[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]




 
        FENTANYL ANALOGUES: PRESPECTIVES ON CLASSWIDE SCHEDULING

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

                                HEARING

                               BEFORE THE

        SUBCOMMITTEE ON CRIME, TERRORISM, AND HOMELAND SECURITY

                                 OF THE

                       COMMITTEE ON THE JUDICIARY

                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED SIXTEENTH CONGRESS

                             SECOND SESSION

                               __________

                            January 28, 2020



                           Serial No. 116-71



         Printed for the use of the Committee on the Judiciary
         
         
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]          
         
         


               Available via: http://judiciary.house.gov
               
               
               
                            ______

             U.S. GOVERNMENT PUBLISHING OFFICE 
44-408               WASHINGTON : 2021                
               
               
                       COMMITTEE ON THE JUDICIARY

                    JERROLD NADLER, New York, Chair
               MARY GAY SCANLON, Pennsylvania, Vice-Chair
ZOE LOFGREN, California              DOUG COLLINS, Georgia, Ranking 
SHEILA JACKSON LEE, Texas                Member
STEVE COHEN, Tennessee               DEBBIE MUCARSEL-POWELL, Florida
HENRY C. ``HANK'' JOHNSON, Jr.,      VERONICA ESCOBAR, Texas
    Georgia                          F. JAMES SENSENBRENNER, Jr., 
THEODORE E. DEUTCH, Florida              Wisconsin
KAREN BASS, California               STEVE CHABOT, Ohio
CEDRIC L. RICHMOND, Louisiana        LOUIE GOHMERT, Texas
HAKEEM S. JEFFRIES, New York         JIM JORDAN, Ohio
DAVID N. CICILLINE, Rhode Island     KEN BUCK, Colorado
ERIC SWALWELL, California            MARTHA ROBY, Alabama
TED LIEU, California                 MATT GAETZ, Florida
JAMIE RASKIN, Maryland               MIKE JOHNSON, Louisiana
PRAMILA JAYAPAL, Washington          ANDY BIGGS, Arizona
VAL BUTLER DEMINGS, Florida          TOM MCCLINTOCK, California
J. LUIS CORREA, California           DEBBIE LESKO, Arizona
SYLVIA R. GARCIA, Texas              GUY RESCHENTHALER, Pennsylvania
JOE NEGUSE, Colorado                 BEN CLINE, Virginia
LUCY MCBATH, Georgia                 KELLY ARMSTRONG, North Dakota
GREG STANTON, Arizona                W. GREGORY STEUBE, Florida
MADELEINE DEAN, Pennsylvania

        PERRY APELBAUM, Majority Staff Director & Chief of Staff
                 CHRIS HIXON, Minority Staff Director 

        SUBCOMMITTEE ON CRIME, TERRORISM, AND HOMELAND SECURITY

                     KAREN BASS, California, Chair
                    VAL DEMINGS, Florida, Vice-Chair
SHEILA JACKSON LEE, Texas            JIM JORDAN, Ohio, Ranking Member
LUCY MCBATH, Georgia                 F. JAMES SENSENBRENNER, Jr., 
TED DEUTHCH, Florida                     Wisconsin
CEDRIC RICHMOND, Louisiana           STEVE CHABOT, Ohio
HAKEEM JEFFRIES, New York            LOUIE GOHMERT, Texas
DAVID N. CICILLINE, Rhode Island     TOM MCCLINTOCK, California
TED LIEU, California                 DEBBIE LESKO, Arizona
MADELINE DEAN, Pennsylvania          GUY RESCHENTHALER, Pennsylvania
DEBBIE MUCARSEL-POWELL, Florida      BEN CLINE, Virginia
STEVEN COHEN, Tennessee              W. GREGORY STEUBE, Florida

                   JOE GRAUPENSPERGER, Chief Counsel
                    JASON CERVENAK, Minority Counsel
                    
                            C O N T E N T S

                              ----------                              

                            January 28, 2020

                                                                   Page

                           OPENING STATEMENTS

The Honorable Karen Bass, a Representative in Congress from the 
  State of California, and Chair of the Subcommittee on Crime, 
  Terrorism, and Homeland Security...............................     1
  Oral Testimony.................................................     1
The Honorable John Ratcliffe, a Representative in Congress from 
  the State of Texas, and Ranking Member of the Subcommittee on 
  Crime, Terrorism, and Homeland Security........................     7
  Oral Testimony.................................................     7
The Honorable Guy Reschenthaler, a Representative in Congress 
  from the State of Pennsylvania, and Member of the Subcommittee 
  on Crime, Terrorism, and Homeland Security.....................    89
  Oral Testimony.................................................    94

                               WITNESSES
                                Panel I

Admiral Brett P. Giroir, Assistant Secretary for Health, 
  Department of Health and Human Services........................
  Oral Testimony.................................................     8
  Prepared Statement.............................................    10
Amanda Liskamm, Director of Opioid Enforcement and Prevention 
  Efforts, Department of Justice.................................    13
  Oral Testimony.................................................    13
  Prepared Statement.............................................    14

                                Panel II

Sandra D. Comer, Professor of Neurobiology, Department of 
  Psychiatry, Columbia University................................    00
  Oral Testimony.................................................    96
  Prepared Statement.............................................   100
Kevin L. Butler, Federal Public Defender, Northern District of 
  Alabama........................................................   120
  Oral Testimony.................................................   120
  Prepared Statement.............................................   121
Donald A. Holman, Arlington, Virginia............................   130
  Oral Testimony.................................................   130
  Prepared Statement.............................................   132
Daniel Ciccarone, Professor of Family and Community Medicine, 
  University of California, San Francisco........................   137
  Oral Testimony.................................................   137
  Prepared Statement.............................................   139

           STATEMENTS, LETTERS, MATERIALS, ARTICLES SUBMITTED

Statement submitted by Representative Doug Collins, a Member of 
  Congress of the State of Georgia, and Ranking Member of the 
  Committee on the Judiciary.....................................     6
Letter of support from the National Association of Attorneys 
  General for the record.........................................    31
Report submitted by Representative James Sensenbrenner, a Member 
  of Congress of the State of Wisconsin, and a member of the 
  Subcommittee on Crime, Terrorism and Homeland Security of the 
  House, Committee on the Judiciary from Timothy Westlake, MD 
  regarding the SOFA Act.........................................    35
Letter submitted by Representative Debbie Lesko, a Member of 
  Congress of the State of Arizona, and a member of the 
  Subcommittee on Crime, Terrorism, and Homeland Security of the 
  House, Committee on the Judiciary from Major Cities Chiefs 
  Association for the record.....................................    50
Letter of strong support regarding S. 3201 to Speaker Nancy 
  Pelosi, Majority Whip Steny Hoyer, Minority Leader Kevin 
  McCarthy and Minority Whip Steve Scalise from Law Enforcement 
  Associations for the record....................................    58
Letter submitted by Representative Ben Cline, a Member of 
  Congress of the State of Virginia, and a member of the 
  Subcommittee on Crime, Terrorism, and Homeland Security of the 
  House, Committee on Judiciary from Jessica Nichel for the 
  record.........................................................    58
Letter submitted by Representative Sheila Jackson Lee, a Member 
  of Congress of the State of Texas, and a member of the 
  Subcommittee on Crime, Terrorism, and Homeland Security of the 
  House, Committee on the Judiciary regarding S. 3201, nearly 70 
  organizations outlining concerns with DEA ``class-wide'' 
  emergency scheduling of Fentanyl-related substances, dated 
  January 27, 2020 for the record................................    63
Letter submitted by Representative Sheila Jackson Lee, a Member 
  of Congress of the State of Texas, and a member of the 
  Subcommittee on Crime, Terrorism, and Homeland Security of the 
  House, Committee on the Judiciary from the American Society for 
  Pharmacology & Experimental Therapeutics for the record........    72
Statement submitted by Representative Sheila Jackson Lee, a 
  Member of Congress of the State of Texas, and a member of the 
  Subcommittee on Crime, Terrorism, and Homeland Security of the 
  House, Committee on the Judiciary from the American 
  Psychological Association for the record.......................    74
Letter submitted by Representative Sheila Jackson Lee, a Member 
  of Congress of the State of Texas, and a member of the 
  Subcommittee on Crime, Terrorism, and Homeland Security of the 
  House, Committee on the Judiciary from The UT Health, San 
  Antonio for the record.........................................    76
Letter submitted by Representative Sheila Jackson Lee, a Member 
  of Congress of the State of Texas, and a member of the 
  Subcommittee on Crime, Terrorism, and Homeland Security of the 
  House, Committee on the Judiciary from The Sentencing Project, 
  Research and Advocacy for Reform for the record................    78
Letter submitted by Representative Sheila Jackson Lee, a Member 
  of Congress of the State of Texas, and a member of the 
  Subcommittee on Crime, Terrorism, and Homeland Security of the 
  House, Committee on the Judiciary from the Drug Policy Alliance 
  for the record.................................................    80
Article submitted by Representative Sheila Jackson Lee, a Member 
  of Congress of the State of Texas, and a member of the 
  Subcommittee on Crime, Terrorism, and Homeland Security of the 
  House, Committee on the Judiciary, Washington Post Op-Ed by 
  Nancy Gertner titled ``William Barr's New War on Drugs'' for 
  the record.....................................................    89
Letter submitted by Representative Sheila Jackson Lee, a Member 
  of Congress of the State of Texas, and a member of the 
  Subcommittee on Crime, Terrorism, and Homeland Security of the 
  House, Committee on the Judiciary from Addiction Policy Forum 
  for the record.................................................    94
Article submitted by Representative David Cicilline, a Member of 
  Congress of the State of Rhode Island, and a member of the 
  Subcommittee on Crime, Terrorism, and Homeland Security of the 
  House, Committee on the Judiciary from the Providence Journal 
  for the record.................................................   160

                                APPENDIX

S. 3201 An Act submitted by Representative Sheila Jackson Lee, a 
  Member of Congress of the State of Texas, and a member of the 
  Subcommittee on Crime, Terrorism, and Homeland Security of the 
  House, Committee on the Judiciary for the record...............   168
Letter submitted by Representative Sheila Jackson Lee, a Member 
  of Congress of the State of Texas, and a member of the 
  Subcommittee on Crime, Terrorism, and Homeland Security of the 
  House, Committee on the Judiciary from The College of Problem 
  of Drug Dependence, Inc........................................   173
Letter submitted by Representative Sheila Jackson Lee, a Member 
  of Congress of the State of Texas, and a member of the 
  Subcommittee on Crime, Terrorism, and Homeland Security of the 
  House, Committee on the Judiciary from the New England U.S. 
  Attorneys: We need a permanent band on fenanyl analogues.......   175


        FENTANYL ANALOGUES: PERSPECTIVES ON CLASSWIDE SCHEDULING

                              ----------                              


                       Tuesday, January 28, 2020

                        House of Representatives

                       Committee on the Judiciary

                             Washington, DC

    The Subcommittee met, pursuant to call, at 10:07 a.m., in 
Room 2141, Rayburn Office Building, Hon. Karen Bass [Chairman 
of the Subcommittee] presiding.
    Present: Representatives Bass, Jackson Lee, McBath, 
Cicilline, Dean, Mucarsel-Powell, Ratcliffe, Sensenbrenner, 
Chabot, Gohmert, Lesko, Reschenthaler, Cline, and Steube.
    Staff present: John Doty, Senior Advisor; Madeline 
Strasser, Chief Clerk; Moh Sharma, Member Services and Outreach 
Advisor; Anthony Valdez, Professional Staff Member; John 
Williams, Parliamentarian; Ben Hernandez-Stern, Counsel, Crime, 
Terrorism, and Homeland Security Subcommittee; Joe 
Graupensperger, Chief Counsel, Crime, Terrorism, and Homeland 
Security Subcommittee; Milagros Cisneros, Detailee, Crime, 
Terrorism, and Homeland Security Subcommittee; Ebise Bayisa, 
Counsel, Crime, Terrorism, and Homeland Security Subcommittee; 
Veronica Eligan, Legislative Aide/Professional Staff Member, 
Crime, Terrorism, and Homeland Security Subcommittee; Jason 
Cervenak, Minority Counsel; and Andrea Woodard, Minority 
Professional Staff.
    Ms. Bass. [Presiding.] Good morning. The Subcommittee will 
come to order.
    Without objection, the chair is authorized to declare 
recesses of the Subcommittee at any time.
    We welcome everyone to this morning's oversight hearing 
entitled ``Fentanyl Analogues: Perspectives on Classwide 
Scheduling.'' I want to take the opportunity at the outset to 
express my condolences to Mr. Holman for the tragic death of 
his son. As someone who knows that particular type of pain, I 
give you, my condolences. Your presence here is a stark 
reminder that we do indeed need to find a way to stem the tide 
of drug addiction and deaths by opioid overdose. We also must 
do it in a responsible way, and that is based on scientific 
analysis and proper public health responses. As Members of the 
Judiciary, we also have a responsibility to ensure that we 
protect people from dangerous drugs, like fentanyl, but don't 
put systems in place that perpetuate incarceration.
    Our country faces an opioid crisis, including incidences of 
overdoses involving fentanyl and fentanyl analogues. By some 
measures, more than 40 percent of heroin-related deaths in 
recent years involve some level of fentanyl. In 2017, a drug 
overdose crisis tragically claimed the lives of over 70,000 of 
our fellow Americans. Many died from overdoses. In a disturbing 
trend, illicit drug manufacturers, particularly in places like 
China, have found ways to change the composition of fentanyl-
related substances to avoid or postpone the control and 
prosecution of these substances in the United States. Because 
of these dangers, 2 years ago, the DEA placed fentanyl 
analogues temporarily on Schedule 1 of the Controlled 
Substances Act, an administrative action that will expire 
February 6th.
    Schedule 1 controlled substances are substances that have 
no currently medically-accepted use and a high potential for 
abuse. Because of this and the risk of diversion, research is 
significantly restricted when a drug is on Schedule 1. Research 
licenses from DEA are difficult to obtain and maintain. Now 
that we are approaching the deadline, there is a concern from 
many that banning the entire class of fentanyl-related 
substances, especially on a permanent basis, could, in fact, 
significantly restrict important and valuable research into 
substances that could, in fact, be beneficial, such as overdose 
antidotes and treatments for opioid addiction. We want to make 
sure that our response does not undermine the indispensable 
role of our public health agencies.
    The Department of Health and Human Services is critical in 
promoting treatment responses and medically and scientifically 
assessing drugs, including those like fentanyl analogues that 
are on Schedule 1. Because some substances that are chemically 
similar to fentanyl could be found to be medically helpful, we 
have to think about the medical and scientific research of 
fentanyl analogues. This research, which is necessary for the 
development of new treatments and antidotes for overdoses, must 
continue. So, including a class-wide placement of such 
analogues into Schedule 1 of the Controlled Substances Act 
could lead to research delays and could be a disincentive to 
engage in this research in the first place.
    We also have to make sure that it doesn't cut into the 
Department of Health and Human Services processes that 
determines whether or not drugs placed on Schedule 1 are, in 
fact, harmful. HHS' critical role of analyzing drugs and making 
evidence-based recommendations helps ensure the integrity of 
the scheduling process and helps anchor policy decisions in 
scientific analysis.
    I am, of course, very concerned about the need to provide 
law enforcement with tools to battle this serious issue in our 
communities, but I also have a concern of a complete criminal 
justice response to the crisis. I am concerned that addiction 
is a health issue, and rather than relying solely on 
incarceration, we need to also focus significantly on 
treatment. Under current Federal sentencing guidelines, many 
defendants who are not high-level traffickers may be 
unnecessarily subjected to mandatory minimums that, in fact, 
become life sentences. I want to make sure that we don't repeat 
what we have done in past epidemics, which is the 
overcriminalization of an addiction, and making sure that we 
put adequate resources into prevention, intervention, and 
treatment.
    So, our approach to this issue, I also believe, should 
reflect the growing bipartisan recognition that we must do some 
reforms, such as those in the First Step Act, which included 
modest reforms to begin addressing the crisis of incarceration. 
I also want to make sure that we don't expand the scope of 
mandatory minimum sentences. We must consider the appropriate 
use of other mechanisms that give the Justice Department the 
ability to hold traffickers of analogues responsible without 
using the temporarily scheduling authority. For instance, we 
should discuss the appropriate use of the Analogue Act, the 
mechanism already provided in the law that allows the Justice 
Department to prosecute the trafficking in analogues without 
use of overbroad class-wide scheduling.
    I am encouraged by recent reports that China has been 
cracking down on its manufacturers of illicit fentanyl and 
fentanyl-related substances, and I am hopeful that these 
efforts will curb the supply of these substances, but we need 
to also address the problem here in the United States. The 
temporary extension of the DEA order concerning fentanyl 
analogues and the more permanent solutions that have been 
proposed require careful consideration. Today we have the 
opportunity to discuss these issues with government 
representatives and subject matter experts so that we may 
consider how we should proceed informing a long-term strategy 
to stem the tide of this public health episode.
    I now yield to the Ranking Member of the subcommittee.
    Mr. Ratcliffe. I thank the chair, and I ask unanimous 
consent to submit the statement of the Ranking Member of the 
full committee, Mr. Collins, into the record.
    Ms. Bass. Without objection.
    [The information follows:]

?

      

                      DOUG COLLINS FOR THE RECORD

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


                     STATEMENT DOUG COLLINS

    Good morning.
    Nine days.
    Nine days are all that remain until the Drug Enforcement 
Administration's (DEA) 2018 order making all fentanyl-related 
drugs illegal in the United States expires.
    What does that mean?
    It means that all drugs seized by U.S. investigators over 
the past two years that have tested positive as illicit 
fentanyl analogues will no longer be illegal.
    Yes, you heard that correctly. It means that these 
substances that are killing people in communities across the 
country will no longer be illegal.
    Illicit fentanyl and other synthetic opioids are now the 
most lethal category of opioids used in this country. In my 
home State of Georgia, between February 2017 and May 2017, the 
Georgia Bureau of Investigation had received 50 overdose cases 
involving ``gray death.'' ``Gray death'' is a drug cocktail 
described as a mixture of illicit opioids with the appearance 
of concrete.
    When DEA's temporary order expires, fentanyl analogues will 
undoubtedly flood our streets. No doubt, drug dealers and 
traffickers are counting down the few days we have left with 
much anticipation.
    How did we get here? Why are we here at the eleventh hour?
    It is our job in Congress to ensure that the DEA has the 
tools to protect our communities from these deadly drugs. Last 
month, during negotiations of the spending bill, we had the 
opportunity to extend the temporary scheduling order. That 
provision would give Congress time to continue negotiating a 
way to permanently schedule these dangerous substances. The 
chairman and Ranking Member of the Senate Judiciary Committee 
supported that provision. In fact, it was bipartisan in the 
Senate. I supported that provision. However, Chairman of this 
Committee objected, and it was not included in the final bill.
    Less than two weeks ago, the Senate unanimously passed a 
bill extending DEA's temporary scheduling order of fentanyl 
analogues. The bill now sits here in the House awaiting action. 
What will the Speaker and Chairman of this Committee do now? I 
pray they do the right thing: Immediately pass this bill and 
send it to the President's desk. Those peddling these deadly 
drugs are hoping we don't Act at all. So far, they've gotten 
their wish, because House Democrats have failed to take this 
obviously necessary step.
    The most absurd irony in this entire ordeal is that China 
has permanently outlawed all fentanyl-related substances. If we 
allow DEA's temporary scheduling order to expire, we will be 
behind China in dealing with fentanyl analogues. They will 
flood our streets.
    Mr. Chairman, I plead with you to expeditiously allow the 
Senate bill to move to the floor. It really is a matter of life 
or death and time is extremely short.
    While I look forward to today's hearing and listening to 
our witnesses, particularly Mr. Holman, I would be remiss if I 
didn't point out that both the DEA and the Office of National 
Drug Control Policy (ONDCP) are absent. As I understand it, 
ONDCP very much wanted to be here today, but our majority did 
not invite them. It is puzzling why our majority would not want 
to hear from the office that works to reduce drug use and its 
consequences by leading and coordinating the development, 
implementation, and assessment of U.S. drug policy. Like many 
things we've seen as of late, something tells me it simply 
comes down to politics.
    This is an issue where we must rise above political 
tribalism. It is far too important to too many Americans to let 
politics get in the way of finding solutions to combat this 
plague. Our constituents deserve no less.

      
    Mr. Ratcliffe. I thank Dr. Giroir and Ms. Liskamm, our 
witnesses, for being here today. During the rise of the opioid 
crisis, amidst the many lives lost in its wake, law enforcement 
found that the challenge to cracking down on the supply of 
synthetic opioids like fentanyl analogues was that drug 
traffickers could sell a slightly-changed substance that did 
not fall under the existing schedule of the Controlled 
Substances Act. In February of 2018, the Drug Enforcement 
Administration under President Trump's watch used its authority 
to ban all fentanyl substances by placing them into Schedule 1 
of the Controlled Substances Act. By that decision, criminals 
would now face the consequences of the destruction they have 
left throughout our country.
    However, under existing law, the Drug Enforcement 
Administration is only allowed to use its emergency regulatory 
powers to ban all fentanyl substances for 2 years. After that, 
it could be extended for, at most, 1 year after consultation 
with the Department of Health and Human Services. You would 
think that the least this Congress could do is to extend the 
scheduling of fentanyl under the Controlled Substances Act 
indefinitely.
    A proposed bill, the Stopping Overdoses of Fentanyl 
Analogues Act, is supported by attorneys general in all 50 
States. This isn't a conservative issue. It is not a liberal 
issue. It is not a rural issue or an urban issue. If the 
attorney general of Texas and the attorney general of 
California can find common ground on this issue, the very least 
we could do is Act on this issue. Instead, we are racing toward 
an expiration on the ban on fentanyl analogues simply because 
Congress is unwilling to act. This is entirely preventable.
    Congress had a chance during the last year's appropriations 
debate to include a measure empowering the DEA to keep the ban 
on fentanyl and fentanyl-related substances indefinitely. It 
failed. According to a Washington Post editorial, it appears 
that the reluctance with giving the DEA this essential 
authority may be due to the concerns of some in Congress about 
sentencing guidelines. I think the reason we haven't heard any 
public opposition from Members about this is that, quite 
frankly, it is hard to publicly stand up and oppose extending 
the scheduling of fentanyl analogues. It is crazy to think that 
the reason we are in this position is that some in Congress are 
concerned that convicted drug traffickers would spend a little 
extra time in jail. A concern about the amount of time drug 
traffickers spend behind bars is a difficult explanation to 
give to the families of people who have died from drug 
overdoses, but here we are. Next week, the scheduling of 
fentanyl analogues expires.
    I urge my colleagues to put partisan politics aside and put 
the needs of our constituents and the American people first. 
Some may think that a public health approach is the best way to 
solve the opioid crisis. Some think that providing law 
enforcement with the tools to hold suppliers and traffickers 
accountable is the best way to solve this issue. But doing 
nothing, waiting until 1 week before the deadline to do 
something, is not the answer. The failure to Act is a 
disservice to our communities. It is a disservice to our 
constituents. It is a disservice to the families of the victims 
who have lost their lives. I yield back.
    Ms. Bass. We welcome our witnesses and thank them for 
participating in today's hearing. Now if you would rise, I will 
begin by swearing you in. Raise your right hand.
    Do you swear or affirm under penalty of perjury that the 
testimony you are about to give is true and correct to the best 
of your knowledge, information, and belief, so help you God?
    [A chorus of ayes.]
    Ms. Bass. Let the record show the witnesses answered in the 
affirmative. Thank you, and you can please be seated. We will 
proceed with witness introductions, starting with the first 
panel. Admiral Brent Giroir--is that right?
    Admiral Giroir. Yes, ma'am.
    Ms. Bass. --serves as assistant secretary for health at the 
U.S. Department of Health and Human Services. As the assistant 
secretary for health, he leads the development of HHS-wide 
public health policy recommendations and oversees several of 
the Department's core public health offices, and leads many 
critical national initiatives, including a historic new plan to 
end the HIV epidemic in America and the physical activity 
guidelines for Americans. He is also responsible for 
coordinating HHS' efforts across the agency to fight the opioid 
crisis.
    Amanda Liskamm is the director of opioid enforcement and 
prevention efforts in the Office of the Deputy Attorney General 
at the Department of Justice. As director, she is responsible 
for assisting the Attorney General, deputy attorney general, 
and Department components in formulating and implementing 
Department initiatives, policies, grants, and programs relating 
to opioids, and coordinating these efforts with law 
enforcement. Previously, she served as deputy chief of 
litigation in the Narcotic and Dangerous Drug section in the 
Department Criminal Division.
    We will now start with the first panel. Please note that 
each of your written statements will be entered into the record 
in its entirety, and, accordingly, I ask that you summarize 
your testimony in 5 minutes. To help you stay within that time, 
there is a timing light on your table. When the light switches 
from green to yellow, you have 1 minute to conclude your 
testimony. When the light turns red, it signals your 5 minutes 
have expired.
    Admiral, you may begin.

                  TESTIMONY OF ADMIRAL GIROIR

    Admiral Giroir. Chair Bass and Ranking Member Ratcliffe, 
thank you for the opportunity to speak with you today about the 
opioid overdose epidemic, and, specifically, the role of 
fentanyl and fentanyl analogues in fueling that epidemic. As 
you said, I'm the assistant secretary for health in the 
Department of Health and Human Services and also the senior 
adviser to the Secretary for opioid policy.
    Between 1999 and 2018, over 770,000 people died of drug 
overdoses in our country, the majority of which were caused by 
opioids. Although 2018 witnessed the first decrease in overdose 
deaths in nearly 2 decades, still over 68,000 Americans died of 
drug overdoses, and over 47,000 of these were caused by 
opioids. In the first waves of the crisis, opioid deaths were 
predominantly caused by misuse of prescription opioids, heroin, 
or both. In 2016, the predominant cause of opioid deaths became 
synthetic opioids, including fentanyl and chemical analogues of 
fentanyl, illegally manufactured, and transported into our 
country either through international mail or smuggled across 
the border. Unfortunately, deaths caused by fentanyl and 
analogues are still increasing at approximately 10 percent 
annually.
    A significant factor that complicates enforcement against 
illicit fentanyl and analogues is that there are several 
thousand potent opioids that can be derived by chemical 
manipulation of the basic fentanyl structure. These are call 
analogues or derivatives. While some of have been identified 
and undergone the formal process of scheduling as controlled 
substances, the power of modern chemistry had led to a deadly 
game of whack-a-mole, such that when an analogue is identified 
and undergoes the process of scheduling, clandestine 
manufactures are able to synthesize different, equally deadly 
molecules that evade enforcement and at a much faster rate than 
they can be identified and undergo the rigorous process of 
scheduling. For this reason, HHS supports the permanent 
scheduling of fentanyl analogues as a class, but we also need 
protections and facilitation of critical research on these and 
other classes of molecules.
    Why research protections? Because certain analogues of 
fentanyl that would be scheduled in the class could potentially 
have profoundly important uses as new medicines, and we cannot 
put barriers on innovation, research, and development when tens 
of thousands of Americans die each year and nearly 2 million 
struggle with opioid addiction.
    So, what are some specific examples of potential medical 
applications? Naloxone has saved tens of thousands of lives, 
but many of the new synthetic opioids overpower naloxone, 
causing patients to fall back into life-threatening overdose 
symptoms within 1 hour after Administration. We need a much 
better version of naloxone, and that version may reside in the 
class of molecules we would schedule. Another example: The NIH 
is leading exciting and potentially transformational research 
using monoclonal antibodies that can effectively reverse even 
the most potent analogues and last for a month, not 30 minutes. 
How could scientists even test this innovative medicine against 
fentanyl analogues if they don't have ready access to these 
analogues for research?
    Another example: Medication-assisted treatment, or MAT, 
works substantially better than treatment without MAT, but 
still at least 40 percent of patients have a relapse into their 
opioid use disorder within 6 months. An improved MAT drug might 
have a chemical structure included in the proposed scheduling. 
Finally, if we don't have protections that enable access to 
these analogues, we cannot develop clinical diagnostic tests to 
determine what analogue caused an overdose. In short, we might 
not even know what is killing us.
    Currently, obtaining or modifying a Schedule 1 research 
registration involves significant administrative challenges 
that not only delay research, but deter many of the young and 
brightest scientists from entering the field, exactly the 
opposite of what America needs. These challenges impede 
critical research on Schedule 1 substances and deter or prevent 
scientists from pursuing their work. The good news is that HHS 
has worked closely with our colleagues at ONDCP and the 
Department of Justice and DEA on a plan that both supports the 
scheduling of the entire class of fentanyl analogues, while 
allowing de-scheduling or reducing the scheduled class based on 
scientific evidence, and several provisions to streamline 
research on Schedule 1 molecules. Details of the research 
issues are indicated in my written testimony, and I would be 
pleased to provide details in today's question period.
    Thank you again for the opportunity to testify today on 
this critically important public health topic.
    [The statement of Admiral Giroir follows:]

              STATEMENT OF ADMIRAL BRETT P. GIROIR

    Chair Bass and Ranking Member Ratcliffe, thank you for the 
opportunity to participate in this hearing. I am the Assistant 
Secretary for Health at the Department of Health and Human 
Services (HHS), as well as the Senior Advisor to the Secretary 
for Opioid Policy. I appreciate the opportunity to speak with 
you today about the opioid overdose epidemic, and specifically 
the role of fentanyl and fentanyl analogues.

                  America's Overdose Epidemic

    America's drug overdose epidemic is the most daunting 
public health challenge of our time. Between 1999 and 2018, 
over 770,000 people died of drug overdoses in our country, the 
majority of which were opioid-related.\1\ Although in 2018, we 
witnessed the first decrease in overdose deaths in over two 
decades, still, more than 68,500 mothers, fathers, sons, 
daughters, friends and colleagues died of drug overdoses, more 
than 47,600 of which were caused by opioids.\2\
---------------------------------------------------------------------------
    \1\ Centers for Disease Control and Prevention, National Center for 
Health Statistics. Multiple Cause of Death 1999-2017 on CDC WONDER 
Online Database, released December 2018. Data are from the Multiple 
Cause of Death Files, 1999-2017, as compiled from data provided by the 
57 vital statistics jurisdictions through the Vital Statistics 
Cooperative Program.
    \2\ Ahmad FB, Escobedo LA, Rossen LM, Spencer MR, Warner M, Sutton 
P. Provisional drug overdose death counts. National Center for Health 
Statistics, 2020.
---------------------------------------------------------------------------
    In the first waves of this crisis, opioid deaths were 
caused predominantly by misuse of prescription opioids, heroin, 
or both. But in 2016, the predominant cause of opioid deaths 
became ``synthetic opioids,'' including illicit fentanyl and 
derivatives of fentanyl known as fentanyl analogues, illegally 
manufactured, and transported into our country, either through 
international mail, express consignment facilities, or 
smuggling across the border.
    The Food and Drug Administration (FDA)--approved, 
pharmaceutically manufactured molecule known as fentanyl is an 
extremely powerful opioid, and when I was engaged in clinical 
practice as a physician, I used it safely and effectively 
nearly every day on children undergoing surgery, or in severe 
pain in my intensive care unit.
    Because of its potency and potential for respiratory 
depression or respiratory arrest, only highly trained 
specialists were allowed to prescribe and utilize this drug, 
and only in carefully controlled settings. Contrast that to 
illicitly manufactured, non-prescription fentanyl and fentanyl 
analogues, entering our country in the thousands of pounds, 
with some shipment having the potential to kill millions or 
tens of millions of Americans, which drives the bulk of the 
opioid overdose crisis today.
    Our most recent data unfortunately demonstrates that deaths 
caused by illicit fentanyl and chemical analogues of fentanyl 
are still increasing at about 10 percent, year over year, and 
threaten the overall progress we have made against prescription 
opioids and heroin.\3\ We are seeing new and highly dangerous 
patterns of use, including polysubstance use of both 
methamphetamine and fentanyl or fentanyl analogues--
particularly dangerous and potentially deadly combination.
---------------------------------------------------------------------------
    \3\ hmad FB, Escobedo LA, Rossen LM, Spencer MR, Warner M, Sutton 
P. Provisional drug overdose death counts. National Center for Health 
Statistics, 2020.
---------------------------------------------------------------------------
    With the leadership of President Trump and Congress, HHS 
has implemented unprecedented and effective efforts to combat 
this crisis, including encouraging appropriate prescribing 
practices that have reduced the total amount of opioids 
prescribed by more than 32 percent since January 2017;\4\ a 
greater than 400 percent increase in naloxone prescriptions,\4\ 
in addition to more than double that amount directly 
distributed to first responders and community organizations; an 
estimated 1.28 million people receiving medication-assisted 
treatment, also known as MAT;\5\ and investing billions of 
dollars in enhanced data and basic, translational, and clinical 
research.
---------------------------------------------------------------------------
    \4\ IQVIA National Prescription Audit. Retrieved November 2019. 
Note: These data are for the retail and mail service channels only and 
do not include the long-term care channel.
    \5\ IQVIA National Prescription Audit; SAMHSA Opioid Treatment 
Program Self-Report; N-SSATS.
---------------------------------------------------------------------------

              The Challenge of Fentanyl Analogues

    In addition to these public health measures implemented by 
HHS and other sectors in our nation, we must prevent these 
dangerous drugs from coming into our country, through the mail, 
express consignment carriers, or across our borders.
    A significant factor that complicates enforcement against 
illicit fentanyl and related compounds is that there are a 
myriad--thousands and perhaps tens of thousands--of potent 
opioids that can be created by chemical manipulation of the 
basic fentanyl structure. These are called analogues. While 
some have been identified and undergone the formal process for 
scheduling as controlled substances, under the Controlled 
Substances Act (CSA), the power of chemistry has led to a 
deadly game of ``whack a mole'' such that when an analog is 
identified and undergoes the process of scheduling, clandestine 
manufacturers are able to synthesize a different, potentially 
even more deadly chemical that evades enforcement, and at a 
much faster rate than the chemical can be identified and 
undergo the rigorous process of scheduling.
    For this reason, HHS supports the permanent scheduling of 
these fentanyl analogs as a class, but with critical 
protections and facilitation of potentially vital research on 
this and other classes of molecules.

        The Process of Scheduling Controlled Substances

    HHS plays an important role in scheduling-controlled 
substances. For a substance to be permanently scheduled under 
the CSA, the FDA conducts a scientific and medical evaluation, 
also known as an ``eight factor analysis,'' on the specific 
drug (molecule). Following consultation with the National 
Institute on Drug Abuse, FDA makes a recommendation to the 
Assistant Secretary for Health (ASH) on the appropriate level 
of permanent controls for a substance with the potential to be 
abused. The ASH, who has the delegated authority from the HHS 
Secretary for matters related to scheduling, then conveys the 
HHS recommendation to the Drug Enforcement Administration (DEA) 
for action.
    The CSA also allows the DEA to place certain substances not 
already scheduled, and not subject to an approved or 
investigational new drug application, into schedule I on a 
temporary basis to address an imminent hazard to the public 
health. Under these circumstances, HHS receives notice from the 
Attorney General (through DEA) of the proposed action. FDA then 
reviews the records of drugs approved or being investigated for 
therapeutic use, communicates the findings to the ASH, and the 
ASH conveys to DEA whether or not HHS has any objection to the 
proposed temporary order to place the substance in schedule I.
    In this regard, on November 6, 2017, the DEA Acting 
Administrator notified the HHS Acting Assistant Secretary for 
Health, of the DEA's intent to publish in the Federal Register 
a Notice of Intent to issue a temporary order adding all 
fentanyl-related substances (a.k.a., fentanyl analogues) to 
schedule I of the CSA. The Acting ASH responded on November 29, 
2017, that according to FDA, there did not at that time appear 
to be any approved new drug applications or active 
investigational new drug applications for these fentanyl-
related substances and that HHS did not object to the temporary 
placement of these substances in Schedule I of the CSA. DEA 
subsequently issued the temporary order on February 6, 2018. 
HHS was not asked for, and did not produce, an ``eight-factor 
analysis,'' on fentanyl-related substances as a class. Such an 
evaluation for permanent scheduling of a class of substances, 
rather than specific substances, would be a significant change 
from the normal process of scheduling, and might not be 
feasible for the FDA to develop.

                  The Need to Advance Research

    As the leading cause of overdose deaths in our nation, and 
in many nations around the world, fentanyl and fentanyl 
analogues are our highest priority to keep off our streets. The 
chemical structures and pharmacological activity targeted by 
illicit opioid manufacturers overlap not only with illicit, and 
potentially dangerous, schedule I substances, but also with 
many molecules that may be shown by future research to have a 
potential for legitimate therapeutic uses. Research with 
fentanyl- related substances and other synthetic opioids is 
important in the development of new and improved treatments for 
opioid addiction and overdose, chronic pain, and other 
neurologic and psychiatric conditions, as well as to understand 
the effects these substances have on human health. That is why 
we must ensure access to these substances for legitimate 
research to develop new therapies and improve scientific 
understanding of their effects on human health.
    Currently, obtaining or modifying a schedule I (and, in 
some cases, a schedule II-V) research registration involves 
significant administrative challenges. Under the law, 
scientists who wish to conduct research on schedule I 
substances, including fentanyl-related substances pursuant to 
the temporary scheduling order issued by the DEA, must hold a 
schedule I research registration. Obtaining a schedule I 
research registration is a multistep process that involves 
review and approval of a scientist's research protocol by 
multiple regulatory or review bodies, including the DEA, FDA, 
institutional review boards (for research with humans), and 
institutional animal care and use committees (for research with 
animals). The DEA conducts background checks on individuals who 
would be granted access to the substances for which a 
registration is sought and may perform site inspections to 
ensure that appropriate security safeguards are in place to 
mitigate against diversion. In addition to obtaining a federal 
schedule I registration, researchers may be required to obtain 
a separate registration from their State licensing authority 
before their federal application can be processed.
    Researchers have reported that obtaining a new registration 
can take more than a year. Adding new substances to an existing 
registration can also be time-consuming. These challenges can 
impede critical research on schedule I substances and deter or 
prevent scientists from pursuing such work. HHS has worked 
closely with our colleagues at the Office of National Drug 
Control Policy (ONDCP), the Department of Justice (DOJ), and 
DEA on the following proposals to mitigate potential negative 
impacts on research or development of therapeutics, including 
those mentioned above.
    Working together this summer, we reached an interagency 
solution that balances the need to control these substances as 
a class, with the researcher access necessary to study these 
substances. We submitted the results of our work to House and 
Senate Committee staff in early September.

    1. LAllow HHS to identify a substance with no potential for 
abuse, based on consideration of certain of the eight factors, 
and require DOJ to remove the substance from schedule I within 
90 days. Additionally, allow HHS to identify a substance with a 
low potential for abuse, based on consideration of the same 
factors, and allow DOJ 180 days to decide whether to remove the 
substance from scheduling for research purposes only.
    2. LAllow individuals conducting research with a substance 
subsequently placed into schedule I who hold a registration to 
conduct research with any other schedule I or schedule II 
substance to continue work on the newly scheduled substance 
until their new or amended registration application is approved 
or denied. These individuals will have to submit their new or 
amended registration application within 30 days of the 
substance being added to schedule I.
    3. LClarify that individuals who are agents or employees of 
the person holding the research registration are not required 
to have a separate registration.
    4. LAllow registered researchers to store, administer, and 
otherwise work with any substances for which they hold a 
researcher registration at multiple practice sites, on a single 
contiguous campus so long as the registrant notifies the 
Attorney General prior to conducting research at those sites.
    5. LAllow a researcher who is registered to do research 
with a controlled substance, and who needs to perform limited 
manufacturing activities on small quantities of that substance 
consistent with their research protocol (for example, creating 
a particular dosage formulation for research purposes), to do 
so without having to obtain a separate manufacturing 
registration.
    6. LRequire the Attorney General and the HHS Secretary to 
conduct a review of the process for obtaining or modifying a 
research registration under the CSA to identify redundancies, 
inefficiencies, or burdens on persons seeking registrations 
that can be reduced while ensuring public safety, and 
subsequently require the Attorney General and the HHS Secretary 
to issue joint guidance clarifying the registration process.
    7. LClarify that if a person is registered to conduct 
research with a controlled substance and applies to conduct 
research with a second controlled substance that is in the same 
schedule or in a schedule with a higher numerical designation, 
an inspection that was performed for purposes of the existing 
registration shall be sufficient to support the application.

    Thank you for the opportunity to testify today on this 
important topic. I am happy to answer any questions you have.

    Ms. Bass. Ms. Liskamm?

                  TESTIMONY OF AMANDA LISKAMM

    Ms. Liskamm. Chairwoman Bass, Ranking Member Ratcliffe, and 
Members of the committee, thank you for the opportunity to 
discuss the Department of Justice's work to combat the opioid 
episode, the challenges our prosecutors face, and the 
expiration of DEA's Emergency Temporary Scheduling Order of 
Fentanyl-Like Substances. As discussed before, I am the 
Department's director of opioid enforcement and prevention 
efforts. I have over 13 years of experience as a drug 
prosecutor, working both as an assistant United States attorney 
and as the deputy chief in the Criminal section of the 
Department, where I have prosecuted the most dangerous drug 
traffickers and cartels. I know drug traffickers, and I know 
the deadly lengths that they will go to make money.
    As our Nation faces unprecedented overdoses and deaths 
caused by opioids, the Department is responding with every tool 
available. My position in the Deputy Attorney General's Office 
was created to focus entirely on this issue, to implement the 
Department's initiatives and policies relating to opioids and 
coordinate the efforts of our many components. Over the years, 
the demand for illicit opioids became more pervasive following 
years of over-prescription of legal medications. Yet while the 
Department and the Nation have seen usage of controlled 
prescription drugs decrease, the number of overdose deaths in 
the United States has reached record levels. One of the chief 
causes is the proliferation of fentanyl and, relevant for 
today's hearing, of illicitly produced potent substances 
structurally related to fentanyl.
    Traffickers of these fentanyl-like substances specifically 
engineer them to skirt a coverage gap in U.S. drug control 
laws, and, oftentimes, the first time we would learn of these 
new fentanyl-like substances was through a sudden rash of 
overdose deaths in our communities. This unprecedented threat 
called for unprecedented measures, and in February of 2018, DEA 
responded by scheduling the entire class of fentanyl-like 
substances on a temporary emergency basis.
    Since DEA's scheduling action, this gap has been filled. In 
response to the class-wide scheduling order, we've seen a 
significant decrease in encounters of fentanyl-like substances 
and a reduced production of these substances by traffickers. 
DEA's emergency temporary scheduling action controlling all 
fentanyl-like substances will expire on February 6th, 2020 
absent further action by Congress to make it permanent. That's 
in just 9 days. If that gap in U.S. law controlling fentanyl-
like substances reemerges, the Department and DEA fully expect 
drug traffickers to fill it and take the United States back to 
the even more deadly phases of this epidemic.
    I can personally tell you how savvy these drug traffickers 
are. When there's a gap in U.S. law, they take full advantage 
of it, which results in more drugs and more deaths. We've seen 
Chinese criminal organizations, Mexican cartels, and other 
traffickers push illicit fentanyl for its profitability and its 
potency. Permanent class-wide scheduling is the necessary step 
to counter these criminal organizations. From a legal 
perspective, class-wide scheduling alleviates DEA's cat-and-
mouse game of emergency scheduling newly encountered fentanyl 
analogues substance by substance, and gives law enforcement and 
prosecutors like me an efficient tool to bring these 
traffickers to justice.
    With DEA's temporary order, the United States became an 
international leader in addressing the emergence of fentanyl-
like substances. The U.S. has engaged with many countries who 
are likewise facing these public safety challenges. Prompted in 
part by the urging of the United States, China announced the 
class-wide scheduling of fentanyl-like substances on May 1st of 
2019, a significant step to alleviate the production in China 
and the influx of these poisonous substances in our 
communities. We must Act and make DEA's order permanent to 
ensure the United States is doing as much as China in 
responding to our own Nation's opioid epidemic.
    To close, I want to reiterate the importance of this issue 
to the Department and to me. As a prosecutor, I can tell you 
that a legislative solution for class-wide scheduling of 
fentanyl analogues is necessary. We are running out of time, 
and if a solution isn't found, prosecutors will undoubtedly be 
hindered, and drug traffickers will undoubtedly be helped. 
There are many proposed solutions to counter the threat from 
fentanyl being debated, but permanent class-wide scheduling is 
a necessary step. We cannot afford to take a step backwards in 
our fight against fentanyl and other synthetic opioids. We are 
at a crossroads, and in just 9 days, we have a choice to make 
with dealing with this public health crisis. We can revert to 
the reactive phase that we dealt with each substance on a 
substance-by-substance basis only after a rash of deaths in our 
communities, or we can continue the class-wide scheduling which 
has proven effective and is working in keeping this deadly 
poison out of communities.
    Thank you for the committee's interest and attention to 
this important issue, and I look forward to answering your 
questions.
    [The statement of Ms. Liskamm follows:]

                STATEMENT OF THE AMANDA LISKAMM

    Chairwoman Bass, Ranking Member Ratcliffe, and Members of 
the Committee: Thank you for the opportunity to discuss the 
dangers posed by illicit fentanyl and its analogues, and the 
challenges the Department of Justice (Department) faces when 
holding traffickers accountable. The Department appreciates the 
Committee's interest in this important topic.
    It is well-known that overdose deaths in the United States 
have been on the rise and have already reached record levels. 
While the most recent provisional overdose death data published 
by the Centers for Disease Control and Prevention (CDC) 
indicate that deaths have plateaued and that we are finally 
starting to see a slow decrease, deaths from synthetic opioids 
continue to rise. From 2016 to 2017, 31 states experienced an 
increase in synthetic opioid overdose deaths, including 
Arizona, California, Georgia, New York, Ohio, Rhode Island, 
Tennessee, Texas, Virginia, and Wisconsin.
    Although a number of factors appear to be contributing to 
this public health crisis, one of the chief causes is the 
proliferation of illicitly produced, potent substances 
structurally related to fentanyl, commonly called ``fentanyl 
analogues'' or ``fentanyl-related substances.'' Fentanyl is 
approximately 100 times more potent than morphine. Because of 
fentanyl's low dosage range and potency, one kilogram of 
fentanyl purchased in China for $3,000-$5,000 can generate 
upwards of $1.5 million in revenue on the illicit market--and 
is enough to support 1,000 users for 2 years' worth of abuse. 
The lethality of fentanyl is virtually unmatched. It is 30-50 
times more potent than heroin, which is quite lethal in its own 
right. That unmatched lethality is not reflected in sentencing 
ranges for fentanyl trafficking, which punish dealers of 
fentanyl and fentanyl-related substances less severely than 
sellers of less lethal drugs.
    However, licit fentanyl is an important treatment agent in 
the practice of medicine and is utilized for its potent 
analgesic effects. Because of its potency, careful dosing and 
titration are essential. Some forms of the drug are indicated 
for use in people who have high opioid tolerance. Due to their 
high potential for abuse, fentanyl and various fentanyl-related 
substances were controlled in Schedule I or Schedule II of the 
Controlled Substances Act (CSA) on a substance-by-substance 
basis. Unfortunately, clandestine chemists have with relative 
ease created new synthetic variations of fentanyl by 
introducing minor structural modifications, resulting in new, 
non-controlled fentanyl-related substances. These substances 
are specifically engineered to skirt U.S. law.
    Whether delivered via mail, express consignment, or through 
Mexico, China is a major source of fentanyl-related substances 
and other synthetic opioids, producing most illicit fentanyl 
and fentanyl-related substances that reach U.S. users. The Drug 
Enforcement Administration (DEA) has worked with, and continues 
to work closely with, China to bring attention to, and help 
combat, the rise of illicit fentanyl and fentanyl analogues. 
Because of this robust engagement, China has made great strides 
in this space, and, on April 1, 2019, announced the classwide 
control of fentanyl-related substances effective May 1, 2019.
    The Chinese scheduling action, coupled with the DEA's 
regulatory authority, enacted on February 6, 2018, which placed 
all non-scheduled fentanyl-related substances in Schedule I 
temporarily, on an emergency basis, for two years, has resulted 
in a significant decrease in direct Chinese-origin fentanyl-
related substances being encountered in the United States since 
Fiscal Year 2019.
    In addition to China, many countries have experienced their 
own ongoing public safety challenges caused by the rapid 
emergence of fentanyl-relate substances. The DEA's temporary 
actions are the catalyst for communication with a number of 
international counterparts who are interested in following our 
example and implementing a similar class-based control for 
fentanyl related substances. The Department, DEA, and 
ultimately the United States are leading from the front with 
our efforts to establish controls on fentanyl-related 
substances as a class on an emergency basis, and did so, by 
utilizing authority provided by Congress in the Comprehensive 
Crime Control Act of 1984. The action is believed to have saved 
many lives related to the unpredictable nature of fentanyl-
related substances by removing an incentive for traffickers to 
attempt to circumvent the control, and, thus, reducing supply 
on the illicit market. However, this potentially life-saving 
temporary scheduling action, absent extension, expires soon. 
Absent an approach to permanently schedule these dangerous, 
lethal substances as a class, in just 9 days from today, they 
will again fall out of our controls. Should the temporary order 
expire, it will result in significant consequences for our 
communities.

   DEA'S Temporary Emergency Scheduling of Fentanyl-Related 
                           Substances

    DEA utilizes its regulatory authority to place many 
synthetic substances into the CSA, pursuant to the 
aforementioned temporary scheduling authority. As provided by 
Congress, Factors 4, 5, and 6 of the Eight Factor Analysis are 
considered for temporary control to make the finding that a 
substance poses an imminent hazard to public safety. Once a 
substance is temporarily placed in Schedule I, DEA may move 
toward permanent control by requesting a scientific and medical 
evaluation, and a scheduling recommendation, from the 
Department of Health and Human Services (HHS). DEA and HHS also 
gather and analyze additional information in order to consider 
the eight factors for permanent control. Since March 2011, DEA 
has utilized this authority on 24 occasions to place 74 
synthetic drugs temporarily (using emergency control) into 
Schedule I, including 17 fentanyl-related substances. In 
comparison, during the first 25 years (1985-2010) after 
Congress created this authority, DEA utilized it a total of 13 
times to control 25 substances. The process is workable but is 
highly reactive, lagging behind the dynamic pace of illicit 
drug producers and distributors.
    In recognition of the unprecedented escalation in opioid-
related overdoses, as well as the White House directive to 
declare the opioid crisis a national public health 
emergency,\1\ on February 6, 2018, DEA used its authority under 
section 201 of the CSA\2\ to place all nonscheduled fentanyl-
related substances into Schedule I temporarily, on an emergency 
basis, for two years to combat the scourge of these illicit 
substances.\3\ As a result, anyone who possesses, imports, 
distributes, or manufactures any illicit, fentanyl-related 
substance is subject to criminal prosecution in the same manner 
as any other Schedule I controlled substance. This makes it 
easier for federal agents to seize fentanyl-related substances 
and investigate traffickers of these substances, and for 
prosecutors to prosecute such traffickers.
---------------------------------------------------------------------------
    \1\ President Donald J. Trump is Taking Action on Drug Addiction 
and the Opioid Crisis, The White House Office of the Press Secretary, 
Oct. 26, 2017, https://www.whitehouse.gov/the-press-office/2017/10/26/
president-donaldjtrump-taking-action-drug-addiction-and-opioid-crisis.
    \2\ U.S.C. Sec. 811(h)(1).
    \3\ Schedules of Controlled Substances: Temporary Placement of 
Fentanyl-Related Substances in Schedule I, 83 Fed. Reg. 5188 (Feb. 6, 
2018), https://www.federalregister.gov/documents/2018/02/06/2018-02319/
schedulesofcontrolled-substances-temporary-placement-of-fentanyl-
related-substances-in-schedule-i. There is a possibility of extending 
temporary scheduling for one additional year if proceedings are 
underway for permanent scheduling. 21 U.S.C. Sec. 811(h)(2).
---------------------------------------------------------------------------
    The positive impacts in the two years since implementation 
are significant. Since 2018, there has been a significant 
decline in law enforcement reports to the National Forensic 
Laboratory Information System (NFLIS) of substances 
structurally related to fentanyl, including those captured 
under the February 2018 class control temporary order. In the 
24 months preceding the temporary order (February 2016 through 
January 2018), there were more than 17,500 reports of these 
substances to NFLIS, excluding those controlled prior to 2016.
    Conversely, since the temporary class control (February 
2018 through December 2019), and as of January 7, 2020, there 
were fewer than 8,800 reports to NFLIS for substances 
structurally related to fentanyl, a 50 percent reduction. It 
should be noted that NFLIS reporting is still on-going for 
2019. The DEA attributes this significant decline to the series 
of control actions in recent years, culminating in the February 
2018 class control. Under the temporary emergency scheduling 
order, there is little incentive for drug trafficking 
organizations to invent new substances related to fentanyl for 
the purpose of evading DEA's control.
    DEA's experience under the relatively short temporary 
scheduling regime is proof of concept that classwide scheduling 
of fentanyl-related substances produces solid law enforcement 
results, while also having a positive impact on the controlled 
substances research application process. Instead of an 
application for research based on individual substances, the 
temporary order allows for research on an entire class of 
compounds for the licensee. It must be noted that expiration of 
a temporary classwide scheduling results in the termination of 
this streamlined process, which results in research reverting 
to an individual substance-by-substance application.
    The Department and DEA worked with our colleagues at the 
Office of National Drug Control Policy (ONDCP) and the 
Department of Health and Human Services to develop a 
legislative solution to this problem. This proposal, which 
represents the Administration's intent to promote public safety 
by aggressively fighting the scourge of synthetic opioids, 
while protecting the medical community's ability to perform 
critical research, would permanently schedule the very 
substances that are the cause of so many of deaths.

