[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

                              ----------                              
                                                                   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
 GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT

    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
 GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT

    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.,
             
 GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT
    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
 GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT

    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:]
     GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT
    
    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:]
     GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT
    
    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:]
     GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT
    
    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:]
     GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT
    
    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 
********
    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

 GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT