[House Hearing, 117 Congress]
[From the U.S. Government Publishing Office]
THE OVERDOSE CRISIS: INTERAGENCY PROPOSAL TO COMBAT ILLICIT FENTANYL-
RELATED SUBSTANCES
=======================================================================
HYBRID HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
__________
DECEMBER 2, 2021
__________
Serial No. 117-59
GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT
Published for the use of the Committee on Energy and Commerce
govinfo.gov/committee/house-energy
energycommerce.house.gov
_______
U.S. GOVERNMENT PUBLISHING OFFICE
56-896PDF WASHINGTON : 2024
COMMITTEE ON ENERGY AND COMMERCE
FRANK PALLONE, Jr., New Jersey
Chairman
BOBBY L. RUSH, Illinois CATHY McMORRIS RODGERS, Washington
ANNA G. ESHOO, California Ranking Member
DIANA DeGETTE, Colorado FRED UPTON, Michigan
MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois STEVE SCALISE, Louisiana
G. K. BUTTERFIELD, North Carolina ROBERT E. LATTA, Ohio
DORIS O. MATSUI, California BRETT GUTHRIE, Kentucky
KATHY CASTOR, Florida DAVID B. McKINLEY, West Virginia
JOHN P. SARBANES, Maryland ADAM KINZINGER, Illinois
JERRY McNERNEY, California H. MORGAN GRIFFITH, Virginia
PETER WELCH, Vermont GUS M. BILIRAKIS, Florida
PAUL TONKO, New York BILL JOHNSON, Ohio
YVETTE D. CLARKE, New York BILLY LONG, Missouri
KURT SCHRADER, Oregon LARRY BUCSHON, Indiana
TONY CARDENAS, California MARKWAYNE MULLIN, Oklahoma
RAUL RUIZ, California RICHARD HUDSON, North Carolina
SCOTT H. PETERS, California TIM WALBERG, Michigan
DEBBIE DINGELL, Michigan EARL L. ``BUDDY'' CARTER, Georgia
MARC A. VEASEY, Texas JEFF DUNCAN, South Carolina
ANN M. KUSTER, New Hampshire GARY J. PALMER, Alabama
ROBIN L. KELLY, Illinois, Vice NEAL P. DUNN, Florida
Chair JOHN R. CURTIS, Utah
NANETTE DIAZ BARRAGAN, California DEBBBIE LESKO, Arizona
A. DONALD McEACHIN, Virginia GREG PENCE, Indiana
LISA BLUNT ROCHESTER, Delaware DAN CRENSHAW, Texas
DARREN SOTO, Florida JOHN JOYCE, Pennsylvania
TOM O'HALLERAN, Arizona KELLY ARMSTRONG, North Dakota
KATHLEEN M. RICE, New York
ANGIE CRAIG, Minnesota
KIM SCHRIER, Washington
LORI TRAHAN, Massachusetts
LIZZIE FLETCHER, Texas
------
Professional Staff
JEFFERY C. CARROLL, Staff Director
TIFFANY GUARASCIO, Deputy Staff Director
NATE HODSON, Minority Staff Director
Subcommittee on Health
ANNA G. ESHOO, California
Chairwoman
G. K. BUTTERFIELD, North Carolina BRETT GUTHRIE, Kentucky
DORIS O. MATSUI, California Ranking Member
KATHY CASTOR, Florida FRED UPTON, Michigan
JOHN P. SARBANES, Maryland, Vice MICHAEL C. BURGESS, Texas
Chair H. MORGAN GRIFFITH, Virginia
PETER WELCH, Vermont GUS M. BILIRAKIS, Florida
KURT SCHRADER, Oregon BILLY LONG, Missouri
TONY CARDENAS, California LARRY BUCSHON, Indiana
RAUL RUIZ, California MARKWAYNE MULLIN, Oklahoma
DEBBIE DINGELL, Michigan RICHARD HUDSON, North Carolina
ANN M. KUSTER, New Hampshire EARL L. ``BUDDY'' CARTER, Georgia
ROBIN L. KELLY, Illinois NEAL P. DUNN, Florida
NANETTE DIAZ BARRAGAN, California JOHN R. CURTIS, Utah
LISA BLUNT ROCHESTER, Delaware DAN CRENSHAW, Texas
ANGIE CRAIG, Minnesota JOHN JOYCE, Pennsylvania
KIM SCHRIER, Washington CATHY McMORRIS RODGERS, Washington
LORI TRAHAN, Massachusetts (ex officio)
LIZZIE FLETCHER, Texas
FRANK PALLONE, Jr., New Jersey (ex
officio)
C O N T E N T S
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Page
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, opening statement............................... 2
Prepared statement........................................... 4
Hon. Brett Guthrie, a Representative in Congress from the
Commonwealth of Kentucky, opening statement.................... 6
Prepared statement........................................... 8
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 12
Prepared statement........................................... 14
Hon. Cathy McMorris Rodgers, a Representative in Congress from
the State of Washington, opening statement..................... 16
Prepared statement........................................... 18
Hon. Richard Hudson, a Representative in Congress from the state
of North Carolina, prepared statement.......................... 122
Witnesses
Kemp L. Chester, Senior Advisor, Executive Office of the
President, Office of National Drug Control Policy.............. 22
Prepared statement........................................... 25
Answer to submitted questions................................ 260
Nora D. Volkow, M.D., Director, National Institute on Drug Abuse,
National Institutes of Health.................................. 40
Prepared statement........................................... 42
Answer to submitted questions................................ 279
Douglas C. Throckmorton, M.D., Deputy Director, Regulatory
Programs Center for Drug Evaluation and Research, U.S. Food and
Drug Administration............................................ 50
Prepared statement........................................... 52
Answer to submitted questions................................ 290
Louis J. Milione, Principal Deputy Administrator, U.S. Drug
Enforcement Agency............................................. 60
Prepared statement........................................... 62
Answer to submitted questions \1\
----------
\1\ Mr. Milione did not answer submitted questions for the record
by the time of publication.
Submitted Material
Statement of Hon. John Katko of New York, December 2, 2021,
submitted by Ms. Eshoo......................................... 126
Dashboard, from Operation Lone Star, November 25, 2021, submitted
by Ms. Eshoo................................................... 128
Statement of Hon. French Hill of Arkansas, December 2, 2021,
submitted by Ms. Eshoo......................................... 129
Letter of August 24, 2021 from the Drug Policy Alliance, the
Leadership Conference, and 142 organizations, to President
Biden, and Vice President Harris, submitted by Ms. Eshoo....... 131
Statement of the U.S. Department of Justice, December 2, 2021,
submitted by Ms. Eshoo......................................... 138
Article of ``Biden Administration Grapples With American
Addiction as Overdose Deaths Hit a Record High,'' CNN,
submitted by Ms. Eshoo......................................... 145
Statement of Sandra D. Comer, Ph.D., Public Policy Officer, The
College on Problems of Drug Dependence, December 2, 2021,
submitted by Ms. Eshoo......................................... 151
Letter of September 2, 2021, from the Drug Policy Alliance, et
al., to Ms. Pelosi, et al., submitted by Ms. Eshoo............. 160
Article of September 15, 2021, ``White House Walks Political
Tightrope With Plan to Criminalize Fentanyl,'' by Kevin
Robillard, Huffington Post, submitted by Ms. Eshoo............. 167
Article ``Follow the Science,'' Inquest, submitted by Ms. Eshoo.. 172
Letter of October 22, 2021, from the Drug Policy Alliance, et
al., to Ms. Pelosi, et al., submitted by Ms. Eshoo............. 182
Letter of November 30, 2021, by Steven B. Wasserman, President,
National Association of Assistant United States Attorneys, to
Ms. Eshoo and M. Guthrie, submitted by Ms. Eshoo............... 194
Article of November 23, 2021, ``The war on drugs didn't work. But
Biden is doubling down on it with fentanyl analogs,'' NBC News,
submitted by Ms. Eshoo......................................... 197
Article of ``A proposed Biden drug policy could widen racial
disparities, civil rights groups warn,'' NPR, submitted by Ms.
Eshoo.......................................................... 201
Letter of November 30, 2021, from the Drug Policy Alliance,
National Harm Reduction Coalition, People's Action and VOCAL-
NY, to Ms. Pelosi, et al., submitted by Ms. Eshoo.............. 204
Statement of December 2, 2021, from People's Action, submitted by
Ms. Eshoo...................................................... 214
Article ``Sen. Portman save Ohio lives by supporting the MAT and
STOP Fentanyl acts: Justin Hanley,'' Clevland.com, submitted by
Ms. Eshoo...................................................... 218
Article ``Potential unintended consequences of class-wide drug
scheduling based on chemical structure: a cautionary tale for
fentanyl-related compounds,'' from the College on Problems of
Drug Dependencies, submitted by Ms. Eshoo...................... 223
Article of October 8, 2021, ``Democrats extend Trump drug policy
that widened racial disparities-now Biden wants to keep it,''
by Igor Derysh, Salon, submitted by Ms. Eshoo.................. 231
Letter of November 28, 2021, by Steven L. Filson, Secretary,
Victims of Illicit Drugs, to Ms. Eshoo, submitted by Ms. Eshoo. 238
Statement of November 30, 2021, from Timothy Westlake, M.D.,
FFSMB, FACEP, Wisconsin Medical Examining Board, Immediate-Past
Chairman, submitted by Ms. Eshoo............................... 241
Article of October 24, 2021, ``Rhode Island Set to Be First State
to Pilot Safe-Injection Sites for Drug Users,'' by Julie
Wernau, Wall Street Journal, submitted by Ms. Eshoo............ 255
THE OVERDOSE CRISIS: INTERAGENCY PROPOSAL TO COMBAT ILLICIT FENTANYL-
RELATED SUBSTANCES
----------
THURSDAY, DECEMBER 2, 2021
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:31 a.m., in
the John D. Dingell Room, 2123 of Rayburn House Office
Building, and remotely via Cisco Webex online video
conferencing, Hon. Anna Eshoo (chairwoman of the subcommittee),
presiding.
Members present: Eshoo, Butterfield, Matsui, Castor,
Sarbanes, Welch, Schrader, Cardenas, Ruiz, Dingell, Kuster,
Kelly, Barragan, Blunt Rochester, Craig, Schrier, Trahan,
Fletcher, Pallone (ex officio), Guthrie (subcommittee ranking
member), Upton, Griffith, Bilirakis, Long, Bucshon, Hudson,
Carter, Dunn, Curtis, Crenshaw, Joyce, and Rodgers (ex
officio).
Also present: Representatives Schakowsky, and McKinley.
Staff present: Lydia Abma, Health Fellow; Tania Calle,
Health Fellow; Waverly Gordon, Deputy Staff Director and
General Counsel; Tiffany Guarascio, Staff Director; Fabrizio
Herrera, Staff Assistant; Zach Kahan, Deputy Director, Outreach
and Member Service; Mackenzie Kuhl, Press Assistant; Meghan
Mullon, Policy Analyst; Juan Negrete, Junior Professional Staff
Member; Kaitlyn Peel, Digital Director; Asad Ramzanali,
Legislative Director; Tim Robinson, Chief Counsel; Chloe
Rodriguez, Clerk; Kylea Rogers, Staff Assistant; Andrew
Souvall, Director of Communications, Outreach and Member
Services; Kimberlee Trzeciak, Chief Health Advisor; C.J. Young,
Deputy Communications Director; Alec Aramanda, Minority
Professional Staff Member, Health; Sarah Burke, Minority Deputy
Staff Director; Seth Gold, Minority Professional Staff Member,
Health; Grace Graham, Minority Chief Counsel, Health; Nate
Hodson, Minority Staff Director; Peter Kielty, Minority General
Counsel; Emily King, Minority Member Services Director; Bihan
Koohmaraie, Minority Chief Counsel, Oversight and
Investigations Chief Counsel; Clare Paoletta, Minority Policy
Analyst, Health; Kristen Shatynski, Minority Professional Staff
Member, Health; Olivia Shields, Minority Communications
Director; and Michael Taggart, Minority Policy Director.
Ms. Eshoo. Good morning, everybody. The subcommittee on
Health will now come to order. Due to COVID-19, today's hearing
is being held remotely as well as in person. For members and
witnesses taking part in person, we are following the guidance
of the CDC and the Office of the Attending Physician, so please
wear a mask when you are not speaking. For members and
witnesses taking part remotely, microphones will be set on mute
to eliminate background noise. Members and witnesses, you will
need to unmute your microphone when you wish to speak.
Since members are participating from different locations at
today's hearing, recognition of members for questions will be
in the order of subcommittee seniority. Documents for the
record should be sent to Meghan Mullon at the email address we
have provided to your staff. All documents will be entered into
the record at the conclusion of our hearing. The Chair now
recognizes herself for 5 minutes for an opening statement.
OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
As our country has grappled with the public health crisis
caused by a novel virus for nearly two years now, we have also
faced a more familiar threat in the form of drug addiction.
More than 100,00 Americans have died. Let me repeat that. More
than 100,000 Americans have died from drug overdoses since the
COVID-19 pandemic began, a grim record that shows no sign of
abating.
The fastest-growing cause of overdose deaths has been
synthetic opioids, including fentanyl. Since 2018, all
fentanyl-related substances that are not already scheduled have
been temporarily listed under Schedule I of the Controlled
Substance Act, and the current extension will expire at the end
of--no, I think the date--at the end of January. The continuing
resolution introduced this morning extends the deadline to
February 18. Despite this temporary scheduling, deaths due to
fentanyl-related overdoses have continued to rise even as
deaths caused by other drugs have fallen.
Our subcommittee hearing today is to learn from the
Administration its recommendations to Congress for permanent
scheduling of all fentanyl-related substances. The interagency
proposal calls for permanently scheduling these drugs under
Schedule I but with an expedited process to reschedule those
that are later found not to be dangerous enough to warrant such
regulation.
Over 100 civil rights groups have expressed concerns about
class-wide scheduling because it expands the number of drugs
subject to mandatory minimum sentences that contribute to the
disproportionate incarceration of racial minorities. To address
this concern, mandatory minimums would not apply in most cases
involving fentanyl-related substances unless there is death or
serious bodily harm. And if a substance is later removed from
Schedule I, incarcerated individuals could have their sentences
reduced or vacated.
The proposal would make it easier for researchers to get
permission from the Federal Government to study all Schedule I
substances. The current restrictions deter many researchers
from studying these drugs and removing some of these barriers
will help us better understand how to treat addiction.
Today, we will hear from some of the agencies that
developed these recommendations, including the FDA, the
National Institute on Drug Abuse, the Drug Enforcement
Administration, and the Office of National Drug Control Policy,
and we look forward to their insights on how the
Administration's proposals will help address the overdose
epidemic.
I want all Members to know that we invited the Department
of Justice, the DOJ, to testify, but they chose not to appear
at today's hearing. Our staff began conversations with the DOJ
about this hearing in September, last September, and I formally
invited them to send a witness on November 18. DOJ's refusal to
testify, I find to be troubling, and they offered no legitimate
reason. They just declined. Their perspective on their own
recommendations to Congress would have been valuable for us to
hear.
[The prepared statement of Ms. Eshoo follows:]
Prepared Statement of Hon. Ann Eshoo
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So now the Chair is pleased to recognize the distinguished
Ranking Member of our subcommittee, Mr. Guthrie, for his
opening statement.
OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH STATE OF KENTUCKY
Mr. Guthrie. Thank you, Chair Eshoo, for holding this
important hearing, and thanks to all of our witnesses for being
here today.
Today, we are discussing how to permanently combat the
trafficking of illicit fentanyl-related substances. This
committee has a bipartisan history of addressing the growing
opioid epidemic. For example, the SUPPORT for Patients and
Communities Act include in my bill the Comprehensive Opioid
Recovery Centers Act, which authorizes the creation of
comprehensive opioid recovery centers throughout the Nation.
These centers provide evidence-based comprehensive care with
those with substance abuse disorders.
However, I am frustrated, and I am pleased to see that we
are going to move forward with scheduling through February 18,
but I am really frustrated that we failed to come up with and
join together to permanently schedule fentanyl analogs. We lost
100,000 Americans last year to drug overdoses. In my home State
of Kentucky, overdose deaths increased by 54 percent between
spring 2020 and spring 2021. The Kentucky Office of Drug
Control Policy described the trend as one of the most critical
public health and safety issues facing Kentucky.
Additionally, the agency attributed most of these deaths to
the illicit use of fentanyl and fentanyl analogs, which their
2020 overdose fatality report noted was responsible for over 70
percent of all of the Commonwealth's drug overdoses in 2020.
But these aren't just numbers on a page. There are mothers,
fathers, brothers, sisters, friends, and children. In March of
this year, a Kentucky mother purchased drugs laced with
fentanyl, and not too long after, found her 2-year-old son dead
after he reached into her purse while she was napping and
ingested the deadly poison. These tragedies have unfortunately
become too familiar to not just Kentuckians, but to thousands
of Americans across the country.
Healthcare closures have also caused disruptions or lengthy
delays in care for individuals who are seeking substance use
disorder treatment. These delays have also affected those
seeking first-time care for substance use disorder and have
tragically led to a sharp increase in overdoses.
I worry about further disruptions to care due to workforce
shortages exacerbated by Federal vaccine mandates. CDC found in
a recent survey that 30 percent of health workers in hospitals
are unvaccinated. I oppose this government overreach on our
healthcare heroes, although I am vaccinated and encourage
people to do so if they so choose.
Even worse, President Biden's border crisis has essentially
made Kentucky and every other State a border State. Only two
milligrams of fentanyl could be a lethal dose. And the U.S.
Customs and Border Protection has reported almost 4,000 pounds
of fentanyl seized at the southern border. Drug Enforcement
Administration's own leadership cited statistics showing that
the agency seized enough fentanyl this past year alone to give
every American a lethal dose.
The Biden administration's failure to address this problem
at our southern border is driving increases in drug overdoses.
I have been urging my colleagues to permanently schedule
fentanyl analogs by supporting the Federal Initiative to
Guarantee Health by Targeting fentanyl Act. And although the
administration recently issued a plan to permanently schedule
these substances, the proposal misses the mark by failing to
impose mandatory minimums on fentanyl analog traffickers. By
excluding mandatory minimum for trafficking fentanyl analogs,
the proposal effectively incentivizes the cartels to continue
to develop more variation of fentanyl and ship these deadly
substances to our own backyards. Given that fentanyl and its
analogs have contributed to the highest levels of overdose
rates this country has ever seen, excluding them from the
mandatory minimum is disturbing.
It is unfortunate that the Department of Defense--the
Department of Justice can't be here today to explain this
policy. Did the DOJ refuse to show up to today's hearing
because they are unable to justify the policies in this
proposal? Why didn't this administration send their top Federal
law enforcement agency to share their plans with the American
people on how they will get these deadly poisons off our
street?
I appreciate the hair's strong remarks to that because it
is important and disturbing that they wouldn't be here. It is
their job. I know sometimes these hearings aren't convenient
for people to appear, but it is our job for oversight, and it
is their job to be here.
I will continue to press permanently scheduling fentanyl
analogs and giving law enforcement the resources needed to
fight back against the illicit trafficking of fentanyl and
fentanyl-related substances across the United States that are
sadly taking the lives of thousands of Americans.
Thank you. Thank you, Madam Chair, and I yield back.
[The prepared statement of Mr. Guthrie follows:]
Prepared Statement of Hon. Brett Guthrie
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Ms. Eshoo. The gentleman yields back.
The Chair is now pleased to recognize the Chairman of the
Full Committee, Mr. Pallone, for your 5 minutes for an opening
statement.
OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Chairwoman Eshoo.
Today, we continue this Committee's work of combating the
ongoing drug overdose crisis. This crisis is a tragedy, taking
more than 100,000 Americans far too soon during the first 12
months of the COVID-19 pandemic. For years, we have worked to
combat this crisis. Earlier this year as part of the American
Rescue Plan, we included $3 billion in funding for the mental
health and substance use block grant programs at the Substance
Abuse and Mental Health Services Administration. And this
funding was the largest aggregate amount of funding for these
programs and it goes to critical programs and services for
people experiencing substance use disorder.
The American Rescue Plan builds upon the work we have done,
but we obviously must do more. Today, we are, once again,
discussing solutions to the overdose issue and what more
Congress can do to end this crisis. Synthetic opioids, such as
fentanyl and fentanyl analogs, have been a significant driver
of overdose deaths in the United States. Last year, the Centers
for Disease Control and Prevention estimated that more than
half of overdose deaths involved synthetic opioids and drugs
mixed with synthetic opioids, primarily illicit fentanyl. The
availability of illicit fentanyl in the United States has
dramatically increased, and manufacturers have been able to
evade regulations by rapidly manufacturing new versions of
fentanyl substances that aren't subject to control.
Today, fentanyl-related substances are temporarily placed
in Schedule I of the Controlled Substances Act, which is the
strictest category of regulation. Schedule I is reserved for
drugs that have no accepted medical use, a high potential for
abuse, or lack of accepted safety. Schedule I also prohibits
the manufacturing, distribution, or dispensing of these
substances unless given explicit approval to do so.
The current temporary scheduling order subjecting fentanyl-
related substances to these restrictions is set to expire on
January 28 of 2022. However, the CR we will consider this week,
and probably today, will provide for an extension through
February 18 of next year. And it is critical that Congress and
this Committee work together in a bipartisan fashion with the
Administration to put in place a long-term solution.
In September, the Biden Administration released
recommendations to address illicit fentanyl-related substances
prepared by the Office of National Drug Control Policy, the
Department of Health and Human Services, and the Department of
Justice, and I appreciate the witnesses for joining us today.
The Administration's proposal would create a class-wide
definition of fentanyl-related substances and permanently place
them as Schedule I. It would also create a mechanism to
expedite rescheduling or descheduling of substances as needed.
And I am pleased that the proposal also includes provisions to
streamline registration requirements for all Schedule I
substances. Aligning Schedule I registration requirements more
closely with Schedule II requirements will help expedite
registration for researchers who want to study Schedule I
substances and will hopefully help to expand further research
in this space and development of future treatments.
I look forward to learning more about the details of the
Administration's proposal, and why Congress should pass
legislation to reflect the recommendations. As we discuss this
proposal, it is also important to remember that this is a set
of recommendations. This Committee is responsible for crafting
the actual legislation that will help dramatically improve the
lives of many Americans. There are many ideas and proposals to
meet this goal, including strategies to strengthen prevention,
treatment, harm reduction, and recovery services. There is no
idea too big or too small to get ahead of this crisis and we
must work together to solve it.
And, finally, I wanted to say that I am pleased that DEA is
represented here by its Principal Deputy Administrator and I
look forward to also working directly with DOJ on the
Administration's proposal so this Committee can better
understand the intent and rationale behind their policy
recommendations related to enforcement.
So, I look forward to hearing from all our witnesses, and
Madam Chair, I know that this is something that you are very
concerned about and have been for some time. And thank you for
having this important hearing today. I yield back.
[The prepared statement of Mr. Pallone follows:]
Prepared Statement of Hon. Frank Pallone Jr.,
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Ms. Eshoo. The Chairman yields back. The Chair is now
pleased to recognize Congresswoman Cathy McMorris Rodgers. She
is the distinguished Ranking Member of our Full Committee for
her 5 minutes for an openings statement.
OPENING STATEMENT OF HON. CATHY McMORRIS RODGERS, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF WASHINGTON
Mrs. Rodgers. Thank you, Madam Chair.
Fentanyl and fentanyl-related substances are killing a
record number of Americans. Making sure that these deadly
poisons are permanently made illegal requires urgent action.
Lives are on the line. An unthinkable amount of fentanyl and
its analogs are coming across our border, enough to kill every
American seven times over. According to CDC's National Center
for Health Statistics, there were over 100,000 drug overdoses
in the United States from April 2020 to 2021. In my home State
of Washington, the overdose death rate increased by more than
36 percent. It is higher than the national average, all because
fentanyl and its many analogs. Here is the recent headline in
the Spokesman-Review: ``Deaths and killings rise in Spokane.''
The report reflects increase in fentanyl overdoses.
I wanted to share a story about someone from my community
where in Spokane, the illicit drug market is completely flooded
with fentanyl. Alan had battled addiction and despair since he
was a child. He recently had lost his job, relapsed, and,
unfortunately, overdosed on heroin. The paramedics administered
Narcan to save his life, and he woke up in an ambulance. He
later learned that the heroin he consumed was laced with
fentanyl. He was lucky. He survived. And each time Alan uses,
he is playing a game of Russian roulette with his life, because
fentanyl and its analogs are everywhere.
As of this year, the DEA has seized a record number, 9.5
million fake prescription pills containing lethal amounts of
fentanyl. More counterfeit pills have been seized so far in
2021 than the previous two years combined with two out of every
five pills containing a potentially lethal dose of fentanyl.
This is not your typical street drug. This is a weapons-grade
poison that is killing our children.
I learned another story about a young woman in my district
named Kayla. She and her friend split what they thought was a
Percocet tablet. That one pill, which was laced with fentanyl,
immediately killed them both. They had no chance.
For people like Alan and Kayla, Republicans have been
trying to permanently place fentanyl-related substances in
Schedule I. We are hearing from an army of parents every day,
parents who deserve justice because they have lost a child, and
they don't want anyone else to experience their pain.
The Biden administration agrees that we should permanently
schedule fentanyl-related substances in Schedule I. The Biden
administration recommends also support more research into
innovation and detect dangerous drugs like fentanyl and treat
those with substance use disorders. That is where we agree.
Unfortunately, the administration is also trying to treat
these deadly poisons differently from fentanyl and other
currently scheduled fentanyl analogs. The administration is
proposing to exempt the entire class from trafficking mandatory
minimums. This would prevent our law enforcement from finding
and putting away drug traffickers who are bringing these
chemical weapons across the border.
For the parents we are fighting for, it would mean
criminals who killed their kids who keep trafficking these
lethal substances with lower repercussions. Surely, there is
bipartisan support to deliver justice for these families. We
should be working together to punish those who make, import,
and distribute these poisons to our children, and help those
with substance abuse disorders with treatment and recovery.
Congress must work together on the SUPPORT for Patients and
Communities Act.
In addition to permanently scheduling fentanyl analogs, I
stand ready to work together again to reauthorize key programs
at the Substance Abuse and Mental Health Services
Administration that expire next year to help get treatment for
those who need it. We need to take urgent action on fentanyl
analogs. It is too deadly a substance to be weak on
traffickers, and to those who sell it to our children in our
communities.
Even if Congress passes the CR later on today, after
February 18, fentanyl-related substances will be street legal.
I remain deeply concerned that we will not take action in time,
tying law enforcement's hands in their battle to keep this
poison out of our communities and simply kick the can another
few months. Congress needs to make permanent the fentanyl
analogs ban immediately, along with existing criminal
penalties. Parents, communities, and our constituents need it.
With that, I yield back.
[The prepared statement of Mrs. Rodgers follows:]
Prepared Statement of Hon. Cathy McMorris Rodgers
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Ms. Eshoo. The gentlewoman yields back.
I would like to advise members that pursuant to committee
rules, all Members' written opening statements shall be made
part of the record.
I now would like to introduce our witnesses. Mr. Kemp
Chester is the Assistant Director of the Office of National
Drug Control Policy in the Executive Office of the President.
Welcome to you, and thank you for being with us today.
Dr. Nora Volkow. She is the Director of the National
Institute on Drug Abuse at the National Institutes of Health.
We can say welcome back. You have graced the witness table
several times before, and we welcome you back.
Dr. Douglas Throckmorton is the Deputy Director for
Regulatory Programs in the Center for Drug Evaluation and
Research at the FDA. Welcome to you, and thank you for being
with us.
And Mr. Louis Milione is the Principal Deputy Administrator
of the Drug Enforcement Administration, the DEA. Welcome to
you, and thank you for being here today.
We look forward to the testimonies that you are going to
provide to us. You are probably familiar with the light system.
It isn't anything complex. You have 1-minute remaining when the
yellow light comes on, and I think everyone knows what red
means.
So, Mr. Chester, you are now recognized for your 5 minutes
of testimony, and thank you again for being here with us today
for this very important hearing.
STATEMENTS OF KEMP L. CHESTER, SENIOR ADVISOR, EXECUTIVE OFFICE
OF THE PRESIDENT, OFFICE OF NATIONAL DRUG CONTROL POLICY; NORA
D. VOLKOW, M.D., DIRECTOR, NATIONAL INSTITUTE ON DRUG ABUSE,
NATIONAL INSTITUTES OF HEALTH; DOUGLAS C. THROCKMORTON, M.D.,
DEPUTY DIRECTOR FOR REGULATORY PROGRAMS, CENTER FOR DRUG
EVALUATION AND RESEARCH, U.S. FOOD AND DRUG ADMINISTRATION; AND
LOUIS J. MILIONE, PRINCIPAL DEPUTY ADMINISTRATOR, U.S. DRUG
ENFORCEMENT AGENCY.
STATEMENT OF KEMP L. CHESTER
Mr. Chester. Chairwoman Eshoo, Ranking Member Guthrie,
members of the subcommittee, thank you for inviting me to
testify today.
The Biden years administration approaches America's
overdose epidemic with the urgency it demands, through
evidence-based drug policy that effectively addresses both the
public health dimension of the problem, as well as the dynamic
nature of the drug trafficking environment facing the United
States and the world.
At present, one of the most complex and consequential
challenges we face is illicitly manufactured fentanyl, fentanyl
analogs, and fentanyl-related substances, or FRS. They confound
our efforts to reduce opioid-related overdoses and deaths, have
pervaded the Nation's illicit drug supply, are found throughout
country, and are the main driver of the increase in drug
poisoning deaths in the United States.
In 2020 alone, overdose deaths involving synthetic opioids,
primarily illicit fentanyl and its analogs, increased by 55
percent. New and emerging FRS are being manufactured faster
than the United States can schedule them individually,
necessitating the permanent class-wide scheduling of FRS as a
whole. Recent Customs and Border Protection data show that it
may be possible to synthesize as many as 4,800 fentanyl analogs
with relatively simple modifications to the base fentanyl
molecule.
Time is of the essence. And although scheduling is not
sufficient in itself to solve this problem, it is absolutely
necessary to control substances yet to be made, and yet to be
made available in America's communities. We must deter the
creation of these new substances, and disrupt their flow into
the United States in order to allow our historic investments
and public health interventions to take hold and make tangible
progress.
For the past several months, the Office of National Drug
Control Policy, the Department of Justice, and the Department
of Health and Human Services met regularly to develop
recommendations for a comprehensive consensus approach that
addresses the complex issues surrounding the scheduling of FRS.
This process involved input from the Congress, public health
officials, law enforcement partners, and stakeholder groups.
These recommendations would permanently schedule these
dangerous substances as a class, while ensuring that access for
scientific research is not burdensome, and civil rights
protections are safeguarded. This is a delicate balance, and we
have sought to provide a responsible and comprehensive
approach.
The administration recommends the following: First,
permanently schedule all unscheduled FRS into Schedule I in
accordance with the Controlled Substances Act of the CSA;
second, for these class scheduled FRS, exclude quantity-based
mandatory minimum penalties normally associated with domestic
trafficking of Schedule I substances. This exemption does not
apply, however, where there is a direct link to death or
serious bodily injury; third, create a streamlined process
overseen by HHS to remove or reschedule any FRS found not to
have a high potential for abuse as defined in the CSA; fourth,
ensure a Federal court is able to vacate or reduce the sentence
of an individual convicted of an offense involving an FRS that
is subsequently removed or rescheduled from Schedule I; fifth,
establish a simplified process to align research registration
for all Schedule I substances, including FRS, more closely with
the research registration process for Schedule 2 substances;
and, finally, direct the Government Accountability Office to
analyze the implementation of permanent class scheduling of
FRS, including its impact on research, civil rights, and the
illicit manufacturing and trafficking of these dangerous
substances.
These recommendations follow the approach outlined in the
administration's first year drug policy priorities, which
include expanding access to evidence-based prevention,
treatment, harm reduction, and recovery support services, as
well as reducing the supply of illicit drugs.
The foundation of these recommendations rests with making
our communities healthier and safer without causing unintended
harm. They are a critical part of our comprehensive effort to
reduce drug use and its negative consequences throughout the
Nation.
On behalf of Dr. Gupta and the men and women of the Office
of National Drug Control Policy, I would like to thank you and
your congressional colleagues for your leadership, and thank
our Federal partners as well for their close elaboration on
this critical issue. I thank you for your time, and I look
forward to your questions.
[The prepared statement of Mr. Chester follows:]
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Ms. Eshoo. Thank you very much.
Dr. Volkow, you have 5 minutes for your testimony, and we
once again welcome you here today.
STATEMENT OF NORA D. VOLKOW, M.D.
Dr. Volkow. Good morning. Chairwoman Eshoo, Ranking Member
Guthrie, and members of the subcommittee, thank you for
inviting me to speak with you today.
Illicitly manufactured fentanyl and fentanyl-related
substances are driving the steep rise in overdose deaths in the
United States. The latest data show overdose deaths exceeded
100,000 in a year, a staggering figure, and the highest number
ever recorded in a 12-month period in the United States.
Overdose deaths involving synthetic opioids increased by 49
percent during that period. Therefore, it is imperative that we
reduce trafficking and manufacture of these dangerous
substances. However, this should not be done at the expense of
criminalizing people who use drugs, an approach that we know
does little to deter drug use or alleviate substance use
disorders. Instead, an evidence-based approach that prioritizes
prevention and treatment of substance use disorders is needed
to address the opioid and overdose crisis.
In this regard, research on fentanyl-related substances is
essential to develop treatments for opioid addiction and
overdose, particularly in light of reports that current
medications may not be as effective against fentanyl. However,
obtaining a DEA registration to study fentanyl-related
substances and other Schedule I drugs presents challenges to
researchers. Even experienced researchers report that obtaining
or modifying a DEA registration can take many months. The
application process is often redundant with the reviews needed
to obtain a Federal grant or an FDA investigational new drug
authorization.
Establishing the security infrastructure to conduct
Schedule I research, which is expensive, may need to be
duplicated for each registrant working within a single
department. Researchers have also reported a lack of clarity on
the registration requirements on variability in their
interpretation. These challenges can slow research progress and
dissuade investigators from working with Schedule I substances.
That is why the administration's proposals to permanently
schedule fentanyl-related substances includes a process for
rapidly removing those with no or low abuse potential from the
scheduling.
This is critical because a class-wide scheduling, which is
based on chemical structure alone, bypasses the usual
substance-by-substance analysis of the compounds abuse
potential. These will result in the permanent placements of
thousands of compounds into Schedule I, potentially including
substances with little or no addictive potential, and those
that hold promise for treating fentanyl overdoses, opioid use
disorder, pain, and other conditions.
Equally important is facilitating research on the
substances that remain in Schedule I. The administration
proposes an alternative registration process for Schedule I
research funded by HHS or the VA, or conducted under an FDA
IND, but more closely aligns with the process for Schedule 2
substances, such as methamphetamine and cocaine. It will remove
duplicative practical reviews, expedite the process for
modifying current registrations, and still prevent the version
for maintaining the security and inventory controls currently
in place. The proposal also addresses aspects of the law that
researchers report to be confusing, burdensome, or
inconsistently applied as well as to facilitate transparency in
the registration and review procedures.
I am very grateful to our colleagues at ONDCP, HHS, and DOJ
for their support of this important proposal, and to the
committee for considering it. I am happy to answer any
questions you may have.
[The prepared statement of Dr. Volkow follows:]
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Ms. Eshoo. Thank you very much, Doctor.
I now am pleased to recognize Dr. Douglas Throckmorton for
your 5 minutes of testimony. Thank you again.
STATEMENT OF DOUGLAS THROCKMORTON, M.D.
Dr. Throckmorton. Chairwoman Eshoo, Ranking Member Guthrie,
members of the subcommittee, I am Dr. Douglas Throckmorton,
Deputy Director for Regulatory Programs at the Center for Drug
Evaluation and Research at the Food and Drug Administration.
Thank you for the opportunity to appear before you today to
discuss the comprehensive approach to the scheduling of
fentanyl-related substances developed with the Office of
National Drug Control Policy, the Department of Justice, and
the Department of Health and Human Services, as well as the
important role the FDA plays in scheduling illicit substances
that pose a danger to public health, while also supporting the
development of needed new drug therapies.
As the committee has heard, new illicit synthetic drugs
derived from fentanyl are coming into the U.S. and are being
mixed with heroin and other drugs. The result has been a
dramatic increase in opioid-related deaths in the U.S. in
recent years.
While the DEA is the lead Federal agency responsible for
regulating controlled substances and enforcing the Controlled
Substances Act, HHS has a number of critical responsibilities
under the Act, several of which have been delegated to the FDA.
Given this, FDA and DEA have worked very closely together in
the area of controlled substances, including opioids, including
the work we are here to discuss today related to the
appropriate level of control for the fentanyl-related
substances that are flooding into our country with tragic
results.
DEA issued a temporary order in 2018, as has been
mentioned, controlling the entire FRS class. Congress has since
extended that order through January 28, 2022. In 2020, DEA
asked HHS to make a scheduling recommendation for the entire
FRS class. Following careful evaluation, the FDA concluded that
such a recommendation was not possible for the FRS class for
several reasons:
First, the class is vast in terms of the number of
hypothetically covered substances; second, data on the
pharmacological effects and epidemiological data about the
harms and overdose deaths are available for fewer than 30
members of that FRS class; and third, among the individual FRS
members that we have pharmacological data, FDA has identified
examples of substances that do not activate the mu-opioid
receptor. This activation is the primary pharmacology that
would lead to opioid-related harms, such as those caused by
fentanyl, Oxycodone, and Hydrocodone.
Instead, recognizing the significant public health risk
posed by fentanyl-related substances, we have worked closely
with our interagency colleagues on a legislative approach that
would control the entire class while minimizing the impact of
control on research and drug development by providing for a
rapid decontrol or recontrol of individual members, as
appropriate, when new data become available. This proposal
would provide law enforcement with the tools they need to
promptly respond to the traffic and manufacturing of illicit
FRS substances. But because not all of them will demonstrate
pharmacology that predicts a high risk of abuse and risks of
injury, and in that way, do not warrant control as a dangerous
Schedule I substance. And because we believe some members of
the FRS class could have important therapeutic potential, the
proposal includes a science-based mechanism to rapidly remove
an individual compound from scheduling the most restrictive
schedule into Schedule I if sufficient data emerge that the
substance does not share Fentanyl's dangerous pharmacological
properties.
Under the streamlined approach for decontrol, HHS would
determine if a substance should either be moved to a lower
schedule or removed from scheduling altogether, again, focused
on an assessment of its pharmacology. This work would focus on
the substance's effect on the mu-opioid receptor, the receptor
responsible for many of the dangerous effects of opioids,
including sedation and respiratory depression.
We believe the proposed approach would appropriately
balance the pressing need to address the public health risk
posed by the illicit use of these substances, while also
addressing the important need to support scientific research
into these substances to develop new therapies, and to improve
our scientific understanding.
We appreciate the combined work of the Federal partners to
develop this proposal and the willingness of this committee to
discuss it with us here today. FDA stands ready to do all we
can to support this important work on this critical public
health issue. I am happy to answer any questions I can. Thank
you.
[The prepared statement of Dr. Throckmorton follows:]
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Ms. Eshoo. Thank you, Doctor.
And it is a pleasure to recognize Mr. Louis Milione now for
your 5 minutes of testimony. Welcome, and thank you again.
STATEMENT OF LOUIS J. MILIONE
Mr. Milione. Thank you, Chairman Eshoo, Ranking Member
Guthrie, and members of the committee. Thank you for inviting
DEA to testify here today.
DEA's mission is to protect the public from the most
significant drug threats harming our communities. I have had
the privilege of serving as a DEA agent for over 20 years. I
have worked in New York City and around the world investigating
sophisticated criminal drug networks that were pushing
different drugs into our community, into our country.
My DEA brothers and sisters and Administrator Milgram and I
have never seen anything as dangerous as this fentanyl threat.
Fentanyl is an existential threat to our country. Fentanyl is
killing countless Americans every day in all our communities.
It knows no geographic or economic bounds. As a synthetic drug,
the supply and different variations of the drug are limitless.
Who is manufacturing it and pushing this deadly poison into
our country? Mexican cartels working with criminal chemical
companies in China; they are exploiting our opioid crisis by
manufacturing massive quantities of fentanyl, flooding our
country with it, and profiting from the devastation that they
leave behind in our communities.
DEA's fentanyl seizures this year have reached an all-time
high, largely because of the temporary class-wide scheduling of
fentanyl-related substances. We have already seized 13,000
pounds of fentanyl this year. That is enough fentanyl, as was
mentioned earlier, to give every member of the United States
population a potentially lethal dose.
What is extremely alarming is that Mexican cartels and
other criminal networks are mixing fentanyl with other drugs
like cocaine, meth, and heroin, and also marketing this
fentanyl in a new form, fake prescription pills. These pills
are filled with deadly fentanyl, and pushed on our population
by these criminal networks. They are made and marketed to
deceive users, often on social media platforms, making their
target audience think that the fake pills are legitimate
prescription medications, but they are not.
So far this year, DEA and our law enforcement partners have
seized more than 15 million fake pills. Ten million of these
pills were laced with fentanyl. DEA's lab testing confirmed
that four out of ten of these pills are laced with a
potentially lethal dose.
As I said earlier, DEA's mission is to protect the public.
We are laser-focused on this threat. In September, we issued
our first public safety alert in six years, warning the public
about fake pills laced with fentanyl. The prior public safety
alert was also dealing with fentanyl. At the same time, we
launched a public awareness campaign titled One Pill Can Kill,
trying to get the message to anyone we could reach that just
one of these fentanyl-filled fake pills can kill a user.
We also did a nationwide enforcement search focused on the
fentanyl and counterfeit pill threat. Over a period of 6 to 8
weeks, we took action in all our DEA offices around the
country. We seized millions of fake pills, thousands of pounds
of fentanyl powder, dozens of guns, and arrested more than 800
drug traffickers. We will be relentless in the work that we
have to do to protect the public.
The fentanyl threat, as I said earlier, is an existential
threat to our country. Now, more than ever, it is critical that
Congress permanently schedule fentanyl-related substances as a
class to enable DEA and our law enforcement partners to seize
these substances before they enter the country, and as they are
encountered in our communities.
DEA is also committed to expanding and enhancing research
on controlled substances. This is a key pillar of DEA's
commitment to fighting overdose deaths, and a critical part of
DEA's mission to protect the public. We look forward to
continued collaboration with the research community and our
interagency partners to facilitate access to research and learn
more about these substances.
We at the DEA are committed to doing anything that we can
to protect the public from these dangerous drugs that are
harming Americans and devastating our communities. We look
forward to working with Congress and our interagency partners
to address this threat and our Nation's overdose epidemic. I
look forward to taking your questions. Thank you.
[The prepared statement of Mr. Milione follows:]
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Ms. Eshoo. Thank you very much, Mr. Milione. That is
compelling testimony.
We will now move to member questions and I recognize myself
for 5 minutes to do so.
To Dr. Throckmorton. Since the temporary class-wide
scheduling of fentanyl-related substances began in 2018,
overdose deaths, and it is contained in the testimony as well,
have only risen. So, tell us why the Administration's proposal
will succeed where the temporary scheduling hasn't.
Dr. Throckmorton. Thank you, Madam Chairwoman. No single
solution exists for the problems that confront us around the
opioids crisis, so I believe we have to acknowledge this is one
important step among many that we need to take. One reason I
believe this is a particularly important step is because of its
focus on this class of substances, this class that is causing
particular harm.
Temporary scheduling has been effective. It has helped
prevent and controls these substances. Permanent scheduling
will take that next step, then, and make it permanent to send a
strong message that these substances are something that we take
very seriously.
Ms. Eshoo. But even with that temporary scheduling, deaths
have risen.
Dr. Throckmorton. The deaths have risen, I believe, as a
consequence of other influence, other factors that have
occurred in the system.
Ms. Eshoo. What are those?
Dr. Throckmorton. Well, there are other social influences.
One is simply the economics of the misuse and abuse of opioids.
We have transitioned from a time where prescription opioids,
prescription pills were driving a substantial fraction of the
overdose, overdose deaths that were experienced, to a place
where this--where the fentanyl and the fentanyl-related
substances are causing a much larger fraction of the overdose
deaths.
Ms. Eshoo. I see.
Dr. Throckmorton. So this change in the complexion of the
crisis leads to a need for us to focus particularly in this
area.
Ms. Eshoo. Well, I wanted to ask Mr. Chester and Mr.
Milione what role fentanyl-related substances play in the
overdose epidemic relative to other opioids?
Mr. Milione. Thank you for the questions. DEA's main focus
is protecting the public, targeting those that are causing the
harm and helping those that are harmed. Without question,
Mexican cartels are driving the substance into our country.
They are driven by greed, they will stop at nothing, and they
are flooding our communities with it. These substances are so
deadly, as I said earlier, with the analysis that we have done
that four out of ten of the pills, and only a small amount, a
miniscule amount, potentially will take the life of a user, so
they are very deadly substances. The cartels are driving them
in here, driven by greed, and will stop at nothing.
Ms. Eshoo. Dr. Volkow, the administration's proposal would
make it easier to conduct research on all--and you mentioned
this in your testimony, on all Schedule I substances, not just
fentanyl-related substances. What is the importance of
including this broader category of drugs instead of just
focusing on FRS? Turn your microphone on, please.
Dr. Volkow. Thanks very much for the question. And, indeed,
to be able to do research is crucial for us to come up with
solutions on how to address a problem, in this case, of opioid
overdoses but other substance disorder problems that we face as
a Nation.
For example, with the fentanyl overdoses, we are finding
difficulty in reverting some of those overdoses, and people die
despite the fact that they are given Naloxone. So we need to
investigate what are the pharmacological effects of fentanyl
that are producing this, and for that, we need access to these
drugs.
Ms. Eshoo. I see.
Dr. Volkow. And so being able to hold researchers to work
with them is crucial and indispensable.
Ms. Eshoo. Let me go back to Mr. Milione. Thank you,
Doctor.
Are these--the FRS, does it--do they come through the U.S.
Postal system? Has DEA worked with any of the social media
platforms relative to simply not carrying pharmaceuticals,
pharmaceutical--supposed pharmaceutical drugs? Tell us more
about the reach across other sectors other than what you--you
know, the cartels that are highly responsible for moving this
into our country.
Mr. Milione. Our focus at the DEA is on wherever the harm
is being caused, and we have to work with our interagency
partners. We will work with anyone that we can to try to
address the threat and reduce that harm.
There is no question that the Mexican cartels, sourced with
chemicals from China, are manufacturing massive amounts and
flooding them throughout this country. We work with our State,
local, and Federal partners consistently around the country. We
will need to continue to do that.
Ms. Eshoo. Are they carried in the U.S. mail, though?
Mr. Milione. Trafficking organizations will use every
single possible method to get them into the United States, and
to move--and the distribution networks in the United States
will use any means necessary to distribute this poison.
Ms. Eshoo. I think you are saying yes.
Mr. Milione. Any conveyance that is possible, they will
use.
Ms. Eshoo. OK. Thank you.
The Chair now is pleased to recognize Mr. Guthrie, our
Ranking Member, for his 5 minutes of questions.
Mr. Guthrie. Thank you so much, and I appreciate all of
y'all for being here.
I am still distressed, disappointed DOJ chose not to be
here. But in September, I had an opportunity to host law
enforcement roundtables. Kentucky's Attorney General, Daniel
Cameron, was with us. Local officials, Federal officials came.
I think DEA had representatives, and we had discussion of the
crisis in our Commonwealth.
First, Dr. Gupta. I met with him the other day. Mr.
Chester, I met with Dr. Gupta the other day and am encouraged
by his enthusiasm he brings to the job, and I look forward to
hopefully a very successful and supporting a way to fight this
plague against us. But, Mr. Chester, I do want to ask you, the
Biden's administration most recent proposal permanently
schedules fentanyl analogs as Schedule I drugs, but does so
without imposing mandatory minimums for trafficking these
deadly substances. And there is some debate about what we
should do with mandatory minimums, but eliminating or not
scheduling, not applying the mandatory minimums through the
scheduling of the analogs.
So does the Biden administration have data or other
relevant research it can share with members of this committee
that suggest excluding mandatory minimums from all fentanyl
analogs will lead to less fentanyl and fentanyl-related
substances on our streets?
Mr. Milione. Thank you for the question, Congressman. I
would offer you a few things. Number one, the President opposes
mandatory minimums, and the administration is committed to
criminal justice reform that eliminates race and income-based
disparities.
That having been said, in this particular proposal, we are
talking about a narrow class of substances that are causing
harm in America's communities that are considered part of this
proposal as part of an overall balanced and comprehensive
approach that balances the safety of the American people, civil
rights, and also researcher access.
In terms of criminal justice elements and mandatory
minimums, I know the Department of Justice has submitted a
written statement that addresses that, but I would defer to the
Department of Justice on that.
Mr. Guthrie. OK. When you say this deals with a narrow
class of substances, this is one that as we are all talking
about that is killing our people with the overdoses. It may be
a narrow class, but it is a substantial plague upon our
society. A lethal dose of fentanyl is 2 milligrams compared to
200 milligrams for a lethal dose of cocaine and
methamphetamine.
Is there a reason why this proposal includes increasing a
substance like fentanyl-related substances but keeps this--but
it keeps--so the proposal keeps the mandatory minimums on, or
allows them to stand on less potent drugs like cocaine. So why
would they be the disparity of the one that is causing the
overdoses versus the others? Why not address them all?
Mr. Milione. Right. And so, when we are talking about this
particular class of substances, I think it is important to note
we have a few things. Number one, we have fentanyl itself, the
base fentanyl molecule. Then we have fentanyl analogs and an
entire category of fentanyl related substances that have
already been scheduled. So they have done the testing, they
have already been classified, they have already been scheduled.
But as we talked about earlier, the universe of potential
substances is about 4,800 that are chemically possible here,
and so, we have an entire population of substances that have
not yet been created, but have the potential to be created, and
that is what we are talking about in terms of fentanyl-related
substances in this particular class as a whole.
But as I said, you know, when it comes to the criminal
justice, and it comes to the mandatory minimums, I would have
to defer to the Department of Justice.
Mr. Guthrie. So currently--so fentanyl is scheduled, but
fentanyl analogs, the reason they are being created is because
they weren't scheduled, not permanently scheduled, is my
opinion. They are trying to get around that. And so, by
excluding these from the mandatory minimums, it seems
arbitrary.
Mr. Milione. Right. So those fentanyl analogs that have
been identified have been placed in Schedule I, or in their
proper place----
Mr. Guthrie. So they create a new one----
Mr. Milione [continue]. Regime, right.
Mr. Guthrie [continue]. Until we are willing on our side of
the aisle--or in Congress to make them.
Let me switch. I would like to go to Dr.--Mr. Milione. In
your testimony, you state that we must use every tool available
to combat the opioid, and you note that DEA and your partners
have seized ten million pills laced with fentanyl but fail to
mention how criminal penalties can be used to keep these drugs
out of our communities. Does the Department of Justice believe
mandatory minimums are a viable tool in the toolbox that we
should use to keep criminals from selling these drugs in our
communities? If not, why not, and what are the alternatives?
Mr. Milione. Thank you for the question. DEA, as a law
enforcement agency, is focused on protecting the public from
the greatest harms, the greatest drug threat. There is no
question that fentanyl is that greatest threat. It is killing
Americans every day at every corner within the United States.
Our focus, our laser focus, is on getting these fentanyl
substances permanently scheduled so that when we encounter
them, we can stop them before they come into the country, and
we can seize them and take them when we engage--when we
encounter them in our communities. We also need them
permanently scheduled so that we can dismantle criminal
networks that are distributing these drugs in our country.
Mr. Guthrie. But exempting them from the mandatory
minimums, does that have an impact?
Mr. Milione. DEA is a law enforcement agency. We conduct
our investigations. We work with our prosecutorial partners,
and we allow the judges to follow the laws that Congress have
enacted. So that is for the judges to determine.
Mr. Guthrie. Thank you much. I see my time--I wish I had
more time. My time has expired, and I yield back.
Ms. Eshoo. I think we all wish we had more time. There are
so many questions that need to be asked.
The Chair now recognizes the Chairman of our Full
Committee, Mr. Pallone, for his 5 minutes of questions.
Mr. Pallone. Thank you, Chairwoman Eshoo.
I just wanted to ask each of you to focus on the Biden
administration's FRS proposal. There are many that are opposed
to classified scheduling of fentanyl-related substances in the
proposal the administration has put forward to Congress. So
what--basically, what would each of you say to those who
expressed concerns about why this proposal deserves their
support? And what happens if the current emergency scheduling
order for fentanyl-related substances expires? I mean, I would
just like maybe each of you to spend a minute or so answering
that question, if you will. I guess I will start with Mr.
Milione.
Mr. Milione. Thank you. At DEA, we are focused on going
after those that are causing this terrible harm in the country
and helping those that are harmed. Fentanyl, without a
question, is the most significant drug threat that we are
facing. It is much better to be proactive in dealing with this.
These drugs are deadly. They are temporarily scheduled. We need
to get them permanently scheduled so that when they are--we can
stop them from coming across the border into the United States.
We can deal with the Mexican cartels that are pushing this into
our country. And when we encounter these substances in our
communities, we need the authority to be able to seize them----
Mr. Pallone. But that is why----
Mr. Milione [continue]. To remove the poison out of this
country.
Mr. Pallone. But my question is, does that administration
proposal accomplish that goal?
Mr. Milione. We believe that this administration--the
administration's proposal will help us protect the public
safety and health.
Mr. Pallone. OK. Let me go to Dr. Throckmorton, same
question. Because there are some that say, you know, that we
shouldn't be, you know, doing this. They don't like the
proposal, so that is why I am asking you.
Dr. Throckmorton. Thank you, sir. The FDA supports this
proposal in its current form. We believe it achieves that
important balance that is mentioned here today already, the
balance between placing these products under appropriate
control, recognizing their deadly potential, while also
providing a rapid mechanism, science-based mechanism to support
additional research, which, as Dr. Volkow has said, is
necessary. We believe losing control would be an important loss
to the public health efforts that we have all been making with
regards to confronting the fentanyl crisis.
Mr. Pallone. And you think the administration's proposal
accomplishes that?
Dr. Throckmorton. I think it is--in its entirety within
control of the class with a possibility of rapid decontrol
based on further science and research, it does achieve that
goal, yes.
Mr. Pallone. All right. And I will ask Dr. Volkow the same
question, keeping in mind that, you know, we are getting those
that say they are opposed to the administration's proposal and
the class-wide scheduling.
Dr. Volkow. Yes. And thanks for the question because,
indeed, we have been getting a lot of concerns from scientists.
And that is why we are very supportive of these new proposals
that will actually allow us not only to address the challenges
of doing research on fentanyl and fentanyl analogs, or related
substances, but also other Schedule I substances.
So in its current form, it actually provides also a
mechanism when it is found that some of these compounds may not
have addiction potential and are therapeutically useful to
remove them. And let me just give you an example of why this is
so important that we do that.
Naloxone, which is the most effective intervention that we
have to save lives, it reverses overdoses. That was Schedule I,
because its chemical structure is very similar of that of other
opioid drugs, like Morphine. So being able to remove it now
gives us a very powerful therapeutic, and the provision, as
proposed, will allow us to do that. So it achieves protection,
and it will help us accelerate research.
Mr. Pallone. All right. Mr. Chester, the same thing. But
the one thing no one has asked--answered is what happens if the
current emergency scheduling expires. So, the same question,
but maybe you can address that, too.
Mr. Chester. I will. Thank you, Congressman. So to answer
that question, I would say that currently, particularly in the
era of synthetic drug use, this is the most dynamic drug
trafficking and use environment that we have had in our
history. I would say that these drugs are particularly deadly
and because they are opioids, first use leads to chronic use
very, very quickly, as well as them being deadly in their own
right. I would say that drug traffickers are being able to
create these drugs faster than they can be scheduled
individually. And if we do not follow through on this proposal
in some form, it will be profoundly dangerous to the American
people to allow these drugs to be uncontrolled and essentially
legal for sale and for purchase.
And so this proposition, along with the more comprehensive
approach that the administration is taking that includes
prevention, reducing barriers to treatment, harm reduction, as
well as reducing the supply of illicit drugs in the United
States, we believe is the absolute right approach for the
environment that we face.
Mr. Pallone. Thank you.
Thank you, Madam Chair.
Ms. Eshoo. The gentleman yields back.
The Chair is pleased to recognize Mrs. McMorris Rodgers,
Ranking Member of our Full Committee, for her 5 minutes of
questions.
Mrs. Rodgers. Thank you, Madam Chair.
Dr. Volkow, we have received many letters from parents who
have lost their children to fentanyl. The stories are
heartbreaking. One pill, ordered through Snapchat, instead of
waking up her son for school one morning, a mother found her
son had passed away.
No parent wants their child to take illicit prescription
drugs. If a pill is on the street, you should assume that it is
not one made by the manufacturer in an FDA-inspected facility.
But I wanted to ask, are there ways to test pills for the
presence of fentanyl? And is there research going on to find
innovative ways to prevent and stop overdoses?
It is time that we did our part to permanently make these
fentanyl-related substances illegal and Schedule I, but I think
we are all desperate for some innovation to help arm parents to
better protect and educate their children.
Dr. Volkow. Thanks very much for this question.
Again, this is another example why we need to do research.
And, indeed, we are doing research that relates to try to
understand how the fentanyl strip tests that allow you to
actually measure if a drug that has been purchased contains
fentanyl or not affect behavior of the users, and also, do they
have the sensitivity to detect not just fentanyl or fentanyl-
related substances.
We are also doing research to improve of the levels of
sensitivity so that it is not only a yes/no test, but actually
can give us an indication of the amount of drugs and whether
other drugs are concomitantly mixed, because what we are seeing
also is that more and more people are dying from drug
combinations.
So, indeed, that there is a lot of interest to understand
how to optimally implement testing and what guidelines we can
give people so that they can take the most advantage from it.
Mrs. Rodgers. OK. Thank you.
Mr. Chester, Mr. Milione, I just wanted to ask, do you
agree--yes, I think you have spoken to this a little bit--but,
for the record, do you agree that we cannot let fentanyl-
related substances become unscheduled?
Mr. Chester. Yes, ma'am. We agree with that. And that is
why we believe this proposal is the right approach.
Mrs. Rodgers. OK.
Mr. Milione. Yes. We agree with that, yes.
Mrs. Rodgers. Thank you.
Do you agree that fentanyl-related substances should be
permanently placed in Schedule I?
Mr. Chester. They should be permanently placed in Schedule
I until the research community can have access to them and
determine whether there is any medical merit and where they
should fall permanently in the scheduling regime.
Mr. Milione. I agree with Mr. Chester.
Mrs. Rodgers. OK. Why is it helpful for these compounds to
be placed in Schedule I?
Mr. Chester. To make them illegal for purchase and sale in
the United States until the research community has the ability
to determine just exactly whether they are active in the body
and how dangerous they are.
Mr. Milione. So that we can protect the public and seize
them, stop them from coming in the country, stop them from
killing so many Americans, and seizing them in our communities.
Mrs. Rodgers. Would you speak to how you believe this would
deter the bringing in and the selling of fentanyl-related
substances?
Mr. Chester. Yes, Congresswoman. And what I will do is I
will kind of answer it in the opposite.
So what if they are not illegal?
Mrs. Rodgers. OK.
Mr. Chester. Then the individuals are incentivized to
create these novel substances, sell them on the internet or
sell them on social media or bring them into the United States
in order to do this.
And so, as I spoke to in my oral statement, we must deter
the creation of these new substances before they can be created
and introduced into our communities.
Many of these substances, in fact, you can argue the vast
majority of them, are active in the body and potentially
dangerous to Americans.
Mrs. Rodgers. Thank you.
Is there anything you want to add?
Mr. Milione. No, other than that our job at the DEA is to
make our communities safer and to stop these drugs from coming
into the United States, but also to investigate the groups that
are trafficking in them. Having this scheduled gives us that
ability and helps us make our country safer.
Mrs. Rodgers. Thank you.
It seems to me that exempting only certain fentanyl-related
substances from mandatory minimums will encourage more
trafficking in those substances. And I am worrying that we are
playing politics with this issue. By insisting on pairing
scheduling of fentanyl-related substances with lessening the
penalties on traffickers and importers of fentanyl-related
substances, we are jeopardizing making these substances
permanently illegal.
We need to act. We need to act now, permanently schedule
this fentanyl-related substance, and hold traffickers
accountable for those substances. It is a matter of life and
death.
I yield back.
Ms. Eshoo. Thank you very much.
I don't quite understand the following, and that is the
need to study fentanyl-related issues. We already know what
fentanyl does.
So it is not clear to me. Everyone has stated how
devastating fentanyl is and fentanyl-related substances, and
yet you are not treating--you state that, but you say the study
has to continue in order to keep them or drop them from
Schedule I.
What is it that we don't know about this drug and its
related parts?
Mr. Chester. Madam Chairwoman, I will start, and then I
will turn it over to the two doctors that I share the table
with.
These substances have in common their relationship to the
base fentanyl molecule, or the fentanyl skeleton, that we know
its activity in the body. This involves substances that have
modifications to that base fentanyl skeleton.
In some cases, these analogues have already been tested.
They have been subjected to testing, and we understand their
activity in the body. We are talking about a population of
substances that have not yet been created and, therefore, not
yet been identified and, therefore, the testing has not been
able to take place.
However, they all share that same fentanyl skeleton and
that same basic molecular identity. And so that is, from a
policy perspective, that is how we set the four corners of the
substances that we are dealing with.
But I would defer to Dr. Volkow and Dr. Throckmorton as
well.
Dr. Volkow. Yes, and I think that you describe it very
well, and it has to do with the notion that the chemical
structure by itself does not necessarily predict what the
pharmacological actions of that compound can be. And slight
modifications, for example, can make the molecule very, very
potent, or it can make it inactive. And that is why it is
important to understand the unique characteristics of the
thousands of molecules that can be derived that way.
Ms. Eshoo. You mean there could be a case where fentanyl is
OK? Is that what you are saying?
Dr. Volkow. There could be a case where a chemical--a drug
that has a chemical structure similar to fentanyl could have
potential therapeutic benefits and not be as toxic or addictive
as the fentanyl molecule itself, yes.
Mr. Throckmorton. Madam Chairman, let me give you a very
concrete example of exactly that.
So the DEA shares the data that they collect on members of
the FRS class with the FDA. Our technical staffs talk to each
other all of the time. And we have looked at a group of
somewhere over 25 FRSes, and we have studied their
pharmacology.
Among that group, there are members of that class, and one
in particular, that has no activity to turn on the opioid
receptor that we worry about here. In fact, it looks like an
antagonist. It looks like it would be a blocker of the mu
opioid receptor in the way Naloxone is a blocker of the mu
opioid receptor.
So Dr. Volkow mentioned the concerns we have about
reversing the overdose effects of fentanyl. This would be a
substance that would have some potential for being a treatment
for fentanyl. I am not saying I know that it is, but I am
saying that is what we are going to learn as we study these
individual compounds.
We are going to understand if there are some that have no
dangerous effects and instead have--they could be antagonist.
They could be new treatments for opioid use disorder. They
could be new treatments for preventing overdose or reversing
overdoses.
Those are the things that we need to make certain we don't
lose even as we put this entire class under the control that it
merits given the larger public health need.
Mr. Griffith. And, Madam Chair, if I might?
Mr. Chester, in his opening statement, said there were
4,800 potential--based on math--4,800 potential analogues, and
Dr. Throckmorton has just told us they have looked at 25. That
is why you have to continue research.
Ms. Eshoo. Well, I thank the Ranking Member for yielding
the time. I think I understand it a little better, but it is
complicated.
The Chair now is pleased to recognize the gentleman from
North Carolina, Mr. Butterfield, for his 5 minutes of
questions.
Mr. Butterfield. Thank you very much.
Ms. Eshoo. He is joining us virtually.
Good to see you.
Mr. Butterfield. Thank you very much. It is good to see
you, Madam Chair. Thank you so very much for recognizing me
this morning, and certainly thank you for your leadership on
the committee.
And to the Ranking Member, I love the spirit of cooperation
that I see between you and the Chair.
And just thank you and your colleagues for all the work
that you are doing. We have great challenges in front of us,
and just thank you for your cooperation.
Madam Chair, as we consider legislation to address the
opiate crisis, we must pay special attention to communities
that have been historically marginalized. And I refer, of
course, to communities of color.
Recent findings from the NIH found that, within a subset of
counties disproportionately affected by the overdose epidemic,
opioid overdose death rates from 2018 to 2019 level off across
all of our racial groups with the exception of African
Americans.
Isn't that strange?
Among African-American individuals, the opioid overdose
death rate increased by some 40 percent. This is tragic, and we
must take action to address this trend.
And as history has shown us, communities of color are also
disproportionately punished by drug policies. A report
published by the Sentencing Commission this past January found
that in 2019 African-American individuals composed a greater
proportion of fentanyl and fentanyl analogue offenders, of
which over 50 percent faced a mandatory minimum penalty even
though less than eight percent were importers or high-level
suppliers.
These staggering statistics are just absolutely a sobering
reminder of the stakes held in our discussion today, and that
is why it is important that we have a bipartisan approach to
this problem.
And so, Mr. Chester, let me ask you, please. And thank you
not only to Mr. Chester, but to all of our witnesses today.
But, Mr. Chester, the Biden administration has been clear
in its intent to address the disproportionate impact that past
drug policies have had on communities of color--he said it in
the campaign, he is saying it today--from both a justice and a
public health perspective.
How does the fentanyl-related substances proposal meet that
goal?
Mr. Chester. Thank you, Congressman.
And for that very reason that has created the contours of
this proposal. And so, while permanently scheduling this class
of substances is what is done on the front end in the interest
of public safety, we must also understand that we can't do
unintended harm by doing that.
And so the very reason that you explained is the reason why
this proposal looks the way it does, why it is comprehensive,
and why we were able to bring together the Department of
Justice and the Department of Health and Human Services to make
sure that we make all of those considerations.
Mr. Butterfield. Let me now talk about criminal penalties.
As a former judge, I have particular interest in this.
There are concerns among criminal justice and civil rights
organizations that this proposal will lead to harsh criminal
penalties, even with the inclusion of provisions excluding
fentanyl-related substances from quantity-based mandatory
minimums.
Now, do you agree with that assessment? And if not, can you
tell me why?
Mr. Chester. Congressman, as I mentioned before, the
President opposes mandatory minimums, and the Biden-Harris
administration is committed to criminal justice reform by
eliminating race- and income-based disparities in our criminal
justice system. And that is one of the foundational elements
that the administration has used to approach this incredibly
complex issue.
When it comes to detailed criminal justice matters, I know
the Department of Justice has submitted a statement for the
record. But I would defer to the Department of Justice on those
matters, sir.
Mr. Butterfield. Thank you.
And my final question, Mr. Chester. What guardrails are in
place, or what guardrails should be considered, to promote
racial equity in drug enforcement efforts?
Mr. Chester. Congressman, I can only speak to the proposal
that is here before us today. And guardrails is probably the
exact right term. If we were just to simply schedule all these
substances as a class, that is the bluntest instrument that we
have.
Rather than do that, we ensured that we also not only
considered research provisions, but the criminal justice
aspects to it as well.
And so we were able to provide the tool that our law
enforcement community needs in order to be able to protect the
community, but at the same time make sure that we were not
doing unintended harm. And guardrails is the exact right term
for the approach that we used.
Mr. Butterfield. Thank you very much, Mr. Chester.
And I will conclude, Madam Chair, by repeating what you and
others have said throughout this hearing. It is absolutely
unacceptable that the Department of Justice is not
participating in this conversation. Shame on them. I hope we
can hear from them very soon.
I yield back.
Ms. Eshoo. Hear, hear, Mr. Butterfield. Thank you.
The Chair is now pleased to recognize the gentleman from
Michigan, former chairman of the Full Committee, Mr. Upton, for
your 5 minutes of questions.
Mr. Upton. Well, thank you, Madam Chair.
And I join with everyone here voicing our disdain for the
Department of Justice not appearing and knowing that they had a
number of months to be prepared for this. It is really sad on
an important issue like this.
I had the privilege of being selected by Kevin McCarthy to
serve on the White House Commission on Combating Synthetic
Opioid Trafficking, and we have had great meetings. Another
scheduled for this afternoon, in fact. And just a couple weeks
ago, I was able to send one of my staffers on a commission trip
to Mexico and the southern border.
That is why I am troubled about the administration's
September recommendations on fentanyl-related substances. At a
time when we are seeing the highest rates ever--100,000 folks,
man, in 2020--it is so disturbing that the administration seems
to be favoring weakening penalties for drug traffickers who are
flooding every community with potent and deadly fentanyl
analogues. And I don't hesitate to say that everybody here on
this panel probably knows someone who was maybe part of that
100,000 in our families.
Mr. Chester, is there a concern that the Mexican drug
cartels, who are large-scale manufacturers of these fentanyl
analogues, are going to take advantage of the loophole by
producing fentanyl analogues with arbitrarily lower mandatory
minimums for trafficking while continuing to take advantage of
our lack of proper enforcement at the southern border?
Mr. Chester. Thank you for the question, Congressman.
And I would say the first thing is that the men and women
of Customs and Border Protection and our law enforcement
partners who are at the southwest border do a tremendous job.
Mr. Upton. They do, absolutely.
Mr. Chester. They absolutely do.
Mr. Upton. They are overwhelmed, which is unfortunate.
Mr. Chester. And I would also tell you that one of the
reasons we need this proposal is to do just what you described,
and that is to deter the creation of these new substances by
making them illegal.
And we make them illegal before they have even been tested.
And we do that to ensure that drug traffickers know and
understand that these are Schedule I substances. You cannot
create a novel substance based upon the fentanyl skeleton and
sell it in the United States with impunity. That is not going
to happen.
And so I think it is critically important that not only
Mexican drug traffickers, but anyone else with the potential to
make these substances and push them into the United States
understands that this entire universe of 4,800 substances is
illegal.
Mr. Upton. Well, I know that every one of us wants to make
sure that we do everything that we can to deter the creation of
these new analogues. I mean, there is no question about that.
Mr. Milione, we have talked a little bit about numbers,
4,800 potential analogues. I guess the DEA has looked at some,
a couple dozen.
Do any of them have a legitimate medical use?
Mr. Milione. Thank you for that question.
I would defer that question to Dr. Throckmorton or Dr.
Volkow.
Mr. Upton. OK. And let me just follow up with that, because
I was going to ask them the same question.
For those that may have some legitimate medical use, are
all of those in Schedule II, or are any of them in Schedule III
or IV?
Dr. Throckmorton. So fentanyl has an approved medical use.
It is a component in approved drugs that are on the market and
available. It also has a high potential for abuse, and so it is
in Schedule II.
There are no fentanyl-related substances otherwise in
schedule other than in Schedule I.
Mr. Upton. Mr. Milione, an ONDCP press release from
September of 2021 announced that the administration's
recommendations to Congress on reducing illicit fentanyl-
related substances states that, and I quote, ``The Justice
Department reported only eight cases with FRS charges from the
time temporary class scheduling was adopted in 2018 through
December of 2020, of which only a handful even included charges
of quantity-driven mandatory minimums,'' end quote.
Given the extremely low prevalence of cases involving
quantity-driven mandatory minimums and already established
statutes to waive mandatory minimums like the safety valve for
low-level drug offenders and the substantial assistance
provision for providing prosecutorial or investigative help to
the government, why did the administration release
recommendations that would further hamper enforcement of those
crimes?
Mr. Milione. Congressman, my colleagues at the DEA, myself,
my whole career as a DEA agent, we are laser focused on
protecting the public from these dangerous substances. It is a
top priority to have all these deadly substances scheduled in a
classwide way so that we can seize them at the border,
investigate them in our country, and seize them when we
encounter them in our communities.
Mr. Upton. OK. My time has expired. Thank you, Madam Chair.
Ms. Eshoo. Thank you. The gentleman yields back.
Pleasure to recognize the gentlewoman from California, Ms.
Matsui, for her 5 minutes of questions.
Ms. Matsui. Thank you very much, Madam Chair.
And I want to thank you for having this hearing.
And thank you for the witnesses for joining us today.
I, along with others, are concerned about the rise of
street drugs in our districts, including counterfeit pills
containing fentanyl. We have to work together on a
comprehensive approach to combat this next wave of the opioid
epidemic, and that includes cutting off how these illicit
fentanyl products are getting to our communities and helping
those who are already addicted get the treatment that they
need.
When Congress passed the Ryan Haight Act of 2008, our
intent was to curb online sales of controlled substances while
recognizing there is great value in legitimate prescribing via
telemedicine. We worked to ensure that the law struck the right
balance between safety and access.
Unfortunately, DEA restricted teleprescribing to patients
located in-person, and this narrow interpretation has
historically limited the number of patients who can access
care.
Now, most recently, DEA has waived that in-person
requirement during the COVID public health emergency to allow
remote prescribing of MAT via telemedicine regardless of a
patient's location.
Mr. Milione, to start off the question, I just need a yes
or no. Has DEA tracked any increased use of teleprescribing of
MAT since waiving the in-person requirement in response to
COVID-19?
Mr. Milione. Congresswoman, DEA knows that medical-assisted
treatment is critical to help those suffering with opioid use
disorder.
Ms. Matsui. Could I get a yes or no to that, please?
Mr. Milione. We are committed to working----
Ms. Matsui. OK. So has the waiver expanded access to
substance use services and interventions during the pandemic?
Mr. Milione. I am sorry. Could you repeat the question?
Ms. Matsui. Has the waiver expanded access to substance use
services and interventions during the pandemic?
Mr. Milione. Congresswoman, we are committed to working
with our interagency partners and have done so to expand access
to treatment. We believe that that is critical, helping those
that are harmed.
Ms. Matsui. OK. So you are saying it has expanded access.
Is that correct?
Mr. Milione. I am saying that we are committed to working
with our interagency partners to expand access to treatment and
working with the White House.
Dr. Volkow. If I can interject there, because we have been
monitoring it from the research perspective, and the answer,
yes, it has facilitated access to treatment, for example, of
individuals in our communities. It has made it much more
accessible for people that are in the justice setting, on
parole, to have access to buprenorphine much more widely.
Ms. Matsui. OK. Let me just ask this. OK. The SUPPORT Act
of 2018 required the DEA to complete a special registration
process to allow more providers to prescribe MAT via
telemedicine. I have authored legislation that would
specifically authorize community mental health centers and
community behavioral health organizations to use this process
to register as eligible provider sites.
To my knowledge, DEA has yet to carry out that
congressional directive.
Mr. Milione, when can Congress expect the DEA to complete
its statutory requirements and issue the special registration
rules in accordance with the law?
Mr. Milione. Congresswoman, as I said, we are committed to
working with the interagency community to expand access to
treatment. I am not familiar with the specific answer to that
question, but I am happy to take that back and get back to you.
Ms. Matsui. Yes, would you please do that? Because this
addiction crisis has gone on far too long, and it has always
been clear to me that Congress and DEA must come together to
meaningfully put an end to the opioid epidemic.
Now, I want to quickly shift focus to how the proposal
before us today will impact research eligibility.
Dr. Volkow, there has been some question regarding whether
the streamlining for Schedule I research registration would be
limited to Federal researchers.
Can you clarify who would be eligible to conduct Schedule I
research under the provisions included in the administration's
proposal? Would it include private researchers, or just
federally funded researchers?
Dr. Volkow?
Ms. Eshoo. Excuse me. Use your microphone, please.
Dr. Volkow. Sorry.
Yes, it will, it will include private--researchers funded
by private foundations or private investors as long as they
have an IND with the FDA. But if they do not, then it will not
include them.
Ms. Matsui. OK. So researchers are already able to conduct
research on Schedule I. This change will allow them to use a
new process for other Schedule I substances, such as marijuana?
Dr. Volkow. It will--the proposal will basically apply for
all Schedule I substances. So it will expedite research on THC
as well as any other substance that is Schedule I.
Ms. Matsui. OK. Thank you.
I am particularly interested in eroding existing barriers
in Federal law that limit researchers at academic medical
centers from studying Schedule I substances. So I am grateful
that our research agencies are working to find effective
solutions to help [inaudible] Continue important work here.
Thank you very much, and I yield back.
Ms. Eshoo. Gentlewoman yields back.
The Chair is pleased to recognize the gentleman from
Virginia, Mr. Griffith, for your 5 minutes of questions.
Mr. Griffith. Thank you very much, Madam Chair. And I
appreciate the questions of all my colleagues.
And this panel is great. Thank you all very much for being
here.
Dr. Volkow, let me start with you. I believe that much more
research on fentanyl analogues is necessary. Based on what we
know now, how do these fentanyl-related substances compare to
traditional fentanyl in terms of how they affect the body as
well as their addictive properties?
Dr. Volkow. Thanks for the question.
There has not been as much research in fentanyl analogues,
and it has to do with the complexities and difficulties of
doing research on Schedule I substances. It takes longer. It is
much more costly. It is cumbersome.
So that has deterred researchers. And I am optimistic that
this proposal will make it easier so that we can get more
talent and expand our knowledge.
Mr. Griffith. Well, I will tell you--and I appreciate
that--and I will tell you, both Ms. Matsui, my colleague, and
others, I have been working for years to try to get more
research on Schedule I. And I have a bill that has already been
introduced this Congress, House Resolution 2405, that does
that. So I am glad to be in agreement with the administration
on this issue.
I was looking this morning at a bill that addresses many of
the administration's requests and concerns that I hope to be
introducing soon. So I am big on that.
Dr. Throckmorton, if I can go to you.
And then, Dr. Volkow, I wouldn't put the mask back on yet.
I am coming back to you.
You indicated in your testimony, both written and oral, and
then in some of the questions, that there is at least one of
the analogues that may have some potential. And could you
provide me the name of that one?
In your written testimony, there was an ``s'' on there. It
indicated there may have been more that didn't have problems.
Were there others that were inert or didn't function the way
most opioids do?
Dr. Throckmorton. Sure. Thank you for the question.
First, it is really important to understand that we have
only looked at a relatively small number of these compounds.
Mr. Griffith. Twenty-five, right.
Dr. Throckmorton. And without being able to give you the
exact number, we are sharing the information with the DEA,
looking at them as much as we can. I have a group of scientists
that are focused mostly on that.
Having said that, within that group there is more than one
compound that does appear to have other effects than activating
the mu opioid receptor. So whether it is this one compound that
I mentioned that appears to have this antagonism effect or
other compounds that have effects at other receptors--there is
another opioid receptor, for instance, and some compounds--the
major point, the point I want to make is that those exist.
The details are important to study, but fundamentally they
illustrate why just putting these all into Schedule I is not
sufficient. We have to do it along with the mechanism for
removing these promising substances that have these other
effects that are potentially less dangerous so that we don't
miss an opportunity to identify a new reversal agent like
Naloxone, or a new treatment for opioid use disorder. And this
small number of compounds illustrate that.
Mr. Griffith. And I appreciate that.
And I want to get back to Dr. Volkow.
So based on your previous testimony and his testimony, what
I am gathering the administration wants to do and what I want
to do--I want you to tell me if I am on the right path, that we
are in agreement--is put it all into Schedule I permanently,
but then have research available even on the Schedule I
substances so we can determine if we have got something that
may be helpful, and then can come back and take it out later if
it is inert, it doesn't do the mu opioid receptor, or if it has
some medicinal value, then allow that to move forward with
research as well.
Is that my understanding? Is that correct?
Dr. Volkow. I mean, you are asking a question in terms of
the scheduling, and I think that that is much better sent to
the Department of Justice.
Mr. Griffith. Who are not here, by the way. But go ahead.
Dr. Volkow. My view on this is that, as Dr. Throckmorton
was saying, we have an opportunity of actually, by doing
research, and not just coming with better overdose reversals
and treatment for opioid use disorder, but another area that
has been neglected is better treatments for pain.
So, as he mentioned, there is another opioid receptor,
[inaudible] Receptor, that can produce analgesia, but it is not
in [inaudible] Areas of the brain. So to the extent that we
could have a compound that specifically binds to it, you could
have an analgesic that is not addictive.
But this is why science becomes so relevant. And that is
what we focus on, to try to make that knowledge accessible.
Mr. Griffith. And, unfortunately, my time is up. I have got
lots of other questions, and this is a fabulous discussion.
Thank you all very much.
Thank you, Madam Chair, for holding the hearing.
Ms. Eshoo. The gentleman yields back.
I think we all have many questions. And, to our witnesses,
every member, I think, is going to be submitting written
questions, detailed written questions to you, and look forward
to your timely response to them.
The Chair now has the pleasure of recognizing the
gentlewoman from Florida, Ms. Castor, for her 5 minutes of
questions.
Ms. Castor. Thank you, Madam Chair.
And thanks again to our terrific witnesses here today.
I really appreciate President Biden and the
administration's forceful and comprehensive strategy to tackle
the opioid crisis, especially this deadly fentanyl and the
synthetic opioids flooding into the country.
Unfortunately, my community in the Tampa Bay area has not
been immune. If you look back at the trends over the last 5
years, like other parts of the country, we have seen a dramatic
increase in opioid deaths fueled by synthetic opioids.
And I really want to compliment the Tampa Police
Department. They have an opioid task force where they have
brought in, working with the DEA, FBI, ATF, and then a lot of
our nonprofit partners, our research university at the
University of South Florida. They are criminally pursuing and
prosecuting the folks who are perpetuating the abuse, going
after the dealers.
But what they have advised me is they cannot arrest their
way out of this. They received a DOJ grant a few years ago. And
after surveying everyone, they really wanted to put more into
crisis intervention.
And you all know that President Biden and the Democrats in
Congress earlier in the year passed the American Rescue Plan
where we devoted historic amounts of new money into crisis
intervention, mental health, substance use disorder services.
I would like to know, Mr. Chester, are those moneys now
getting out? Because we really need them on the street. My
police department and nonprofit community, they say they need
more crisis intervention services to save lives, get folks
treatment, in addition to what they are doing on going after
folks criminally.
What is the status of the American Rescue Plan dollars
getting out to communities like mine?
Mr. Chester. Yes, Congresswoman. Thank you very much. And
we will provide you an exact, accurate answer as to what the
status of all those dollars are, because it would be
irresponsible for me to say off the top of my head. So we will
make you know for sure.
I will also tell you, though, that what you described in
the Tampa area, in Hillsborough County, is an approach that is
taking place nationwide, and it is the approach that the
administration uses as well.
And so while you need to have a strong law enforcement
component to what we need to do, we also need to prevent drug
use before it starts and reduce barriers to treatment and
incorporate harm reduction as a whole as a comprehensive
approach. One single dimension of this is insufficient in and
of itself to be able to do that.
And I appreciate you mentioning the American Rescue Plan.
That was $4 billion for SAMHSA and HHS to expand mental health
services and substance use disorder services, which also
included another $30 million to support harm reduction
interventions as well.
And I will get you the exact answer on where those dollars
are. I would be glad to do that.
Ms. Castor. And then didn't ONDCP and Secretary Becerra
from HHS, haven't you all come together to do a deeper dive on
how you support those collaborations? And tell us about that.
Mr. Chester. Yes, Congresswoman.
So, yes, ONDCP and HHS work incredibly closely, hand-in-
hand, on all of the public health aspects of this. And I think
it is important also to remember that the President's fiscal
year 2022 budget, in and of itself, which includes HHS and all
the Federal drug control programs, is $41 billion, $41 billion
across the span of both supply and demand reduction applied to
this very difficult problem. And it is about $670 million above
the previous year's enacted levels.
A lot of that money goes to HHS, but a lot of it goes to
several other places throughout the Federal Government in order
to do many of the things that we are talking about here today,
to not only reduce the supply of these drugs in our
communities, but also the span of public health interventions
that are necessary in order to reduce the pull of these drugs
across our borders.
Ms. Castor. Thank you very much. I yield back.
Ms. Eshoo. Gentlewoman yields back.
The Chair is pleased to recognize the gentleman from
Florida, Mr. Bilirakis, for his 5 minutes of questions.
Mr. Bilirakis. Thank you, Madam Chair. I appreciate it.
Thanks for holding this hearing.
I am saddened that the overdose epidemic continues to
worsen across our Nation as deaths involving synthetic opioids
continued to skyrocket over the past year. That includes my
district, and specifically Pasco County, where 193 people have
died from overdose since January, the vast majority involving
fentanyl.
This crisis has led me to call for a roundtable in my
district this month where I will be consulting with local
leaders, providers, and local law enforcement from Pasco,
Pinellas, and Hillsborough counties. We must continue to be
engaged on all levels of government to fight back against this
scourge to our communities.
Again, Assistant Director Chester, in a previous hearing we
have had in this committee, I questioned then Acting Director
LaBelle about our relationship with China and the role it plays
in preventing the entry and sale of fentanyl and its analogues.
She mentioned that China is now channeling much of their
fentanyl-related substances and its components through Mexico
and thus across the border.
In fact, the Biden administration's own Justice Department,
whose Deputy Attorney General, unfortunately, decided not to
come here--and, again, that is inexcusable. I agree with you,
Madam Chair.
But, again, the Attorney General stated, and I quote,
``Mexican criminal drug networks are mass producing illicit
fentanyl and fentanyl-laced fake pills using chemicals sourced
largely from China and are distributing these pills through
U.S. criminal networks.''
I don't think anybody will dispute that.
``These fake pills are designed to appear nearly identical
to legitimate prescriptions, such as OxyContin, Percocet,
Vicodin, Adderall, Xanax, and other medicines. Criminal drug
networks are selling these pills through social media, e-
commerce, the dark web, and existing distribution networks. As
a result, these fake pills are widely available,
unfortunately.''
Now, that is a quote from the Assistant Attorney General.
If we have learned anything from the COVID pandemic, it is
that we should be skeptical of China. The Trump administration
was very tough on China and the border issues, as you know, and
yet the Biden administration's proposal fails to address these
components.
The question, Mr. Chester. Can you provide an update on how
the administration is engaging not only with Mexico, but with
China directly on its role in proliferating this deadly
substance? And can you tell me whether China has been
consistently enforcing its laws in this area? And what
mechanisms do we have to hold China accountable to its
commitment to ban the export of fentanyl and its analogues?
Please, Mr. Chester.
Mr. Chester. Yes, Congressman. Thanks for the question.
You have in your question identified the two fundamental
countries involved in the flow of these drugs into the United
States, and that is China and Mexico.
China's role has changed over time. So there was a time,
pre-2019, when China was the preponderant source of finished
fentanyl and fentanyl analogues coming into the United States.
And it was either routed through Mexico or, quite
significantly, we talked about the Postal Service before,
ordered on the interweb and shipped directly through express
consignment like FedEx or UPS or through the Postal Service.
We approached the Chinese Government--and this was actually
a conversation between the Presidents in December of 2018--and
asked the Chinese Government if they would do just what we are
discussing today, and that is to schedule all fentanyl-related
substances as a class.
They did that effective May of 2019, and it had a couple of
impacts. The first one was we saw direct from China to the
United States shipments of fentanyl and analogues go down to
essentially zero. But that didn't solve the problem.
What happened was a lot of the fentanyl synthesis shifted
to Mexico, with Mexican drug trafficking organizations, with
the raw materials provided from China, and a lot of Chinese
traffickers got into the precursor chemical business. So it
shifted, the locus of production shifted from China to Mexico,
but then it was enabled by China.
Mr. Bilirakis. I would like to ask another question, if I
may, Madam Chair. Is that all right? Thank you.
Mr. Chester. Yes, sir.
Mr. Bilirakis. Another concern I have is the availability
of sales of fentanyl-laced drugs online, and you are getting to
that.
One prominent study regarding the fake prescription pills
states, and I quote, ``fentanyl networks are among the world's
first digital native drug networks. Global internet
connectivity has opened a new era of drug distribution by
facilitating direct-to-consumer transactions, rapid reaction to
enforcement trends, and the delivery of retail rather than
wholesale drug volumes through legal commercial delivery
services.''
Again, Mr. Chester, Assistant Director, and Deputy
Administrator Milione--if you will allow them to respond, Madam
Chair--given the dynamics of legal immunities available for the
big tech companies to essentially incentivize them to bury
their heads in the sand, how is the administration working with
these companies, if at all, to prevent these illegal sales? And
what is the level of transparency and information sharing
between these companies and law enforcement agencies?
First, Director Chester, please.
Mr. Chester. Yes, Congressman. I will tell you that you
have identified a key part of the problem, which is we have
many vectors for these drugs to come into the United States and
we have many platforms on which they can be sold, which include
social media.
I would like to stay within the limits of the FRS
scheduling right now. But we could get you an answer, a more
specific answer, I would like to provide, on specific actions
that the administration is taking. But what you identify
obviously is a critical component of this threat.
Mr. Bilirakis. Administrator Milione, if that is allowable,
please? Oh, OK.
Ms. Eshoo. Finish answering the question briefly from the
panel to Mr. Bilirakis.
Mr. Bilirakis. Mr. Milione, please?
Mr. Milione. DEA is focused on the largest threats to
protect the public. I have said that throughout the hearing.
There is no question----
Ms. Eshoo. You have.
Mr. Milione. What?
Ms. Eshoo. You have.
Mr. Milione. It is critical to our mission.
Ms. Eshoo. Consistently.
Mr. Milione. You mentioned earlier Mexico and China.
Certainly Mexican cartels are flooding the country, working
with Chinese chemical companies.
Ms. Eshoo. But you are not answering the direct question,
though, with all due respect to you, sir, and that is, who are
you working with? It has been testified that there are social
media platforms and such. I think that is what the gentleman is
asking.
Mr. Bilirakis. Absolutely.
Ms. Eshoo. I asked the same question. Who is DEA working
with? Can you name any of the companies? Is there outreach? If
there is, with whom? Have you been successful? If not, have
they turned you down? Maybe the Congress needs to do something
about that.
Mr. Milione. Where DEA is focused is wherever the threats
are. So if the social media platforms and e-commerce platforms
are being used, we will focus our investigative efforts there.
Ms. Eshoo. Will, or have, and shall?
Mr. Milione. We will continue every day to do that. We will
continue every day to do that. We have been doing that.
Ms. Eshoo. So you are doing it.
Mr. Milione. We are focused on wherever the threat is. And
if social media platforms are being used, or e-commerce
platforms are being used, or Mexican cartels are flooding the
country----
Mr. Bilirakis. But they are being used. Is that correct?
Mr. Milione. There is no doubt that social media companies
should do more to prevent their platforms from pushing this
poison into our homes.
Mr. Bilirakis. Thank you for following up, Madam Chair. I
appreciate it.
Dr. Throckmorton. Madam Chairman, can I just say that the
FDA does have an active, ongoing set of efforts in this space
we would be happy to talk to you about. We agree it is a very
serious threat.
We take counterfeit drug sales, especially online drug
sales, very seriously and have taken actions, including
discussions since 2018 with some of the internet providers and
some of the groups that control access to the internet, the
internet service providers and the like it, for instance. Happy
to talk with you more.
Ms. Eshoo. Thank you, Doctor.
The gentleman from Florida yields back.
A pleasure to recognize the gentleman from Maryland, Mr.
Sarbanes, for his 5 minutes of questions.
Mr. Sarbanes. Good morning, Madam Chair. Thanks very much
for this hearing. Appreciate it.
Obviously this is a very delicate and pretty complicated
topic, this one of scheduling fentanyl, because there are a lot
of obstacles to navigate or issues to address.
Maryland hasn't escaped the scourge of this pandemic that
we are seeing, or epidemic really, of opioid-related deaths.
And my constituents obviously are as interested as anyone in
how we are going to address this and strike the right balance
here. And I know that is the effort that has been undertaken.
Now the Biden administration is coming with a proposal that
attempts to do that.
I would like to get a little bit back into the weeds on
this. So given the significance of the scheduling, the
recommendation for permanent classwide scheduling of fentanyl-
related substances, I would like to hear a little bit more
about that process.
So, Dr. Throckmorton, can you lay out for us plainly--I
mean, you have done this a little bit, I would like you to come
back to it--what the scientific or medical evidence is that is
needed to remove or reschedule a substance?
Dr. Throckmorton. Thank you, Congressman.
There are two parts, two possible answers to that question,
so I just want to clarify. Are you asking about the FRS class
proposal that the administration is putting forward, or are you
talking about the more general approach that has been
historically used to remove a substance or change a scheduling?
Mr. Sarbanes. I am speaking now sort of more generally.
What are the kind of scientific reference points that we use
when we are removing or scheduling or rescheduling a substance
for that matter?
Dr. Throckmorton. So the general process involves eight
factors that are laid out in statute, and we are obliged, we,
the FDA, are obliged to look at each one of those factors. And
they include things from the pharmacology, the available
information about public health, injury, deaths, any accepted
medical uses the product might have. We look at all of those
eight factors and then provide a recommendation to HHS.
In this case, we would have to conclude that the available
data suggests that the compound has no abuse potential based on
those full eight factors, which is a considerable amount of
data that are needed to be developed.
Mr. Sarbanes. So you have anticipated, you anticipate a
little bit the next question I was going to ask, because under
the expedited process--and you were alluding to this, I guess--
to reschedule or deschedule a fentanyl-related substance, HHS
would only consider one of these eight factors that you are
mentioning.
And I am curious, or can you elucidate a little bit more
how the interagency working group determined which factors
would be required to be considered when removing a substance
from the schedules? Just draw that comparison, if you could.
Dr. Throckmorton. Yes. Thank you, Congressman. That is a
really great question.
First, the focus on the one factor, which is the factor
related to the pharmacology, comes from the focus of the FRS
class legislation as a whole.
So the idea of placing something in the FRS class and
putting it into Schedule I reflects this pharmacology that the
drug causes and effect on the mu opioid receptor, that its
effects are pharmacologically like what we see with fentanyl
and hydrocodone and oxycodone and other lethal things.
What we believe as an interagency group is that, if we are
satisfied that, in fact, that pharmacology is not present for
one particular compound based on all of the available data, not
just that factor, then that compound belongs in other places in
the schedule. It may still have abuse potential, but we don't
yet have all the information.
But it is not a substance that has the high risk of abuse
and misuse like oxycodone, like fentanyl. And so it belongs in
a lower part of the schedule, Schedule III, or decontrolled
entirely.
And so it is not that we are ignoring any data. We would
look at all of the available data. It is that we are focusing
on the same part of the compound's effects that led to it being
placed into Schedule I in the first place.
Mr. Sarbanes. Thank you. It is pretty complicated stuff. I
appreciate those answers. I think that will be helpful to us in
understanding these various proposals that are coming forward
and trying to do something responsible from a legislative
standpoint.
With that, Madam Chair, I will yield my time back.
Ms. Eshoo. The gentleman yields back.
The Chair is pleased to recognize the gentleman from
Indiana, Dr. Bucshon, for your 5 minutes of questions.
Mr. Bucshon. Thank you. I want to thank the Chair and the
Ranking Member for holding this very important hearing on drug
overdose and fentanyl-related substances.
I do want to mention, though, without demand there is no
supply. And I think for many years we have not addressed what
the factors are in our country that are creating such a demand
for these substances, and we should maybe do that.
Members of the committee have had a long history of working
to help combat substance abuse of opioids, and I believe the
country is making some great strides in those efforts.
Specifically related to fentanyl and its analogues, I don't
particularly get the connection in the proposal from the
administration to the larger discussion on mandatory minimums
and racial disparities in sentencing for drug-related offenses.
And specifically related to fentanyl and analogues, I disagree
with the administration.
Unfortunately, the pandemic has created the perfect storm
and sent our country backwards in many ways in this battle
against drugs. One of the contributors--and I am a doctor, so
this could--is we halted elective surgeries and other
procedures that allowed patients to have access to medical
care, which many people were left in pain, bad knees, bad hips,
other things.
And, while I understand the reasoning for a short while,
many States waited too long, honestly, to reinstitute these
type of treatments. And there are States now, New York State,
for example, has done this, because of the Omicron variant
before we even had a case in the U.S., and I think it is
problematic. And when someone is in pain and can't get the
relief they need through medical procedures, it is much more
likely for them to turn to opioids to manage their pain, which
can obviously lead to abuse.
And as has been described, a lot of the prescription drugs
that have been prescribed, that is decreasing the use, and this
illicit is getting higher, but it is still an issue.
So, Dr. Throckmorton, what can Congress and the FDA do
better to promote nonopioid treatments? And is the FDA
currently prioritizing review of devices and other opioid
alternatives that patients can use to better control their
pain?
Dr. Throckmorton. Thank you, Doctor.
Short answer to your second question, absolutely yes. We
are doing anything we can to prioritize the development of safe
alternatives to opioids, whether it is devices or drugs.
We recognize that there are two forms to those alternatives
to the drugs. They could be drugs that look like opioids but
that do not have the addiction and overdose potential that many
of our current opioids do. That is an area of strong importance
for us.
Mr. Bucshon. Yes. Can I just say this? And that is why it
is important to have a strong procedure in place if we are
going to schedule these as a class to make sure that, if we
find one of those, that we can get that back to Schedule II so
patients have access, correct?
Dr. Throckmorton. Could not agree more with you. And NIDA
and we talk regularly about those kinds of products and how we
can bring them forward.
The second class of products is obviously the ones that are
nonopioids but are effective at treating severe pain. We have
to acknowledge that we don't have a broad armamentarium there.
We have other medicines that treat pain that is less severe.
But opioids are uniquely effective in certain places. And
so we need to do everything we can to understand that science
better and identify nonopioid alternatives that will work for
those really severe pains, end-of-life pain and things like
that.
Again, those are the highest priority for us as a center.
We have breakthrough designation that we stand ready to extend,
priority review. We have other mechanisms. Basically we will do
anything we can to help.
Mr. Bucshon. And we in Congress have also created a
separate payment structure for a period of time, as you know,
for these nonopioid alternatives to encourage their use,
because the reality is opioids are cheap.
And so if you have a more expensive nonopioid product that,
for example, under a diagnostic-related group at a hospital, a
DRG, those may not be used if they are going to cost the
facility more money because the opioids are so cheap.
So we have worked on that part of it also to make sure
there is reimbursement encouragement to use nonopioid
alternatives.
Mr. Chester, so we have talked about the illicit drugs in
Mexico. How are they getting into the country? They are in
Mexico. They are being created. How are they getting here?
Mr. Chester. Yes. Congressman.
Mr. Bucshon. And be short, because I have got a follow-up.
Mr. Chester. Yes. Principally across the southwest border.
Mr. Bucshon. OK. So if we were to work to secure the border
better, would that help?
Mr. Chester. There are multiple vectors by which they come
in, both the southwest border, which is the short answer, but
also through the mail system and also through other----
Mr. Bucshon. We did some changes in the mail system to
allow the FDA--to allow the DEA, I think. You mail a crate of a
thousand little boxes, right?
Mr. Chester. Right.
Mr. Bucshon. And each one of them has drugs in it. We
allowed them not to have to open up every one of those. I think
we did that a number of years ago.
Mr. Chester. The most effective thing we can do is our
relationship with Mexico to help deter the production of the
drugs themselves.
Mr. Bucshon. And not to criticize any other government, but
do you realize that, as you know, the cartels, the amount of
money involved, it is very difficult to get public officials
across our southern border to engage in this process, both
because they worry about their own personal security and,
honestly, because there is just so much money.
I yield back.
Mr. Chester. Yes, sir.
Ms. Eshoo. The gentleman yields back.
The Chair is pleased to recognize the gentleman from
Vermont, Mr. Welch, for his 5 minutes of questions.
Mr. Welch. Thank you very much, Madam Chair.
I mean, this opioid crisis is just so horrifying for so
many Americans. And my colleague, Mrs. McMorris Rodgers,
describes those who succumbed to the opioid crisis. It is a
death of despair.
And there are really two things about it. We are not
talking about the dealers, but we are talking about many of the
good Americans who find themselves in the grip.
One is that we need treatment more than we need prosecution
of those folks, my view.
And, secondly, although it is not the topic of this
hearing, we need to rebuild our communities, because people who
are alone and lonely, who are dealing with COVID and don't have
any support systems, they often make a mistake thinking an
opioid might be that support system that they want.
The second thing, though, that is very disturbing is that,
where we do have an overreliance on the criminal justice system
rather than treatment, there is real disparate treatment within
the criminal justice system, with Black and Brown Americans
being much more highly prosecuted.
Just as an example, in Vermont the odds of a person of
color being prosecuted are significantly higher, maybe 14 times
as high. So it is another reason why the over, my view,
overreliance on prosecution versus treatment for the users, not
the dealers, is something that we, I think, have to be mindful
of.
Let me ask Mr. Milione--thank you for your work, by the
way--how do we ensure that we are taking the right steps in the
criminal justice system, on the one hand, to address the public
health crisis, while simultaneously ensuring that we are not
exacerbating an already problematic criminal justice system
that does have disproportionate impact on people of color?
Mr. Milione. Thank you, Congressman. At the DEA, we are
very concerned about those that are inflicting the harm in our
communities, and obviously, with something as deadly as
fentanyl, that is our primary concern. That is where we are
focused on the most significant drug threats. But we are also
interested in helping those that are harmed, and that is why we
support expanded access to treatment and will work with our
interagency partners to do that.
Our focus are on the biggest drug threats that--right now,
that is fentanyl, and a close second is methamphetamine, and
the Mexican cartels that are flooding our country and
distributing it throughout all communities across the country.
Mr. Welch. You know, on that topic, a lot of us here have
seen the benefit of telemedicine, and that is a tool that can
be helpful to provide treatment to the individuals, not the
ones you are going after in the Mexican cartel. And it is
really true for those of us who represent rural districts.
There are many temporary flexibilities in place right now to
allow telemedicine that could benefit from being permanent, and
I want to ask about the telehealth ability to prescribe.
Earlier this year, the ONDCP indicated that a rule might be
coming regarding telemedicine and special registration. And how
do you see DEA's progress here, and what might be the status of
this rule to ensure that patients are getting the care that
they need?
Mr. Milione. Well, as I said, we are focused on doing
whatever we can to help those that are harmed. I know that we
are working with our interagency partners on anything
consistent with the Controlled Substances Act. I would have to
get back to you with some specifics about that.
Mr. Welch. All right. Well, your role in that is really
important because you have got a dual responsibility, you know.
We look to you for really hard and effective law enforcement,
but on the other hand, you are making that distinction between
where to focus your resources and where to facilitate treatment
for people that we want to help, so I thank you for that, and I
thank all the witnesses. I yield back.
Ms. Eshoo. The gentleman yields back.
A pleasure to recognize the gentleman from Florida, Mr.
Dunn, for his--for your 5 minutes of questions, sir.
Mr. Dunn. Thank you very much, Madam Chair and Ranking
Member Guthrie, for hosting this hearing today to discuss the
enormously important issue of proper scheduling of fentanyl
analogs.
I fully support the permanent scheduling of fentanyl
analogs as Schedule I substances, and I am proud to co-sponsor
the Fight fentanyl Act introduced by my colleagues, Congressmen
Chabot and Latta. I also support strong punishments for those
who are responsible for producing and distributing fentanyl
analogs on our streets.
You know, the cartels are producing synthetic opioids, and
they are pouring over our southern border, and they are
assisted by Chinese chemical companies who are sourcing their
precursors. Lax punishment for those found trafficking in these
substances will only incentivize the spread of these deadly
substances in our communities. I think the Biden administration
proposal gets one thing absolutely right, and that is, the
permanent scheduling of the fentanyl analogs. I think it fails
in its shortsighted decision to exclude fentanyl analogs from
mandatory minimum sentencing requirements.
You know, the fentanyl analogs are literally, as has been
said already today, poison on our streets. In a single drug
bust in my district, Marion County, earlier this year seized
two ounces--I am sorry--two pounds of fentanyl. Two pounds of
fentanyl, pure fentanyl, is potentially enough to kill 80
million people. We are talking about wiping out cities here.
When it is prescribed as a medication--I am a doctor as
well--in a healthcare setting, we administer this in microgram
doses. That is one-millionth of a gram.
Excluding one of these deadliest drugs in the world from
the mandatory sentencing is simply irresponsible, in my mind,
and it will surely shift the illicit drug market towards moving
more of these analogs through our communities. I think now is
not the time, and these are not the charges to encourage
prosecutorial leniency. The proposal we are reviewing today
will empower organized fentanyl producers, mostly Mexican
cartels who are getting their precursors from chemical
companies in China. It will just empower them.
So, Mr. Milione, a quick question. In the DEA's 2020
intelligence report, they determined that China was the number
one source of producing these precursors. Is that still true?
Mr. Milione. Yes.
Mr. Dunn. Excellent. Good. That is a factoid we can work
with. Dr. Throckmorton, is the DEA--this is interesting to me
just as a science end of this thing--to confidentiality
identify the sources, the origins, if you will, of fentanyl
analogs and fentanyl when you seize drugs?
Dr. Throckmorton. I think I would defer to the DEA on their
detection and deciding where these things came from.
Mr. Dunn. Very good.
Mr. Milione.
Mr. Milione. Can you repeat the question?
Mr. Dunn. Yes. So if it is--you can--can you
confidentiality determine the origin of a compound, an analog,
a fentanyl analog when you seize it? Is there enough chemical
analysis that you know the telltale signatures of where it came
from?
Mr. Milione. In DEA's labs, we have a significant profiling
program that looks at all of that.
Mr. Dunn. I am pleased. Thanks so much. Mr. Milione, again,
has the administration dedicated enough resources to our
southern border to adequately empower you to reduce the
fentanyl trafficking and analog trafficking across our southern
border?
Mr. Milione. We are very concerned with the threat of
fentanyl. We are very concerned with what is going on in
Mexico. Every day, agents on the southwest border and
throughout country are investigating these criminal drug
networks.
Mr. Dunn. Are there any particular tools you would like us
to provide?
Mr. Milione. Congressman, we can always use more resources.
This is a very, very difficult, challenging problem, and we can
always use more resources.
Mr. Dunn. Thank you so much. Let me say that I am--I will
vote for this bill. I am glad we are doing it, but I am
disappointed that there is no mention made of the problem we
have of sourcing all of these drugs across our southern border.
With that, Madam Chair, I yield back.
Ms. Eshoo. Dr. Dunn yields back.
The Chair is pleased to recognize the gentleman from
California, Mr. Cardenas, for his 5 minutes of questions.
Mr. Cardenas. Thank you very much, Madam Chairwoman, and
also Ranking Member Guthrie. We really appreciate this
opportunity for us to discuss this very, very critical and
important issue.
When it comes to overdose deaths, they are rising, and it
is clear we must do what we can to act to control the
distribution, sale, and use of fentanyl-related substances. To
do this successfully, Congress must address rising overdoses as
the public health crisis that it is rather than a problem of
not enough enforcement. Because of this, I am concerned that
class-wide scheduling takes the approach of guilty until proven
innocent. We would be criminalizing compounds which haven't
even been discovered yet. This approach applies harsh Federal
penalties and restrictions even if a compound turns out to be
non-harmful. It could be helpful, as a matter of fact. For
example, fentanyl and fentanyl-related substances are in a
category of compounds which also includes medication for pain,
diarrhea, Parkinson's disease, depression, anxiety, and
dementia.
I would like to submit for the record this paper titled
``Potential Unintended Consequences of Class-Wide Drug
Scheduling Based on Chemical Structure, a Cautionary Tale for
fentanyl-Related Compounds.'' It was published in the Journal
of Drug and Alcohol Dependence by Dr. Sandra Comer, who is a
Professor at Columbia University and testified earlier this
year before Congress on this very topic. She warns that, quote,
``class-wide banning based on chemical structure is likely to
have unintended consequences, including severely limiting
biomedical research, and in the long term, adversely impacting
public health,'' end quote.
Dr. Volkow, I think we all agree that the current
scheduling classifications system has made it very difficult to
scientists to research the effects of scheduled compounds which
may have medicinal properties. For example, we know that
compounds in marijuana have legitimate and beneficial medical
uses, despite it being Schedule I. So I am encouraged to see
that efforts are being made to allow researchers to study the
effects of various compounds in this proposal.
However, I am concerned with the idea of treating entire
categories of compounds as a Schedule I for enforcement
purposes but differently for research purposes. I think this
puts the entire scheduling system into question. Question one--
schedule one compounds are, by definition, compounds with no
medical use and a high potential for abuse. I will say that
again. Schedule I compounds are, by definition, compounds with
no medical use and a high potential for abuse.
In this specific situation, if we don't have the data to
support fentanyl-related substances as Schedule I, why is it
being recommended to classify an entire category as such, and
also, including compounds which haven't even been discovered
yet?
[The information appears at the conclusion of the hearing.]
Dr. Volkow. In general, certainly, I would be also very
much worried about just taking chemical structure as a way of
scheduling, but I also recognize that we are really in an
emergency situation. It is not business as usual. And we have
never seen so many people dying from overdoses ever, and
fentanyl is one of the drivers as well as fentanyl-related
compounds. They are highly, highly profitable. They are not
going to go away. And we need to actually do everything that we
can to make it harder for the manufacturer and dealers to do
it.
At the same time, we need to also be very conscious that
the way we are going to be addressing the crisis, as said by
the other agencies, is not one intervention. We need to
actually provide prevention, treatment, recovery. And that
requires research, and that is why I am so--I am very
supportive of these provisions because it will give us an
opportunity to make research simpler and faster on these
Schedule I compounds. So we are in no ideal world. We are in an
emergency situation.
Mr. Cardenas. Yes. It definitely is an emergency situation.
I also would like to add to what my colleagues have mentioned
about our disappointment that Department of Justice is not
here. I hoped that we would have been able to hear from the
Justice Department on these issues as they played a key role in
developing and potentially enforcing this proposal. I
appreciate the feedback of all of the witnesses who are here
today.
Being the DOJ is not here, I want to ask a question to the
DEA and also ONDCP. The bottom line is, why is it being
recommended we continue the same strategy of criminalizing
compounds which clearly isn't working so far?
Mr. Milione. I will take that. Thank you for the question.
Fentanyl is killing hundreds of people every single day in
every community across this country. Tens of thousands are
dying every year. These are incredibly dangerous substances.
Mexican cartels are flooding the country with these substances,
working with chemical companies in China, and they are
profiting off the opioid crisis in our country.
So our focus is on those that are harming the country and
investigating them and bringing them to justice, but also, it
is critical for us to have these drugs scheduled so that we can
prevent them from coming in and harming our public citizens in
our country, and also seizing it when we encounter it as well
as dismantling the groups that are profiting off this.
Mr. Cardenas. Thank you. My time has expired. I yield back.
Ms. Eshoo. The gentleman yields back.
The Chair now recognizes the gentleman from Georgia, Mr.
Carter, for your 5 minutes of questions.
Mr. Carter. Thank you, Madam Chair, and thank all of you
for being here. I am so glad that we are having this hearing,
and I appreciate you calling this hearing, Madam Chair, but I
am frustrated. I am very frustrated. I mean, here we are at
this hearing, and we have a border where fentanyl is pouring
across the border, pouring across the border. Enough fentanyl
was seized during the month of September to kill 2.1 billion
people. Enough fentanyl has been seized at that border this
year to kill every American three times over. And yet, do we
have a representative from the Department of Justice? Do we
have a representative from the Department of Homeland Security?
No. It is ridiculous, ridiculous that we are doing this.
You know, drug traffickers are murderers, period. Drug
traffickers are murderers. Ask any of 100,000 family members--
the family members of 100,000 people who died this past year as
a result of drug overdoses. Ask them, and they will tell you.
They are murderers. Until we resolve the situation at our
southern border, anything we do is ridiculous. This has got to
be addressed. And, again, if we have to subpoena the Department
of Justice, subpoena Homeland Security, get them here and
answer these questions.
I want to ask you, Mr. Chester, and I will ask Mr. Milione
in a second. If ever there was a time, if ever there was a time
to debate reforming mandatory minimum laws, do you believe it
should be now with the unmatched lethality of fentanyl-related
substances which are even more lethal than fentanyl itself?
Mr. Chester. Thank you for your question, Congressman, and
I want to talk to you from a policy perspective. I am not an
attorney, and I am not part of Department of Justice, but I do
want to answer your question directly.
And the first one, the first element of that is this: What
is not included in that exception are fentanyl analogs that
have already been identified and are already placed in the
scheduling regime of which there have been close to 30 that
have been seized and identified by CBP and maybe another
handful by our Canadian partners that we deal with. So that is
valeryl fentanyls, sufentanyl, methoxyacetylfentanyl. Those
have already been identified. Those are in the schedule regime.
That is a Schedule I drug. This provision does not apply. It
also does not apply for those substances in which there is a
case of death or serious bodily injury. That also does not
apply. So what you have is kind of this very narrow universe of
substances that have not yet been identified that this
exception applies, and so I want to make sure that we are
absolutely clear on that particular provision.
To the previous statement about the mechanism by which we
gather these up, it is true that these substances have not been
tested in vitro or in vivo. That is true. But it is also true,
as you state, that this class of fentanyl substances is
remarkably dangerous from the ones that we have detected and
potentially dangerous for the ones that we have yet to detect
and yet to be able to put to testing, and that is why this is
important.
Mr. Carter. And, you know, I dealt with this when I was in
the Georgia State Legislature. Being a pharmacist, I often
carried the update of the pharmacy rules in Georgia. And every
year, we would identify the dangerous drugs and include them on
there, and every year they would change them, just technically,
and we would be behind. We were behind before we even started.
Mr. Milione, I am going to ask you the same question. Do
you need me to repeat it?
Mr. Milione. No. Thank you. We are focused every day,
obviously, on the threat that we are facing with these drugs.
This is an existential threat to the country. The fentanyl
substances are coming in. What is critical for us is the class-
wide scheduling so that we can seize them before they come in,
and seize them when we encounter them.
As a law enforcement agency, we will continue to
investigate those groups that are harming our communities, and
we will do everything we can to get help for those that are
being harmed. Prosecutors make decisions about charging. Judges
follow the law. They will sentence. We will continue to
investigate and protect the public with all the tools that we
have.
Mr. Carter. Let me ask you something. Isn't it true--I will
ask you, Mr. Milione. I am sorry.
Mr. Milione. That is all right.
Mr. Carter. Isn't it true that the fentanyl and the
fentanyl variants are so potent that even at low doses, they
can be dangerous, even so much so that the DEA agents are
warned about touching them?
Mr. Milione. Fentanyl is an incredibly dangerous substance.
Two milligrams, a few grains of salt, is a potentially lethal
dose. That is why we have put out a public safety alert to warn
about the pills that are laced with fentanyl. Four out of ten
of those pills are----
Mr. Carter. That you can get over the internet. That is the
ones you are talking about?
Mr. Milione. That is correct.
Mr. Carter. Absolutely.
Madam Chair, I cannot believe the Department of Justice and
the Department of Homeland Security are not here. We should
subpoena them and make them come here.
Thank you, Madam Chair, and I yield back.
Ms. Eshoo. The gentleman yields back.
I think when an agency declines to come and testify, they
injure their own case. This is--you know, this is a--this is
the people's House, and we are examining, with every
legitimacy, the administration's proposal, and it is an agency
that is key in this. So I think that they have hurt themselves
by the choices they have made, and I think it is regrettable,
and it is troubling to me. I think we all feel the same way
about it.
OK. The Chair now recognizes the gentleman from California,
Dr. Ruiz, for your 5 minutes of questions.
Mr. Ruiz. Thank you very much, and thank you for this
hearing. I am saddened that we are here, yet again, to discuss
this crisis that continues to sweep our Nation, affecting each
and every one of our communities. As a physician, I treated far
too many patients with substance abuse disorder in the
emergency department, many fighting for their lives.
Just this week, I heard from one of my constituents,
Jennifer, from Bermuda Dunes in my district in California, who
tragically lost her son last year. Steven Loza was just 18
years old and had recently graduated from high school when he
died of fentanyl poisoning. He should have had his whole life
ahead of him. Unfortunately, this case is not unique. These
tragedies cannot continue. We must continue fighting for
Jennifer, Steven, and the families across the country who have
been afflicted by this crisis and enact policies that help
prevent more suffering and unnecessary loss of life.
Earlier this year, the Biden-Harris administration's Office
of National Drug Control Policy released their drug policy
priorities which included various bold approaches to reduce
overdose deaths. I applaud this proactive approach. This
overdose epidemic is one of the most important public health
issues of our time and requires urgency.
Mr. Chester, I am interested in hearing about the
administration progress on these priorities, and more
specifically, what major actions has the administration taken
to increase access to evidence-based treatment services since
releasing its policies priorities.
Mr. Chester. Thank you, Congressman. So I would like to
bring you up to date on a few things. So at the administration
level, the American Rescue Plan invested nearly $4 billion, and
that was to allow HHS and SAMHSA resources to expand vital
mental health and substance use disorder services. The funding
also included $30 million specifically for harm reduction, and
we know how important that is in saving lives and preventing
overdoses.
The President's fiscal year 2022 budget, $41 billion across
the National Drug Control program, but that is both demand
reduction and supply reduction as well, and that is about $670
million above the fiscal year 2022 enacted. We have also
designated six new counties as part of the HYTA program, the
highly successful HYTA program. We have also funded the
nationwide expansion of the overdose response strategy for the
HYTA, which is not only law enforcement, but also brings
together critical public health interventions in our
communities as well. We met with more than 300 State, local,
and Tribal leaders from all 50 States and territories to talk
about how they could use opioid litigation settlement dollars
and focus them in the right place for substance use disorders.
Mr. Dunn. Mr. Chester, since you mentioned Tribes, we know
that many--like in many other areas of healthcare, there is
marked disparities in access to substance abuse treatment for
underserved communities of color, rural communities, and
Tribes. So what steps has the Biden-Harris administration
taken, or is planning to take to close these disparities to
access to treatment?
Mr. Chester. Yes, Congressman. I would offer you two
things: The first one is there is never a time that we talk
about a particular policy that we don't mention State, local,
and Tribal as well. And we understand the unique aspects and
the unique needs of the Tribal community, and the fact that
substance use disorder has fallen on our Tribal communities in
an outsized fashion.
Two things that I can offer. One of them is, and this was
HHS released practice guidelines for the administration of
buprenorphine for treating OUD. We know that there has been an
expansion in the provision of buprenorphine over the COVID
pandemic, and that has been incredibly useful in getting more
people into treatment.
And the other thing, we are very proud of the fact that the
DEA, in working with ONDCP, lifted a decade-long moratorium on
opioid treatment programs that have a mobile component that is
critically important for rural and Tribal communities to be
able to extend treatment in areas that are traditionally
underserved. And so that is two examples of things that we are
very proud of that we have done just within the last 10 or 11
months.
Mr. Ruiz. Thank you. And are these efforts also conducted
and these outreach educational efforts also conducted in
Spanish?
Mr. Chester. I can get you the absolute answer on that, but
what I can tell you is I just--let me just talk about the drug-
free communities program for a second. Because the drug-free
communities program is entirely local, their motto--and they
are managed through the Office of National Drug Control Policy,
their motto is local problems require local solutions, and that
is one that I would be glad to provide you some more
information on that, and it being culturally and linguistically
focused because we are very proud of that program and announced
$13.2 million in funds just over this past year.
Mr. Ruiz. Thank you. I yield back.
Ms. Eshoo. The gentleman's time has expired.
The Chair is pleased to recognize the gentleman from
Pennsylvania, Dr. Joyce, for 5 minutes.
Mr. Joyce. Thank you, Chair Eshoo and Ranking Member
Guthrie, for convening this hearing on what we all recognize is
a grave and important matter. We are aware that the expiration
date for the current emergency class-wide scheduling order for
fentanyl-related substances is coming up next January, or now
will be likely punted until February. Congress cannot, I
repeat, Congress cannot allow this life-saving order to expire
and, rather, finally needs to pass legislation to permanently
schedule fentanyl-related substances to empower our brave law
enforcement officers to get these deadly drugs off the streets,
and to bring the traffickers and the dealers of these poisons
to justice.
In the face of this escalating crisis, I share with Chair
Eshoo and Ranking Member Guthrie's concerns that the DOJ hasn't
even allowed themselves to be present at this important
hearing. Drug overdoses are killing more Americans than ever
before, and nearly two-thirds of these deaths are the fault of
synthetic opioids, like fentanyl, and fentanyl-related
substances.
My district in Pennsylvania has been hit hard by this
crisis over the last two years. Every single one of the ten
counties that I represent has experienced increase--increases
in the overdose death rates from 2019 to 2020, over 30 percent
in each and every one of those 10 counties. While I am pleased
to see the Biden administration finally releases a plan to
permanently schedule these substances, I worry that this plan
is misguided, and that the changes of the proposed mandatory
minimum sentences for these drugs specifically will have the
reverse impact and encourage the traffickers, the traffickers
that you talked about to us today, to continue to bring these
substances into our communities and kill our families and our
friends.
My first question is for you, Mr. Milione. Is it reasonable
to believe that class-wide scheduling would not expand the
application of mandatory minimum sentences, as some might
suggest?
Mr. Milione. Thank you, Congressman. Our job at the DEA is
to make sure that we are making our communities safer, and that
includes conducting the investigations into those groups that
are flooding our country with fentanyl. As I said before,
fentanyl is an incredibly dangerous substance. What is critical
is that those drugs are classified permanently so that we can
stop those drugs from coming into the country and seize them
and dismantle the networks that we are investigating.
Mr. Joyce. My next question is for Dr. Throckmorton. As a
physician, I followed with interest the discussion about
streamlining the process to remove fentanyl-related substances
from Schedule I based on just one factor, not all eight. Does
that mean a fentanyl-related substance could be removed from
Schedule I even if there is no medical use?
Dr. Throckmorton. The short answer is yes, under the
current proposal. It would remain in Schedule 3, presumably, if
the pharmacology anticipated that it would have low amount of
potential for abuse, but it would still be controlled under
other various aspects of drug development. My agency has a
series of controls that we have over drugs that are
understudied--as new drugs for us, investigational review
boards would continue to be watching them, for instance.
But the short answer is yes. Under the current proposal,
the focus is on the pharmacology that we anticipate would cause
greatest harm, identifying that pharmacology, and if it exists,
that compound stays in Schedule I. It should not leave the
tightest possible controls.
Mr. Joyce. I agree with that. It should not leave the
tightest possible controls.
Mr. Milione, I think you said some important issues to us.
You stated that these cartels are permeating our southern
border. They are flooding every community with fentanyl-related
substances, driven by greed, your terms, and stopping at
nothing, your terms, and I agree.
But my question is for you, Mr. Chester. Is it not
incredibly dangerous to leave the door open for hypothetical
future compounds? Why not fix the threat today? Wouldn't it be
prudent to be on course if there are research exemptions to
address those as the research guides us?
Mr. Chester. Yes. I appreciate your question, Doctor, and I
agree with your characterization of the threat, but not that we
are leaving the door open. I mean, the fundamental element of
this particular proposal is to gather these substances up and
bring them under control, substances not even yet created. And
I think that is the important aspect of this is that we are
permanently scheduling these substances as Schedule I until the
research community has the ability to access them and determine
their proper place in the scheduling regime.
Mr. Joyce. I thank you all for being here today. I thank
Chair Eshoo and Ranking Member Guthrie. This is informative,
and this is an important hearing to have. Again, I want to
state my grave concerns that the Department of Justice refused
to participate in this hearing today. Thank you, and I yield.
Ms. Eshoo. Thank you, Doctor. Always a gentleman.
The Chair is happy to recognize the gentlewoman from
Michigan, Mrs. Dingell, for her 5 minutes of questions.
Mrs. Dingell. Thank you, Madam Chair. I would also like to
thank our witnesses for being here today and just telling you
how important this hearing is. Most of you know I lost my
sister to an opioid drug overdose, but in the last year, I also
lost a family member from fentanyl. And we all talk about the
southern border, but people don't talk about the fact that the
Canadian border is also a very dangerous source, and law
enforcement at the time told me about how deadly this is that
is coming in, and most of the people that are buying it have no
idea what is about to happen to them, and that is why it is so
important to continue this discussion.
These witnesses from the Justice Department should be here.
I do believe these people are murderers [inaudible] Which we
need to take that on. But it would be good to hear about
additional policies that the Biden administration is proposing
for addressing the opioid crisis. We all recognize that multi-
faceted problems require multi-faceted solutions with over
100,000 deaths in only a year period in this country, and
almost 3,000 just in Michigan. It is important we consider all
possible strategies to combat the crisis.
Mr. Chester, could you briefly summarize other avenues that
the Biden administration is pursuing to reduce overdose deaths,
particularly those around prevention, treatment, harm
reduction, and recovery services?
Mr. Chester. Yes, Congresswoman. Thank you very much. The
first thing is, you mentioned it, prevention, and that is
preventing drug use before it starts. The second one is
reducing barriers and access to treatment leading to long-term
recovery. And some of those we talked about earlier,
particularly extending into underserved populations, reducing
financial and other barriers to accessing treatment. But the
third thing is harm reduction. And I think it is critically
important that we remember that harm reduction is a critical
part of ensuring that individuals are not losing their lives to
overdose. And that is not only syringe service programs,
fentanyl test strips, which I know that have been spoken about
a lot in the press lately, but also access to Naloxone.
Naloxone is critically important as a harm reduction
intervention to make sure that we can ensure that Americans do
not lose their lives to opioid overdose. Thank you.
Mrs. Dingell. Let me build on that, Mr. Chester. A number
of States have adopted co-prescribing programs when a doctor
pairs an opioid prescription with a prescription of the
overdose reversal drug, like Naloxone. I can't talk today. Mr.
Chester, what role can increased utilization of co-prescribing
programs play in assisting with response to the opioid crisis?
Mr. Chester. Thank you for the question, Congresswoman, and
I know Congressman Sarbanes is also a supporter of co-
prescribing. What I can tell you is, and specifically about
ONDCP's role is, we look across the span of possible policies,
possible interventions, and those that could be extended across
the country that could be useful in co-prescribing is one of
those things that we have looked at and that we will
[inaudible].
Dr. Volkow. If I may interject. I am sorry. I apologize.
But I also think that the importance of science in counting the
fentanyl crisis should be highlighted because the reality is
being we are faced with a drug that we don't have so much
information to optimally reverse overdoses or to optimally
treatment. So, therefore, the importance, again, of doing
clinical research that will allow us to implement policies that
are more likely to be effective.
Mrs. Dingell. I think that's very important, and you--I
think it was you who spoke earlier about one of my biggest
bugaboos is that we do not have pain relievers that are not
addictive. We need to be investing in more pain reduction
medicines. I mean, it is a combination of reasons why people
are using these drugs.
And I do want to say that my colleague, Congressman French
Hill, and I are leading legislation, Preventing Overdoses and
Saving Lives Act, to provide State grants to encourage uptakes
of these programs which have proven effective in helping
address the opioid crisis.
I was going to ask you all more questions, but I have 30
seconds left, so I won't. I will yield back, Madam Chair, but I
will have additional questions for the panel, especially on
what they think we should be considering in the policies to
reduce overdose deaths. Thank you, and I yield back my time.
Ms. Eshoo. The gentlewoman yields back.
I think all members are going to be heard from in terms of
detailed questions to our witnesses because there is so much
to--more to be learned and questions answered, so we will be
doing deep dives on that.
The Chair is pleased to recognize the gentleman from Texas,
Mr. Crenshaw, for 5 minutes.
Mr. Crenshaw. Thank you, Madam Chair. Thank you all for
being here. It is an important topic, and I think it has a lot
of potential for bipartisan agreement and policymaking.
I want to start--I want to try and understand the mandatory
minimum policy by the administration and understand what the
intent is, and maybe get at what some of the repercussions are.
So the administration--Mr. Chester, this is for you. The
administration supports mandatory minimums for cases where
death or serious bodily injury can be directly linked to the
fentanyl analog that was trafficked. I understand where we are
going with this. You don't want to put people in jail just
because they are a drug addict, but you do want to put the drug
dealers in jail.
Now, the problem is, why support this standard rather than
a standard that would get at the serious trafficking cases,
because these are notoriously hard to prove, for prosecutors to
prove that this overdose was directly linked via intent and the
substance to this dealer. They are having a very hard time
prosecuting that.
Mr. Chester. Thank you for your question, Congressman. I
will give you the policy aspect of it, but I would like to
defer to the Department of Justice. And I know that they have
submitted a statement for the record on this particular. I am
kind of the arcana of it as well, but I will tell you, you
asked the question, where we were coming from on this, and so I
want to make sure that we are clear.
I would make a different distinction than the one that you
made between the trafficker, and actually, the user and make a
distinction, actually, among--upon the substance itself. And so
you mentioned fentanyl analogs. Those fentanyl analogs that
have been identified and have been tested, those are Schedule
I. They have been placed in the scheduling regime. That is not
what we are talking about.
What we are talking about is we have gathered up an entire
class of substances, uncreated, that within that class of
substance, there may be substances that either have medical
merit, or are not the least bit harmful. They are not any more
harmful than water.
So the question is, what do you do with those particular
cases where an individual has been convicted of a substance
that is only within Schedule I by virtue of its class
scheduling? That is why that particular guardrail was put in.
Mr. Crenshaw. OK. And maybe if DOJ was here, we would ask
them what we could do to make it easier to prosecute drug
dealers with bad intent that are dealing fentanyl that is
killing people. I mean, I am just going to simplify what we are
trying to get at, and this seems to get in the way of it.
On a separate note, the administration talks about harm
reduction as a method to deal with this crisis. San Francisco,
Philadelphia, New York City, they are promoting harm reduction
programs. They had great success in mitigating opioid abuse,
more so than cities that have just cracked down harder on
illegal drug use. And what does the literature say on safe
injection sites? Are these workable solutions or not?
Mr. Chester. I can get you an exact answer on kind of the
science behind safe injection sites. And, in fact, I could turn
it over to Dr. Volkow. I will tell you in broader terms, when
it comes to harm reduction, it is saving people's lives and
preventing them from overdosing to drugs. That is kind of one
element.
The second element of that is it is the first step on the
road, hopefully, to treatment leading to long-term recovery.
That is ultimately the goal, but when it comes to the science
behind safe injection sites, Dr. Volkow, if you would like to
add something.
Mr. Crenshaw. Quickly, please, because I have another thing
I want to hit.
Dr. Volkow. Yes. We have done research in other countries
but not in the United States, and from that research, it has
actually mitigated some of the adverse effects of drug use,
including HIV, hepatitis C, and overdoses, but we need to test
these in our country.
Mr. Crenshaw. I understand. And thank you for being here.
Thank you for your answers. I do want to point out something.
When it comes to the opioid crisis and 100,000 deaths in the
past year, we can talk about mandatory minimums. We can talk
about harm reduction. And these things are very important to
talk about, but we wouldn't have to be talking about those
things if there was no fentanyl in the system in the first
place.
Now, we are lucky in a sense because we know where it is
coming from, all right? The Chinese supplies the chemicals, and
the Mexican drug cartels are pushing it across our southern
border. I say we are lucky to know that, because it allows us
to focus on something. It allows us to focus on the source of
the problem, which is an open southern border, where our drug
cartels are simultaneously shoving hundreds of people at a time
across the border to tie up border patrol.
Meanwhile, border patrol is not actually patrolling the
border, and the drug cartels can put their drugs through the
gaps in our border. And then they come here, and we seize
hundreds and hundreds of pounds of fentanyl, which can kill
tens of millions of Americans. We seize that on a regular
basis. I would like to submit for the record from Operation
Lone Star these statistics from Texas, specifically, and I
yield back. Thank you.
[The information follows:]******** COMMITTEE INSERT
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Ms. Eshoo. The gentleman yields back.
The Chair recognizes the gentlewoman from New Hampshire,
Ms. Kuster, for your 5 minutes of questions. Are you there, Ms.
Kuster? Going, going, gone.
The Chair recognizes the gentlewoman from Illinois, Ms.
Kelly.
Ms. Kuster. I am here.
Ms. Eshoo. Are you there?
Ms. Kuster. I am here. I apologize.
Ms. Eshoo. OK. Well, you are recognized.
Ms. Kuster. I am so sorry. I apologize. Thank you so much.
Delighted to be here today to discuss the administration's
recommendations on combating the fentanyl overdose epidemic.
And I want to submit for the record a letter from over 150
advocacy groups and public health professionals in support of
bipartisan legislation that I have introduced with
Congresswoman Blunt Rochester to address the fentanyl overdose
crisis. It is called the Stop fentanyl Act, and I hope our
colleagues on both sides of the aisle will join us.
In New Hampshire, we saw very early on the devastation of
this addiction epidemic. What began in the doctor's office with
overprescribing pain medication evolved into a full-blown
opioid epidemic that could literally be tracked along our
highway map. Communities hooked on pills, they were prescribed
by doctors, were inundated with less costly alternative, first
heroin, and now other drugs and substances. Today, this
epidemic continues to evolve with stronger, more dangerous
synthetic opioids, like fentanyl and fentanyl-related
substances. And what makes this even more concerning is that
oftentimes, these lethal synthetic opioids are laced into other
drugs, unbeknownst to the person struggling with addiction.
Since coming to Congress, I have worked tirelessly with my
colleagues on the bipartisan Addiction and Mental Health Task
Force, and on this committee, to help those with substance use
disorder, but our work continues. As many have already pointed
out, just this past year, over 100,000 Americans have died of
drug overdose, but that number does not begin to capture the
many other overdoses that have occurred during the pandemic.
I want to turn my attention to a comprehensive, holistic
approach to ending this epidemic, one that invests in public
health treatment, in prevention, and in support for those
battling with substance use disorders. I want to focus on the
interagency working group, examine and developing its
recommendations on scheduling fentanyl. As policymakers, one of
the challenges in keeping up with the pace of the overdose
epidemic is working with lagging data from different sources
that is not integrated in a readily available way, and we have
focused on this in the Stop fentanyl Act.
Mr. Chester, the COVID pandemic has shown the value in
real-time data. We know the number of deaths the next day and
we wait--yet, we wait months for overdose data and critical
information on the synthetic opioids. How can we better access
data in both public safety and public health?
Mr. Chester. Thank you, Congresswoman, for the question.
And, you know, we agree. Data is the key to understanding the
environment the best that we can, understanding where our
vulnerabilities are, and being able to come up with policies in
order to close those vulnerabilities. We are better than we
used to be in data. Particularly, the National Center for
Health Statistics within CDC now has the provisional data which
is much--which we get on a quarterly basis, and is much faster
than the data we got before previously, and that has been very
important.
The second thing that we do is we stay very much in touch
with our State, local, and Tribal partners who can feed us
bottoms up data. Although you can't extrapolate it across the
country, it gives us a sense for our understanding of what the
environment is like.
And then the third one is to listen to the Congress. And
the Congress, over the years, has been clear about what it is
looking for in terms of this particular legislative proposal,
and that was helpful in allowing the Departments of Justice and
HHS to be able to shape what you have--what we have here. But
we don't disagree with the fact that we have some gaps on data,
and it is an area that we need to work pretty heavily.
Ms. Kuster. OK. Thank you. I am going to ask this last
question with Mr. Chester and Dr. Throckmorton. A key priority
of mine and the administration is increasing resources for harm
reduction. Can you tell us what more can be done at the FDA
perspective to make Naloxone more accessible?
Mr. Chester. I can start off, and then I will turn it over
to Dr. Throckmorton. We know that Naloxone is incredibly
effective at preventing overdoses and saving lives and that
increasing Naloxone availability across the country is one of
the critical elements of harm reduction under the first-year
priorities under the Biden-Harris administration. But I will
turn it over to Doug.
Dr. Throckmorton. Yes. Thank you very much. I could not
agree more. One of FDA's highest priorities is expanding the
formulations, the available types of Naloxone that people can
make use of. Just recently, we approved a higher dose
formulation of Naloxone to make available for people that might
use it. We believe we have recently started and continue to
support----
Ms. Kuster. I am going to have to take your response for
the record. My time is well up, and I will yield back.
Dr. Throckmorton. Happy to, ma'am. Thank you.
Ms. Eshoo. It has expired.
The Chair is more than pleased to yield to the gentlewoman
from Illinois, Ms. Kelly, for your 5 minutes.
Ms. Kelly. Thank you, Madam Chair, and Ranking Member
Guthrie, for holding this important hearing to curb the opioid
crisis in this country. Unfortunately, overdose deaths were
beginning to rise even before the pandemic. I know we have
talked a lot about that. And Black and Brown communities are
experiencing the fastest increased rates of overdose deaths
involving synthetic opioids.
I continue to be concerned about using the criminal justice
system to address a public health issue. I worry about the
impact this will have on the very communities that are
suffering in silence without the sympathy of the media and of
society at large. We need to make sure that we are taking a
deep look at how this proposal to move fentanyl-related
substances to Schedule I may perpetuate the existing racial
disparities in our criminal justice system.
Mr. Chester, what is the evidence that increasing criminal
penalties of fentanyl-related substances will actually reduce
drug-related mortality and morbidity, particularly among Black
and Brown communities?
Mr. Chester. Thank you, ma'am. I would offer you this, that
we are--that what we are not doing is increasing criminal
penalties, but rather, gathering up a class of substances and
placing them in Schedule I, and I think it is an important
distinction. And so I appreciate your question, but what we--we
are not increasing penalties, we are taking substances that are
dangerous substances as part of a class of dangerous substances
and placing them in Schedule I, not increasing penalties.
Ms. Kelly. OK. As fentanyl-related substances are
increasingly criminalized, this may increase the development of
new synthetic opioids. How does ONDCP plan to address this to
avoid a whack-a-mole approach to regulating harmful synthetic
opioids?
Mr. Chester. Thank you, Congresswoman. You used the exact
right word. I think you characterized it perfectly, whack-a-
mole, right? So we have got to--we have to ensure that that is
not what we are doing. I think we need to understand a few
things. The first one is, it is clear that when we take an
action, drug traffickers change their behavior. It is almost
impossible to get ahead of that, but at least we can close the
gap. This particular action, class scheduling, was done for the
exact reason that you just mentioned. So we were in a situation
in the past--and by the way, we asked the Chinese Government to
do this as well, and they did. We were in a situation in the
past where we would detect a fentanyl analog in the United
States. We knew it came from China. We would go to the Chinese
and say, please hold somebody accountable, and they would say,
it is not illegal in my country, but we would be glad to do
that. And by the time it was made illegal in China, and they
were very cooperative on this, the traffickers had already
moved to another substance. That necessitates class scheduling.
So, you know, in my oral statement when I said that they are
creating these substances faster than we can schedule them
individually, it is exactly the situation that you are talking
about.
Ms. Kelly. Thanks. I just want to make sure that Congress
is taking a holistic approach to tackling this epidemic which
includes investing significantly in prevention, treatment, and
recovery also. This committee has heard from the research
community that current research requirements under the
Controlled Substance Act take significant time and effort to
obtain. One of the criticisms of placing substances in Schedule
I is the chilling effect that may have on research of those
substances.
Dr. Volkow, the administration's fentanyl-related
substances proposal seeks to establish a simplified process
that would align research registration for all Schedule I
substances more closely with the research registration process
for Schedule 2 substances. Can you explain the difference
between the two processes?
Dr. Volkow. Yes. And this will make it, basically the
proposal to do research on Schedule I equivalent to doing
research on Schedule 2. And it eliminates the need of an extra
review of the proposal of the researcher which is not necessary
for Schedule 2, but it is Schedule I. And that takes time and
is much more lengthy, so it will facilitate that in addition to
other provisions that will make it easier for researchers to
actually perform their work. So with these in advance, and we
are excited and supportive of this proposal.
Ms. Kelly. Thank you so much. Research is essential for
understanding the opioid epidemic, identifying effective
solutions, and informing our policymaking, and it is critical
that we ensure that no barriers to this type of research exist.
So thank you so much, and thank you to all the witnesses. I
yield back.
Ms. Eshoo. I am going to recognize the gentlewoman from
California, Ms. Barragan, but I also want to say before she
begins her questioning, that we have votes on the floor. We
still have several members that are in the queue to ask their
question of the witnesses. So I think the good news for the
witnesses is you are going to get a break for at least 45
minutes, and the downside is that we are going to be back after
that 45 minutes to finish out our hearing by allowing all
members who wish to question the time to do so.
So, with that, I recognize the gentlewoman from California,
Ms. Barragan, for your 5 minutes of questions, and then we will
recess after her questions for 45 minutes.
Ms. Barragan. Thank you, Madam Chair.
Ms. Eshoo. You are recognized.
Ms. Barragan. Thank you, Madam Chair. I am glad that we are
here today to discuss legislation that will hopefully allow us
to stem the overdose epidemic that has taken far too many lives
too soon. I want to thank all of our witnesses today for your
testimony.
In Los Angeles County and across the country, we are seeing
an unprecedented humanitarian crisis of people experiencing
homelessness that requires a compassionate, thoughtful public
health response. According to the Los Angeles County Department
of Public Health, between 2 and 2019, people experiencing
homelessness in L.A. County were more than 36 times more likely
to die of a drug overdose compared to the general L.A. County
population.
Drug overdose deaths involving fentanyl tripled between
2018 and 2020. And drug overdose remains the primary cause of
death for people experiencing homelessness in L.A. County.
Comprehensive drug policy aimed at reducing harm caused by
fentanyl-related substances must include an integrated public
health approach and investments in infrastructure that
addresses upstream social determinants of health.
This question is for Mr. Chester. Can you discuss
strategies the Office of National Drug Control Policy are
working on to tackle social factors, like homelessness, that
exacerbate illicit fentanyl-related substance overdoses among
the more than 500,000 people experiencing homelessness in our
country?
Mr. Chester. Yes. Thank you, Congresswoman, for that
question. I think you have brought up a very important point.
The first thing I would like to say is that evidence-based
prevention and prevention strategies are a key part of the
first-year priorities that the office has laid out for the
Biden-Harris administration when it comes to drug policy.
The second thing I will tell you is that the social
determinants of drug use are an important part of our academic
understanding of what it is that leads to the initiation of
drug use in the first place, and that is one of the key areas
that the office will be working on in the coming year in order
to reduce overall drug use around the country.
And as we say, and we have talked about it several times
today, there is absolutely a direct linkage among the fentanyl-
related substances that are available in our communities, their
trafficking, and their use in our communities, and, therefore,
overdose deaths. You can't pull one of those strands apart. You
need to be able to deal with it in a comprehensive and holistic
fashion, and that is the approach that we have taken.
Ms. Barragan. Thank you.
Dr. Volkow, in Los Angeles County, there was a 52 percent
increase in accidental drug overdose deaths, and a 136.4
percent increase in the number of fentanyl-related death rates
during the first ten months of the pandemic compared to the
same period in 2019. This alarming uptick of deaths is
disproportionately affecting people of color. How can improving
research with fentanyl-related substances help us address the
opioid overdose crisis and combat drug overdose deaths within
highly populated urban areas, particularly among people of
color?
Dr. Volkow. First of all, I think that--and we resonate
completely with you about the question about the social
determinants of health, because they do pertain very much about
why you are seeing such a dramatic increase in overdose
mortality during the COVID pandemic, and why it is affecting
some populations that were vulnerable to start with more than
others.
Understanding the processes and the challenges of people
that are homeless, for example, is crucial for providing
solutions. Without it, about people that don't have a place to
sleep cannot sustain treatment, nor can they actually, when
they go to jail, get exposed to others taking drugs. So
understanding the social and cultural factors that have been
exacerbated during the pandemic, including the uncertainties
and the social isolation, is crucial for containing the
epidemic that we are seeing.
In terms of how the fentanyl research can help us,
basically be better able to do treatment and prevention is,
first of all, we need to understand what are the
characteristics of the use of the substances, who is using
them, how they are combining them. We need to also understand
actually how to optimally, as I mentioned before, reverse them
because Naloxone is not effective in all of the reversals.
And third, how do we optimally not just initiate people on
treatment for their opioid use disorder, but retain them on
treatment so they can recover, and we can prevent an overdose.
That requires that we work with--that researchers get their
hands on working with fentanyl, so that they can develop animal
models. They can actually develop new products, new ways of
testing it, new ways of being able to document where people are
dying from what so you can test rapidly right away as opposed
to waiting months. So these are just some of the examples.
Ms. Barragan. Thank you so much, Doctor. I am out of time.
With that, I yield back.
Ms. Eshoo. The gentlewoman yields back. We will now recess
for 45 minutes, why don't we say 50 minutes. The Ranking Member
and myself will race back after the third--after we cast our
third vote, and the witnesses take a break. I think that there
you will find a cafeteria and whatever downstairs here in the
Rayburn building. Thank you.
I am sorry we couldn't conclude before votes, but we have--
you are an all-star cast with just one department missing. But
you can see that there is very deep, broad interest in this
issue, and you are the experts, and we want to make sure that
everyone be able--is able to question. So we will be back at
2:15.
[Recess.]
Ms. Eshoo. All right. The subcommittee will come back to
order.
The Chair is pleased to recognize the gentleman from Utah,
Mr. Curtis, for your 5 minutes of questions.
Mr. Curtis. I am so grateful, Madam Chair, to yourself and
our Ranking Member and our witnesses. Obviously a very
important hearing.
I feel like, if I am honest, compared to our witnesses and
other members of the committee, that I actually knew very
little about fentanyl when this hearing was called, and I
decided to go on a fact-finding mission to learn how fentanyl
was impacting Utahans directly.
It won't surprise you that I was shocked by the facts about
fentanyl, particularly its use in Utah and the personal story
of Utahans.
According to the Utah Highway Patrol, in Utah there has
been a 900 percent increase in fentanyl seizures in the first
three months of this year compared to the entire last year. It
is 900 percent more in three months than in the entire last
year.
The number of overdose deaths involving fentanyl in Utah
doubled from 2019 to 2020. And the largest percentage increase
in fentanyl deaths--won't surprise you--was 18 to 24, followed
by 25- to 34-year-olds.
Obviously this is an increasing risk to our communities
that needs local government, State government, and Federal
Government, all hands on deck, everybody working together.
I also spent time with a coalition of entities fighting
fentanyl addiction, including the Utah Attorney General's
Office Overdose Strategic Response Team, DEA, and the Utah
State Bureau of Investigation's drug recognition experts.
Additionally, I put out word to my district that I would
like to hear their stories, and within 24 hours I was delivered
250 personal stories of the way these families have been
impacted.
Every one of these stories will break your heart. Every one
of these stories represents not just an individual, but family
and their network. And I think it has been said earlier today
that it would be hard to find any one of us that hasn't been
impacted by this. And if you will indulge me, I would like to
read just a couple of quick parts of two of these stories.
``When my brother, Adam, was young, he was involved in an
accident that saw him severely burned. The hospital prescribed
him what turned out to be a highly addictive opioid, and for
years afterwards he struggled with addiction, going in and out
of rehab for alcohol, marijuana, and eventually heroin.
``In the fall of 2013, he enrolled in Utah Valley
University after completing rehab with plans to get a degree in
construction management.
``I remember the night of that September the 21st and what
happened afterwards in a blur. I remember getting a call from
my mom that night. I remember lowering my brother's coffin into
the ground. I remember feeling numb for months. And, worst of
all, I remember feeling ashamed of what my brother did.
``Nothing can turn back what happened to my brother, but I
hope that we can talk more openly about addiction, opioid use,
and the deadly influx of fentanyl into our country. Addiction
doesn't discriminate, and the first step to solving this
problem is talking about it. Thank you for taking that step.''
Next story.
``I am a recovering heroin addict where my addiction began
with prescription opioids at age 13. I suffered a dislocated
knee and was prescribed Percocet and other prescription opioids
for ongoing knee injuries.
``My story isn't going out of the norm. By age 18, I was
addicted to heroin and went through overdose, ambulance rides,
being homeless, induced with a coma, went through immense
trauma, put my family through more turmoil than any family
should endure.
``In 2013, I went through treatment and have been sober
since. But the story far from ends there. In 2015, I lost my
older brother to a heroin overdose. And his story isn't out of
the norm. His story is mine. It is all of ours.
``We feel like enigmas in our society that has made us into
a taboo, when in reality every family and community is affected
by this. It is a societal norm that no one talks about.
``Currently, I work as a program director and utilization
review specialist for a residential and outpatient substance
abuse and mental health treatment facility in Utah County where
I can work on breaking the stigma against this in other
recovering addicts.''
A couple of questions.
Mr. Milione, Deputy Administrator, I learned that fentanyl
can be prescribed, but most of the fentanyl in Utah is
illegally produced, I was told as much as 90 percent of it
related to substances or analogues that are being distributed
through illicit channels.
As you know, the 5-year mandatory minimum for illicit
fentanyl is 40 grams, but one gram of illicit fentanyl can
potentially contain 500 lethal doses. That is 500 potentially
dead people.
Fentanyl-related substances can be even more deadly. A
Department of Justice official from the prior administration
testified before the Senate Judiciary Committee that the
current quantity thresholds necessary to trigger mandatory
minimum penalties for fentanyl and fentanyl analogues are
extremely out of date and inadequate.
Given what we know about the tremendous potency, toxicity,
and harm associated with these substances, do you agree?
Mr. Milione. Congressman, thank you for sharing those
letters. We get those letters also. And, yes, members of the
DEA have lost loved ones also, myself included. It is a
challenge. It is a terrible thing. And that is why we are
focused on trying to help those that are being harmed by this,
going after those that are harming the community.
As far as the mandatory minimums, we are a law enforcement
agency. Our mandate is to go after those that are harming the
community, those that are flooding the country. That is where
we focus. We work with our prosecutorial partners. And judges,
working with the construct that Congress has provided them,
will dole out sentences.
Mr. Curtis. Dr. Throckmorton, I understand the Biden
proposal includes a streamlined process for rescheduling
fentanyl analogues, but when considering the potentially
dangerous nature of these substances why should we not go
through the eight-factor analysis to ensure due diligence? Why
are we rushing this?
Dr. Throckmorton. It is a really good question.
I don't think we are rushing it. I don't think the proposal
does that. I think the proposal identifies appropriately the
pharmacology----
Mr. Curtis. I am going to run out of time, so I just want
to----
Mr. Throckmorton. Thank you.
Mr. Curtis. One more quick. Is there precedence for this?
Dr. Throckmorton. Is there precedence for decontrol?
Mr. Curtis. For skipping the eight-factor analysis and just
using one factor?
Dr. Throckmorton. I am not familiar with the precedent that
would be exactly the same as what is proposed under this
proposal. Normally we would go through the full----
Mr. Curtis. And I apologize. Unfortunately, I am out of
time. I would love to let you explore that a little bit more.
But, Madam Chair, I yield my time.
Dr. Throckmorton. Happy to help.
Ms. Eshoo. Gentleman yields back.
The Chair now recognizes the gentlewoman from Delaware, Ms.
Blunt Rochester, for your 5 minutes of questions.
Ms. Blunt Rochester. Thank you so much, Madam Chairwoman,
for the recognition.
And thank you to our witnesses for being here today to
discuss the Biden administration's interagency proposal to
reduce illicit fentanyl drug substances.
Like my colleagues, I have heard from parents, small
businesses, State officials, and even children about the
devastation that illicit fentanyl has inflicted on Delaware
communities and families.
In 2020, more than 80 percent of the overdose deaths in
Delaware involved fentanyl, and provisional data from 2021
suggests that we may be on track for another record-breaking
year.
This underscores how important it is that we get these
policies right. And the last time that the Acting Director of
the Office of National Drug Control Policy was before this
committee, I highlighted my concerns on previous approaches to
drug control that were rooted in stigma and punishment and not
public health.
And as a result, Congresswoman Kuster and I introduced the
STOP fentanyl Act, a comprehensive package of public health
policies to address the proliferation of synthetic opioids like
fentanyl-related substances.
I want to thank the witnesses who have provided feedback on
our bill and hope that we continue to work together.
Mr. Milione, in 2020 we tragically lost over 93,000 people
to drug overdoses. Based on the most updated data you have, can
you tell us how many overdose deaths were caused, not just
present, but caused by fentanyl-related substances?
Ms. Eshoo. Can you use your microphone, please?
Mr. Milione. I apologize.
Ms. Eshoo. That is all right.
Mr. Milione. Thank you for the question.
I believe that the number is 70,000 of the 100,000, but I
would want to confirm with the colleagues on the panel. But it
is a massive number. The vast majority are attributed to the
fentanyl overdose deaths.
Ms. Blunt Rochester. And does the DEA have surveillance
systems in place to understand how many overdose deaths are
attributed to fentanyl and illicitly manufactured fentanyl,
including fentanyl analogues and related substances?
Mr. Milione. We work--we do work with our interagency
partners to try to collect that information. There is always
more to do in those partnerships across the health community
and with the science community.
So we are moving in that direction with our current
Administrator, Anne Milgram, who is very much focused in those
heat maps and how better to understand where the threats are.
Ms. Blunt Rochester. Great. Thank you.
And, Dr. Throckmorton, has the United States ever
implemented a classwide schedule based solely on structure of a
substance?
Dr. Throckmorton. Thank you.
Yes, we have. The best recent example would be the
androgenic steroids, which are scheduled as a class based on
structure.
Ms. Blunt Rochester. And is it possible to tell if a
substance would lead to opioid-related harms by just looking at
the structure?
Dr. Throckmorton. Thank you.
No, it is absolutely not possible to do that yet. Structure
gives us one piece, and it is an important piece. We think it
is sufficient to identify compounds at high risk of being
dangerous substances in the FRS class.
But that is why we are recommending the potential for using
other testing, the pharmacologic testing that we are proposing
in the Biden administration proposal, because we believe that
those kinds of data are necessary to fully understand whether a
product is going to be dangerous or whether, in fact, it is
less dangerous or not dangerous at all and should be eligible
for research more easily.
Thanks.
Ms. Blunt Rochester. And a structural definition of
fentanyl-related substances could potentially classify
thousands of substances as Schedule I drugs under the
Controlled Substances Act without knowing whether they are
addictive or have potential medical use.
What are the consequences of that?
Dr. Throckmorton. Well, I share your concern, but I think
the proposal, as it is laid out, addresses that in the right
balance. It recognizes the emergency that we face with this
class of dangerous compounds, uses a structure-based mechanism
to place them under control so that the DEA can make sure that
they are not available, but then also puts in place a mechanism
to remove them quickly from that scheduling if the data show
that they are not dangerous.
I think that balance really is the right approach to take
here. It affords the greatest public health protection while
still protecting the need to be able to support the research of
compounds that are not like oxycodone, that are not like
fentanyl, that have less danger.
Ms. Blunt Rochester. Right. And could potentially--maybe
there is some kind of cure or thing that we could use like
Naloxone or other things.
Mr. Chester, representatives from the criminal justice and
civil rights communities believe that a classwide scheduling
would remove the prosecutorial burden to prove that a substance
has a psychoactive effect similar to fentanyl. And I know that
my time is up, so if maybe, as a follow-up, if we could comment
on that concern.
And I don't know, Madam Chair. I think we have votes.
So I am going to ask if you could submit that in writing to
us. And I am going to say thank you so much for your answers.