  Department of Justice Interactions With CHinese Counterparts

            China: Government Action and Cooperation

    As part of the Administration's whole-of-government 
approach, the Department and DEA, which has an active Beijing-
based country office, have engaged Chinese counterparts on the 
control of emerging fentanyl-related substances and other new 
psychoactive substances.
    When China controls a drug or precursor chemical, we see a 
significant drop in the use of that substance for illicit 
purposes in the United States. It is through these bilateral 
communications and bridge-building efforts that we can work to 
reduce the supply of illegal substances around the world.
    On April 1, 2019, China announced that it would schedule 
fentanyl-related substances as a class, effective May 1, 2019; 
the Department understands that the action is now in place. 
This will help prevent chemical work-arounds by clandestine 
synthetic opioid producers in China, and will allow the United 
States and China to cooperate on a broader range of cases. Like 
DEA's temporary scheduling order of fentanyl-related 
substances, this is a novel approach in China, and responsive 
to our Nation's unprecedented opioid threat. Indeed, officials 
from the Ministry of Public Security Narcotics Control Board in 
China had indicated that their scheduling process was long and 
complicated, that China had always scheduled one drug at a time 
pursuant to its law, and that any change in that process would 
be groundbreaking for China.
    As the opioid threat continues, the Department and DEA are 
committed to working with Chinese officials through well-
established bilateral efforts: Liaison presence; the Counter 
Narcotics Working Group; Bilateral Drug Intelligence Working 
Group; regular meetings of scientists; and enhancing 
collaboration with DEA's interagency partners stationed abroad 
and in the United States. The Department remains encouraged by 
China's classwide controls of fentanyl-related substances.

    Legal Implications of Expiration of Temporary Scheduling

    DEA's emergency temporary scheduling action controlling 
fentanyl-related substances will expire on February 6, 2020, 
absent Congressional action. At that time, any substance that 
meets the definition of a fentanyl-related substance, but has 
not completed the multi-step, dual agency review process, which 
includes scientific and medical evaluation and recommendation 
by HHS to place permanently under the CSA on a substance-by-
substance basis, will no longer appear on a controlled 
substance schedule. Re-scheduling of such substances may 
encounter regulatory obstacles, and trafficking of such 
substances would then have to be prosecuted under the 
Controlled Substance Analogue Enforcement Act of 1986 (Analogue 
Act, enacted at 21 U.S.C. Sec. 802(32) (definition) and 
Sec. 813 (operative)).

                     Regulatory Challenges

    Upon the expiration of classwide scheduling, the Department 
will utilize all available tools to protect the public, 
continuing to collect information on incidents of trafficking 
and harm to prioritize the most harmful and persistent of 
fentanyl-related substances for scheduling on a substance-by-
substance basis. As per previous experience, it will remain 
critical to rapidly identify new encounters of these substances 
and connect them to their harm and lethality. This remains a 
significant challenge for public health and law enforcement in 
a rapidly evolving illicit market where traffickers outpace our 
ability to determine the potential harm of newly developed 
analogues. However, in doing so, the Department would enter 
uncharted legal and regulatory terrain. It is unknown whether a 
newly encountered fentanyl-related substance, having just been 
allowed to lapse from the class-scheduling regime, could later 
be quickly subject to temporary control. The Department will 
continue to evaluate all options to best protect the public; 
however, the introduction of new fentanyl-like substances will 
only result in additional deaths and continuing the cycle of 
problematic opioid use.

         Law Enforcement: Investigation and Prosecution

    If class scheduling of fentanyl-related substances expires, 
the overall effect on law enforcement activities by DEA, U.S. 
Immigration and Customs Enforcement Homeland Security 
Investigations, and others, as well as on Department 
prosecutions, is unknown, but may be significant. DEA expects 
savvy clandestine manufactures and traffickers to respond to 
the re-emerging gap in U.S. law by again producing novel 
fentanyl-related substances. This is the normal response of 
traffickers who wish to avoid prosecution and still profit from 
peddling poison, and is consistent with previous attempts to 
circumvent reactive substance-specific control measures. While 
China has helpfully taken the bold step of scheduling all 
fentanyl-like substances, we run the risk that manufacturers 
and drug traffickers may move operations to other countries.

   Legal Significance of Legislative Scheduling of Fentanyl-
                       Related Substances

    A legislative solution to adopt class scheduling of 
fentanyl-like substances would remove any legal uncertainty 
surrounding the authority of the Attorney General, through DEA, 
to schedule fentanyl-related substances. Implicit in the 
structure and text of the CSA's scheduling authority is the 
concept that specifically identified substances are scheduled 
one at a time. The Department is confident that the DEA 
temporary scheduling action would withstand judicial scrutiny, 
but it remains an untested approach. Temporary scheduling 
actions, while not subject to direct judicial review, are 
subject to challenges. One or more rulings invalidating 
fentanyl class scheduling would yield confusing and possibly 
devastating consequences, both in pending cases and post-
conviction. Congressional action would resolve this issue and 
permanently address the United States' response to these deadly 
fentanyl-related substances. Class scheduling of fentanyl-
related substances is an urgent and necessary first step. This 
situation highlights the need to next address the scheduling 
system on a more comprehensive basis in order to avoid having 
this situation re-occur when the next broad class of dangerous 
analogues is developed, as we know it will, by savvy illicit 
drug manufacturers seeking to avert current controlled 
substances scheduling authorities.

                           Conclusion

    Absent extension, DEA's temporary class scheduling of 
fentanyl-like substances expires on February 6, 2020, at which 
time any substances that have not been permanently scheduled 
will fall outside the CSA drug schedule. As a result, the 
Department and DEA would enter relatively unknown territory. 
Temporary class control has been shown to be very effective in 
substantially reducing the number of fentanyl analogue 
encounters in the United States. The class of fentanyl-related 
substances needs to be categorically and permanently scheduled. 
A solution that prevents fentanyl-related substances from 
falling out of control is essential to continue tackling the 
opioid epidemic our Nation currently faces, and the Department 
firmly believes that a solution can be found that will achieve 
this goal, while also accommodating interests in continued 
research on these substances.
    Thank you for the opportunity to testify today, and the 
Department looks forward to continuing to work with Congress to 
find solutions necessary to address the threats posed by 
illicit fentanyl and its analogues.

    Ms. Bass. Thank you very much. We will now proceed under 
the 5-minute Rule with questions, and I will begin by 
recognizing myself for 5 minutes.
    Admiral, I wanted to know if you could, in plain English, 
if you could describe a little bit about the process that you 
go through in determining a scheduling decision. So, there is 
the 3-factor analysis for a temporary scheduling decision, and 
then there is an 8-factor analysis for a permanent decision. I 
was wondering if you could explain a little bit about what that 
means.
    Admiral Giroir. Yes, ma'am. So traditionally, the DEA 
requests that the FDA does a scientific analysis based on a 
specific molecule that they are concerned about to potentially 
be put in a schedule according to the Controlled Substances 
Act. Without going into a huge amount of detail, here are 8 
factors that should be considered the law: The potential for 
abuse; the scientific evidence of its effect; the State of 
current scientific knowledge; history and current pattern of 
abuse; scope, duration, and significance of abuse; what, if 
any, risk there is to the public health; psychic or physiologic 
dependence; or whether it is an immediate precursor of another 
drug.
    So, the FDA does its analysis based just on the evidence 
that is there. They make a recommendation to the ASH, the 
assistant secretary for health, who is the designated official 
by the Secretary to make a recommendation to DEA. So, after 
that process occurs, and this occurs on a regular basis for 
schedules, we make a recommendation back to the DEA, and the 
Attorney General and his or her delegates make the decision on 
whether to schedule. That is the basic process that is 
undergone.
    Ms. Bass. So the only way you know to do that is, I 
believe, what you were describing. There are a rash of deaths, 
and then you take that sample. It goes to you, and then you go 
through that factor analysis? Is that how that process occurs?
    Ms. Liskamm. That is correct. Either the substances are 
seized by law enforcement or we respond to a rash of deaths in 
the community, which is a more typical way that we encounter 
this, and we send that over to HHS.
    Ms. Bass. So you were explaining that with the permanent 
ban, you are still able to do that, what you described in 
your--
    Admiral Giroir. So, the issue with the fentanyl analogues 
is we estimate there are over 3,000 of them within the class, 
any of which could be deadly, even more deadly than the ones we 
see right now. The scientific evidence to try to look at 3,000 
chemicals--
    Ms. Bass. Right.
    Admiral Giroir. --and try to do that is just not meant for 
what the process is meant to be. So, our approach that we 
really came up with is we know one thing for a fact, and that 
is 65,000 to 68,000 Americans are going to die of drug 
overdoses this year, the majority of which are from fentanyl 
and analogues, and we have to stop that, but we tried to put in 
research protections. For example, if one of those 3,200 turns 
up to not have potential for abuse or to be an important 
molecule for research, then we could rapidly de-schedule or 
reduce the schedule so it can be available to researchers, and 
a number of other items like just streamlining some of the 
processes of inspection and clarifications that inhibit the 
process.
    Ms. Bass. So, you know if it is a problem by the deaths, 
but how do you know if it has the potential to have an 
advantage? I mean, I was shocked to hear what you said, that 
there are now analogues that are stronger than Narcan.
    Admiral Giroir. So, you know, it could be discovered 
anywhere in the world or by academic scientists that a 
particular compound that they are focusing on or investigating 
on might have an important effect. Remember, the naloxone, the 
reversal drug looks a whole lot like morphine.
    Ms. Bass. Yeah. Right.
    Admiral Giroir. It was--
    Ms. Bass. Is it called ``Narcan?''
    Admiral Giroir. Pardon me, ma'am?
    Ms. Bass. Narcan, is it--
    Admiral Giroir. Narcan, yes, ma'am.
    Ms. Bass. Yeah.
    Admiral Giroir. Narcan is a specific form, the nasal, but 
it looks a whole lot like morphine, but it has no effect. In 
fact, it reverses all those effects.
    Ms. Bass. Right.
    Admiral Giroir. So, it is certainly possible and likely, I 
would say, that among those 3,200 compounds, there are going to 
be some that are very, very interesting that could be reversal 
agents. When I talked about overpowering naloxone or Narcan--
    Ms. Bass. Uh-huh.
    Admiral Giroir. --it is drugs like carfentanil, you know, 
the elephant tranquilizer that unfortunately is at least 100 
times more potent than fentanyl. Although Narcan works within a 
few minutes or 15 or 20 minutes, a new word that I learned from 
Dr. Volkov is people become re-narcotized. They fall right back 
into their overdose because the naloxone is overpowered. So, 
these are the kind of things that we really need to work on, 
particularly as the transnational cartels become more and more 
sophisticated in bringing these horrible analogues to us.
    Ms. Bass. So, the analogues are created either in Mexico or 
China?
    Ms. Liskamm. That is correct. What we have seen is a 
growing trend of chemists in Mexico who are working with these 
cartels, specifically the Sinaloa Cartel and the CJNG, to 
manipulate the chemical structure to create these analogues. 
They will do anything they can to make profits and bring this 
poison into the country, which is why this tool is so necessary 
to the Department.
    Ms. Bass. Thank you.
    Mr. Ratcliffe. I thank the chair. Ms. Liskamm, as a former 
DOJ alumnus, thank you for your service and good work. From 
your testimony, you very clearly believe that the current ban 
is working. What would happen to the ongoing prosecutions of 
traffickers of fentanyl analogues if this temporary scheduling 
order will expires next week on February 6th?
    Ms. Liskamm. So, we are going to have to look at those 
cases on a case-by-case basis to determine how we are going to 
handle them. It is going to create, at a minimum, a lot of 
legal uncertainty about whether we can still proceed forward 
under the current statute, or whether we would have to turn 
back to prosecute under the Analogue Act, which poses a whole 
host of issues, and, as I am sure you may know, in trying to 
get a conviction against these individuals.
    Mr. Ratcliffe. I was afraid that was going to be your 
answer, and I think it just underscores the urgency of the 
issue that we are facing. Dr. Giroir, actually Admiral, when we 
crossed paths back in Dallas years ago, you were ``Doctor.'' 
So, congratulations on your promotion.
    Admiral Giroir. Thank you.
    Mr. Ratcliffe. In your testimony, you described the 
different ways the basic fentanyl structure can be manipulated 
to create analogues, and that that is a significant factor, I 
think you said, in how that complicates enforcement against 
illicit fentanyl and fentanyl analogues. I was particularly 
struck by your description of how the process of scheduling 
each individual analogue under the Controlled Substances Act 
one at a time leads to what you referred to as a deadly game of 
whack-a-mole, where clandestine manufactures are able to 
synthetize a different fentanyl analogue to evade enforcement. 
Given all of that--I think I know the answer--is it your 
opinion that permanent scheduling of fentanyl analogues will 
further efforts to combat the opioid crisis? Assuming that it 
is, can you expand in practical terms how that would be 
effective?
    Admiral Giroir. So let me reaffirm that HHS and I 
absolutely support the permanent scheduling of fentanyl 
analogues. Of course, as I testified, we would like to see 
coincident with that the research protections, because out of 
those 3,200 or so classes/compounds, there are going to be ones 
that are very important that we need to do research on. As I 
said, we know tens of thousands of Americans will die this 
year, and we have to support DOJ's enforcement.
    Now, how does this really work? I think it has worked, as 
Ms. Liskamm says, and we work together literally all the time 
to get the public health and the law enforcement working 
together simultaneously. We have to treat anyone who has opioid 
use disorder, but we have got to keep these substances from 
coming in on our streets as much as possible. And when there is 
a loophole, we see that manufacturing going up, and we see 
overdoses because of those agents.
    So, we are strongly supportive of DOJ trying to keep these 
off our streets because addiction is treatable. That is the 
good sign, but it is really hard. Once you have a use disorder, 
it is a chronic brain disease. It is a lifelong struggle. So, 
keeping these away from everyone in our country is the most 
important thing we can do. Of course, treatment is equally 
important for those who currently suffer.
    Mr. Ratcliffe. Ms. Liskamm, do you want to expand on that 
at all?
    Ms. Liskamm. The Department takes research very seriously. 
As Admiral Giroir said, we have been working in partnership to 
make sure that we can do everything that we can to combat this 
opioid epidemic. As an example, there is an Appalachian 
Regional Task Force that goes out and works to prosecute 
individuals in one of the hardest-hit areas in the country in 
Appalachia. They are medical professionals who are charged with 
title 21 offenses. Yes, we are taking it off the street, but we 
work hand-in-hand with HHS to deploy these rapid responses to 
the area so that individuals who are seeking legitimate medical 
treatment or addicts who need assistance are not just left out 
in the cold and turning to street dealers. It has been a really 
great collaboration between the two departments.
    Mr. Ratcliffe. Well, I thank you both for your efforts in 
this vitally important issue. With that, I yield back.
    Ms. Bass. Ms. Dean?
    Ms. Dean. Thank you, Madam Chair, and I thank you for 
offering us this hearing today. As I sit here, Madam Chair, I 
am hearing testimony, and do you ever have that feeling of both 
things are true? Both what you are talking about is importantly 
true, and I think it is our job as policymakers to figure out 
that place in between. How do we balance criminal justice-
appropriate behaviors while not harming the attempts for 
research? So, know that I come at it from that perspective, and 
that I admire both Prosecutor Liskamm and Admiral Giroir, the 
work that you are doing and how you bring this to us.
    The numbers are staggering. This is an issue I care deeply 
about. It is an issue that is closely connected to my 
community, to my own family. I have a son in recovery, 7 years, 
3 months, from opioid addiction. So, I have learned through our 
family experience of the real knowledge that this is a disease. 
This is a public health crisis, and I have seen how it has 
wrecked our communities. We have friends who have lost children 
and adults as well.
    I want to avoid the overcriminalization. I want to avoid 
the overuse of mandatory minimums where it is not appropriate. 
I want to protect the ability to do research. So maybe I will 
begin with you, Ms. Liskamm. Knowing that the opioid crisis 
takes more 50,000, or up to 50,000, people a year as of 2018, 
70,000 folks die of overdose in a single year. I call it a 
jetliner a day. It is staggering: Monday, Tuesday, Wednesday, 
Thursday, 365 days a year. What is the best way for us to 
attack this problem?
    I worry that we will effectively go for low-level so-called 
traffickers using resources to incarcerate and over-
incarcerate, when really what we are dealing with often is 
addiction, the public health crisis. How do we more 
effectively, how does DOJ more effectively use our resources to 
go at the cartels, to go at the border, to make sure that that 
which is coming in from China or Mexico is not getting into our 
communities, because that is where our problem is?
    Ms. Liskamm. Understood, and I appreciate all those 
comments. I have to say the Department, again, is using every 
tool that we have our disposal. I think that if you look at the 
past 2 years since this order has gone into effect, since 
February of 2018, that the results speak for themselves. The 
amount of fentanyl and analogues we see coming through the mail 
from China has dropped drastically. The number of fentanyl 
encounters that DEA has seen here in the United States since 
2018 has dropped by 50 percent. It went from 17,500 to 8,800, 
which is--
    Ms. Dean. What are those numbers reflecting, 17,000 what?
    Ms. Liskamm. Encounters of fentanyl analogues. So, before 
the order, DEA was seeing 17,500 examples of fentanyl analogues 
that were found here in the United States. Once that order went 
into effect, that dropped by 50 percent. That shows that it is 
working. I just want to point also to, and we are very 
cognizant of the concern about overcriminalization, and that is 
not the Department's goal here. I think, again, pointing to the 
last 2 years, we have not seen a big uptick, and we have not 
seen overcriminalization bear that out over the past 2 years. 
The Department--
    Ms. Dean. Could I just give you an example and ask your 
opinion of it? I don't know what the answer is. I am not 
presupposing what the justice was in this case. I am from 
suburban Philadelphia, but in neighboring Bucks County, a young 
woman, now 24, 25 years of age, was incarcerated for 20 years' 
imprisonment. She and her friend sadly were shooting heroin in 
a KFC. Emma left her friend to die in that bathroom at a KFC. 
Emma went on, and the death of the woman, trust me, it is just 
crushing and heartbreaking. She was only 20. It was her 
birthday, and her friend had shared drugs with her. Now, that 
friend, the one who survived, went on to recovery, to work in 
the area of addiction, but was sentenced to 20 years' 
imprisonment. I don't know what justice looks like in that 
case. Do you have an opinion on mandatory minimums in that kind 
of a case?
    Ms. Liskamm. So, I don't know the underlying facts and why 
that case was prosecuted the way that it was. I know that in 
Fiscal Year 2018, the fentanyl prosecutions that we saw that 
year, we saw less than half of those fentanyl prosecutions were 
subject to the mandatory minimum. Then of those, about half of 
those had either a safety valve provision that they were 
eligible for, so if they were a low-level criminal history and 
they pled guilty, that would apply, or those individuals pled 
guilty and cooperated with the government, and 5K or Rule 35 
substantial assistance was available to them.
    Ms. Dean. I see my time is up, and, unfortunately in this 
case, under the statute in Pennsylvania, a new statute in 
Pennsylvania, that wasn't an option. Admiral, I apologize. I 
would love to have asked you more questions. Maybe I can 
privately. Thank you, Madam Chair.
    Ms. Bass. Mr. Sensenbrenner?
    Mr. Sensenbrenner. Thank you, Madam Chair. Before I begin, 
I would like to unanimous consent to insert 3 items into the 
record: First, a Washington Post op-ed by Attorney General Barr 
dated January 10th, 2020, saying we ought to pass legislation; 
secondly, a letter from all of the attorneys general in the 
country, State attorneys general in the country, supporting 
legislation; and thirdly, an extensive report from Dr. Tim 
Westlake, who is a full-time emergency room physician in 
Oconomowoc, Wisconsin, who has been involved in this issue as a 
result of what he has seen in the ER in the hospital in which 
he works. So, I ask unanimous consent that they be included.
    Ms. Bass. Without objection.
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                    MR. SENSENBRENNER FOR THE RECORD

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    9Mr. Sensenbrenner. Now, Madam Chair and Members of the 
committee, let me say what got me interested in this entire 
issue probably about 4 years ago, was a constituent named Lauri 
Badura. Her son died of an overdose. Dr. Westlake was the ER 
physician that saw her son go into the hospital and could not 
save him. So, I introduced both in the last Congress and this 
one the SOFA bill. It is an acronym. It is called Stopping 
Overdose of Fentanyl Analogues or Save Others for Archie.
    Now, we are talking about saving lives here, and unless the 
fentanyl analogues are scheduled the same way that fentanyl is 
scheduled, you are going to see the drug pushers using the 
analogues if the temporary order expires because they know they 
won't get prosecuted, and it is as simple as that. Now, nobody 
here wants to inhibit any type of research on how we can 
develop better antidotes on that, and there should be some kind 
of an exemption where government-licensed research can be done.
    To say that we shouldn't put fentanyl analogues under 
Schedule 1 because if you are convicted of a fentanyl-related 
offense, you are subject to a mandatory minimum, and we 
shouldn't subject more people to a mandatory minimum, ends up 
saying that we ought to put our opposition to mandatory 
minimums ahead of savings of hundreds of thousands of lives. If 
there ever were wrong priorities, that is it. You know, keeping 
people out of jail on a mandatory minimum and hundreds of 
thousands of people dying is no tradeoff that should be 
acceptable to this Congress or to anybody else, and that is why 
the SOFA Act ought to be passed. It shouldn't be tweaking 
fentanyl a little bit, so you get off the hook if you are 
pushing drugs. That we ought to say that there is no scheduling 
of that, is an argument that in the forum of public opinion 
will not stand up very long at all.
    So, what should we do about this? We have got temporary 
scheduling expiring next week. I wish we had been able to do 
this sooner, but there has been opposition to doing this sooner 
from a whole lot of corners. You know, it is time to realize 
that the opposition, while valid in a number of instances, is 
small in bringing forth the public good compared to saving all 
of these lives. I am sure that the DEA will take the extra year 
that it is given under the law, but it means that we have to 
pass the SOFA Act, maybe as amended, some time this year 
through both houses and have it gone to the President for 
signature. When are we going to put lives first?
    All our civil rights laws are supposed to protect people's 
civil rights. I think the right to life is the paramount civil 
right because if you are not alive, all the other laws aren't 
going to mean anything when you are in the graveyard. So, let's 
get on with doing the right thing. Let's pass the SOFA Act. 
Let's get it through the House and through the Senate, and make 
sure by February 6th, 2021, the law is such that it has no 
loopholes left. I yield back.
    Ms. Bass. Ms. Mucarsel-Powell?
    Ms. Mucarsel-Powell. Thank you, Chairwoman, for having this 
hearing. You know, I think that we all agree that we have a 
public health crisis on our hands, and the opioid epidemic has 
devastated thousands of communities across the Nation. I 
represent southern Florida. In Florida alone, over 5,500 
opioid-related deaths were reported in 2018, and a lot of these 
deaths were not only from use of heroin, but they are actually 
from fentanyl and analogues like you were stating now. They are 
highly addictive substances which have deadly consequences. I 
actually toured an area in my district, Banyan Health Systems, 
that treats individuals that continue to come back for 
treatment because of these highly addictive substances.
    In 2018, there were at 3,100 fentanyl- and analogue-caused 
deaths in my home State, a 35 percent increase from 2017, but 
we are unsure that the State is accurately measuring all the 
effects of fentanyl. Analogues are very hard to track, and 
especially when screening incidents of overdose, they are 
difficult to measure. So, I wanted to hear directly from an ER 
doctor in our community. He works at Jackson Memorial Health 
System, which covers my district, and he is the medical 
director of the Florida Poison Control Center and the 
toxicologist for Jackson Memorial. He outlined the drastic 
increase in fentanyl-related overdoses that he has witnessed in 
recent years.
    He described to me that just 2 years ago, in one 
particularly bad day in the ER, he treated 16 fentanyl 
overdoses in just 1 shift alone. This is just one story from my 
community. I can tell you hundreds of stories that are similar 
to those. I wanted to start with Admiral Giroir. I wanted to 
ask you, going back to Dr. Bernstein's story, why do you think 
it is so difficult to track fentanyl- and analogue-related 
deaths?
    Admiral Giroir. So, I think, as you pointed out, we have 
invested over the last couple of years, with obviously the 
support of Congress, hundreds of millions of dollars from the 
CDC to support local testing laboratories. So, in the past, you 
might not have been able to detect all the analogues. That is 
really changing very drastically and very rapidly. So, we feel 
pretty good about our ability to detect, but what we don't want 
to see is after the person dies, over 2 months for a medical 
examiner to be able to detect it. We really need to keep them 
out of the limelight of use to begin with.
    We are doing many things right now, for example, trying to 
do novel things working together with DOJ, like getting 
anonymized so we don't know who the patient is, but anonymized 
data from all over the country about urine drug screens at a 
very high level so we could begin to start seeing in real time 
when fentanyl analogues or other substances are starting to 
invade a community. Again, we need to treat patients. It is a 
chronic brain disease. If a new fentanyl analogue comes around, 
the local public health department or emergency room may not 
know that. What if it is a very potent one and you reverse it, 
and that ER doctor says everything is good, but 30 minutes 
later the person becomes re-narcotized and back into a coma? 
So, these are the kinds of things we struggle with. What you 
talked about, ma'am, that is happening every day all over the 
country.
    Ms. Mucarsel-Powell. Yeah.
    Admiral Giroir. There is no question about that, Florida, 
ma'am, Pennsylvania. I was visiting Pennsylvania. I was just 
visiting Florida.
    Ms. Mucarsel-Powell. I do think that, you know, it is a 
huge systemic problem, but we need to deal with supporting 
those individuals that have become highly addicted to the 
substances because I don't think we do enough to support these 
centers that treat addiction. So, I mean, it is a whole chain, 
a whole system. I want to ask very quickly, and I wanted to ask 
the Department of Justice. Ms. Liskamm, can you tell me what 
the mandatory sentence is for individuals and the amounts--
    Ms. Liskamm. Sure.
    Ms. Mucarsel-Powell. --that they carry when you find 
someone, and you convict someone?
    Ms. Liskamm. Sure. So, with respect to fentanyl analogues, 
and I am glad you asked this because I think there is a 
misconception about what levels are actually at those 
thresholds. To get a 5-years mandatory minimum sentence, in 
doing the math, with just 2 milligrams of a fentanyl substance 
being a lethal dose, a 5-year mandatory minimum would require 
5,000 lethal doses.
    Ms. Mucarsel-Powell. A hundred milligrams, correct?
    Ms. Liskamm. Correct.
    Ms. Mucarsel-Powell. So, that is like half a cup of 
fentanyl.
    Ms. Liskamm. It is. I don't know how large it is, but 2 
milligrams is--
    Ms. Mucarsel-Powell. I was just looking at the formulas.
    Ms. Liskamm. --2 granulars of salt or something like that.
    Ms. Mucarsel-Powell. Right. When someone carries 100 
milligrams of fentanyl, is that for personal use that you have 
found, or is it to distribute?
    Ms. Liskamm. So, we would have to look at the circumstances 
of the case, and that is one of the things that I think is so 
important to remember. Everyone keeps pointing to the fact that 
we have the Analogue Act to fall back on. One of the prongs is 
that the prosecutors must prove under the Analogue Act that 
something is meant for human consumption, which, in my 
experience, takes months of investigation to prove that this 
substance is being used for human consumption. We have 
wiretaps. We use confidential sources, undercover buys, as 
opposed to a package coming through the mail or stopping a load 
coming into the U.S. The government is charged with proving 
beyond a reasonable doubt that that substance, that kilo of 
fentanyl crossing the border, is meant for human consumption, 
which is a large challenge for the prosecutors who are on the 
line prosecuting these cases every day.
    Ms. Mucarsel-Powell. Would you say that at the bottom of 
the distribution chain, those are the people that get convicted 
at high numbers?
    Ms. Liskamm. No, I actually would disagree with that. The 
Department is always trying to work those cases up and go after 
the El Chapo Guzmans, the leaders of these cartels who are 
responsible for bringing all this poison into the country.
    Ms. Mucarsel-Powell. What do you need from us?
    Ms. Liskamm. We need permanent class-wide scheduling.
    Ms. Mucarsel-Powell. Thank you. I yield back.
    Ms. Bass. Oh, Mrs. Lesko?
    Ms. Lesko. Thank you, Madam Chairman. First, before I ask 
any questions, I would like to ask unanimous consent to place 
in the record a letter from the Major Cities Chiefs 
Association, which represents the police chiefs.
    [The information follows:]



