[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\
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\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.
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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.
[The information follows:]
MR. SENSENBRENNER FOR THE RECORD
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[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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
=======================================================================
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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\
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\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).
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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\
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\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.
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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\
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\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.
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\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).
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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.
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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.
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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/.
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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.
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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.
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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.
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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\
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\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).
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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).
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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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