going to solve the problem 
when the problem is as big as what Dr. Logan describes at his 
crossroads pharmacy. And yet, that data is known. Somebody 
knows that those bills are going out the door, right?
    Dr. Kolodny. Yes. And I think we do agree that doctors are 
not to blame. I think that doctors were responding to brilliant 
marketing. And that is why we are seeing litigation from 
counties and States across the country and why the Department 
of Justice and Attorney General Sessions announced yesterday 
that the Federal Government is going to be helping out. There 
is an understanding that the medical community has been 
deceived about the risks and benefits of these drugs.
    The pill mill doctors, we have to try and stop them because 
they are killing a lot of people, but they are really not the 
root of the problem. The bigger problem is the well-meaning 
doctors and dentists who are inadvertently creating customers 
for these doctors. We have to stop those doctors because they 
kill people. But this epidemic will not end unless we prevent 
more people from becoming opioid-addicted.
    Mr. Burgess. And here is where we disagree. I practiced in 
the 1980s and 1990s. I can rarely remember writing a 
prescription for more than 12 doses of a controlled substance. 
I had a surgical practice, and someone who was operated on was 
going to need pain relief. I recognized that. It did seem like 
in the old days we could allow for a refill on a prescription. 
And that may be a State function in Texas, but it seems like 
that went away at some point. And I don't know if that led to 
the conclusion that people are going to write larger numbers of 
pills so they don't get a telephone call on the weekend. I 
don't know. I am inferring that. I have no data to back that 
up.
    But it just seems like the world changed somewhere between 
the late 1990s and the end of the first decade of the 21st 
century.
    Dr. Kolodny. You are absolutely right. In fact we know 
exactly what year the prescribing began to take off. It 
happened in 1996. And it wasn't just OxyContin that starts to 
take off in 1996. Hydrocodone, hydromorphone, morphine, the 
fentanyl patch. Starting in 1996 is when the prescribing really 
begins to explode.
    In 2014, the fall 2014, we put Vicodin into a more 
restrictive category where it couldn't be phoned in easily and 
where you couldn't write refills. And that may have had an 
influence on the quantity in a prescription, but the overall 
impact of that change was a dramatic reduction in the number of 
hydrocodone pills that were prescribed.
    So I think the bigger part of the problem was starting in 
1996, a multifaceted campaign that was very effective that told 
doctors that we need to prescribe more. And many doctors are 
still very badly misinformed. I think in an ideal world we 
would not have to make doctors take a training course. We could 
rely on doctors. But in this situation, doctors are not able to 
accurately weigh the risks versus the benefit for the patient 
in front of them.
    Mr. Burgess. I disagree with that. That is our job. That is 
what we do. That is what we were trained to do. So you and I 
are going to fundamentally disagree on that. I will just 
conclude with the observation, I have gone way over time, but 
since I am the chairman, I can do that.
    I don't know that any of the doctors who are writing those 
prescriptions that Mr. Logan gets presented with at 2:00 or 
3:00 in the morning, I don't know if--you may force them to 
take a continuing education course, but I don't think it is 
going to alter their behavior in the least.
    And I also agree with you that some of the courses that are 
available, I, in fact, took for my CME last August, I did an 
online course on opiate use and proper prescribing. One thing I 
have learned to do over the years is how to take a test. I 
disagreed with the philosophic premise that was coming out of 
this large medical school in the east, but I was able to answer 
the questions the way they wanted and got what my goal was, 
which was my continuing education hours.
    You all have been very generous with your time today and I 
do appreciate it.
    Mr. Green, do you have a followup?
    Mr. Green. Yes, Mr. Chairman. I am not going to ask for the 
full 6 minutes that you took but I just want to ask, is 
anybody----
    Mr. Burgess. You see, I aggregated all of the extra time 
that was taken on your side of the dais.
    Mr. Green. Well, I just want to ask other witnesses, if you 
have any short statements in response to the chair or any of 
the stuff we did, because our efforts are to try a find a 
solution, and the balance, what we can do. Because we know we 
have an epidemic, but I have also seen overkill and that is 
what some of the testimony is, but we also know we need to deal 
with this issue. And does anybody have anything else for what 
the Chair responded to?
    Yes, Doctor.
    Dr. Subbiah. I think the main thing you heard from all of 
us is that it requires a multi-pronged approach. It is going to 
require the treatment, it is going to require telemedicine. It 
is going to require education. And I think all of those are 
going to be very important. It is very encouraging today that 
you did allow all of us to give those different perspectives. 
So thank you.
    Mr. Burgess. That is what a hearing is all about.
    Mr. Green. Yes. One thing. I had a constituent in our 
district who worked for many years in construction and he 
needed an opioid. And one of the chain drug stores, Walgreens 
that I work with all the time, because they help do 
immunizations in my area. The independent pharmacist has the 
right to decide that. And so I asked the regional director, I 
said, well, could this fellow go to another Walgreens? He said 
well, that pharmacist might decide not to. We ended up finding 
his medication, probably not at the most reputable pharmacy 
that we should have.
    So there is an issue about people who really need it just 
to survive because of their lifestyle or their work. As we get 
older, we find out that where we fell down and we are 30 years, 
when you are 65 you all of a sudden say, hey, that hurts. So, 
but anyway, thank you, Mr. Chairman.
    Mr. Burgess. The Chair will not refer to you as an enabler.
    I do want to thank all our witnesses again for being here 
today, and for the time you have invested. As you can see, this 
is an important topic. And as the Chairman said we are going to 
have multiple hearing on this.
    I would like to submit statements from the following for 
the record: Congressman David Kustoff, Prime Therapeutics, 
National Association of Chain Drug Stores, the University of 
Texas, Johns Hopkins University, CVS Health, Braeburn.
    [The information appears at the conclusion of the hearing.]
     Mr. Burgess. Pursuant to committee rules, I remind members 
they have 10 business days to submit additional questions for 
the record, and I ask the witnesses to submit those responses 
within 10 business days upon receipt of said questions.
    Without objection, the subcommittee is adjourned.
    [Whereupon, at 5:12 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]
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