      

                        MS. LESKO FOR THE RECORD

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    Mrs. Lesko. Thank you. In that letter, it specifically 
asked to support Senate Bill 3021 to extend temporary 
scheduling of the fentanyl class. It also says, ``If the 
current scheduling of the fentanyl class is allowed to expire, 
the United States risks opening itself up to a flood of new 
fentanyl analogues,'' as we have heard already. Specifically 
designed to skirt current law, these analogues are slight 
molecular variations of fentanyl, and despite being just as 
dangerous as traditional fentanyl, are technically new, non-
scheduled, and non-controlled substances.
    Furthermore, if the scheduling of the fentanyl class 
lapses, the penalties for manufacturing, trafficking, and 
distributing fentanyl and its analogues will be severely 
diminished. Classifying the fentanyl class as Schedule 1 
controlled substance is a strong deterrent to criminals that 
should be maintained. As others have said, at least on my side 
of the aisle, I wish we had done this sooner instead of waiting 
until the last minute.
    I represent Arizona, and just on January 22nd of this year, 
just the other day, the U.S. Border Patrol agents in my State 
seized more fentanyl on a man they arrested that had bags of 
fentanyl taped to his thighs. This is a fairly common problem 
and as has been attested, either they are manufacturing these 
analogues in Mexico, or China is shipping them to cartels in 
Mexico, and then they are being shipped across the Arizona 
border and other southern borders, and Canada, so I have heard.
    In Arizona, I used to be in the State legislature, and we 
tried to combat this because the opioid addiction is a huge 
problem there. We allowed naloxone to be given by pharmacists 
basically over the counter without a prescriptions. It is 
prescribed along with opioids over a certain strength, I guess 
is the right word. One of the changing subjects, one of the 
concerns that I have about not acting on this is what is going 
to happen with China. We convinced China to do this and go 
along and schedule fentanyl, and they did so on May 1st, I 
think, of 2019. Now we are not going to do it here, and then, 
you know, what message is that sending to China? I think this 
is a really bad move, and I am really concerned actually for 
the lives of all Americans.
    One of the questions that I have for you, Doctor, is do you 
know of any specific cases where research has been hindered 
because of this class-wide temporary scheduling, because that 
was one of the concerns that was brought up.
    Admiral Giroir. So I can't give you at this moment in time 
a specific name of a specific person particularly related to 
this, but we know that as a general rule, any substance in 
Class 1 requires very significant research, and I am going to 
say, of course, we all have to balance the needs, right, 
because we are worried about diversion, we are worried about 
people working with those investigators, but it requires a very 
significant period of time. On average, it could be about 100 
days, but it can take up to a year.
    It is very complicated. When you want to use another 
substance or a different protocol even for the same substance, 
it requires re-application. If you move your laboratory to a 
different part of the campus, it is unclear whether that needs 
a whole separate registration or not. If a lot of people work 
for you, as many of these groups do, it is very unclear still 
whether all of those need to be registrants as well. So, what 
we did together, and, again, we did work this together, is, and 
I want to be clear. We support, HHS supports, permanent 
scheduling of fentanyl analogues for all the reasons I said. We 
would like to see simultaneous, or in the future, the actions 
that we agreed upon to enable research to continue, because it 
is a problem with Schedule 1 drugs now, and it could be more of 
a problem as we schedule 3,000 as part of this class.
    Mrs. Lesko. Thank you very much. I think I have gone over 
time, so I will yield back.
    Ms. Bass. Ms. Jackson Lee.
    Ms. Jackson Lee. Thank you very much and thank you to the 
witnesses. Good to see you, Dr. Giroir, Admiral, and as well to 
Ms. Liskamm. Let me say that we have a sense of urgency that I 
know we are working on, and I thank this Committee for 
convening this hearing. Let me make a few pointed statements 
and then raise questions with all of you.
    Fentanyl, of course, has been used to enhance other drugs, 
and it is deadly. I want to make that very clear. It has killed 
people. I have no opposition. It needs to remain on Schedule 1. 
I hope we will move as swiftly as possible, but you must 
separate the two. You must give comfort to loved ones who have 
lost children, family Members. Fentanyl, my recollection is it 
came out of China, or at least it has been used, and it has now 
proliferated here in a deadly manner. So, I am interested in, 
you know, what you think are your tools that you need.
    I do want to go on record that mandatory minimums have 
never helped anything. It hasn't solved any problems, and I 
will not cede to that. What I will cede to is what I did when 
we were discussing in passing legislation in the last 2 
Congresses on the issue of drugs. I made note of the point that 
the rise in empathy for opioid users and the devastation and 
spread of such did not likewise engage my community in the 
epidemic of crack and then cocaine. They were victims of 
mandatory minimums, and it served no purpose, and it created 
mass incarceration. So, I can't sit here and not put on the 
record what I am willing to do, which is to have it on the 
list, Schedule 1, but I want to see what the government intends 
to do. I think there is a second panel, and I hope to be able 
to hear from them, but how we intend to raise the ante of 
treatment and promoting treatment.
    So, I will start with you, Admiral, and then to Ms. 
Liskamm, how will you frame your prosecution, because Schedule 
1 puts it clearly in the Department of Justice's wheelhouse, 
but getting the poor guy or girl down on the street taking this 
deadly, devastating drug and not trying to respond to the 
larger marketers and sellers. I want to see what legislative 
tool you think you need. Obviously, we know what happens with 
Schedule 1 drugs. DEA, all are involved. How will you focus 
your efforts in trying to weed this out? So, first, Admiral?
    Admiral Giroir. So, thank you, ma'am. It is good to see you 
again.
    Ms. Jackson Lee. It is good to see you.
    Admiral Giroir. I have used this analogy before, but I 
think it works. If I could ask anyone on the Committee to hold 
their breath for 10 minutes and not breathe, I can ask a person 
with a chronic brain disease of addiction of opioid use 
disorder to just stop. You cannot do it. It is a chronic brain 
disease that requires treatment, and that is why everything we 
have been doing at HHS is focused on treatment; of course, 
prevention, but on treatment, and that treatment requires 
medications in almost all circumstances. And we work very 
closely with the DEA and DOJ to be able to do that. 
Psychosocial support, and it requires wraparound services, 
right? If a person is on the street, has food insecurity, does 
not have employment, does not have education, does not have a 
faith-based home, they are going to go right back to where they 
were because we must fix those parts of it, too. So, I couldn't 
agree with you more.
    I will just make just a brief comment is that thanks to the 
work of Congress and working with the Administration, the 
billions of dollars that have gone on the streets to support 
States have been used very well to provide naloxone, to provide 
therapy. What we are trying to enter now, and sort of one of 
our themes, is more sustainable, resilient solutions. We need 
to keep supporting, for example, the expansion of the 
behavioral health workforce that can take care of people with 
chronic behavioral disorders like addiction, both in our cities 
as well as in our rural areas. We have to work on ways to make 
this longstanding because this is not going away tomorrow.
    I would just highlight that we all are very afraid and 
working diligently against the next wave, which are 
methamphetamines. Now methamphetamines are being combined with 
fentanyl and fentanyl analogues, which is really an even more 
poisonous cocktail. So, the next wave is upon us, and we need 
to keep our efforts going.
    Ms. Jackson Lee. Can she have a second just to answer? DOJ, 
yes?
    Ms. Liskamm. Yeah, I just wanted to make a couple points. 
First, I take your comments very seriously, and I just want to 
assure you that the Department is not targeting drug addicts. 
We need this tool of permanent class-wide scheduling to go 
after the cartels, the transnational criminal organizations who 
are trying to flood our streets in order to make enormous 
profits.
    Ms. Bass. Thank you.
    Ms. Liskamm. I would just also point out that this order 
has been in effect for almost 2 years now, since February 6th 
of 2018, and we have not seen the overcriminalization that many 
critics have pointed to as a concern for the permanent class-
wide scheduling. Lastly, I would just point out that the 
Department is very much committed to its outreach efforts as a 
part of a sort of whole-of-government approach to solving this 
crisis, and we have been working, as I mentioned, hand-in-hand 
with HHS on a number of initiatives. Every district throughout 
the country has an opioid coordinator, and part of their 
mission is to not only focus the prosecution efforts, but also 
the outreach efforts depending on what that district looks 
like.
    Ms. Bass. Thank you.
    Ms. Liskamm. Thank you.
    Ms. Bass. Mr. Cline?
    Mr. Cline. Thank you, Madam Chair. I appreciate holding 
this timely hearing on this issue. I would ask unanimous 
consent to enter into the record a letter from the Federal Law 
Enforcement Officers Association and the National Sheriffs 
Association urging passage of S. 3201, the Temporary 
Reauthorization and Study of the Emergency Scheduling of 
Fentanyl Analogues Act.
    Ms. Bass. Without objection.
    [The information follows:]



      

                        Mr. CLINE FOR THE RECORD

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    6Mr. Cline. Madam Chair, I want to thank the witnesses for 
being here as well. The opioid crisis has ravaged our Nation 
and has touched the lives of thousands of American families who 
have lost loved ones to this terrible plight. Since 2013, fatal 
drug overdoses have been the leading cause of unnatural deaths 
in my home State of Virginia. In 2018, 54 percent of the fatal 
drug overdoses in Virginia were caused by fentanyl. In total, 
there were over 800 fatal fentanyl-related drug overdoses, and 
over 300 were from fentanyl analogues.
    Later today, this Committee will hear firsthand from Dr. 
Donald Holman, whose family previously lived in Lynchburg in 
the 6th Congressional District of Virginia and has been forever 
impacted by the opioid crisis. Tragically, Mr. Holman lost his 
son, Garrett, in 2017 after he took a synthetic opioid 
delivered through the mail. The courage of the Holman family 
has shown to tirelessly advocate to keep these dangerous drugs 
off our streets is inspiring. Mr. Holman's story and Garrett's 
story offers Members of Congress and others a window into the 
opioid crisis, which has taken a heavy toll on our local 
communities.
    In just a few short days, the DEA's emergency scheduling 
will end, and communities already battling opioid addiction 
will face a wave of deadly drugs flooding our cities and towns 
if Congress does not Act swiftly. Yes, the issue of mandatory 
minimums is one that we should debate, but in the meantime, 
people are dying, and we can take action to prevent these 
tragedies from occurring. I hope my colleagues here in Congress 
will come together to ensure that dangerous fentanyl analogues 
remain scheduled and are kept off our streets.
    So, I would ask Ms. Liskamm, you stated that the quantity 
of analogues seen in law enforcement actions has decreased 
since the class scheduling was enacted 2 years ago. Are we 
seeing fewer fentanyl analogues at land border seizures as 
well?
    Ms. Liskamm. I can't speak to the border seizures as the 
Department of Homeland Security through Customs and Border 
Patrol controls that area. I do know that, my understanding is 
at least, that the data that DEA is reporting with respect to a 
50 percent decrease are for fentanyl analogues that are coming 
in through any manner. I don't have the statistic, but we have 
definitely seen a large decrease in the amount of fentanyl and 
fentanyl analogues coming through the mail from China. So, 
again, this is a testament to the fact that this scheduling 
order is working.
    Mr. Cline. How has the current temporary scheduling order 
helped DOJ in their efforts to pursue and prosecute individuals 
for drug trafficking? If you could focus on the process by 
which they are sent through the mail.
    Ms. Liskamm. Sure. So, I think the biggest distinction is 
that DOJ prosecutors are able to prosecute these crimes under 
title 21, United States Code 841, as opposed to using the 
Analogue Act. Under the Analogue Act, which is incredibly 
resource and time consuming, the Department is required to 
prove that the substances are intended for human consumption, 
that they are chemically similar to the underlying substance, 
such as fentanyl in this case, and that they have the same--I 
am summarizing here--but the same psychostimulant effect.
    That requires experts on both sides. Many of those experts 
are actually DEA chemists who are being taken away from labs 
and actually testing the drugs. The prosecutors have to get 
savvy on all of this type of lingo. They have to educate the 
jury and the judge, and then they have to sort of walk the jury 
through and get them to a point where they can find this 
individual guilty beyond a reasonable doubt. It is a huge 
resource drain, and being able to prosecute under title 21, 841 
and 846, allows us to go after these transnational criminal 
organizations and use our resources correctly.
    Mr. Cline. Good. What would be the impact on communities 
already battling the opioid epidemic if Congress doesn't extend 
the scheduling of fentanyl-related substances?
    Ms. Liskamm. So, again, I think we can point to what we 
have seen over the past 2 years: A 50 percent decrease in the 
amount of fentanyl analogues coming in. That is what the 
communities are seeing on the street, a 50 percent decrease in 
these substances that are killing Americans.
    Mr. Cline. Thank you. Madam Chair, I yield back.
    Ms. Bass. Mrs. McBath?
    Mrs. McBath. Thank you, Madam Chair. Thank you both so much 
for being here today and being here to discuss this serious 
public health crisis that we have before us. I want to thank 
the many researchers at the Centers for Disease Control and 
Prevention, which is part of my district and basically near my 
district. Their research is critical to making sure that we are 
making informed decisions that will our communities and our 
loved ones safe.
    Admiral, in your testimony, and I have actually had a 
chance to read a bit of your testimony, you discuss several 
recommendations that are a part of what you described as an 
interagency solution that balances the need to restrict access 
to these substances with the need for continued research. Are 
there any policies that you feel are especially important so 
that we can continue to get a better understanding and a better 
sense of this life-threatening problem without overburdening 
our researchers?
    Admiral Giroir. Yes, ma'am, thank you, and thank you for 
reading the testimony. We outlined about 8 steps that we agreed 
to, and, again, I want to say this was truly interagency. We 
had Members of the Centers for Disease Control and Prevention, 
multiple centers at the National Institutes of Health, the FDA, 
as well as representatives of myself, along with Mr. Dhillon, 
the administrator of the DEA, and Deputy Attorney General Jim 
Carroll, that we all worked on this together because we do 
recognize there is a balance that we need to achieve both 
goals. We need to get analogues and keep them off the street 
and keep them scheduled, but we do need to make both these and 
other Schedule 1 substances more available to CDC, NIH, even 
the FDA to approve drugs.
    So, we outlined those 8 simple steps that might not be all 
inclusive, and one of those steps was that the Attorney General 
and the Secretary of HHS would put a task force together to 
really look at this comprehensively to see if there were 
further things we can do. But clearly the first 7, as we saw in 
the testimony, I don't want to waste your time, but would be 
really, really important, and everybody around the room agreed.
    Mrs. McBath. Thank you for that. Also can you elaborate on 
how HHS considers the impact of special populations, such 
people that have particular illnesses, and how do we make sure 
that we are keeping kids safe from these dangerous drugs, while 
also making sure that researchers are fully able and capable to 
seek out new treatment?
    Admiral Giroir. Yes, ma'am. Special populations are a 
particular interest. I am a pediatric intensive care physician 
by training, and so taking care of children from newborns to 
15- or 16-year-olds are what I do and what my passion is for. 
So let me say that we are investing an enormous amount of 
resources, for example, in children who are born dependent on 
opioids because their mothers were using opioids. We approach 
this as a treatment, right? We must keep the mother and child 
together. We want them both to recover. The NIH is investing 
literally $50, $60 million into their program for that.
    I am personally very concerned. One of our big initiatives 
is also to not deny pain medications to special populations who 
need it. For example, patients with cancer, or I am a 
particular advocate for children and adults with sickle cell 
disease. In our reports, for example, our pain management task 
force, there is a whole section treating special populations, 
like people with sickle cell disease, like people with cancer 
or with other chronic illnesses, because we don't want to 
devastate people who are in real pain when they really need the 
drugs while we are achieving this. So, there are a number of 
special populations, and I would be happy to go through them 
with you, to make sure we get all of them because we want to 
treat everyone, not just the average person but everyone and 
their particular needs. We want to meet them where they are.
    Mrs. McBath. Right. Thank you for that answer. Ms. Liskamm, 
we all want to keep these dangerous substances away from our 
communities, and especially away from our children, and some 
have recommended tough criminal penalties that actually do 
that. We also want to make sure that if these drugs do reach 
our communities, the emergency responders and medical 
professionals are able to intervene to prevent these tragedies. 
How can we make sure that these goals don't conflict?
    Ms. Liskamm. I don't believe that they do conflict. The 
Department is very much committed to outreach efforts targeting 
children to make sure that they are not getting involved in 
experimenting with opioids and getting addicted to them. One of 
the districts has an opioid youth summit where they send a 
youth ambassador from each high school to learn from victims' 
family Members, law enforcement, and public health officials 
about the dangers of opioid use, and then brings that back to 
their high schools to tell everyone about that, what they have 
learned. That is an incredibly important part of what the 
Department is doing, but it is separate and apart from the 
tools that we need to go after these transnational criminal 
organizations that are flooding our communities with this 
incredibly lethal poison. So, I think that we can sort of 
accomplish both of those through the Department's efforts.
    Mrs. McBath. Thank you.
    Admiral Giroir. With your permission, I just want to 
highlight Drug Takeback Day is very important. Many children 
get first exposed to opioids by leftover drugs in the cabinet, 
and this has been a tremendous national success. About 1 
million pounds of pills are turned in for destruction multiple 
times per year, so getting rid of those excess drugs so they 
don't fall into the hands of your children or your relatives is 
still a very important thing that we do.
    Mrs. McBath. Thank you.
    Ms. Bass. Mr. Gohmert?
    Mr. Gohmert. Thank you, Madam Chair, and I appreciate 
having this hearing. I am glad we are having it before the 
expiration of the laws that restrict fentanyl and its 
analogues. I guess we could have had it last year, but time was 
of the essence. The President was a clear and a present danger. 
That was before the month we didn't take up impeachment after 
it was passed in the House. But eventually we got around to 
this hearing, and obviously it is important, as the Holmans 
know, having lost a son. We are talking about something that is 
extremely addictive, and I am glad, Admiral Giroir, to hear you 
say you are in favor of continuing the listing because I had 
concerns from your written testimony that you might want to see 
that eased up so it would be easier for researchers to get to 
fentanyl analogues. Clearly that is something we need to work 
on so it is easier for researchers to get it.
    Fentanyl is used in some lawful medications, right? I mean, 
I tore my meniscus in the congressional baseball game, and when 
I had surgery, I said as I was about to go under, what is in 
this anesthesia, and he named a couple of things and said 
``fentanyl.'' I went ``fentanyl,'' and that was the last thing 
I heard before I went out.
    [Laughter.]
    Mr. Gohmert. Also, you had mentioned the DEA. I am 
surprised the majority did not want to hear from the DEA. They 
did not want to hear from the Office of National Drug Control 
Policy. From my experience as a felony judge, nobody knows more 
about the illegal drug situation in America than the DEA, would 
you all agree with that, from the law enforcement standpoint?
    Ms. Liskamm. I think that DEA is one of the preeminent 
experts on drug trafficking trends, both international and 
domestically.
    Mr. Gohmert. Admiral, have you had that experience?
    Admiral Giroir. Yes, sir, and literally every week, if not 
multiple times a week, the interagency, including DEA, ONDCP, 
DOJ, and myself, HUD, are all around a single table. So, we are 
pretty highly coordinated.
    Mr. Gohmert. I have here a letter from the national 
President of the National Fraternal Order of Police, Patrick 
Yoes, and he says he is ``writing on behalf of the Members of 
the Fraternal Order of Police to advise you of our strong 
support for the swift consideration and passage of S. 3201''--
that is the Senate bill--``Temporary Reauthorization and Study 
of Emergency Scheduling of Fentanyl Analogues Act, which the 
Senate passed by unanimous consent. The legislation would 
extend for 15 months the classification of fentanyl as a 
Schedule 1 drug, a classification which expires 6 February.'' 
Next week. ``For this reason, the consideration and passage of 
this bill is a matter of some urgency as drug overdose deaths 
are surging across the country,'' although we know that 
actually since it has been listed, Ms. Liskamm, as you 
indicated, 17,000 contacts by our law enforcement have been 
reduced to 8,000. You know that has got to mean fewer deaths as 
a result. It seems to me, from what I have seen, if law 
enforcement is having half as much contact with the drug that 
normally can be projected, that there is probably half as much 
coming in as there was previously. Would you agree?
    Ms. Liskamm. I would, sir.
    Mr. Gohmert. Okay. Anyway, it just goes on to make the 
point that the police across the country, the National Order, 
they all agree this needs to be listed. Like I say, Admiral, we 
want to make it easier for researchers to get it, use it, and 
find answers, but I understand the problem here has been some 
in the majority were very concerned about mandatory minimums. 
In Texas, we call that a range of punishment. There is a low 
level, and then there is minimum and a maximum, and depending 
on the level of the crime, that determines the minimum and the 
maximum, and it is a good way to do things, as I found having 
sent someone to prison whose family hated my guts. They were 
extremely wealthy, but she had experimented with everything, 
and her mother says, thank you, you saved our daughter's life. 
It can help. We do need addiction centers to deal with some 
prisoners, and I hope we can work together on that. I yield 
back.
    Ms. Bass. For the record, the Committee did invite the DEA, 
and we were honored that they recommended Ms. Liskamm to come.
    Mr. Gohmert. Madam Chair, could I offer or ask unanimous 
consent to--
    Ms. Bass. Without objection. Ms. Jackson Lee wants to enter 
some articles.
    Ms. Jackson Lee. Yes, thank you so very much, Madam Chair. 
A letter from nearly 70 organizations that outline their 
concern about extending the DEA quickly; a statement for the 
record submitted by the American Psychological Association; a 
letter from the American Society for Pharmacology and 
Experimental Therapy; a letter from Charles P. France, Ph.D., 
professor, about concerns of this legislation; a letter from 
the Sentencing Project regarding today's hearing; a letter from 
the Drug Policy Alliance regarding today's hearing; a January 
2020 report from the Drug Policy Alliance, titled, ``Criminal 
Justice Reform in the Fentanyl Era''; and finally, a January 
26th, 2020 Washington Post op-ed by Nancy Gertner, titled, 
William Barr's New War on Drugs. I ask unanimous consent that 
each of these be submitted to the record.
    Ms. Bass. Without objection.
    [The information follows:]



      

                     MS. JACKSON LEE FOR THE RECORD

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    Ms. Jackson Lee. Thank you.
    Ms. Bass. Mr. Reschenthaler?
    Mr. Reschenthaler. Thank you, Madam Chair. I do ask for 
unanimous consent to enter a letter from the Addiction Policy 
Forum.
    Ms. Bass. Without objection.
    [The information follows:]



      

                    MR. RESCHENTHALER FOR THE RECORD

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    Mr. Reschenthaler. Thank you. Thank you, again, Chairwoman 
Bass. Thank you for our witnesses for being here today. I am 
incredibly disappointed that my colleagues across the aisle are 
dragging their feet on legislation to combat the flow of 
fentanyl substances into our communities. This is an extremely 
lethal drug. It only takes 3 milligrams of fentanyl to kill an 
average-sized adult. By comparison, a fatal dose of heroin is 
30 milligrams.
    The opioid crisis is an issue that hits every single 
congressional district, Republican or Democrat. It is a 
pandemic. We should not play partisan politics when it comes to 
people's lives. In 2017, my home State of Pennsylvania was 
ranked 3rd in the United States for drug overdose deaths, and 
fentanyl was present in roughly two-thirds of those fatalities. 
Speaking bluntly, people are dying, and my Democrat colleagues 
are sitting on their hands. The House should have approved the 
Senate bill, which passed the other chamber unanimously without 
opposition. We should have been working on this instead of 
wasting all our time on this sham impeachment. This is 
absolutely shameful.
    But thankfully, we have a President who is treating this 
crisis with the seriousness it deserves. In 2018, President 
Trump secured a commitment from China to address the flow of 
fentanyl into the United States. The following year, China 
permanently scheduled fentanyl, making fentanyl drugs illegal 
for manufacture, possession, and sale. President Trump's 
actions are working. If you look at the stats, in 2019, the 
amount of fentanyl and fentanyl analogues smuggled in from 
China decreased. So, it is critical that the House follow the 
Senate's lead to pass legislation and extend the temporary 
scheduling of fentanyl-related substances before the February 
6th deadline. American lives are at risk. Admiral Giroir?
    Admiral Giroir. Yes, sir.
    Mr. Reschenthaler. I have heard pushback from the other 
side that scheduling fentanyl hinders important medical 
research. Can you briefly outline steps that HHS has taken to 
provide researchers with access to study these substances?
    Admiral Giroir. So, thank you for that, and I want to be 
absolutely clear that in an ideal world we would like it 
permanently scheduled and the research protections to be at the 
same time, but we have to schedule these drugs or else we are 
going to have thousands more deaths this year. The emergency 
rooms are not going to be able to detect it. Some of the harm 
reduction measures have not been effective. So, we do support 
it being scheduled.
    The kinds of research protections we talked about, again, 
are the ability to rapidly de-schedule or reduce the schedule 
of drugs, and, again, this is not something just from HHS. This 
is something that the interagency has decided is very important 
because, look, they want reversal agents and better treatment 
as well as we do, as well as some activities that would, for 
example, if you are approved to do work on one substance, you 
have to go back through the whole process if you want to go 
through another analogue. That just doesn't make, you know, 
sort of common, logical sense.
    So, these kind of simplified procedures, we think, are very 
consistent with scheduling, but also achieving our goals. They 
are not mutually exclusive. We think we can do both.
    Mr. Reschenthaler. Thank you, Doctor. I appreciate it, and 
I would yield the remainder of my time to my colleague from 
Arizona, Mrs. Lesko.
    Mrs. Lesko. Thank you. I have a question. Ms. Liskamm, can 
you repeat what you said about to get a 5-year minimum 
sentence, what has to happen, because we heard, at least I 
heard, that Chairman Nadler, this was one of the reasons for 
the holdup because of the concern over this minimum mandatory 
sentencing.
    Ms. Liskamm. So, in order to trigger a 5-year mandatory 
minimum, there needs to be the equivalent of 5,000 lethal doses 
of a fentanyl analogue. To trigger a 10-year mandatory minimum, 
you need the equivalent of 50,000 lethal doses of a fentanyl 
analogue.
    Mrs. Lesko. What does that mean? They have to be dealing 
it, possessing it? What does that mean?
    Ms. Liskamm. So, under the statute, it could be possession, 
possession with intent to distribute, manufacturing, 
distribution, importation, conspiracy of all of these different 
crimes as well. We need every tool that we can to go after 
these criminals.
    Mrs. Lesko. Thank you.
    Ms. Bass. Thank you. I would like, one, to thank the 
panelists. Thank you, witnesses, for being here today. I would 
like call forward the next panel: Dr. Comer, Mr. Butler, Mr. 
Holman, and Dr. Ciccarone. Before you sit down--thank you--I 
want to swear everyone in.
    We welcome our second set of witnesses and thank them for 
participating in today's hearing. Now, if you would please--
well, you have already risen--I want to begin by swearing you 
in. Raise your right hand.
    Do you swear or affirm under penalty of perjury that the 
testimony you are about to give is true and correct to the best 
of your knowledge, information, and belief, so help you God?
    [A chorus of ayes.]
    Ms. Bass. Let the record show the witnesses answered in the 
affirmative. Thank you, and please be seated.
    We will now proceed with introductions, starting with the 
panel. Dr. Comer is professor of neurobiology in the department 
of psychiatry at the Columbia University, and a research 
scientist at the New York State Psychiatric Institute. She is 
also director of the opioid laboratory in the Division on 
Substance Use Disorders and runs a very active research program 
devoted to examining various aspects of the abuse liability of 
opioids. Mr. Butler is the Federal public defender for the 
Northern District of Alabama. Prior to his appointment, Mr. 
Butler served as the chief deputy defender and chief trial 
attorney for the Office of the Federal Defender for the Middle 
District of Alabama.
    Mr. Holman is a father who lost his son, Garrett, to 
overdose from a synthetic opioid called U-47700. Since his 
family's loss, he has been an advocate to help address the 
opioid crisis. He has attended roundtable meetings with 
Governor Christie and First Lady as well as testified in 
Pennsylvania for Senator Jay Costa. Through his advocacy, he 
works to ensure other families do not lose loved ones to 
addiction.
    Dr. Ciccarone is a Board-certified clinician in family 
medicine and addiction medicine. In his position as professor 
of family and community medicine at the University of 
California--San Francisco, he has been principal or co-
investigator on numerous NIH-sponsored public health research 
projects, including his current heroin and transition study. He 
is also the associate editor for the International Journal of 
Drug Policy and has recently edited a special issue on the 
triple-wave crisis of opioids, heroin, and fentanyl in the 
United States.
    Dr. Comer, you can begin.