And I yield back my time.
Ms. Eshoo. The gentlewoman yields back. And just make sure
that you submit that last question in writing so that it is
actually seen and not have to be--don't rely on me to repeat
it.
Ms. Blunt Rochester. Thank you, Madam Chair.
Ms. Eshoo. We want everyone's questions answered.
No Republicans?
The Chair is very pleased to recognize, last but not least,
the gentlewoman from Minnesota, Ms. Craig, for her 5 minutes of
questions. Great to see you.
Ms. Craig. Great. Thank you so much, Madam Chair. And thank
you, in particular, for calling this really important hearing.
Clearly the fentanyl and opioid crisis remains one of the
defining public health challenges of our time.
I want to dig in a little further on the focus of the
administration's proposal on fentanyl-related substances and
clarify how they are distinct from other controlled substances.
The opioid epidemic has been described in really three
waves. When it began, overdose deaths were mostly due to
prescription opioid pills. Then heroin-related overdose started
rising. Now, synthetic opioids, such as fentanyl, are
responsible for the majority of overdose deaths. This wave is
causing more deaths than ever.
In September, the DEA issued a public safety alert on the
unprecedented amount of fentanyl-laced counterfeit prescription
pills in circulation. By midyear, the Minnesota Department of
Public Safety had already seized 23,000 pills, a dramatic
increase over the previous year.
These fake pills are often sold through social media
platforms to people who think they are purchasing painkillers.
That is what happened to a young man from my district, Devin,
who died from an accidental overdose last year after he took a
pill that he bought on Snapchat.
Devin's birthday is December 19. This year, he would have
turned 21 years old. Like too many others, Devin should still
be with us.
I look forward to working with my colleagues and the
administration on crafting an effective and humane strategy to
deal with the scourge of fentanyl and fentanyl-related
substances.
As we confront the challenges that synthetic opioids pose,
it is important that we understand these substances as we
consider how to regulate them most effectively.
In Mr. Chester's testimony, he noted that based on
substances seized and identified by CBP, partner forensic
laboratories, and international labs, it may be possible to
synthesize as many as 48,000 fentanyl analogues with relatively
simple modifications.
Can you explain in layman's terms why it is relatively
simple to manufacture and produce these fentanyl-related
substances?
Mr. Chester. Yes, Congresswoman. Thank you very much.
And I may have misspoke earlier. That is 4,800 substances.
Ms. Craig. OK.
Mr. Chester. Yes. So, in layman's terms, which I am not a
chemist and so I have chemists who explain this to me in
simplistic terms, what you are talking about is a base fentanyl
molecule that has four distinct rings on it, and then other
molecules that are attached to it. And so you can make an
addition to that skeleton or a substitution, substitute one
chemical for another.
That causes an alteration in the chemical itself that turns
it into a fentanyl analogue or ultimately a fentanyl-related
substance. And that is the basic chemistry of how these things
are altered. Although I could turn it over to Dr. Volkow or Dr.
Throckmorton for probably a bit of a more sophisticated
examination.
Ms. Craig. Dr. Volkow, any other comments on that?
Dr. Volkow. Well, it basically does identify with the
advances that we have actually done in chemistry, so now we can
modify molecules in ways that were unprecedented, and we could
use it for good or for nefarious purposes, as is the case for
the drug dealers.
Unfortunately, technology is not just in the hands of those
that want to do healthcare intervention. So there is an
enormous amount of innovation in the chemistry side. And that
is why I said before these synthetic drugs are here to stay,
because they are tailored and manufactured to get extremely
addictive and toxic compounds and very, very profitable.
Ms. Craig. Yes. Thank you so much.
Mr. Milione, the Federal Analogue Act allows for substances
that are chemically similar to a Schedule I or II substance to
be treated as if it were listed in Schedule I. Some have
suggested that we should instead utilize the authorities under
the Federal Analogue Act to control fentanyl-related
substances.
Was this considered during the intra-agency conversations?
And, if so, why does the administration's proposal not take
that approach?
Mr. Milione. With the massive amount of fentanyl that is
coming in, the fentanyl-related substances that are flooding
the country, and the risk that it poses to all of the members
of our community we need a proactive response, and the most
certain way to do that is to keep everything scheduled so that
we can seize it before it comes in and deal with it when we
encounter it in our communities.
The Analogue Act has some parts of it that are very
reactive and very cumbersome, and it doesn't meet the current
threat sophisticated drug traffickers and the threat that the
fentanyl substances pose.
Ms. Craig. Thank you so much for that answer.
And with that, Madam Chair, it looks like I am out of time.
So thank you all for testifying today. It is certainly an
issue we all have to be engaged and work on together.
Madam Chair, I yield back.
Ms. Eshoo. The gentlewoman yields back.
Mr. McKinley has joined us, but I am told that, because you
are waiving on, I need to take the Democrats first.
Mr. McKinley. Yes, that is fine.
Ms. Eshoo. All right. So the Chair recognizes Dr. Schrier
of Washington State for your 5 minutes of questions.
Ms. Schrier. Thank you, Madam Chair.
And thank you to our witnesses today.
This is such an important issue. I am listening to all my
colleagues, and it clearly affects every community. And I think
about 100,000 people lost just in the last year from opioid
overdoses, mostly from fentanyl.
And I am so glad to see the Biden-Harris administration
working across all of these agencies to find solutions, curb
demand, crack down on traffickers, and save lives.
In my home State of Washington, like every other State,
fentanyl has had a profound and devastating impact. In 2020,
there were 672 deaths involving synthetic opioids, fentanyl,
and fentanyl analogues, which is double the number we saw in
the year before.
And just for perspective, 672 compared with 3,700 people
who have died from COVID in Washington State in 2020. And there
has been a massive effort to manage the pandemic, and we really
need a proportionate response to take on the challenge of
fentanyl and similar compounds.
I have to tell you this hit way too close to home in 2019
when three high school students in King County ingested
fentanyl-laced pills. They had no idea what it was, like all of
these stories, and they died. Two of those were at my
community's high school, the one my son will attend.
So this issue is very personal, just like it is for so many
of you, and we need to ensure that less of this is imported and
it is not accessible.
Mr. Chester, given your background in international drug
policy, can you explain briefly, just in plain language, the
impact this proposal would have on the prosecution of fentanyl-
related substance importation and exportation offenses and how
these penalties differ from those corresponding to the
importation or export of fentanyl?
Mr. Chester. Thank you very much, Doctor, for the question.
And the first thing is, and I think one of the most elegant
things about this solution, is there would be no difference
between fentanyl-related substances and fentanyl itself,
because they would both be Schedule I drugs, with the exception
of prescription fentanyl, which is Schedule II. But talking
about illicit fentanyl, so there is no difference between a
fentanyl-related substance and an illicitly produced fentanyl
substance.
When you talk about the international side of the house, I
am glad you asked that question, because the----
Ms. Schrier. Can you----
Mr. Chester. Yes, ma'am. Go ahead.
Ms. Schrier. Well, I was just going to say thank you for
clarifying that.
Can you tell me how this might impact international affairs
with China and other countries?
Mr. Chester. Excellent question.
The issue of fentanyl and synthetic opioids is not a U.S.-
only problem. It is a global problem. And the United States is
a global leader on this issue. And for better or worse, we are
global leaders in the issues of addiction medicine and
understanding the opioid crisis and all of the things that we
have been through as a Nation over the last decade or so on
this, and other countries look to us for our leadership.
We went to the Chinese Government in 2018 and asked them if
they would schedule fentanyl as a class because they were the
preponderant source of these substances coming into the United
States and we wanted their help, and they did that. And when
they did that, it had a demonstrable effect on the amount of
fentanyl coming from China into the United States.
This action allows us to do two things. Number one, to meet
the Chinese requirement that we asked them to do in order to do
this. But, number two, to show other countries around the world
that the United States understands how difficult this is, can
come up with comprehensive, commonsense solutions, even in our
complicated government, in order to be able to get a handle on
this particular problem.
I think it is enormously helpful for our legitimacy around
the world in dealing with this problem.
Ms. Schrier. I agree. We lead, and others follow in
respect.
I have just a couple of quick questions. I am just going to
turn to Dr. Volkow for yours.
In my pediatrics residency--and I am dating myself--we used
fentanyl all the time for sedation and pain management, for
hospital procedures, and in the ICU, in drips and the like. And
I was just wondering if you could just clarify, can Morphine,
hydromorphone, some other opioid easily substitute for fentanyl
to fill all of those in-hospital medical uses? Are there any
things that fentanyl can do that nothing else can?
Ms. Eshoo. Your microphone, please.
Dr. Volkow. Sorry. I keep on doing this mistake.
Fentanyl is actually a very helpful pharmacological agent,
and it is used in anesthesia departments all around the United
States. So it enables, by combining it with anesthetic agents,
this allows you to decrease the amount of drug that you are
giving to subjects. Also, because of its short half-life, it
gives you the ability to bring them back rapidly.
So fentanyl, as a drug, has many advantages when used
properly and under supervised conditions. The problems become
when it is an illicit substance, and most of the drug that is
misused and leading to the overdoses is illicitly manufactured
fentanyl.
So I think that in understanding that a drug has potential
for negative actions with misuse, we cannot neither jeopardize
all of the potentially valuable things that fentanyl offers as
a pharmacological agent.
Ms. Schrier. Thank you. I appreciate that.
I yield back. I am out of time.
Ms. Eshoo. The gentlewoman yields back.
The Chair is pleased to recognize the gentlewoman from
Massachusetts, Mrs. Trahan, for your 5 minutes of questions.
Mrs. Trahan. Thank you, Madam Chair.
And thank you to the witnesses here today.
I really appreciate the administration's urgency to
properly address the opioid and overdose crises, especially the
COVID pandemic.
Unsurprisingly, since the temporary classwide scheduling of
fentanyl-related substances in 2018, offenses involving
fentanyl and fentanyl analogues have rapidly increased.
However, evidence also shows overdoses involving fentanyl
and analogues have drastically risen. The provisional data from
the CDC show that drug overdose deaths exceeded 100,000, as all
of my colleagues have mentioned today, from 2020 to April 2021,
the highest number of overdose deaths ever recorded in a 12-
month period.
Clearly more needs to be done to save lives, and Congress
must take the multipronged approach to pass policies that
experts say will work.
So in addition to the interagency proposal to address
fentanyl-related substances, the Biden administration recently
released an overdose prevention strategy which prioritizes
primary prevention and highlights the FDA's consideration of
mandatory prescriber education.
Ensuring that prescribers have a baseline knowledge of how
to prevent addiction and identify, treat, and manage patients
who have a substance use disorder is tremendously important. My
bipartisan bill, the Medication Access and Training Expansion
Act, requires prescribers to complete a one-time 8-hour
training on identifying, treating, and managing patients with a
substance use disorder.
In practice, the requirement is a minimal burden for
practicing physicians in most States, as many continuing
medical education requirements already include training
requirements for opioid prescribing and pain management. The
bill would simply result in addiction training being more
widely incorporated into CME programming for physicians.
So, Mr. Chester, could you provide an update on ONDCP's
work with medical schools to ensure adoption of a curriculum
that includes a focus on preventing addiction as well as
treating patients with a substance use disorder?
Mr. Chester. Yes, Congresswoman. I would be glad to.
One of the major points of emphasis in both the first-year
Biden-Harris administration priorities and one of the things
that Dr. Gupta has emphasized as well is building the addiction
treatment workforce.
I think there is an understanding that the addiction
treatment workforce that we have is being overwhelmed by the
subject that we are talking about today, which is this dynamic
nature of synthetic opioids, in that the need for treatment,
the need for quality treatment is so large that we need to
leverage more resources in order to be able to provide that.
And the second thing is that an addiction treatment
workforce that is not as large as it should be is a barrier in
and of itself, just like all of the other barriers that we have
discussed.
So reducing barriers to treatment, providing evidence-
based, quality treatment, and building the addiction treatment
workforce are three areas of big emphasis that Dr. Gupta has
had since he has shown up as the Director.
Mrs. Trahan. Great. And the MATE Act also reauthorizes the
practitioner education grant program established by SAMHSA,
which expands the integration of SUD education into the
standard curriculum of healthcare education programs.
And just last month, I had the opportunity to visit UMass
Medical School's substance abuse and mental health services
administration program, and they are already aligning with the
provisions in the MATE Act, and it is just critical for medical
schools across the country to build up its comprehensive
curriculum.
Again, Mr. Chester, could you just comment on the value of
practitioner education grant programs in mainstreaming SUD
education and expanding the number of practitioners who can
provide this high-quality, evidence-based treatment?
Mr. Chester. Thank you for that question.
As we just discussed, the ability for an individual who
clearly has--and we will just call it an opioid use disorder
now--who clearly has an opioid use disorder and clearly needs
to get access to treatment, the gap between their ability to be
able to identify for themselves that they need it and to be
able to get it is absolutely critical.
And into that gap one or two things can happen. Either the
treatment can be provided by the mainstreaming, as to what you
talk about, or, as we talked about earlier, the mobile vans for
OUD treatment or telemedicine, there is a whole series of
things that we could do in order to close that gap.
What is most important is that we ensure that the illicit
actors that we have talked about all day today who have these
substances available, they are not the ones that fill that gap
and serve as a barrier to keep a person from getting the
treatment that they need.
And that is why this particular proposal is important to
forestall the production and the movement of these substances
into the country. However, it is part of a more comprehensive
approach that we need to do to provide treatment leading to
long-term recovery for Americans who need it desperately.
Mrs. Trahan. Thank you for that.
I am out of time, Madam Chair. I yield back.
Ms. Eshoo. The gentlewoman yields back.
The Chair recognizes the gentlewoman from Illinois, Ms.
Schakowsky, who is waiving onto our subcommittee--and she often
does, and she is always welcome--for 5 minutes of questions.
Ms. Schakowsky. Thank you, Madam Chairman. As usual, I
thank you so much for allowing me to waive on.
I have a question both for Mr. Chester and also for Mr.
Milione. Here is my question. The interagency proposal and the
agencies themselves seem to agree that classwide scheduling
will inevitably lead to misclassification as Schedule I and
that some individuals could be wrongly prosecuted.
So here is my question. How are you addressing the
concerns--at least it is certainly my concern--to ensure that
we are not contributing to the mass incarceration crisis by
cause of inevitability, I think, of misclassification?
Mr. Chester. Yes, Congresswoman. I can start, and then I
can turn it over to our interagency partners here.
I don't know if we could say it inevitably will lead to
that, but we do know that there is some possibility that that
could be the case, because these are substances that have not
yet been examined yet, and so there is the case that, within
class scheduling, which is necessary to ensure public safety
because these are dangerous substances, there may be one that
gets scooped up that is ultimately not harmful.
So the question is, what do we do about that?
Ms. Schakowsky. Right.
Mr. Chester. And what we have done is two things.
The first one is to allow the colleagues that are at the
table with me here today to have an unprecedented level of
access to these substances, even though they are in Schedule I,
to have a streamlined process so that they can do the testing
on them and they can determine where they fall within the
scheduling regime and if they are, in fact, harmful or not.
In the case that something is scooped up and an individual
is convicted of that and it subsequently is determined that the
substance should be moved, either unscheduled or scheduled
down, then there are provisions in this to ensure that
individuals are not unduly harmed by that from a criminal
justice perspective.
And so, when we talk about this being a comprehensive
approach and being balanced, those are the elements that we use
in order to make sure that we don't do undue harm in our desire
to protect the American people.
But I can turn it over to Dr. Volkow.
Ms. Schakowsky. Before she does, so you are saying that
those provisions are already in there, that they are locked
into the provisions?
Mr. Chester. The researcher access, yes. Yes, ma'am,
absolutely.
Ms. Schakowsky. Yes. Well, let's go to Mr. Milione.
Mr. Milione. Thank you for the question.
Look, we believe that the administration's proposal will
allow us to protect the public and keep them safe from these
deadly drugs.
The challenge, the balance, as Mr. Chester managed, there
are proposals in here that will streamline access to research.
We have worked with the interagency. We are committed to
working with them to streamline where we can, consistent with
the CSA. But we have to balance that against these deadly
substances that are killing so many every day in our
communities.
Ms. Schakowsky. Well, thank you. That is really all I had.
But I just want to say we have lived through this, the war
on drugs. Obviously we want to protect the public. What we
don't want to do is to set up a process that is going to end up
with incarcerating people who really shouldn't be.
And I hope that this process of making sure that the drugs
that are classified or misclassified don't end up incarcerating
people that shouldn't be.
We have been there. We have done that. It was a really bad
mistake. And we want to make sure that there is really vigorous
oversight, investigation, and that it be timely, that we don't
have to go unlock jail doors of people that have been
misclassified.
So I will be watching for that, because we don't want to
repeat the mistakes of the past.
Thank you very much, Mr. Milione, and your answers.
Ms. Eshoo. Gentlewoman yields back.
The Chair is more than pleased to recognize the gentleman--
and that, he is--from West Virginia, Mr. McKinley, for your 5
minutes of questions.
Mr. McKinley. Thank you, Madam Chairman, for letting me
waive on, and thank you for the patience of your panel that
have been going on for hours here today.
My question. Unfortunately, during this COVID pandemic the
Nation, I think, has overlooked the opioid crisis. We took our
eye off the ball, as we have heard testimony all day how
overdoses have skyrocketed by 30 percent. We have experienced
such deadly numbers in West Virginia. We are the epicenter of
that.
No other industrialized nations have a drug crisis like we
have in America. Our death rates from overdoses are 50 times
higher than Japan, 33 times higher than Europe, and five times
higher than the U.K.
A hundred thousand people lost their lives last year.
Husbands have lost their wives. Wives have lost their husbands.
Parents have lost their children. We could go on and on with
this.
So I want to make sure I understand this. Let me get this
straight. The Biden administration's policy to combat this
overdose epidemic is to shorten sentences for fentanyl
traffickers? Seriously? This is your answer?
Come on, man. We can do better than this. Our communities
in States like West Virginia and New Hampshire and Delaware are
expecting something far better than that kind of response.
So, Dr. Volkow, you have probably more experience in the
treatment aspect of this disease, so I would like--I have heard
from other doctors--I am an engineer, not a doctor--I have
heard from other doctors that have said that the methadone,
having methadone clinics, could be a real key to the reduction
of overdose deaths. Would you agree?
I am sorry. I can't hear you very well.
Dr. Volkow. Methadone clinics are clearly part of the
solution, and the solution is to expand----
Mr. McKinley. So I want to build off that. West Virginia
has the highest death rate in the Nation, unfortunately, and,
unfortunately, we only have, our ratio is about one methadone
clinic per 200,000 people. New Hampshire used to be number two
in the Nation in overdose deaths, but they have concentrated on
methadone clinics and increased their ratio to one per 100,000,
twice the situation we have in West Virginia. And in response,
they lowered their numbers.
But here is the catch, Doctor. Delaware is now the number
two in the country, but they have one methadone clinic per
60,000 people, three times a higher ratio than we have in West
Virginia. So the numbers just don't add up to me.
Could you reconcile why Delaware has emerged as number two,
but yet they have three times the number of methadone clinics
as part of the solution? Can you give me some idea how to
reconcile that?
Dr. Volkow. Well, there are multiple factors that are
driving higher numbers in one State versus the other. And I was
three weeks ago in West Virginia, Morgantown, and I was
visiting some of the treatment programs.
So we have to recognize that it is not just about methadone
clinics, which are very valuable, but also at the expanded use
of buprenorphine and the increased utilization of healthcare
systems to be able to treat.
Mr. McKinley. But the people in New Hampshire said that
is--they credit that for driving it from--they had one in
200,000, like West Virginia, but now they have markedly
increased the number of clinics, and they have seen their
number drop, they are no longer number two. So they are looking
for it. Are you saying they are wrong?
Dr. Volkow. No, I am not saying they are wrong. I am saying
that there is actually--methadone clinics will help. They are
not the only treatment available. And, if we use healthcare
systems to deliver buprenorphine, we massively expand.
Think about New Hampshire. It is a rural area. West
Virginia, a lot of rural areas. There is no transportation.
There are no methadone clinics, no way to get there and get
treated with buprenorphine.
Mr. McKinley. So given the time, and I only have 15
seconds, 14 seconds, what would you suggest is, if we could do
in States that are hard hit, what would be the first thing you
think would be the best thing that a State like ours could do?
Dr. Volkow. Expand all types of treatment, no barriers.
Expand all types of treatments for opioid use disorder.
Mr. McKinley. Thank you very much. I yield back.
Mr. Cardenas [presiding]. Hello. This is Congressman
Cardenas.
As the chairwoman has left the dais, I remotely will be
chairing the committee.
It appears that we do not [inaudible] List of documents for
the record. I would like to ask my Republican colleagues to
waive the reading of the list to enter them into the record.
Mr. Guthrie. Are you yielding to me? This is Ranking Member
Guthrie.
Mr. Cardenas. Yes.
Mr. Guthrie. I couldn't quite follow because you broke up
here.
Mr. Cardenas. Oh, I am sorry.
Mr. Guthrie. But I would like to enter a video of parents
telling their story for the record. It can be found at stop the
V-O-I-D, ``Dead on Arrival,'' stoptheVOID.org. So I would like
to introduce that to the record. I think the majority has been
made aware.
Mr. Cardenas. That will be introduced for the record, yes.
[The information appears at the conclusion of the hearing.]
Mr. Cardenas. Can you hear me, Mr. Guthrie? Mr. Guthrie,
can you hear me?
Mr. Guthrie. Yes, I can hear you now. I can hear you now.
You are breaking up a little bit, but I can hear you.
Mr. Cardenas. Pertaining to the list of other documents
that like to be entered into the record by our colleague, are
you willing to approve the reading of the list--waive approving
the--waive the reading of the list?
Mr. Guthrie. I will approve waiving of the reading. Yes, I
have no objections. We will approve waiving. I have no
objections.
Mr. Cardenas. OK. Thank you so much.
Therefore, the record will reflect the documents that have
been entered into the record.
[The information appears at the conclusion of the hearing.]
Mr. Cardenas. Thank you very much for your cooperation,
Ranking Member Guthrie.
With that, being no other responsibilities and duties of
the committee at the moment, then this committee is now
adjourned. So ordered.
[Whereupon, at 3:15 p.m., the subcommittee was adjourned.]
Prepared Statement of Hon. Richard Hudson
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