                  TESTIMONY OF SANDRA D. COMER

    Ms. Comer. Chair, Ranking Member, and Members of the 
subcommittee, thank you for holding today's hearing on class-
wide scheduling of synthetic fentanils. I am Dr. Sandra Comer, 
public policy officer of the College on Problems of Drug 
Dependence, a Membership organization with over 1,000 Members 
that has been in existence since 1929. CPDD is the longest-
standing organization in the U.S. addressing problems of drug 
dependence and abuse. For over 2 decades, my research has 
focused on the development and testing of novel approaches to 
the treatment of opioid use disorder.
    The U.S. is experiencing an unprecedented increase in the 
illicit use of opioids and its associated morbidity and 
mortality. In 2017, opioid overdoses claimed more than 47,000 
lives in the U.S. Many of these deaths have been linked to 
illicitly manufactured fentanyl and its analogues. Fortunately, 
several medications are available and have been used 
successfully for treating opioid use disorder, including 
methadone, buprenorphine, and naltrexone. One concern with the 
introduction of fentanyl and its analogues to the street supply 
of illicit opioids is whether the approved treatment 
medications can effectively reduce use of these drugs.
    Further research on the ability of the approved as well as 
new medications for treating opioid use disorder in patients 
who are predominantly using fentanyl is clearly needed to 
address the fentanyl crisis. Naloxone is an antagonist that is 
used therapeutically to reverse opioid overdose. Recent reports 
suggest that higher or repeated dosing with naloxone may be 
required to reduce fentanyl-induced respiratory depression. The 
reason that higher doses of naloxone may be required is not 
entirely clear. Additional studies are needed to assess the 
effectiveness of naloxone and other antagonists in reversing 
fentanyl-related overdoses.
    Fentanyl and its analogues are exceptionally potent, 
inexpensive, and easy to synthesize. Small modifications in 
these molecules can have profound effects on their activity, 
changing an inactive compound to an exceptionally potent opioid 
with high abuse potential. However, similarity in chemical 
structure does not necessarily translate to similarity in abuse 
liability. For example, oxymorphone is a potent mu opioid 
receptor agonist with high abuse potential, while naltrexone 
and naloxone are opioid antagonists that have saved thousands 
of lives. All 3 medications share the same core chemical 
structure.
    This example illustrates how the antidote to a toxic 
substance and the toxic substance itself can share core 
structures, but the chemical structure of a compound alone 
cannot tell us whether it will have agonists or antagonist 
activity. Basic pharmacological studies must be performed to 
make this determination. Science-based agencies, specifically 
the Food and Drug Administration and the National Institute on 
Drug Abuse, should review the pharmacological activity, not 
just the chemical structures of these compounds. The Committee 
should consider adding a role for HHS subjecting compounds to 
limited tests of pharmacological activity through animal models 
using a rapid process that could be undertaken by NIDA, and a 
designated pre-screened team of extramural scientists.
    The current fentanyl crisis poses a formidable challenge to 
Congress and the DEA since there are literally thousands of 
fentanyl analogues, some of which have high abuse potential. 
CPDD supports efforts to control the distribution, sales, and 
use of these synthetic fentanils. However, to globally put all 
compounds that are chemically similar to fentanyl in Schedule 1 
is likely to severely limit biomedical research and, in the 
long term, adversely impact public health.
    Obtaining a DEA schedule on registration is complicated, 
burdensome, and can take a long time, sometimes more than 1 
year, disincentivizing researchers in general, and, 
particularly, young researchers. To ensure more research on 
synthetic fentanils, Congress should consider instituting 
legislation procedures for streamlining the process for 
obtaining a Schedule 1 license. I can expand on these specific 
recommendations during the question-and-answer session 
following my testimony.
    Scientists have dedicated their careers to research to save 
lives and protect individuals from the devastation caused by 
drug abuse. More information, not less, is the best way we can 
achieve that goal. I encourage you and your colleagues to 
consider alternative approaches so that the potential benefits 
and risks of new chemical entities can be characterized before 
decisions are rendered regarding DEA scheduling.
    [The statement of Ms. Comer follows:]
    
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]    
   
    2Ms. Bass. Mr. Butler?

                  TESTIMONY OF KEVIN L. BUTLER

    Mr. Butler. Chairwoman Bass, Ranking Member Ratcliffe, 
Members of the subcommittee, thank you for inviting my 
perspective as you consider how to best respond to the opioid 
episode. Before I begin, I would like to pause and recognize 
Mr. Holman and your family. I am so sorry for your loss.
    This is a complex issue. I do not pretend to have all the 
answers, but DOJ's proposal will simply repeat what does not 
work: Policies that are trumpeted as targeting kingpins that 
instead severely punish low-end offenders and users. My 
testimony here today is based on my personal experience and on 
behalf of the National Association of Federal Defenders. What 
we fear is that history is repeating itself.
    I grew up in Toledo, Ohio, just south of Detroit. By the 
time I graduated high school in 1984, crack addiction and War 
on Drug laws had devastated my community. Friends and relatives 
with little or no criminal history who were abusing crack and 
selling it to support their habit were going to prison to serve 
long mandatory sentences with no relief. Meanwhile, drug 
kingpins, who had information prosecutors wanted, could 
cooperate, and earn reduced sentences. As a young public 
defender in 1992, I'll never forget the devastation on my 
client's face when I told him he was facing a mandatory minimum 
10-year sentence. He was a young Black man my exact age. He had 
no criminal history, had a severe crack addiction. He was 
arrested for crack found in a car he was driving. Year after 
year, my colleagues and I fought for sentence reductions, but 
it was more of the same: Young minorities charged with 
nonviolent drug offenses being sent to prison for long 
mandatory sentences.
    Over the past decade, I've been encouraged by laws moving 
away from these failed and disruptive approaches. The Fair 
Sentencing Act of 2010 reduced the unjust crack cocaine 
disparity, and about 1 year ago, the First Step Act became law. 
Both passed with overwhelming bipartisan support, and both 
recognized that sentencing nonviolent drug dealers to oversized 
prison terms does not cure our problems. We must focus on 
education, treatment, and reducing overdose deaths. We have 30 
years of evidence showing that a drug policy predicated on 
severe one-size-fits-all punishments does not work. Class-wide 
scheduling is not the solution. Fear and misinformation are 
being used to support the call for class-wide scheduling. Make 
no mistake: A class-wide ban will silence health experts and 
ignore science. I urge you to cast a critical eye on calls for 
this ban.
    Let me first address the misinformation. To be clear, 
harmful fentanyl analogues are illegal now with or without 
class-wide scheduling. If the class-wide ban expires, no 
harmful fentanyl analogue will become legal. I was glad to see 
Judge Nancy Gertner's article this Sunday, and that has been 
entered into the record. This addresses that. The article 
addressed that. The government already, too, has powerful tools 
to ban and prosecute fentanyl and its analogues. The first tool 
is scheduling. With HHS, the Department of Justice can schedule 
any substance that meets certain criteria, and DOJ can use its 
broad authorities under the Controlled Substances Act to 
temporary schedule and then prosecute fentanyl analogues on a 
substance-by-substance basis without even going through the HHS 
process. Many fentanyl analogues have already been scheduled 
this way.
    The second tool is the Analogue Act. This allows DOJ to 
criminalize substances that are chemically similar and have 
similar biological effects compared to drugs that are already 
scheduled. DOJ has used these tools to wage aggressive and 
successful prosecutions. Between 2014 and 2018, the number of 
individuals sentenced for fentanyl-related offenses has 
increased by 4,711 percent. Who is DOJ prosecuting? In 2018, 
the GAO found that DOJ was ``targeting street-level and mid-
level distributors rather than focusing more heavily on 
traditional targets, such as cartels. Less than 6 percent of 
prosecutions involve leaders or supervisors, more than 40 
percent had little or no criminal history, and over three-
quarters of the people were people of color. This is the War on 
Drugs Part 2.''
    Currently, if DOJ wants to schedule a substance quickly, it 
can, but before substances are permanently scheduled, the law 
requires health experts at HHS to confirm that the drug is 
actually harmful and check for any potential beneficial uses. 
The class-wide ban would remove this expertise from the 
process. We don't even know how many substances the ban would 
schedule, let alone their effects on the human body.
    Ms. Bass. Thank you.
    Mr. Butler. Thank you.
    [The statement of Mr. Butler follows:]

                  STATEMENT OF KEVIN L. BUTLER

    Mr. Chairman and Members of the Subcommittee:
    Thank you for holding this hearing and for inviting me to 
testify. At any given time, Federal Public and Community 
Defenders and other appointed counsel under the Criminal 
Justice Act represent 80 to 90 percent of all federal 
defendants because they cannot afford counsel.
    I have spent 27 years as a public defender on the front 
lines of the War on Drugs. From this vantage point, I have 
watched the implementation of law enforcement policies adopted 
in the name of ending drug addiction, reducing supply, and 
making streets safer. I have watched as harsh mandatory 
minimums and the unjust discriminatory 100-to-1 crack cocaine 
penalties sent my clients--many young men of color--to crowd 
our prisons. I have seen the broken families and communities 
left behind. I've witnessed through my clients that the 
policies adopted in this War on Drugs have failed.
    Tens of millions of Americans continue to struggle with 
addiction and its consequences.\1\ Near-daily headlines 
reporting large scale seizures of a variety of drugs prove that 
our nation's choice to address drug dependence through sweeping 
and severe law enforcement efforts, rather than public health 
responses, has failed to alleviate the addiction that fuels 
demand.\2\
---------------------------------------------------------------------------
    \1\ Substance Abuse and Mental Health Services Administration, Key 
Substance Use and Mental Health Indicators in the United States: 
Results from the 2018 National Survey on Drug Use and Health, at 2 
(2019), http://www.samhsa.gov/data/sites/default/files/cbhsq-reports/
NSDUH NationalFindingsReport2018/NSDUHNationalFindingsReport2018.pdf 
(``In 2018, approximately 20.3 million people aged 12 or older had a 
substance use disorder (SUD) related to their use of alcohol or illicit 
drugs in the past year'').
    \2\ See e.g., Kelly McCarthy, $377 Million Drug Bust Includes 
Almost 40,000 Combined Pounds of Cocaine and Marijuana, ABC News (Oct. 
29, 2019), https://abcnews.go.com/US/377-million-drug-bust-includes-
40000-combined-pounds/story?id=66611327 (U.S. Coast Guard seizes 28,000 
pounds of cocaine and 11,000 pounds of marijuana at a Florida port); 
U.S. Customs and Border Control, U.S. Customs and Border Protection 
Seizes Over 17.5 Tons of Cocaine in Philadelphia (June 21, 2019), 
https://www.cbp.gov/newsroom/national-media-release/us-customs-and-
border-protection-seizes-over-175-tons-cocaine (reporting largest 
cocaine seizure in the 230-year history of Customs and Border 
Protection, valued at $1.1 billion); Joel Shannon, Frozen Strawberry 
Shipment from Mexico Contained $12.7 Million Worth of Meth, Authorities 
Say, USA Today (Feb. 20, 2019), https://www.usatoday.com/story/news/
nation/2019/02/20/meth-worth-12-7-million-found-frozen-strawberries-
mexico/2931988002/ (Customs and Border Protection seized 906 pounds of 
methamphetamine, worth $12.7 million concealed in a commercial shipment 
of frozen strawberries).
---------------------------------------------------------------------------
    We can and must do better for the individuals, families and 
communities impacted by addiction and its consequences. I have 
been encouraged by the last decade's bipartisan movement toward 
reform. In 2010, Congress enacted the Fair Sentencing Act to 
reduce the unjust disparity between crack and cocaine from 100-
to-1 to 18-to-1.\3\ President Obama granted clemency to almost 
2,000 individuals serving lengthy sentences for drug offenses, 
and during his Administration the Department of Justice 
(Department) curtailed its use of mandatory minimums.\4\ Just 
over a year ago, Congress passed the First Step Act of 2018 
with overwhelming bipartisan support, reducing sentences for 
certain drug offenses and making the Fair Sentencing Act of 
2010 retroactive.\5\ To date, more than 2,400 individuals 
serving unduly long sentences imposed under the discriminatory 
100-to-1 ratio have seen reductions in their sentences.\6\ And 
recent government efforts to emphasize treatment instead of 
incapacitation, such as the SUPPORT Patients and Communities 
Act,\7\ show a hopeful commitment to reverse our past missteps 
and respond to this public health problem deliberately and 
humanely.
---------------------------------------------------------------------------
    \3\ Fair Sentencing Act of 2010, Pub. L. No. 111-220, 124 Stat 2372 
(Aug. 3, 2010).
    \4\ Sari Horwitz, Obama Grants Final 330 Commutations to Nonviolent 
Drug Offenders, Wash. Post (Jan. 19, 2017), https://
www.washingtonpost.com/world/national-security/obama-grants-final-330-
commutations-to-nonviolent-drug-offenders/2017/01/19/41506468-de5d-
11e6-918c-99ede3c8cafa_story.html (granting a total of 1,715 
clemencies); United States Dep't of Justice, In Milestone for 
Sentencing Reform, Attorney General Holder Announces Record Reduction 
in Mandatory Minimums Against Nonviolent Drug Offenders (Feb. 17, 
2015).
    \5\ First Step Act of 2018, Pub. L. No. 115-391, 132 Stat 5194 
(Dec. 21, 2018).
    \6\ Federal Bureau of Prisons, First Step Act, https://www.bop.gov/
inmates/fsa/ (Jan. 24, 2020).
    \7\ See, e.g., Substance Use-Disorder Prevention that Promotes 
Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT 
for Patients and Communities Act), Pub. L. No. 11-271, 132 Stat 3894 
(Oct. 24, 2018).
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    Since 2015, fentanyl has replaced heroin and crack as the 
face of drug addiction in our country.\8\ Fentanyl is a potent, 
fast-acting, synthetic opioid. There are also fentanyl 
analogues: substances with chemical structures and effects 
substantially similar to fentanyl. Fentanyl and its analogues 
have increasingly emerged in the illegal drug market, most 
often added to heroin or sold in counterfeit opioid 
prescription pills.\9\ In 2018, 30,000 overdose deaths involved 
synthetic opioids.\10\ Fentanyl is now present in most heroin 
in the Midwest and Northeast and its prevalence is spreading 
West.\11\
---------------------------------------------------------------------------
    \8\ Drug Policy Alliance, Criminal Justice Reform in the Fentanyl 
Era: One Step Forward, Two Steps Back, at 6 (2020), http://
www.drugpolicy.org/sites/default/files/dpa-cj-reform-fentanyl-era-
v.3_0.pdf (One Step Forward).
    \9\ Id. See also, Centers for Disease Control and Prevention, 
Synthetic Opioid Overdose Data, https://www.cdc.gov/drugoverdose/data/
fentanyl.html.
    \10\ One Step Forward, at 3; Overdose deaths resulting from these 
substances are grouped together with other synthetic opioids, like 
Tramadol. See Centers for Disease Control and Prevention, supra note 9.
    \11\ One Step Forward, at 7.
---------------------------------------------------------------------------
    There are troubling signs that Congress's response to 
fentanyl threatens to erase the gains of the past decade by 
returning to the failed and unjust strategies of the drug war. 
Some legislators who have supported the bipartisan movement 
away from the War on Drugs are nevertheless endorsing a harsh 
and punitive response to fentanyl.\12\ Classwide scheduling of 
fentanyl-related substances, as proposed by the Department and 
Drug Enforcement Agency (DEA),\13\ and in several pending bills 
in the House and Senate,\14\ is part and parcel of this 
devolution. Classwide scheduling of fentanyl-related substances 
would grant the DEA broad and unilateral authority to place any 
existing or future substance it deems to have a certain 
chemical structure on Schedule I, the highest restriction, with 
no further health or scientific justification required.\15\
---------------------------------------------------------------------------
    \12\ Id. at 8.
    \13\ The Countdown: Fentanyl Analogues & the Expiring Emergency 
Scheduling Order, Hearing Before the Committee on the Judiciary, United 
States Senate (2019) (statement of Amanda Liskamm, Director of Opioid 
Enforcement and Prevention Efforts, Office of the Deputy Attorney 
General and Greg Cherundolo, Chief of Operations, Office of Global 
Enforcement, Drug Enforcement Administration) (DOJ Statement).
    \14\ See, e.g., Federal Initiative to Guarantee Health by Targeting 
Fentanyl Act, S. 2701, 116th Cong. (1st Sess. 2019); Stopping Overdoses 
of Fentanyl Analogues Act, S. 1622, 116th Cong. (1st Sess. 2019); 
Extend Act, H.R. 5233, 116th Cong. (1st Sess. 2019); Stopping Illicit 
Trafficking Act of 2019, H.R. 5421, 116th Cong. (1st Sess. 2019).
    \15\ See, e.g., Schedules of Controlled Substances: Temporary 
Placement of Fentanyl-Related Substances in Schedule 1, 83 Fed. Reg. 
5188, n.4 (Feb. 6, 2018) (2018 Scheduling Order); Stopping Overdoses of 
Fentanyl Analogues Act, S. 1622, 116th Cong. (1st Sess. 2019) 
(proposing codification of 2018 Scheduling Order).
---------------------------------------------------------------------------
    Classwide scheduling would facilitate broader prosecutions, 
with harsher penalties and fewer Constitutional Due Process 
protections. The Department has indicated that it will use 
classwide scheduling to pursue severe mandatory minimums for 
anyone trafficking in an undefined and potentially limitless 
set of substances,\16\ without having to prove these substances 
harm, or were intended to harm, the human body.\17\ I urge you 
to reject this approach.
---------------------------------------------------------------------------
    \16\ United States Dep't of Justice, Drug Enforcement 
Administration, 2018 National Drug Threat Assessment, at 25 (2018), 
https://www.dea.gov/sites/default/files/2018-11/DIR-032-
18%202018%20NDTA%20final%20low%20resolution.pdf. (Explaining that 
classwide scheduling ``signifies criminals who possess, import, 
distribute, or manufacture any [fentanyl-related substance] is subject 
to criminal prosecution in the same manner as for fentanyl and other 
controlled substancesThis action will make it easier for law 
enforcement officers and federal prosecutors to arrest and prosecute 
traffickers of all forms of FRS without having to rely on the Analogue 
Act.'').
    \17\ See 21 U.S.C. Sec. 802(32)(A).
---------------------------------------------------------------------------
    Classwide scheduling would disrupt the careful balance of 
drug policy authority between enforcement and public health 
authorities. The campaign in support of this radical shift 
rests on misinformation.\18\ To be clear: Harmful fentanyl 
analogues are illegal with or without classwide scheduling. The 
Department has a long history of prosecuting crimes involving 
fentanyl analogues, and successfully pursues stringent 
penalties for possessing and trafficking in these substances 
under existing law.
---------------------------------------------------------------------------
    \18\ See, e.g., William P. Barr, William Barr: Fentanyl Could Flood 
the Country Unless Congress Passes This Bill, Wash. Post, (Jan. 10, 
2020), https://www.washingtonpost.com/opinions/william-barr-congress-
pass-this-bill-so-we-can-attack-the-onslaught-of-illegal-fentanyl/2020/
01/10/cbb8ccdc-33cb-11ea-a053-dc6d944ba776_story.html; Drug Enforcement 
Administration (@DEAHQ), Twitter (Jan. 11, 2020), https://twitter.com/
DEAHQ/status/1216094432648409090.
---------------------------------------------------------------------------
    We have been here before: Over 30 years ago, reacting to 
alarmist rhetoric and media coverage of drug abuse in America, 
Congress responded by passing harsh sentencing laws replete 
with mandatory minimums and one-size-fits-all penalties.\19\ 
Decades later, these policies have destroyed communities, but 
they haven't reduced drug supply or demand. I urge this 
Committee to resist the misguided and rhetorically simple 
approach of a drug policy predicated on penalties. Evidence 
shows it will not work, and we will soon again be seeking 
inadequate remedies for the missteps of the past. Opioid 
addiction has devastated too many lives to respond with a false 
antidote. Congress must focus on evidence-based approaches 
directed at education, treatment, and reducing overdose deaths. 
We cannot incarcerate our way out of this health crisis.
---------------------------------------------------------------------------
    \19\ See Lucius Outlaw III, We Have a Growing Fentanyl Problem So 
Let's Not Repeat Past Mistakes, The Hill (Jul. 29, 2019), https://
thehill.com/opinion/criminal-justice/455213-we-have-a-growing-fentanyl-
problem-so-lets-not-repeat-past-mistakes.
---------------------------------------------------------------------------

       I. Classwide Scheduling Would Repeat Past Mistakes

    In 1971, President Nixon declared drug abuse as ``America's 
public enemy number one.'' \20\ ``In order to fight and defeat 
this enemy,'' he said, ``it is necessary to wage a new, all-out 
offensive.'' \21\ Fifteen years later, Ronald Reagan warned 
that ``illegal drugs were every bit as much a threat to the 
United States as enemy planes and missiles.'' We must ``do all 
we can to defeat the drug menace threatening our country.''\22\ 
Congress heeded this command, enacting sweeping and severe 
penalties like the Comprehensive Crime Control Act of 1984 and 
the Anti-Drug Abuse Act of 1986.\23\ A decade later, on the eve 
of his reelection, Bill Clinton reported ``we passed `three 
strikes and you're out' and the death penalty for drug kingpins 
and cop killers,'' touting the accomplishments of the Violent 
Crime Control and Law Enforcement Act of 1994.\24\ The laws 
from this era imposed harsh mandatory minimums for a variety of 
offenses, including drug offenses, and introduced the now-
discredited 100-to-1 ratio between crack and powder 
cocaine.\25\
---------------------------------------------------------------------------
    \20\ Richard Nixon, Remarks About an Intensified Program for Drug 
Abuse Prevention and Control (Jun. 17, 1971), https://
prhome.defense.gov/Portals/52/Documents/RFM/Readiness/DDRP/docs/
41%20Nixon%20Remarks%20Intensified%20Program%20for%20Drug%20Abuse.pdf.
    \21\ Id.
    \22\ Remarks on Signing the Just Say No To Drugs Week Proclamation, 
Ronald Reagan Presidential Library & Museum (May 20, 1986), https://
www.reaganlibrary.gov/research/speeches/52086a.
    \23\ See, Comprehensive Crime Control Act of 1984, Pub. L. No. 98-
473, tit. II, 98 Stat.1976 (Oct. 12, 1984); Anti-Drug Abuse Act of 
1986, Pub. L. No. 99-570, 100 Stat. 3207 (Oct. 27, 1986).
    \24\ The President's Radio Address, 32 Weekly Comp. Pres. Doc. 2282 
(Nov. 2, 1996), https://www.govinfo.gov/content/pkg/WCPD-1996-11-11/
pdf/WCPD-1996-11-11-Pg2282.pdf#page=1; Violent Crime Control and Law 
Enforcement Act of 1994, Pub. L. No. 103-322, 108 Stat. 1796 (Jan. 25, 
1994).
    \25\ See Rachel E. Barkow, Categorical Mistakes: The Flawed 
Framework of the Armed Career Criminal Act and Mandatory Minimum 
Sentencing, 133 Harv. L. Rev. 200, 212 (2019) (Categorical Mistakes); 
see also Ranya Shannon, 3 Ways the 1994 Crime Bill Continues to Hurt 
Communities of Color, Center for American Progress (May 10, 2019), 
https://www.americanprogress .org/issues/race/news/2019/05/10/469642/3-
ways-1994-crime-bill-continues-hurt-communities-color/.
---------------------------------------------------------------------------
    What in 1971 was ``public enemy number one,'' is now in 
2020 ``a tsunami'' of ``legalized poison.'' \26\ Trafficking in 
fentanyl, says the Attorney General (AG), ``amounts to outright 
murder.'' \27\ But while the rhetoric of today is the same of 
that from the past, we know our actions must be different. We 
have three decades of evidence proving that increasing 
sentences does not make communities safer and it does not drive 
down drug supply or demand.\28\ A 2014 report commissioned by 
the Department ``found that lengthy prison sentences are not 
the best way to deter crime,'' \29\ and data indicate that long 
sentences can actually be criminogenic and increase 
recidivism.\30\ To avoid detection, users are less inclined to 
seek treatment and instead more likely to engage in risky drug-
use behaviors.\31\
---------------------------------------------------------------------------
    \26\ Barr, supra note 18.
    \27\ Id. See also Attorney General William P. Barr Delivers Remarks 
at the Grand Lodge Fraternal Order of Police's 64th National Biennial 
Conference, Dept. of Justice (Aug. 12, 2019), https://www.justice.gov/
opa/speech/attorney-general-william-p-barr-delivers-remarks-grand-
lodge-fraternal-order-polices-64th (``A tsunami built up and has been 
crashing over the country, bringing death and destruction.'').
    \28\ See, e.g., Rachel E. Barkow, Prisoners of Politics: Breaking 
the Cycle of Mass Incarceration, 42-44 (2019) (Prisoners of Politics) 
(collecting studies); see also Pew Charitable Trusts, More Imprisonment 
Does Not Reduce State Drug Problems (Mar. 8, 2018), https://
www.pewtrusts.org/-/media/assets/2018/03/
pspp_more_imprisonment_does_not_reduce_state_ drug_ problems.pdf; Drug 
Policy Alliance, Rethinking the ``Drug Dealer,'' 12-13 (2019), http://
www.drugpolicy.org/sites/default/files/dpa-rethinking-the-drug-
dealer_0.pdf (Rethinking the Drug Dealer); Letter from FreedomWorks, 
Prison Fellowship, R Street Institute, et al., to the Hons. Lindsey 
Graham & Dianne Feinstein, at 1 (Jul. 2, 2019), https://
www.rstreet.org/2019/07/02/letter-in-opposition-to-the-stopping-
overdoses-of-fentanyl-analogues-act-sofa/.
    \29\ Prisoners of Politics, at 43 (citing National Research 
Counsel, The Growth of Incarceration in the United States: Exploring 
Causes and Consequences, ed. Jeremy Travis and Bruce Western (2014)).
    \30\ See Id. at 44.
    \31\ See, Rethinking the Drug Dealer, at 13.
---------------------------------------------------------------------------
    These lessons apply to fentanyl and its analogues. A 2019 
Rand study reviewed fentanyl's presence in domestic and 
international drug markets to create a framework for the 
response to fentanyl and other synthetic opioids.\32\ It 
concluded that ``[t]here is little reason to believe that 
tougher sentences, including drug-induced homicide laws for 
low-level retailers and easily replaced functionaries (e.g., 
couriers) will make a positive difference.'' \33\
---------------------------------------------------------------------------
    \32\ See Bryce Pardo, et al., The Future of Fentanyl and Other 
Synthetic Opioids, Rand Corp. (2019),https://www.rand.org/content/dam/
rand/pubs/research--reports/RR3100/RR3117/RAND_RR3117.pdf.
    \33\ Id. at 161.
---------------------------------------------------------------------------
    Our missteps in the War on Drugs are clear. Congress 
enacted harsh mandatory penalty laws with the goal of 
incapacitating high-level traffickers, ``managers of drug 
enterprises,'' and ``king-pins,'' \34\ but it had no evidence 
from experts that higher sentences would achieve that goal in 
practice. Once on the books, the draconian sentencing laws 
impacted a broader population than Congress intended.\35\ 
Indeed, only 14% of all people incarcerated federally are the 
managers, leaders, and organizers Congress intended to 
capture.\36\ Because Congress legislated without evidence or 
the advice of experts, more than 2.2 million people are behind 
bars in America and 1 in 3 adults possess a criminal 
record.\37\ We cannot repeat these mistakes.
---------------------------------------------------------------------------
    \34\ See e.g., United States v. Dossie, 851 F. Supp. 2d 478, 479-80 
(E.D.N.Y. 2012) (collecting legislative history).
    \35\ See Categorical Mistakes, at 217.
    \36\ See Id. at 217, n.138.
    \37\ See Prisoners of Politics, at 2.
---------------------------------------------------------------------------

  II. The Department Can and Does Prosecute Harmful Fentanyl 
             Analogues Without Classwide Scheduling

    In recent months, the Department has claimed that failure 
to enact classwide scheduling will legalize harmful fentanyl 
analogues. ``[T]he legal prohibitions on the various forms of 
fentanyl expire next month unless Congress reauthorizes them,'' 
the AG wrote in the Washington Post earlier this month. Without 
classwide scheduling, he claimed, fentanyl analogues would 
become ``newly legalized.'' \38\
---------------------------------------------------------------------------
    \38\ Barr, supra note 18; see also Drug Enforcement Administration 
(@DEAHQ), Twitter (Jan. 11, 2020, 3:28 PM), https://twitter.com/DEAHQ/
status/1216094432648409090 (``Without the emergency scheduling of the 
entire class of fentanyl-related substances, all non-scheduled fentanyl 
substances will no longer be illegal. This scheduling expires in 26 
days.'').
---------------------------------------------------------------------------
    These claims are untrue.
    With or without classwide scheduling, the Department is 
armed with powerful tools it currently uses to successfully and 
aggressively prosecute fentanyl and its analogues. First, the 
Department can use its broad authorities under the Controlled 
Substances Act (CSA) to temporarily schedule--and then 
prosecute--fentanyl analogues on a substance-by-substance 
basis. Second, the Department can use the Analogue Act to 
immediately prosecute new substances that have not been 
scheduled. In contrast to classwide scheduling, both of these 
existing authorities include essential checks to confirm the 
accuracy of DEA's designation of a substance as harmful.
    First, the CSA. Many fentanyl analogues, such as 
carfentanil and acetyl fentanyl have already been scheduled on 
a substance-by-substance basis.\39\ Fentanyl analogues that are 
scheduled controlled substances can be prosecuted as any other 
controlled substance would be prosecuted. The CSA also equips 
the DEA to swiftly add new substances to the schedule by 
providing it with temporary scheduling authority. Temporary 
designation becomes permanent only if the AG asks the Secretary 
of Health and Human Services (``Secretary'') to confirm the 
accuracy of the designation and the Secretary so confirms.
---------------------------------------------------------------------------
    \39\ 21 C.F.R. 1308.12 Schedule II (2019) (carfentanil); 21 C.F.R. 
1308.11 Schedule I (2019) (acetyl fentanyl).
---------------------------------------------------------------------------
    The second avenue that has been available to the Department 
since 1986 for the prosecution of unscheduled analogues--
fentanyl or not--is the Analogue Act. Congress passed the 
Analogue Act to criminalize the harmful unscheduled chemical 
variants of controlled substances ``that otherwise would escape 
the reach of the drug laws.'' \40\ Under the Act, a 
``controlled substance analogue shall, to the extent intended 
for human consumption, be treated, for the purposes of any 
Federal law as a controlled substance in Schedule I.'' \41\ 
Congress listened to and relied on evidence from experts when 
it defined a ``controlled substance analogue'' to require two 
things: First, a chemical structure which is substantially 
similar to a schedule I or II controlled substance, and second, 
a physiological effect on the central nervous system that is 
substantially similar to or greater than the effect of a 
schedule I or II controlled substance, or a particular person 
must represent or intend to have a physiological effect on the 
central nervous system that is substantially similar to or 
greater than the effect of a schedule I or II controlled 
substance.\42\
---------------------------------------------------------------------------
    \40\ United States v. Hodge, 321 F.3d 429, 437 (3d Cir. 2003) 
(quoting 131 Cong. Rec. 19114 (1985) (statement of Sen. Thurmond) 
(``This proposal will prevent underground chemists from producing 
dangerous designer drugs by slightly changing the chemical composition 
of existing illegal drugs.''); 131 Cong. Rec. 27311 (1985) (statement 
of Sen. D'Amato) (stating that the Analogue Act ``closes the loophole 
in present law that allows the creation and distribution of deadly new 
drugs without violating Federal law''); 131 Cong. Rec. 32950 (1985) 
(statement of Rep. Lungren) (``The focus of this proposal is clearly to 
impact on the designer drug phenomena by making it illegal for the 
clandestine chemists to manufacture and distribute these 
substances.'')).
    \41\ 21 U.S.C. 813(a).
    \42\ 21 U.S.C. 802(32)(A)(i)-(iii).
---------------------------------------------------------------------------
    Whether the government would be required to prove that an 
unscheduled substance had both a substantially similar chemical 
structure, and an actual or intended substantially similar 
effect was carefully considered by Congress in enacting the 
Analogue Act. Although the Department argued for an approach 
that would look only to structure, Congress ultimately accepted 
the views of the American Chemical Society. The Society 
testified before the Senate Judiciary Committee that it 
``believe[d] it necessary to require that designer drugs meet 
both of these tests''--that it must ``be specifically designed 
to have . . . a chemical structure substantially similar to 
that of a controlled substance'' and ``a biological effect 
substantially similar to that of a controlled substance''--``in 
order to protect the legitimate production of drugs that are 
intended for human consumption and that have similar chemical 
structures to those of designed drugs, but that are designed to 
have the opposite or dissimilar biological effects,'' such as 
naloxone and other analogs designed with the purpose of 
countering drug abuse.\43\ So long as an unscheduled substance 
is proven to be a ``controlled substance analogue,'' it can be 
treated and prosecuted as if it was a schedule I controlled 
substance.
---------------------------------------------------------------------------
    \43\ Controlled Substance Analogs Enforcement Act of 1985: Hearing 
on S. 1437 Before the S. Comm. on the Judiciary, 996th Cong. 79 (1985) 
(American Chemical Society Responses to Questions from Senator Biden); 
see also United States v. Roberts, No. 01 CR 410 RWS, 2001 WL 1646732, 
*5 (S.D.N.Y. Dec. 17, 2001).
---------------------------------------------------------------------------
    Despite these authorities, and the Department's history of 
prosecuting fentanyl traffickers under them, the Department now 
claims that it is unable to effectively prosecute fentanyl 
traffickers and that, without classwide scheduling, it would 
enter ``relatively unknown territory.'' \44\ Other statements 
by the DEA and the Department, however, confirm that they know 
well how to use existing scheduling and prosecuting 
methods.\45\ The Department has acknowledged its ``very good 
track record in Analogue Act cases.'' \46\ As of May 2019, the 
Trump Administration reported a 40-fold increase fentanyl 
prosecutions from 2016 to 2018.\47\ Data from the United States 
Sentencing Commission confirms that between 2014 and 2018, 
fentanyl trafficking offenders have increased by 4,711.1%.\48\ 
These cases often involved mandatory minimums: In 2018, 44.6% 
of fentanyl traffickers were convicted of an offense carrying a 
mandatory minimum.\49\ Such prosecutions are felt most harshly 
by minority defendants. In 2018, 77% of those prosecuted for 
fentanyl-related substances were people of color.\50\
---------------------------------------------------------------------------
    \44\ DOJ Statement, at 6.
    \45\ See 2018 Scheduling Order, at n.4 (noting that trafficking in 
fentanyl related substances is ``actually illegal as persons who do so 
can be prosecuted using the controlled substance analogue provisions of 
the Controlled Substances Act''); see also DOJ Statement, at 5 (``In 
terms of investigations and prosecutions, if the temporary emergency 
scheduling order lapses without permanent scheduling, the Department 
would once again have to rely on the Analogue Act to bring fentanyl 
traffickers to justice.'').
    \46\ DOJ Statement, at 5.
    \47\ See An Update on the President's Commission on Combating Drug 
Addiction and the Opioid Crisis: One Year Later, https://
www.whitehouse.gov/wp-content/uploads/2019/05/Opioid-Commission-Report-
One-Year-Later-20190507.pdf (last accessed Jan. 24, 2020).
    \48\ See USSC, Quick Facts on Federal Fentanyl Trafficking Offenses 
1 (2019).
    \49\ See Id.
    \50\ See Id.
---------------------------------------------------------------------------
    Despite claims to the contrary by proponents of classwide 
scheduling,\51\ the Department has not shown an intent to only 
target high-level traffickers. Available information indicates 
that most of the Department's prosecutions have not been of 
high-level importers or traffickers but rather of couriers, 
mules, street-level dealers, and users. In 2018, only 5.7% of 
prosecutions involved individuals who were given increased 
sentences for having a leadership/supervisory role in the 
offense.\52\ Almost half--41.1%--of those prosecuted had little 
or no criminal histories.\53\ Indeed, the Department has made 
explicit that low-level dealers and addicts are exactly whom 
they intend to target. In 2018, former AG Sessions initiated an 
``enforcement surge,'' directing prosecutors in ten regions of 
the United States to ``prosecute every readily provable case 
involving the distribution of fentanyl, fentanyl analogues and 
other synthetic opioids, regardless of drug quantity.'' \54\ 
That same year, the Government Accountability Office issued a 
report that recognized that federal drug enforcement agencies 
are ``target[ing] street-level and mid-level distributers, 
rather than focusing more heavily on traditional targets, such 
as cartels.'' \55\
---------------------------------------------------------------------------
    \51\ See Editorial, Congress Should Act to Allow a Ban on Fentanyl 
Indefinitely, Wash. Post, Jan, 5, 2010, https://www.washingtonpost.com/
opinions/congress-should-act-to-allow-a-ban-on-fentanyl-indefinitely/
2020/01/05/432b94b2-2e67-11ea-bcb3-ac6482c4a92f_story.html (``there is 
little evidence that the Justice Department plans to target individual 
users rather than traffickers'').
    \52\ See Quick Facts, supra note 48.
    \53\ See Id.
    \54\ Dep't. of Justice, Attorney General Jeff Sessions Announces 
the Formation of Operation Synthetic Opioid Surge (S.O.S.), July 12, 
2018, https://www.justice.gov/opa/pr/attorney-general-jeff-sessions-
announces-formation-operation-synthetic-opioid-surge-sos. AG Barr has 
confirmed his intention of ``ratchet[ing] up'' this initiative. See 
Attorney General William P. Barr Delivers Remarks at the Grand Lodge 
Fraternal Order of Police's 64th National Biennial Conference, supra 
note 27.
    \55\ Illicit Opioids: While Greater Attention Given to Combating 
Synthetic Opioids, Agencies Need to Better Assess Their Efforts, 
Government Accountability Office, March 29, 2018, https://www.gao.gov/
assets/700/690972.pdf.
---------------------------------------------------------------------------
    These enforcement statistics are particularly troubling in 
light of testimony from the Acting Chief of the DEA's Synthetic 
Drugs and Chemicals section that, most often, people do not 
know that the substances they are selling contain fentanyl.\56\ 
Sentencing Commission data supports this testimony: in 2016, 
only 16% of defendants sentenced in fentanyl-related cases 
clearly knew they had fentanyl.\57\ And, more recently, the DEA 
agreed that: ``It is highly likely many distributors do not 
know what exactly they are selling when it comes to 
differentiating between heroin, fentanyl, and fentanyl-laced 
heroin, as well as differentiating between diverted pills and 
fentanyl-containing counterfeit pills. This probably means many 
distributors are not intentionally deceiving customers; 
instead, suppliers do not always inform distributors 
specifically what substances or combinations of substances they 
are selling.'' \58\
---------------------------------------------------------------------------
    \56\ See Transcript of Public Hearing before the United States 
Sentencing Commission, Washington, D.C., at 28 (December 5, 2017) (Joe 
Schleigh, Acting Chief, Synthetic Drugs and Chemicals Section, 
Diversion Control Division (DEA). https://www.ussc.gov/sites/default/
files/pdf/amendment-process/public-hearings-and-meetings/20171205/
transcript.pdf.
    \57\ See USSC, Public Data Presentation for Synthetic Cathinones, 
Synthetic Cannabinoids and Fentanyl and Fentanyl Analogues Amendments 
(January 2018), https://www.ussc.gov/sites/default/files/pdf/research-
and-publications/data-briefings/2018_synthetic-drugs.pdf; see also 
Letter from Freedomworks, supra n. 28 at 2; Letter from American Civil 
Liberties Union (ACLU), Drug Policy Alliance, FAMM, The Leadership 
Conference on Civil and Human Rights, et al., at 3-4 (Dec. 11, 2019), 
https://www.aclu.org/sites/default/files/field_document/
sofa_and_class_wide_ban_extension_opposition_letter_final.pdf.
    \58\ DEA 2018 Threat Assessment at 25, supra note 16.
---------------------------------------------------------------------------
    Indeed, distinguishing between users and low-level dealers 
is simply not possible because ``many people do both.'' \59\ 
Drug users sell drugs to support their habits and many low-
level actors in the supply chain are not paid in money, but 
rather in drugs.'' \60\ ``People who use drugs often sell them 
in small quantities to their friends, leaving little daylight 
between the role of the user and seller.'' \61\
---------------------------------------------------------------------------
    \59\ Rethinking the Drug Dealer, at 13; see also Zachary A. Siegel, 
How to Rethink Drug Dealing and Punishment, The Appeal (Dec. 17, 2019), 
https://theappeal.org/how-to-rethink-drug-dealing-and-punishment/.
    \60\ See Rethinking the Drug Dealer, at 36.
    \61\ See How to Rethink Drug Dealing and Punishment, supra note 59.
---------------------------------------------------------------------------
    A client of one of my federal defender colleagues 
illustrates this point. The client, a 30-year old man with no 
criminal history, was charged with conspiracy to distribute 
fentanyl and fentanyl analogues, distribution of fentanyl and 
fentanyl analogues, and attempted distribution of fentanyl and 
fentanyl analogues. The client had suffered a serious back 
injury in high school but went on to play football in college 
before reinjuring his back and transferring to a school closer 
to home. While the client gave up football, his debilitating 
back pain persisted. He suffered a divorce, grew increasingly 
depressed and isolated, and moved away from his family. He was 
introduced to fentanyl by a girlfriend who was selling fentanyl 
online. He became addicted. Dependent upon his girlfriend for 
housing, finances, and fentanyl, he agreed to assist her with 
mailing and receiving packages and was subsequently arrested. 
While on bond, he successfully completed an inpatient treatment 
program and mental health counseling where he obtained the 
skills and resources to stay sober. He also addressed the root 
cause of his back pain. He has had two spinal fusions, which 
his surgeon described as ``long'' overdue. This individual, 
like so many of the clients I represent, did not sell drugs for 
a profit. He did not have a weapon. He was not a ``king-pin,'' 
manager, or organizer. He distributed drugs to feed his own 
addiction. And now he is a felon, with all of the collateral 
consequences that status carries, who will spend over a year in 
prison because his addiction was treated too late. 
Unfortunately, cases like this one are not outliers.
    While the Department claims a permanent classwide ban of 
fentanyl-related substances is necessary to effective 
enforcement--and despite confusion regarding its use of these 
authorities to date \62\--the Department has not identified any 
case where it has relied on the classwide ban to prosecute any 
major manufacturing or importation cases. Instead, it has made 
effective use of its substance-by-substance controls and the 
Analogue Act, which allows the Department to prosecute 
unscheduled fentanyl analogues.\63\
---------------------------------------------------------------------------
    \62\ In July, ABC News reported, after a Department of Justice 
briefing with reporters about the classwide scheduling request, that 
the classwide scheduling had ``assisted prosecutors in cases, such as 
an August 2018, 43-count indictment against two Chinese Citizens who 
were charged with shipping fentanyl analogues to 37 U.S. states over a 
decade, linked to at least two deaths of Americans in Ohio.'' See 
Alexander Mallin, DOJ Issues Plea to Congress in Battle Against 
Fentanyl Copycats, ABC News, Jul. 1, 2019. But none of the charges in 
that case--United States v. Zheng, 18-cr-00474 (E.D. Ohio)--depended on 
the classwide scheduling. Instead, each fentanyl-analogue related 
charge was for analogues that had been scheduled on a substance-by-
substance basis by the DEA. 10 substances were charged under the 
Analogue Act, but none were fentanyl analogues.
    \63\ See 21 U.S.C. Sec. 813.
---------------------------------------------------------------------------

   III. Classwide Scheduling Would Be a Radical Shift in the 
 Current Balance of Drug Policy Authority Between Enforcement 
                           and Health

    The Department asserts that Congress must enact classwide 
scheduling to preserve an uncontroversial status quo. This 
elides the unprecedented and radical nature of the DEA's 
placement of an entire class of drugs onto Schedule I.
    Congress originally decided in the CSA that the authority 
to schedule substances should be shared between the AG and the 
Secretary of Health and Human Services.\64\ ``This division of 
decisionmaking responsibility was fashioned in recognition of 
the two agencies' respective areas of expertise. Members of the 
House repeatedly stated that the Department of Justice should 
make judgments based on law enforcement considerations, while 
[the Department of Health, Education, and Welfare] should have 
the final say with respect to medical and scientific 
determinations.'' \65\ Although Congress originally gave the 
ultimate decision to control to the AG, it chose to bind that 
decision-making by the medical and scientific findings of the 
Secretary. Typically, both the AG and the Secretary must 
evaluate eight separate factors to determine whether and where 
to classify a substance.\66\
---------------------------------------------------------------------------
    \64\ See 21 U.S.C. 811; see also Thomas M. Quinn & Gerald T. 
McLaughlin, The Evolution of Federal Drug Control Legislation, 22 Cath. 
U. Law. Rev. 586, 607-608 (1973).
    \65\ Nat'l Org. for Reform of Marijuana Laws (NORML) v. Drug 
Enforcement Admin., U. S. Dep't. of Justice, 559 F.2d 735, 745-46 (D.C. 
Cir. 1977).
    \66\ See 21 U.S.C. 811(c).
---------------------------------------------------------------------------
    Thus, in its original form, no drug could be ``placed in 
any schedule unless the findings required for such a schedule 
[were] made.'' \67\ But in 1984, in response to the emergence 
of synthetic drugs, Congress created an exception by granting 
the AG temporary scheduling power, allowing the Department to 
skip formalized review to more quickly control new 
substances.\68\ For that control to become permanent, however, 
the AG must ask the Secretary to initiate a period of 
scientific study to assess the scientific and medical necessity 
of the AG's control.\69\ Congress enacted the temporary 
scheduling authority to ``allow the Attorney General to respond 
quickly to protect the public from drugs of abuse that appear 
in the illicit traffic too rapidly to be effectively handled,'' 
but still required that the more ``extensive scheduling 
procedures required under current law . . . be met.'' \70\ Once 
that analysis is complete, and if the Secretary agrees with 
DEA's designation, the control is made permanent.\71\
---------------------------------------------------------------------------
    \67\ 21 U.S.C. 812(b).
    \68\ See Comprehensive Crime Control Act of 1984, at Sec. 508, 
supra note 23.
    \69\ See 21 U.S.C. 811.
    \70\ S. Rep. 98-225 at 264-265 (1984).
    \71\ See 21 U.S.C. 811(h)(1) and (2).
---------------------------------------------------------------------------
    In February 2018, the DEA announced it would temporarily 
schedule any substance with one of five modifications to the 
fentanyl structure in Schedule I--whether the substance is in 
existence or not.\72\ Prior to the order, approximately 220 
individual drugs were listed on Schedule I.\73\ The number of 
substances that fall with in the class are unknown, but 
estimates have ranged from a thousand to ``nearly infinite.'' 
\74\ The Department did not follow the statutorily provided 
path to permanent scheduling which calls for initiating a 
scientific and medical review of its scheduling action by the 
Secretary. By turning to Congress instead, the Department has 
cut health experts out of the decision-making process. This 
temporary authority will expire on February 6, 2020.\75\
---------------------------------------------------------------------------
    \72\ See 2018 Scheduling Order, at 5189 (``As indicated, the 
temporary scheduling order includes all substances that fall within the 
above definition--even if such substances have not yet emerged on the 
market in the United States. As a result, DEA cannot currently specify 
the chemical name of every potential substance that might under this 
new definition.'').
    \73\ See 21 C.F.R. 1308.11 (2017).
    \74\ The Administration's estimates have varied from ``hundreds to 
maybe a thousand,'' see Sarah Lynch, Trump Administration Officials 
Clash Over How to Combat Fentnayl Copycats, Reuters, Jul. 9, 2019, 
https://www.reuters.com/article/usa-congress-fentanyl/corrected-trump-
Administration-drug-officials-clash-over-how-to-combat-fentanyl-
copycats-idUSL2N248062, to ``over 3,000,'' Kemp Chester, Associate 
Director, National Heroin Coordinate Group, Office of National Drug 
Control Policy, Response to Questions for the Record Following Hearing 
Entitled, The Countdown: Fentanyl Analogues & the Expiring Emergency 
Scheduling Order to S. Comm. on the Judiciary (June 4, 2019 (Chester 
QFRs), to ``millions'' to ``an infinite'' number, see Lynch.
    \75\ See 2018 Scheduling Order. Two weeks ago, the Senate passed a 
measure that would temporarily extend SOFA's codification by 15-months, 
the Temporary Reauthorization and Study of the Emergency Scheduling of 
Fentanyl Analogues Act, S. 3201, 116th Cong. 2 (2020), but Senator 
Graham has nevertheless indicated he hoped ``in the coming days we can 
reach an agreement that will allow fentanyl analogues to be listed as a 
Schedule I drug permanently,'' Press Release, Feinstein, Graham, 
Durbin, Colleagues Pass Bill to Keep Fentanyl-Related Substances 
Schedule I (Jan. 16, 2020), https://www.feinstein.senate.gov/public/
index.cfm/press-releases?id=A4344756-7857-4160-964E-73A14E6B232D.
---------------------------------------------------------------------------
    The CSA does not allow the DEA to do what it did here: 
place an undefined and potentially limitless class of 
``fentanyl-related substances'' on Schedule I.\76\ The 
Department has expressly acknowledged this. In testimony before 
the Senate Judiciary Committee, the Department described 
classwide scheduling--in contrast to substance-by-substance 
scheduling--as an ``untested approach.'' \77\ The Department 
warned of ``legal uncertainty surrounding the authority of the 
Attorney General, through DEA, to schedule fentanyl-like 
substances,'' because it is ``[i]mplicit in the structure and 
text of the CSA's scheduling authority'' that substances ``are 
scheduled one at a time.'' \78\
---------------------------------------------------------------------------
    \76\ See 21 U.S.C. 811(h) (permitting the Attorney General to only 
schedule drugs on a substance-by-substance basis).
    \77\ DOJ Statement, at 6.
    \78\ Id.
---------------------------------------------------------------------------
    In its quest for classwide scheduling, DEA seeks to 
permanently and exclusively vest scheduling authority for these 
substances with the DEA at the expense of scientific evidence 
and research.\79\ Abandoning the expert advice of HHS should 
trouble the Committee. In July, a bipartisan group of Senators 
raised concerns that this ``failure to engage necessary health 
experts vests far too much authority to a law-enforcement 
agency and may result in action that will deter valid, critical 
medical research aimed at responses to the opioid crisis.'' 
\80\ But DEA's effort to cut Health and Human Services out 
could also have devastating consequences for public health and 
participants in the federal criminal system by sweeping a 
potentially limitless set of substances onto Schedule I.
---------------------------------------------------------------------------
    \79\ See Freedomworks Letter, supra n. 28 at 1 (warning that SOFA 
would grant the Department the ``unilateral authority to add substances 
to the federal schedule and pursue harsh penalties'').
    \80\ Letter from Senators Richard J. Durbin, Michael S. Lee, 
Sheldon Whitehouse, Amy Klobuchar, Christopher A. Coons, Mazie K. 
Hirono, Cory A. Booker, Kamala, D. Harris to The Hon. Alex M. Azar II, 
Secretary, United States Department of Health and Human Services (Jul. 
10, 2019), https://www.durbin.senate.gov/imo/media/doc/
Letter%20to%20DOJ%20HHS%207.10 .pdf.
---------------------------------------------------------------------------
    A class-based approach is certain to criminalize substances 
that have no place in Schedule I. The chemical composition of 
different fentanyl-related substances can cause vastly 
different physiological effects. The Administration has 
acknowledged that ``[t]hese analogues have a wide variance in 
potency. Some analogues, like acetyl fentanyl, are less potent 
than fentanyl; others like carfentanil, are many times more 
potent; and still others, like benzylfentanyl, are believed to 
be essentially biologically inactive.'' \81\
---------------------------------------------------------------------------
    \81\ Chester QFRs, at 3; see also Statement of Kevin L. Butler 
Before the U.S. Sentencing Comm'n, Washington, DC, at 28-29 (Mar. 14, 
2018) (``[T]he relative potency of fentanyl and fentanyl analogues 
varies widely.''), https://www.ussc.gov/sites/default/files/pdf/
amendment-process/public-hearings-and-meetings/20180314/Butler.pdf.
---------------------------------------------------------------------------
    The incredible breadth of this request, in combination with 
the wide variance in potency of these substances, makes one 
fact certain: Benign, helpful, and harmful drugs alike will be 
swept onto Schedule I.\82\ Once placed on Schedule I, any 
research into these substances must flow through the DEA.\83\ 
Researchers have warned that this will raise unnecessary 
barriers to critical research into, inter alia, life-saving 
antidotes, and warned that ``the Department of Health and Human 
Services' science-based agencies, specifically the National 
Institute on Drug Abuse and the Food and Drug Administration,'' 
must be involved in ``any decisions regarding scheduling of 
synthetic analogues.'' \84\
---------------------------------------------------------------------------
    \82\ See Letter from the College of Problems of Drug Dependence 
(CPDD) to the Hons. Lindsey Graham & Dianne Feinstein, Senate Judiciary 
Comm. at 2 (Dec. 13, 2019) (on file with author); see also Letter from 
the Friends of NIDA to the Hons. Lindsey Graham & Dianne Feinstein, 
Senate Judiciary Comm. (Jul. 2, 2019) (on file); Letter from the 
American Psychological Association to the Hons. Lindsey Graham & Dianne 
Feinstein, Senate Judiciary Comm. (Jul. 8, 2019) (on file); Statement 
of Patrick M. Beardsely, Ph. D., Re: S. 2701: Federal Initiative to 
Guarantee Health by Targeting Fentanyl, (Nov. 27, 2019) (``Harm could 
be caused by this bill in that it will inevitably inhibit research with 
fentanyl-related substances.'') (on file); Statement of Charles B. 
France (Nov. 29, 2019) (writing to ``express my concerns regarding 
congressional efforts to legislatively add compounds to Schedule I of 
the Controlled Substance Act, in the absence of direct scientific 
evidence for potential harmful effects of those compounds) (on file).
    \83\ See 21 C.F.R 1301, et seq.
    \84\ Letter from CPDD, supra note 82.
---------------------------------------------------------------------------
    There are troubling signs that the Administration views a 
class-based approach that abandons science and evidence as the 
new framework for all new synthetic drugs--fentanyl or not. 
Kemp L. Chester, the Assistant Director of the National Opioids 
and Synthetics Coordination Group Office of National Drug 
Control Policy, explained that classwide scheduling provides 
``a framework for us to better address rapid and emerging 
changes in the dynamic illicit drug market, seize the 
initiative from illicit drug producers and traffickers and set 
the United States on a path to better preventing these drugs 
from entering the country before they kill Americans.'' \85\ 
Congress must be wary of setting a precedent that will cut 
health agencies out of drug policy decisions.
---------------------------------------------------------------------------
    \85\ Statement of Kemp L. Chester, Assistant Director of the 
National Opioids and Synthetics Coordination Group Office of National 
Drug Control Policy, Before the U.S. Senate, Committee on the 
Judiciary, at 6 (June 4, 2019).
---------------------------------------------------------------------------
    Moreover, the Administration has recognized that classwide 
scheduling will be, at best, a short term solution. Mr. Kemp 
has acknowledged that ``scheduling an entire class of fentanyl 
related substances may drive illicit drug manufacturers to 
begin developing non-fentanyl synthetic opioids that would not 
be included in class-based scheduling.'' \86\ There are already 
a growing number of emerging non-fentanyl synthetic opioids--
like the U-Series of drugs--that are not captured under the 
classwide ban and are causing overdose deaths.\87\ Indeed, Mr. 
Chester has warned that ``[G]iven what we know about the 
dynamism and rapid pace of illicit drug production we see 
today, the synthetic opioid that will be killing Americans in 
2021 or 2022 has not yet been invented.'' \88\
---------------------------------------------------------------------------
    \86\ Id.
    \87\ See Id. at 2.
    \88\ Id. at 3.
---------------------------------------------------------------------------
    There is growing recognition that, based on evidence, the 
only way to stop the demand for drugs is through prevention and 
treatment.\89\ Yet an outsize proportion of federal resources 
is still allocated towards enforcement. It is time for the 
government to adjust its drug policy to catch up. It is more 
important than ever to maintain--and increase--the distribution 
of power in drug control policy to the Secretary and prioritize 
evidence-based strategies to effectively fight this critical 
public health issue.
---------------------------------------------------------------------------
    \89\ See supra note 7.
---------------------------------------------------------------------------

                         IV. Conclusion

    Classwide scheduling is a step in the wrong direction and 
would mark a return to the failed approaches of the War on 
Drugs. The Department has used existing tools to successfully 
and aggressively prosecute harmful fentanyl analogues and those 
tools do not disrupt the balance between, on one hand, 
enforcement, and on the other, science, prevention and public 
health. Again, I thank the Committee and appreciate the 
invitation to share my perspective on this issue.

    Ms. Bass. Mr. Holman?

                 TESTIMONY OF DONALD A. HOLMAN

    Mr. Holman. Chairwoman Bass, Ranking Member Ratcliffe, and 
Members of the subcommittee, thank you for inviting me to 
testify today. My name is Don Holman. My son, Garrett's, 21st 
birthday was on February 17th, 2017, but he never saw it. He 
died on February the 9th, just 8 days prior, from his 3rd 
synthetic opioid overdose in less than 2 months.
    Garrett grew up in Lynchburg, Virginia, where he 
established friendships in grammar school that carried through 
high school. Growing up, he spent endless hours playing sports 
and spending time with family and friends. Garrett was 
diagnosed at an early age with ADHD and took medication to help 
him concentrate in school, but as Garrett grew older, he 
resisted taking the medication and started self-medicating with 
marijuana.
    As parents, we were not aware until he started having 
disciplinary schools at school. Our focus then became to make 
sure he graduated from high school and hopefully go to college. 
We went through many different scenarios from trying to set 
down reasoned rules to trying to get him treatment for anxiety 
and depression. We would make excuses for Garrett's behavior to 
friends, family, and co-workers, but never revealed the extent 
to which his illness had progressed. I never gave up hope, and 
I was proud of my son. He needed medication for anxiety, but 
due to his tendency to abuse, he was never diagnosed or treated 
properly. Finally, someone told him about a synthetic opioid 
that would not show up on a drug test, so some time in November 
2016, he ordered U-47700 online, and it was delivered to the 
house by the U.S. Postal Service.
    Garrett overdosed the first time in December 2016 where I 
had to perform CPR until the paramedics arrived to administer 
naloxone and transport him to the hospital. Once he awakened in 
ICU, it was obvious that this was not the wakeup call we had 
hoped, so he was forced into a mental health evaluation. From 
there, he reluctantly went into a 30-day in-house treatment 
program, but a week after he got out, he overdosed the 2nd 
time. I forced him into a 2nd evaluation, but the judge decided 
he did not belong in a mental health facility, and released him 
on February the 6th, 2017. His final overdose was 3 days later, 
on February the 9th.
    You're never prepared to lose a child. Garrett's death has 
pulled our family apart, and we work to deal with our loss in a 
different way, each in a different way. My son's synthetic 
opioid exposure was less than 2 months, and at 20 years old, I 
do not believe he deserved to die for his initial bad choices. 
I understand that today's session is to hear testimony on 
extending the temporary class-wide scheduling on fentanyl 
analogues. By extending the ban, in my opinion, we continue to 
control what is coming into the U.S. killing Americans and 
allow time to finalize the permanent solution that allows for 
research access and ensures the punishment fits the crime.
    Garrett's struggles were not a death sentence until he 
discovered synthetic opioids. I have learned that before the 
temporary ban, analogues were a challenge to schedule, and so 
each slight variation was identified and scheduled 
individually. Class-wide scheduling allows for an urgent 
response to this fast-moving global crisis. Since that time, 
law enforcement has been able to aggressively bring high-tech 
criminal drug traffickers to justice, and China is now with the 
United States in similar scheduling for fentanyl analogues. If 
we back off, China and other countries may follow, and the 
result will be catastrophic because criminals are counting on 
this. Sadly, there are people in the world that see unscheduled 
fentanyl analogues as an opportunity to make a tremendous 
amount of money with absolutely no regard for human life. 
Without class-wide scheduling, they can produce, distribute, 
and kill with less risk of being held accountable.
    I'm also sensitive to situations where mandatory minimums 
may need to be considered, but not today, not here, and not in 
relation to fentanyl. Today, someone using or selling fentanyl 
or one of the analogues for any reason is very likely to kill 
themselves or someone else. I went from fighting to keep my son 
out of jail to fighting to get him into jail to save his life. 
I failed both times. Instead, let's continue to focus on jail 
and prison reform so individuals are treated like human beings, 
and the goal is rehabilitation and a permanent return to 
society.
    My friend, Sheriff Cocchi, in Hamden County, Massachusetts, 
has this type of rehabilitation program in place. He even 
allows adult males not charged with a crime into his facility 
for treatment. If my son would have gone to jail for an 
extended period of time, I would at least be able to visit him. 
If he were receiving treatment for mental health and substance 
abuse issues, I feel sure he would be here today.
    Because of the bipartisan support in fighting the opioid 
crisis, politics do not play a role in the decision to approve 
the extension. Additionally, I have also not read any 
scientific studies that indicate a person's gender, race, 
religion, or political affiliation makes them exempt from the 
tragic effects of the opioid crisis.
    In conclusion, I ask that you please extend class-wide 
scheduling as soon as possible, but also let's continue to work 
towards a permanent solution that will continue to give law 
enforcement an effective tool while also minimizing any 
concerns. Please allow the opioid crisis to be the issue that 
encourages everyone to reach across the aisle and put Americans 
and American lives first. I'd also like to thank this 
committee, Congress, the White House, ONDCP, HHS, CBP, HIS, 
DOJ, and DEA for everything you to do combat the opioid crisis. 
Each step forward is a step closer to resolving this issue, 
which will not only save thousands of American lives, but will 
also ensure that other parents will not have to bear the pain 
of losing a child to overdose. Thank you.
    [The statement of Mr. Holman follows:]

     STATEMENT OF DONALD A. HOLMAN--DAD AND IMPACTED PARENT

                     Donald A. Holman--Bio

    On February 9th, 2017, I lost my son Garrett to an overdose 
from a synthetic Opioid called U-47700. Since that time, I have 
been working to do my part to help fight the Opioid Crisis on 
every front. I have attended round table meetings with Gov. 
Christie and the First Lady as well as testified in PA for 
Senator Jay Costa. I attend HIDTA meetings when possible and 
make myself available to support efforts at the Federal level 
when needed. I have shared information with HSI and CBP PA to 
help identify the source of the Opioids that caused Garrett's 
death.
    Garrett ordered Synthetic Opioids online that were shipped 
through the mail from China and delivered to the House by the 
Mail carrier. When I first shared this story almost three years 
ago no one believed it.
    I firmly believe that my role is to support those at the 
Federal level when I can so together, we can stop this crisis 
and stop losing our children and other loved ones to this 
disease. My mission is not specific and covers a broad range of 
issues and solutions to combat the Opioid Crisis. I will not 
stop until Americans stop dying from overdose.

    Chairman Nadler, Ranking Member Collins of the House 
Judiciary Committee and Chairwoman Bass, Ranking Member 
Ratcliffe, and Members of the Subcommittee on Crime, Terrorism, 
and Homeland Security, thank you for inviting me to testify 
today and share my personal story as well as my perspective on 
Classwide Scheduling for Fentanyl Analogues.
    My Name is Don Holman.
    I am not a Scientist, Politician, Lawyer, or Doctor . . . I 
am just a Dad who wants to share my personal story with you of 
my son Garrett.
    Garrett's 21st birthday was on February 17, 2017, but he 
never saw it. He died on February 9th just 8 days prior from 
his third synthetic overdose in 2 months. Garrett is a 
statistic of the current Opioid Crisis and makes up less than 
1% of the victims that died that day from Overdose in the U.S.
    Garrett was born and grew up in Lynchburg, VA living in the 
same house most of his life with my wife, Bobbie and I and his 
sister Kristen. He established friendships in Grammar school 
that carried through High school and spent endless hours 
playing Football, Basketball, and lacrosse as well as Wake 
boarding in the summer and snowboarding in the winter.
    I would prefer to spend time talking about all the good 
qualities and the person Garrett really was but that would take 
a long time. Garrett was diagnosed at an early age with ADHD 
and took medication to help him concentrate in school. One of 
the side effects of ADHD medication is loss of appetite which 
presented an issue for someone athletic that enjoyed playing 
sports. As Garrett grew older, he resisted taking the 
medication part because he didn't like the way it made him 
feel, and part because emotionally he felt it was what everyone 
else wanted not
    what he needed. I now know that Garrett started self-
medicating early in High School and like so many he was 
introduced to Marijuana and convinced that it was a natural 
alternative to the ADHD Medication. As parents, we were not 
aware, and it wasn't until the 11th Grade that his behavior 
really started to concern us due to several incidents of him 
getting into trouble.
    However, he had many more good days than bad, and it seemed 
to be just a rebellious stage or at least we hoped.
    Our focus was to make sure he kept his grades up so he 
could graduate High School and hoping he would mature so he 
could go to college. With constant pressure and push he was 
able to graduate and even get accepted to Liberty University 
for the Fall Semester.
    Once he got out of High School, he struggled with the 
transition from child to Young adult. He never adapted to 
College and ended up dropping his classes that semester. As 
parents we went through so many different scenarios, trying to 
set boundaries and rules to trying to get him treatment for 
Anxiety and Depression. He was very strong minded and as a 
result of defiance and bad decisions started to get into legal 
trouble. He quickly fell into a downward spiral and soon the 
focus was on keeping him from a felony conviction and going to 
jail.
    Like so many parents, we would make excuses for Garrett's 
behavior to friends, family, and coworkers but never reveal the 
extent on which his illness had progressed. This is where the 
Stigma plays a tough role in the person afflicted as well as 
the Family that supports them. Mental Illness, Substance Abuse, 
and Addiction are not things that people want to talk about or 
other people want to hear. I never gave up hope and I was proud 
of my son. I did not want to imply that he was any more than a 
little wild and would settle down soon and be on track.
    Unfortunately, meeting legal obligations took precedence 
over any treatment for Mental Health or Substance Abuse. He was 
under a lot of pressure but the whole time still struggling 
with the need to escape reality. He needed medication for 
Anxiety but due to his legal issues and his tendency to abuse, 
he was never diagnosed or treated properly. Finally, someone 
told him about a Synthetic Opioid that would not show up on a 
drug test and that is all he heard.
    Sometime in November 2016 he ordered a synthetic Opioid U-
47700 online and it was delivered to the apartment by the mail 
carrier. So today, the mail carrier can inadvertently be the 
new drug dealer.

               This Was the Beginning of the End

    Garrett overdosed the first time in early December 2016, 
and I had to perform CPR until the paramedics arrived to 
administer Naloxone and transport him to the Hospital. Once he 
awakened in ICU it was obvious that this was not the wakeup 
call, we had hoped, so he was forced into a mental health 
evaluation by his Mom and me. He was only required to stay 5 
days. From there he reluctantly went into a 30-day in-house 
treatment program but a week after he got out, he overdosed the 
second time and once again I called 911 then performed CPR 
until Paramedics arrived and revived him. I forced him into a 
second evaluation, but the judge decided he did not belong in a 
mental health facility and released him on Feb 6, 2017. His 
final overdose was three days later on Feb 9, 2017. His cause 
of death was determined accidental as a result of mixed drug 
use. He had taken the synthetic Opioid U-47700 and Xanax.
    You will never be prepared to lose a child. Garrett's death 
has pulled our whole family apart and we are each working to 
deal with his loss a different way. I am not sharing my story 
because I have all the answers, I am sharing because I am sure 
I am not alone, and I would like to do my part to make it 
easier to have the conversation. You may read a headline about 
the opioid epidemic and see information about Heroin, or 
Fentanyl laced Heroin or maybe over prescribing of Pain 
medication. All of which are relevant and still carry the 
negative stigma and in many cases the opinion that a person 
addicted made a choice and deserves what they got. My son's 
Synthetic Opioid exposure was less than 2 months. He did not 
have time to hit bottom. At 20 years old, I do not believe my 
son deserved to die for his initial bad choices.
    I do not have all the answers, I just think everyone needs 
to be asking the questions and working together to fight this 
Crisis.
    Looking back, when I first saw my son in the funeral home, 
I became enraged and all I could think was that this is 
unacceptable, and I am angry! I immediately exclaimed I needed 
to talk to the President and let him know what happened because 
I felt it was a case of National Security that needed attention 
at the highest level of our Government. That fire I felt from 
that day until now has not diminished and I don't think it ever 
will.
    In the last three years I have become very close friends 
with several Parents that have also lost a child to Overdose. I 
have participated in Round table meetings with Gov Christie, 
the First Lady Melania Trump and have talked with the US 
Surgeon General. I have a close relationship with the Director 
of the ONDCP and continue to communicate with DEA, CBP, and 
HSI.
    I truly believe that everyone has something, and I 
constantly meet people that for some reason will share their 
story with me. There is no one solution or silver bullet but if 
we all work together and listen to each other, we can establish 
tools and resources that will collectively save lives.
    My understanding of this hearing is a focus on testimony to 
help determine if the temporary Classwide Scheduling on 
Fentanyl Analogs should be extended for an additional 15 
months. The simple, only answer to that is YES it should, and 
we should not be here at the last hour debating it. Also, 
within the next 15 months we need to pass SOFA or something 
similar to make it permanent.
    Garrett was a good looking, bright, intelligent, and 
athletic young man who had dreams and hopes just like everyone 
else his age. His struggles were not a death sentence until he 
was made aware of a synthetic Opioid that he could order online 
from China and have delivered to the house by mail. Since then 
I have learned that because of Synthetic Analogues both 
Fentanyl and other Synthetics, were a challenge to declare 
illegal until each slight variation was identified and 
scheduled.
    Since that time with the temporary ban on all Fentanyl like 
analogues, DEA and Law enforcement have been able to 
aggressively bring these high-tech criminal drug traffickers to 
justice. The most important accomplishment and the one that 
makes me feel like Garrett's death may not have been in vain, 
is that China is now with the U.S. in similar scheduling for 
Fentanyl Analogues. If we back off our stance against Fentanyl 
Analogues, then China and other countries may follow, and the 
result will be catastrophic because criminals are watching and 
waiting for this to happen. Instead of reducing the current 
ban, my hope is that we not only extend the current Scheduling 
ban for Fentanyl Analogues, but we make it permanent and do the 
same thing for all Synthetic Opioids.
    We hear a lot about the Health issues around Substance 
abuse and efforts to increase Treatment and Recovery which are 
so important and do save lives and give those struggling the 
chance for a future. However, the reality we hear less about is 
that there are people in this world that see Fentanyl and 
especially the unscheduled Fentanyl Analogues as an opportunity 
to make a tremendous amount of money with absolutely no regard 
for human life. Without the classwide scheduling, they are able 
to produce, distribute, and kill with less risk of being caught 
and held accountable.
    I have tried to look at any justifiable reason that might 
make sense to not make this Classwide Scheduling permanent or 
at a minimum approve the 15-month extension. I refuse to 
believe that Politics play any role in the decision not to 
approve the extension. No matter what the political climate is 
in DC, first and foremost we are all Americans and we are all 
human beings. So far, I have not read any scientific studies 
that indicate being of a certain sex, race, religion, or 
political party makes you or anyone in your family exempt from 
tragedy as a result of the Opioid Crisis.
    In the case of mandatory minimums, I am sensitive to the 
fact that there may be situations where they need to be 
considered but not today, not here, and not in relation to 
Fentanyl. I went from fighting to keep my son out of jail to 
two days before I lost him, fighting to get him into jail to 
save his life, I failed both times and now he is gone.
    If someone is arrested and charged with distribution of 
Fentanyl or a Fentanyl Analogue, I understand there are 
provisions to evaluate the person to be sure they are not 
someone using and selling to support an addiction as opposed to 
someone selling solely for profit. In my opinion, instead of 
debating this issue, let's continue to focus on jail and prison 
reform where anyone being arrested is treated like a human 
being and efforts are in place to rehabilitate and return to 
society as a proud person with the skills to succeed and not 
return to prison. I have recently visited a correction facility 
in Mass where Sheriff Cocchi has a program to do this. He even 
allows adult males not charged with a crime into his facility 
for treatment if it is determined they are a danger to 
themselves.
    If my son would have been caught and because of mandatory 
minimums, put in jail for an extended period of time, he may 
have had a chance and could be alive today. I would be fine 
visiting him in jail and if he was receiving treatment for 
mental Health and Substance Abuse, his chances of fulfilling 
his dreams would be a reality. Today, someone using or selling 
Fentanyl or one of the Analogues is very likely to kill 
themselves or someone else.

                           Conclusion

    I ask that you please extend Classwide Scheduling ASAP and 
let's continue to work towards a permanent solution that will 
continue to give law enforcement an effective tool while also 
minimizing any concerns.
    Please allow this to be the issue that everyone reaches 
across the aisle and puts Americans and American lives First.
    I would like to thank the Committee, the White House, 
ONDCP, HHS, CBP, HSI, DOJ and DEA for everything you do to 
combat the Opioid Crisis. Each step forward is a step closer to 
resolving this issue which will not only save thousands of 
American lives but will also ensure family and friends of those 
lost will not have to bear the pain and loss of losing a loved 
one to overdose. I would also like to remind you that myself 
along with other parents and siblings like me that have lost a 
loved one, are here to help in the fight. Take advantage of 
that resource so we can beat this together. Thank You!

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Ms. Bass. Dr. Ciccarone?

              TESTIMONY OF DANIEL CICCARONE, M.D.

    Dr. Ciccarone. Mr. Holman, my condolences for your loss.
    Mr. Holman. Thank you.
    Dr. Comer. It is good to see you again today.
    Mr. Holman. Thank you, Dan.
    Dr. Comer. Chair Bass, Ranking Member Ratcliffe, and other 
distinguished Members of this subcommittee, thank you for the 
opportunity to speak in front of you today. My name is Dan 
Ciccarone. I am a professor of family and community medicine at 
UCSF, and I am an addictions medicine specialist, an academic 
researcher, and drug policy expert. I know the current overdose 
crisis firsthand. I have witnessed it at the ground level in my 
research, and my team and I have published extensively on it.
    Here are my thoughts on how the Class 1 schedule of 
fentanyl derivatives might work counter to the goals of public 
health.
    Point 1: The class of fentanils is a large number of 
unexplored compounds, over 1,400, some of which have been 
identified already as partial agonists and antagonists at the 
opioid mu receptor. Because of the potency of illicit fentanyl, 
it is important to explore new antagonists to reverse overdose 
and new treatments to address greater dependency, and these may 
come from the fentanyl class. Based on my research, users and 
low-level dealers typically do not know if the drug they are 
selling or using contain fentanyl.
    Piont 2: Making a class ban on fentanyl permanent will 
likely increase trends in fentanyl trafficking and prosecution, 
which disproportionately affect those at the bottom of the 
supply chain.
    Point 3: Class 1 scheduling has not been shown effective in 
reducing the number of overdose deaths, nor reducing fentanyl 
availability. The latest provisional data from the CDC as of 
June 2019 shows synthetic opioid overdoses continuing to rise 
at a rate of 8.3 percent over the year prior. This is despite 
15 months of emergency scheduling. In an analysis of 10 years 
of drug seizure data from Ohio, which my team and I have just 
published this month, we found a steady rate of novel 
synthetics, of novel fentanils being introduced through the end 
of 2018. Now, I know that only includes 10 months of emergency 
scheduling, so we need more data on that. However, I do want to 
point out a drug policy metaphor, and that is, squeezing the 
drug supply balloon often causes supply to pop out in 
unexpected places. We've already seen the U series, the AH 
series, the other series of non-fentanyl synthetics coming out. 
We do not know what happens next.
    Point 4: despite decades of strong prohibitionist efforts, 
drug mortality is increasing exponentially. A report in the 
Journal of Science found an exponential growth in overdose 
deaths from 1978 to 2016. This exponential increase in drug 
overdose deaths was not defined by any specific class of drugs. 
The triple-wave fentanyl opioid is just the last phase of this 
38-year phenomenon. The reasons for this worse-case public 
health scenario involves 2 failures: First, that of drug 
prohibition to stop the drug supply balloon from morphing, and, 
secondly, the failure to address the underlying or root causes 
of problematic drug use. There's growing evidence that we need 
to address the social and economic determinants of health, the 
root causes of drug demand, and the overdose crisis if we are 
to fill in the cracks of society that the waves of drug supply 
fall into.
    Overdose deaths due to illicit fentanyl represent a 
historic crisis, one full of challenges, but this era is also 
one of historic opportunity to rebalance our drug policies more 
in favor of demand reduction, including treatment, and away 
from failed prohibitionist policies, and to reorient to a 
healthier society resilient to problematic drug use. 
Specifically, we need to offer treatment of punishment. We need 
to expand treatment, reduce the barriers to buprenorphine, for 
example, with the Mainstreaming Addiction Treatment Act of 
2019, which has House and Senate versions. We need greater 
support for prevention. Harm reduction's goal is to reduce 
deaths and other harms from drug use. Because it is person-
centric, it can reduce stigma and engage folks where they're 
at. It can even serve as a bridge to treatment.
    One could argue that HIV/AIDS was a similar crisis in the 
1990s, one with stigma and a head-in-the-sand approach at 
first, but one which was eventually addressed with a 
comprehensive plan of prevention and treatment. Likewise, now, 
we need a grand piece of legislation, like the Ryan White CARE 
Act, to address the current crisis. In my small way, I've 
helped envision and promote such a comprehensive and balanced 
plan, including treatment, harm reduction, demand reduction, 
and supply reduction. Its implementation could signal the end 
of this unfortunate era.
    I thank you all for your time, and we're willing to answer 
any questions you have.
    [The statement of Dr. Ciccarone follows:]
    
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]    
       
    Ms. Bass. Thank you. We will now proceed under the 5-
minute Rule with questions. I will begin by recognizing myself 
for 5 minutes.
    In 1 minute, Mr. Butler, I am going to let you finish what 
you were trying to say because I did interrupt you, if there 
are other parts of your testimony that you wanted to give. 
Before I do that, I just wanted to know if you would comment. 
In the first panel, I asked the question about where this 
manufacturing of the analogues take place, and it was 
acknowledged it is in China and Mexico, and I don't understand 
why we can't get China and Mexico to stop. We slap tariffs on 
China, we threaten Mexico around the border, but we can't get 
that to happen, and I want to know your opinion about that. In 
other words, what can we do on the international side to stop 
the drugs from coming in? In addition, to trying to stop it 
from crossing the border, I am talking about stopping it from 
being manufactured. Turn your microphone on.
    Mr. Butler. Chairwoman Bass, that is a wonderful question. 
I will be frank with you. It is above my level. By that, I mean 
I am the defender of a wonderful organization. We deal with, 
what I will say, the street-level impact of these drugs. As far 
as what needs to be done at a national level addressing and 
stopping the drugs from coming over the border, I can't answer 
that, but what I can say is this. What we are not seeing on a 
national level is the prosecution of the importers, the major 
traffickers. What we are seeing, like my office and others 
throughout the country, is the prosecution of a 4,000, 5,000 
percent increase in prosecution of low-level and mid-level 
dealers.
    I think DEA and Attorney General Barr in their statements 
regarding this crisis have indicated that they need this 
scheduling order to become permanent so that they can go after 
the higher-level people bringing it in from China, bringing it 
in from Mexico. Well, as to date, we are not seeing those 
prosecutions. What we are seeing is what saw back in the 80s 
and 90s, lower-level people getting mandatory sentences and 
being prosecuted under this offense.
    Ms. Bass. Again, it is one thing to talk about the 
importation, but I am talking about the manufacturing.
    Mr. Butler. Understood.
    Ms. Bass. I don't understand why on a government level, and 
it just doesn't seem as though we are forcing the Chinese or 
the Mexican government to actually crack down on the 
manufacturing of it before it is even brought in. Mr. Holman, 
and then I will go back to you, Mr. Butler, did your son and 
did your family have access to drug treatment? Was it 
inpatient, outpatient?
    Mr. Holman. In our situation, it wasn't primarily the 
substance abuse issue. It was a variety of items that were 
going on. The synthetic opioid overdose or the use of that was 
in a 2-month period. It was so quick. He was not looking for 
something and found it. In essence, it was marketed to him. I 
brought his phone. This is what the drug dealer that sold it to 
him. He was told that he can go online and order this from a 
regular website, use bitcoins. This is a photograph of what was 
delivered to the house. It is an envelope that was addressed 
from China and the material that was in there. Once this was 
brought to his awareness, it was so fast. The struggles we had 
before were seemingly manageable, but with this substance, it 
just totally derailed everything.
    Ms. Bass. Thank you. Mr. Butler, would you like to finish 
the testimony you were giving?
    Mr. Butler. Yes, thank you. The last part of my testimony 
was the Trump Administration estimates that the number of 
banned substances has ranged from hundreds to thousands to an 
infinite number. Even the Administration concedes that 
fentanyl-related substances can range from deadly to beneficial 
to benign. I have already spoken to this, but I will just 
repeat it. This will not work. We know that a punitive war on 
fentanyl will devastate communities and fuel mass 
incarceration. We are seeing that trend already. Let's keep 
evidence and health experts in the room, and together we will 
find a better way. Thank you. That was my last portion.
    Ms. Bass. Thank you. Dr. Comer, you recommended that in any 
scheduling of synthetic fentanils, HHS, and, particularly, its 
science-based agencies, should be integrated into the process 
of reviewing the abuse liability of the suspect compounds. Can 
you talk about how that could be accomplished?
    Ms. Comer. Yes. So, as we heard earlier today, the HHS is 
involved with, you know, scheduling decisions. What I referred 
to was a streamlined process for making it easier to evaluate 
the pharmacology of these compounds without going through the 
full 8-factor analysis, and, in fact, NIDA has a procedure in 
place for doing that. They have screened compounds rapidly for 
several decades actually.
    Ms. Bass. Thank you. Mr. Gohmert?
    Mr. Gohmert. Thank you, Chairman. I appreciate you all 
being here. We had heard testimony from the prior witnesses 
about how many lethal doses could end up or are required to 
send somebody to prison for the minimum. Mr. Butler, do you 
have a recommendation on how many lethal doses of fentanyl 
should trigger a prison sentence?
    Mr. Butler. Well, wonderful question. If your question is 
exactly how much fentanyl someone should have before they go to 
jail, that is not my place. That is, I believe, the 
legislators' place. What I can say that there were 
misrepresentations, I believe, by Ms. Liskamm, not regarding 
the actual doses, but how drugs are actually used in real 
world. By that I mean the circumstances Mr. Holman dealt with--
that is, coming in through the mail and his son unfortunately 
and tragically using it--is not the circumstance that my office 
and other offices are seeing. What we are seeing an individual 
on the street who doesn't know that he has fentanyl, has a 
mixture of substance about the size of an aspirin pill, that he 
believes to be heroin. A small--
    Mr. Gohmert. My time is very limited, so let me move on. 
Mr. Holman, I understand how difficult it must be. We are told 
you can't truly sympathize with somebody unless you have been 
in their shoes. I do think there is something genetically in us 
that causes some people to have a much more addictive 
personality, and that is something I would love to see more 
research on. I can't help but wonder how you would feel about 
what Texas did back in the 90s when I was on the bench. Some 
people disagreed with it, but they were locked down, felony 
punishment, the substance abuse felony punishment facilities.
    Back then, I had some data indicating 70 percent of those 
who went to prison had a drug or alcohol addition, and it 
seemed to make sense to me that we ought to have facilities 
where if you are addicted to something, that is where you go, 
and everything is about furthering education and dealing with 
your addiction. Is that something that you contemplated might 
have been more help for your son?
    Mr. Holman. Yes. Those that are struggling are not maybe 
typical of what you would think. I mean, my son was bright, 
smart, intelligent. He could sit here and talk to you just as I 
am today. So sometimes they need to have that cloud lifted in 
some way so they can actually think clearer to get the 
treatment they need. So, in my case, that was not an option. 
You cannot force an adult into a treatment facility. I grew up 
in the 80s and 90s. I am very familiar. I have personal 
experience with how maybe things were not handled correctly 
then.
    I talk about jail and prison reform, and Sheriff Cocchi I 
mentioned, I actually visited his facility and spent 5 hours. I 
would recommend anyone to look into what he is doing. Because 
of a law on the books, all his inmates are treated for 
substance abuse. They receive MAT. Even people who are not 
arrested go in, and it is not a bad thing.
    Mr. Gohmert. Is that a 12-step program, or what is it?
    Mr. Holman. It is a full program. You can sum it up in a 
few minutes. You have to go look at his facility and so forth. 
I honestly feel like this time where we are at, you have to 
pull people away. With the crack cocaine, just like with other 
substances, you may have a little bit more time. With the 
synthetic opioids, and especially fentanyl, it is not just pure 
fentanyl. It is put in a Xanax bar. It is mixed in with--
    Mr. Gohmert. It is put in all kinds of things.
    Mr. Holman. So, what used to be the low-level dealer then 
is actually a drug trafficker. You people are 95 percent there. 
You are getting close. You are talking about all the right 
things because it is a complex process. My only ask is that 
don't let this expire. Extend, but then let's keep working. I 
am local. I will come, whatever you need, to satisfy mandatory 
minimums, to satisfy research opportunities, that everybody 
wins.
    Mr. Gohmert. Well, my time is about to expire.
    Mr. Holman. Sorry.
    Mr. Gohmert. Let me just indicate that we have been hearing 
through the impeachment proceedings that it is totally 
inappropriate for a President to ask a foreign country to help 
us with some type of criminality that involves our country, but 
it sure sounds like that is something we ought to be doing to 
root this out.
    Mr. Holman. I am very close with those at ONDCP, and they 
are working. China is working with us. The indications are with 
their scheduling, if we do not extend, they will be ahead of us 
with their scheduling. Chairwoman Bass, that is something that 
I believe does help hold those countries accountable, not just 
China, but any other country that is poised to jump in and do 
the same thing, because these are smart people. We don't talk 
enough about the criminals because it is not a good topic, but 
there are people out there that are high tech. They are 
chemists. They are technically capable to market this to our 
children and right under our noses.
    Mr. Gohmert. Thank you, Madam Chair.
    Ms. Bass. Absolutely, and I would agree it is very 
important to hold foreign governments responsible when they are 
impacting the American people. Mrs. McBath?
    Mrs. McBath. Thank you, Madam Chair, and thank you to each 
of you for being here today and just really shedding light on 
this really very deadly epidemic that we are dealing with. Mr. 
Holman, I want to thank you so much for your testimony. I offer 
you my deepest condolences because I understand what it is like 
to lose your child. I lost my child to an epidemic, but it was 
an epidemic of gun violence. So, thank you so very much for 
willing to lend your voice and give great credibility to the 
ills of what we have to be able to challenge and to save our 
families.
    Dr. Comer, thank you for being here to speak with us today 
about the needs of our Nation's researchers that work to make 
our communities safer and healthier. Your testimony explains 
the success that we have had saving lives with naloxone, also 
known as Narcan. You mentioned that it doesn't always work well 
for fentanyl doses, and we may need to develop a related drug. 
How can we facilitate that life-saving research while also 
carefully controlling access?
    Ms. Comer. I think that is the rub here. I understand the 
sentiment about wanting to put class-wide scheduling of 
fentanyl analogues into Schedule 1. The worry that is where the 
gap is, especially regarding antagonists. They have no agonist 
activity, so they would not likely rise to the occasion of 
being identified on the street.
    The best way that they can be identified is by a chemist 
doing what is called structure activity relationships, so a 
chemist and pharmacologist kind of work together. The chemist 
takes the core structure, develops a whole series of compounds. 
As I said in my testimony, you can't tell just based on the 
chemical structure whether it would be an antidote or the toxic 
substance. So, the chemist develops a series of compounds, 
passes it on the pharmacologist, who runs these very rapid 
tests of whether it can be the antidote or whether it is really 
toxic. Those experiments together will help us determine 
whether something is beneficial medically.
    These types of tests that I am talking about, I know that 
the concern of the DEA is this 8-factor analysis that takes a 
really long time to run. These pharmacology experiments that I 
am describing can be performed rapidly. I did them when I was 
graduate school. You can run a basic assay in a week to 
determine whether something is an agonist or antagonist. That 
is what I am suggesting.
    Mrs. McBath. Thank you so much. I yield back the balance of 
my time.
    Ms. Bass. Mr. Cline?
    Mr. Cline. Thank you, Madam Chair. I thank the witnesses 
for being here, for sharing their testimony. Mr. Holman, thank 
you for being here. I want to start with you. Is there anything 
you would like to add today given the testimony that was given?
    Mr. Holman. The only thing I would say, we touch on 
treatment. We touch on prevention. It is prevention, 
enforcement, treatment, and recovery. It is a Rubik's cube. We 
can't get one side correct and ignore the others. My only ask 
is don't let this expire so that we can continue to do what we 
are doing, but let's not give up, and let's not ignore the 
concerns, and let's address those for a permanent solution 
going forward. And let's not stand back. Again, let's look 
forward. Let's get in front of this and stop chasing it. Thank 
you.
    Mr. Cline. Thank you. Dr. Ciccarone, in your testimony, you 
say the class of the fentanils has a large number of unexplored 
compounds, some of which are theoretically beneficial for 
treatment or as overdose antagonists, and Schedule 1 
classification would inhibit basic science and clinical 
research. So, I would ask, once a substance is placed in 
Schedule 1, does it mean researchers can't access it, or does 
it just mean the process for doing so takes more time?
    Dr. Ciccarone. It simply takes more time. I was unaware of 
the interagency agreement. Admiral Giroir had mentioned today 
that there is a way to sort of de-schedule some of these 
things. I do share Dr. Comer's concern, though, and that is the 
discovery phase will have a wet blanket thrown on it.
    Mr. Cline. If a researcher has all the necessary 
permissions to access Schedule 1 drugs, what you are saying is 
they don't need to apply for different permissions to access 
the fentanyl analogues that are temporarily scheduled, right?
    Dr. Ciccarone. That I don't know. Dr. Comer might know 
that.
    Mr. Cline. Okay. Dr. Comer, can you share any information 
on that?
    Ms. Comer. I mean, the way the procedure works now, you 
apply for a Schedule 1 license, and it is compound by compound. 
So, I think, you know, some of the suggestions that have been 
made about, you know, providing research exemptions and 
streamlining the process are really good ones. The biggest 
worry, as I mentioned, that I have is that an antagonist, who 
has no pharmacological activity other blocking the receptor, 
and naloxone is an example of that. People don't get high off 
of it, but it is the antidote.
    The worry is that naloxone in many cases of fentanyl- or 
carfentanil-related overdoses, it just doesn't work. I mean, I 
have heard from EMTs who say they have given 5, 6 doses of 
naloxone, and the person still dies. We need to find other 
kinds of antagonist solutions. So, it makes sense that the 
chemical structure of a compound that is an antagonist would be 
very similar to the agonist. The receptor has a certain 
confirmation, and then the agonist binds there, and it has a 
certain shape that fits into that confirmation, and then it 
activates the receptor. The antagonist is one that fits into 
that receptor, but it doesn't activate it because you add 
something to it. My big worry here is that with the synthetic 
putting everything into Schedule 1 will make it really 
difficult for us to find those kinds of antidotes.
    Mr. Cline. Thank you. I yield back.
    Ms. Bass. Ms. Jackson Lee?
    Ms. Jackson Lee. Thank you very much, Madam Chair. Let me 
thank both of you for holding this hearing again in the 
Judiciary Committee and full Committee Members. This is 
something that I have worked on for a long time. I remember 
when we were discussing fentanyl and nobody knew what it was, 
and it is now an epidemic.
    Mr. Holman, may I offer my deepest sympathy? A child is so 
precious, and I have seen families bury children all over the 
Nation. So, I wanted to just make a point that we need to look 
globally because there are two points that you made that I want 
to pick up with legislation, and I want to ask Mr. Butler as 
well. One, how frustrating it is that you wanted to get your 
son help, and the only option was a jail, except you used the 
example of a sheriff who created instead treatment. A powerful 
country like us, so number one.
    Number two, your son first was exposed to it online from 
China, if I think I was reading the notes, and so we have a 
layered issue that we must deal with. Could you just briefly 
talk about this whole thing of parents being frustrated by the 
fact that the only option you had was a jail, but then he 
couldn't stay in the jail or they wouldn't keep him?
    Mr. Holman. Yes, ma'am. Thank you. It doesn't start with 
that either and there are parents today. It is amazing. Talk to 
your Uber driver this afternoon. Talk to somebody, and mention 
naloxone, mention fentanyl, and they have no idea, and we are 
right here. We all start out with our kids. We want the best 
for them and you taper down. They start getting in trouble. 
Each person has a different path. When you do get to the point 
where you need help, you have to go through a process. First, 
jail, you are right, we don't want them to go to jail because 
there is so much. My opinion is on the mandatory minimum, how 
long they go to jail, yes. I didn't want my son to go to jail 
at all in the beginning. I didn't want him to be in there. My 
biggest concern though is what he was taking away from that. I 
have people that I have talked to since then, amazing, 
productive, great people that have had a situation and they 
have gone to jail for longer than they should, but it helped 
them. They are productive today, but they have felony charges, 
nonviolent felony charges.
    Ms. Jackson Lee. Right. Let me just interrupt you. Might it 
be better if it were a treatment facility that your son could 
go to that he would stay in and not be released to help him?
    Mr. Holman. Yes.
    Ms. Jackson Lee. That is what I was saying.
    Mr. Holman. Yes.
    Ms. Jackson Lee. Your option was a jail. Let me be on the 
record. I am against mandatory minimums because your son could 
get caught up with it as well as others can get caught up. 
First, we need to end this epidemic, but while it is here, we 
need a system that would have protected your child with 
treatment.
    Mr. Holman. Yes.
    Ms. Jackson Lee. Is that yes, or no?
    Mr. Holman. Yes, it is.
    Ms. Jackson Lee. Okay. Let me thank you and say to you that 
I am committed--
    Mr. Holman. Could I add one thing to that?
    Ms. Jackson Lee. Yes, you may.
    Mr. Holman. The example I gave was where someone is held in 
a correction facility and treated, but not charged. Now, that 
is unique, but if you are 18 or over, you can walk out any 
facility unless you are held in.
    Ms. Jackson Lee. Right. Treatment, I understand, might be a 
little different in terms of its framework, even though I 
understand what you are saying. You are saying that if you are 
an adult, they can't hold you against your will. We have dealt 
with that. That is a real serious issue, and that is something 
that we must look at on the State level and otherwise. My 
sympathy again and thank you for bringing your insight to this.
    Mr. Holman. Thank you.
    Ms. Jackson Lee. Let me try to get two more questions. Let 
me say that I am going to look. I am inspired by this Ryan 
White concept, Dr. Ciccarone, and we are going to immediately 
turn to that and see how we can fit it into this epidemic now. 
Let me ask the two of you, Mr. Butler, to clarify your earlier 
testimony of how many grams of a substance with a detectable 
amount of fentanyl trigger a mandatory minimum. I also want you 
to, when I asked the question of DOJ, and they said, oh no, we 
don't prosecute drug addicts, but you have enlightened it. It 
is these low-level people that also are victims of sorts, so I 
would like you to comment on that. I would like the professor/
doctor to comment on framing this, and I only have a couple of 
seconds, so framing this response like the Ryan White treatment 
act. Mr. Butler, just quickly on that point?
    Mr. Butler. Yes, I will try to answer all questions.
    Ms. Jackson Lee. Just answer the one about the triggering 
and the--
    Mr. Butler. In front of Mr. Holman right now is a paper 
clip. That paper clip weighs approximately 10 grams. If an 
individual possesses that much in fentanyl combined with 
something else, an inert substance in order to be mixed with 
it, that person is looking at a mandatory 5 years in jail. If 
that person has something the size of 10 paper clips, he is 
looking at a mandatory 10 years in jail.
    Ms. Jackson Lee. Can I pause you for a moment? I know that 
some others will let you answer. Doctor, you have got about 2 
seconds to say--
    Dr. Ciccarone. I will just say that current Federal 
legislation has helped, but it is a drop in the bucket. 
Overdoses have gone down about 5 percent. We need a lot more if 
we want to tackle this crisis.
    Ms. Jackson Lee. Thank you. I am sorry, but I got your 
answer. Thank you so very much. I yield back.
    Ms. Bass. Mr. Cicilline?
    Mr. Cicilline. Thank you, Madam Chair, for holding this 
really important hearing. First, thank you all for being here. 
Mr. Holman, we all extend to our deepest sympathies for the 
loss of your child, and sadly we have had in all our 
communities the same kind of loss. In my State, 233 Rhode 
Islanders last year lost their lives to opioid overdoses, so we 
want to get this right. We are living with the consequences of 
this addiction epidemic which is ravaging our country.
    I want to understand how we have gotten to this place with 
respect to at least the legal framework. Professor Comer, the 
DEA's emergency authority expires on February 6th, 2020, and 
the DEA is ineligible for a 1-year extension to this timeline 
because it had not asked HHS or the FDA to determine if their 
scheduling action is medically and scientifically valid. Is 
that correct, and if so, why? Do you know why they have not 
made that request?
    Ms. Comer. So, I think it has to do more with the blanket-
wide scheduling issue. So normally, HHS does its 8-factor 
analysis on a single compound, which is reasonable and makes 
sense. You can't do that with a potentially infinite number of 
analogues, so there is nothing really that the FDA could 
evaluate as a single compound. That is where the problem comes.
    Mr. Cicilline. Okay. Now, we have heard the argument that 
if this classification or this extension is not granted, that 
the government will not be able to effectively prosecute 
fentanyl. Of course, there is the Analogue Act, which provides 
for up to 20 years in prison for a first offense, up to 30 
years in prison for a second offense, and a mandatory minimum 
if death resulting. So, Mr. Butler, are there tools in place if 
this expires that would continue to allow the government to 
successfully prosecute fentanyl cases?
    Mr. Butler. Yes, and fentanyl prosecutions under the 
Analogue Act are up approximately 5,000 percent.
    Mr. Cicilline. So, this notion of if we don't do this, the 
Attorney General has made the argument that somehow fentanyl 
will become legal is not true.
    Mr. Butler. Yes.
    Mr. Cicilline. Okay. Yes, it is not true.
    Mr. Butler. Yes, it is not true.
    Mr. Cicilline. Okay. I just want to understand because I 
think this is important, and we must actually get this record 
correct. In fact, if there is any danger that an extension on 
this will make the problem worse and make more victims of this 
public health crisis, then that is not a good idea. I want to 
be sure that the criminal prosecution framework is robust and 
remains in place regardless, and you say it is. Professor 
Comer, what I am also interested in is nearly $6.8 million in 
new Federal grants will enable researchers to collaborate with 
State agencies to investigate innovative public health 
approaches to address the opioid crisis. For instance, 
researchers in my district at Brown University are working to 
find ways to reduce overdoses and provide evidence-based public 
health solutions to the opioid crisis. Is there any risk that 
class-wide scheduling may undermine evidence-based approaches 
to addressing this opioid crisis? If so, can you elaborate on 
how class-wide scheduling poses a risk to finding public health 
solutions to this deadly crisis, because that is the goal here. 
What we don't want to do is an effort to respond to this 
request actually make a very deadly problem more deadly.
    Ms. Comer. So, I am familiar with the research that is 
coming out of your State, and it is excellent, and they have 
done a really great job of trying to move the field forward in 
terms of addressing this issue. The concern that I have, and 
thankfully things like Narcan, naloxone, are available for 
reversing overdose. The problem, as I stated is that it doesn't 
work in all cases, and we don't know why. So the continued 
development of additional types of antagonists is really 
critical to getting a complete handle on this problem.
    The impact on research is really more at the basic science 
level, the level of the chemists, the level of the 
pharmacologists who are searching for these kinds of 
antagonists that will be more effective than naloxone. That is 
where I think the greatest harm would occur.
    Mr. Cicilline. Thank you very much. Madam Chair, I would 
ask unanimous consent that this article, which appeared in the 
Providence Journal, which describes a comparison between the 
State of Rhode Island and Portugal on its public health 
response to the opioid crisis, be made a part of the record.
    Ms. Bass. Without objection.
    [The information follows:]



      

                      MR. CICILLINE FOR THE RECORD

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    Mr. Cicilline. I yield back.
    Ms. Bass. Ms. Mucarsel-Powell?
    Ms. Mucarsel-Powell. Thank you, Ms. Bass. You come into 
these hearings and you have all the questions that you want to 
ask the witnesses. Then I hear testimony, and my head is 
spinning trying to ask specific questions to get answers on 
dealing with this issue. It is such a complicated issue because 
you want to make sure that you criminalize those that are 
distributing and trying to find the chemicals and changing the 
compound to the drug so that it stops, and at the same time, 
you know that this disproportionately affects communities of 
color.
    I represent an area which is a majority minority community, 
and I know that they get into this prison cycle that they can't 
get out of, and people are punished because they have issues 
growing up. Mr. Holman, as a mom, I have an 11-year-old 
daughter. I have a 14-year-old son. It hits close to home. 
Believe me when I tell you that this should not be a political 
issue at all. I think we all want to deal with this issue the 
right way. We need to make sure that we provide support 
services to parents that are dealing with children that are 
experimenting.
    I was just reading that the easiest way to now purchase 
fentanyl is online, that there was an investigative Committee 
in the Senate that found out there are six online sellers. 
People can purchase these drugs online. What are we doing in 
Congress to make sure that we provide the appropriate oversight 
to stop that? So, I don't think that allowing for fentanyl to 
extend in the Schedule 1 is going to be an issue. I think that 
many Members in the House agree that we have to do that right 
now. At the same time there has to be a way that even though we 
provide that extension, we can still do research. So, I wanted 
to ask first to Ms. Comer, do you think that there is a process 
in place for an institution that can conduct research into the 
health benefits of analogues under a Schedule 1 drug?
    Ms. Comer. There is a process in place, and it can be done. 
As I wrote in my testimony and I think we have heard earlier 
today, the process is really complicated and burdensome. I know 
for a fact, so there are only a handful of chemists who are 
either willing or able to research these kinds of compounds, 
and they just don't want to go apply for a Schedule 1 license 
because it is so difficult. I think that the things that we 
have been discussing this morning about ways to streamline the 
process are definitely in the right, direction, and ways of 
removing some of the substances once they get placed into 
Schedule 1 is also helpful from a research perspective.
    What is harder to get a handle on, is the impact of this 
chilling effect that it has on research. That is what is 
worrisome here. I know that, as you said, it is a very 
complicated issue. Our organization, me personally, understand 
the DEA's concerns about prosecuting these people. When I first 
found out that fentanyl was hitting the streets, I was shocked, 
and I was really dismayed because I worked with it when I was 
in graduate school, and I know that the dose that produces a 
euphoric effect and the dose that produces--
    Ms. Mucarsel-Powell. Deadly.
    Ms. Comer. --that is deadly is so small. Then when I heard 
that carfentanil hit the street, I was even more shocked. So, 
we need to do something, and I think having this kind of 
dialogue is critical.
    Ms. Mucarsel-Powell. Thank you. Thank you, Ms. Comer. I 
wanted to ask Professor Ciccarone. That is the way to pronounce 
it, right?
    Dr. Ciccarone. Yes.
    Ms. Mucarsel-Powell. If you could explain the prominence of 
fentanyl in analogues that are used now among minority 
populations.
    Dr. Ciccarone. So, the main thing to be aware of, on the 
street level, folks cannot tell the difference in what they are 
getting. There is no cultural lingo for fentanyl. There is not 
a lot of slang for it, which says that it is not a drug of 
choice. It is a contamination in the heroin stream. So, people 
are looking for heroin, but what they are getting is fentanyl 
and other analogues. The problem with the analogues is they 
come across in a great range of potencies from 3 times morphine 
to 10,000 times morphine. So those vicissitudes alone and the 
clandestine nature of the contamination is what is causing 
overdose, right? There is no way to level that out. There is no 
way that this ban will make the streets safer in terms of 
fentanyl vicissitudes. We see that fentanyl is still there, 
despite the 15 months of the emergency scheduling.
    Let me just point out that all the fentanyl that comes into 
this country could fit into 10 industrial drum barrels right 
between dais and this table. All of it in the country right 
here. How do we stop that with the enormous Pacific Rim trade, 
you know, thousands of container ships that happen to come 
across the Pacific Ocean? How do we stop industrial barrels 
worth of product, right? Interdiction itself is a problem. 
Source control might have opportunity, working with China, 
working with Mexico to stop the production of substance. By the 
time we get to the street level, putting the genie back in the 
bottle ain't happening. It is just not.
    Ms. Mucarsel-Powell. Thank you. Just one last word. Mr. 
Holman, if there is anything you would like to tell parents 
that are dealing with this issue, what would you recommend?
    Mr. Holman. The ``not my child'' thought process doesn't 
work. It doesn't matter what demographic you are, who are you 
are, where you are at, anyone can be affected. You know, I 
don't know. That is why I am here. We need a solution.
    Ms. Mucarsel-Powell. We will work together on that.
    Mr. Holman. Thank you.
    Ms. Mucarsel-Powell. Thank you.
    Ms. Bass. Thank you so much. I would like to thank the 
witnesses for your time today. Just before we conclude, I agree 
with Ms. Mucarsel-Powell that I know that we will extend the 
ban. But at some point, in our country, I hope that we have the 
political will to force China and Mexico to stop manufacturing. 
We put tariffs, we stop Mexico or threaten Mexico around the 
border, but we can't figure out a way to get them to stop the 
manufacturing? I hope one day that we have the political will 
to stop the pharmaceutical industry from excessive 
manufacturing--we don't hold them accountable--and to stop 
online sales. I hope one day that we have the political will in 
this country to provide modalities of treatment instead of 
doing what gives us a false sense of responding by locking 
folks up who are lower-level drug dealers, and missing the big 
kingpins that traffic, or the manufacturing.
    With that we are adjourned.
    [Whereupon, at 12:30 p.m., the Subcommittee was adjourned.]



      

                                APPENDIX

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