[House Report 118-647]
[From the U.S. Government Publishing Office]
118th Congress } { Report
HOUSE OF REPRESENTATIVES
2d Session } { 118-647
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TO AMEND TITLE 38, UNITED STATES CODE, TO DIRECT THE SECRETARY OF
VETERANS AFFAIRS TO REPORT ON WHETHER THE SECRETARY WILL INCLUDE
CERTAIN PSYCHEDELIC DRUGS IN THE FORMULARY OF THE DEPARTMENT OF
VETERANS AFFAIRS
_______
September 6, 2024.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Bost, from the Committee on Veterans' Affairs, submitted the
following
R E P O R T
[To accompany H.R. 7347]
[Including cost estimate of the Congressional Budget Office]
The Committee on Veterans' Affairs, to whom was referred
the bill (H.R. 7347) to amend title 38, United States Code, to
direct the Secretary of Veterans Affairs to report on whether
the Secretary will include certain psychedelic drugs in the
formulary of the Department of Veterans Affairs, having
considered the same, reports favorably thereon without
amendment and recommends that the bill do pass.
CONTENTS
Page
Amendment........................................................
Purpose and Summary.............................................. 2
Background and Need for Legislation.............................. 2
Hearings......................................................... 3
Subcommittee Consideration....................................... 4
Committee Consideration.......................................... 4
Committee Votes.................................................. 4
Committee Oversight Findings..................................... 4
Statement of General Performance Goals and Objectives............ 4
Earmarks and Tax and Tariff Benefits............................. 4
Committee Cost Estimate.......................................... 4
Budget Authority and Congressional Budget Office Estimate........ 5
Federal Mandates Statement....................................... 5
Advisory Committee Statement..................................... 5
Applicability to Legislative Branch.............................. 5
Statement on Duplication of Federal Programs..................... 6
Section-by-Section Analysis of the Legislation................... 6
Changes in Existing Law Made by the Bill, as Reported............ 6
Purpose and Summary
H.R. 7347, ``To amend Title 38, United States Code, to
direct the Secretary of Veterans Affairs to report on whether
the Secretary will include certain psychedelic drugs in the
formulary of the Department of Veterans Affairs,'' was
introduced by Representative Derrick Van Orden of Wisconsin on
February 14, 2024. H.R. 7347 would require the U.S. Department
of Veterans Affairs (VA) to submit a report to Congress no
later than 180 days after the U.S. Food and Drug Administration
(FDA) approval of a psychedelic drug, outlining whether or not
VA is choosing to include the drug in the VA formulary, as well
as justifications as to why or why not.
Background and Need for Legislation
Section 1. Reporting of Determination of the Secretary of Veterans
Affairs Whether to Include Newly Approved or Licensed
Psychedelic Drugs in the Formulary of the Department of
Veterans Affairs
Under current law, psychedelic assisted therapy and the
drugs associated with it are only authorized for use in
clinical trials to study the effects of these drugs on patients
with severe suicidality and Post Traumatic Stress Disorder
(PTSD). This bill would require VA to send a report to the
House and Senate Committees on Veterans' Affairs on whether VA
has decided to include psychedelics in the VA formulary if the
FDA approves the drug, as part of the list of approved drugs
for prescription and clinical use for veterans struggling with
PTSD, thoughts of suicide, or other conditions that may benefit
from the use of the approved drug as determined by the
veterans' primary care physician. The VA formulary is a list of
approved drugs for prescription and clinical use approved by
the Department. As the FDA continues to study and approve
psychedelic drugs for clinical use, the Committee recognizes
the potential benefits these treatments have in saving veteran
lives and mitigating some of the symptoms of PTSD. VA's ongoing
clinical trials are an important part of the research which can
inform the benefits of the use of these drugs. According to
VA's 2023 Annual Suicide Prevention Report, around 17 veterans
per day die by suicide.\1\ Some of VA's research at local
medical facilities show that psychedelic assisted therapy has
strong positive effects on the treatment of PTSD. This
indicates that the use of psychedelics has the potential to
significantly reduce suicides. However, if these drugs are not
placed on the VA formulary, VA providers may not be able to
consider the use of the drug in the veterans' treatment plan.
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\1\2023 National Veteran Suicide Prevention Annual Report,
Department of Veterans Affairs, 2023, https://www.mentalhealth.va.gov/
docs/data-sheets/2023/2023-National-Veteran-Suicide-Prevention-Annual-
Report-FINAL-508.pdf.
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In 2023, the Committee conducted site visits to the Bronx
VA Medical Center, New York University (NYU), and Johns Hopkins
University (JHU) to meet with researchers at the forefront of
ongoing clinical trials aimed at addressing severe suicidality
and depression with psychedelic assisted therapy. Committee
staff learned that NYU has conducted extensive trials with
Methylenedioxymethamphetamine (MDMA). The results of one trial
indicate that 88% of MDMA assisted therapy trial participants
have significantly reduced PTSD symptoms after their third and
final dosing session, with 67% achieving remission.\2\ The
duration of this treatment spans three months, with patients
being monitored by their physician throughout the duration of
the trial. Studies show that psychedelic assisted therapy may
also have tremendous potential in addressing alcoholism and
substance use disorders. Researchers at NYU have seen an 83%
reduction in heavy drinking among patients undergoing
psilocybin assisted therapy treatment, with 48% stopping
drinking altogether.\3\
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\2\MDMA Assisted Therapy for PTSD Completion of Phase 3 Study,
Psychiatric Times, 2022, https://www.psychiatrictimes.com/view/mdma-
assisted-therapy-for-ptsd-completion-of-phase-3-study.
\3\Psychedelic Drug Therapy May Help Treat Alcohol Addiction, NYU
Langone Health, 2022, https://nyulangone.org/news/psychedelic-drug-
therapy-may-help-treat-alcohol-addiction.
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Based upon the results of those trials, the Committee
believes that time is of the essence in getting these therapies
approved for wide-scale use at VA upon FDA approval, which
could happen as soon as the Fall of 2024. The Committee
believes this bill would put pressure on VA to establish a
timeline on the availability of these life saving drugs so that
proper oversight can be conducted, as the Committee does not
want VA to fall behind the private sector in the availability
of these breakthrough treatments that could be available to
veterans through VA.
Hearings
On March 21, 2024, the subcommittee on Health held a
legislative hearing on H.R. 7347. The following witnesses
testified:
The Honorable Mike Bost, U.S. House of
Representatives, Illinois 12th; The Honorable Chris
Deluzio, U.S. House of Representatives, Pennsylvania
17th; The Honorable Jack Bergman, U.S. House of
Representatives, Michigan 1st; The Honorable Greg
Murphy, U.S. House of Representatives, North Carolina
3rd; The Honorable Derrick Van Orden, U.S. House of
Representatives, Wisconsin 3rd; The Honorable Nick
LaLota, U.S. House of Representatives, New York 1st;
The Honorable Debbie Dingell, U.S. House of
Representatives, Michigan 6th; The Honorable Lauren
Underwood, U.S. House of Representatives, Illinois
14th; Dr. Ajit Pai, Executive Director, Office of
Rehabilitation and Prosthetic Services, Veterans Health
Administration, U.S. Department of Veterans Affairs;
Dr. Michael Brennan, Executive Director, Office of
Construction and Facilities Management, U.S. Department
of Veterans Affairs; Dr. Wendy Tenhula, Deputy Chief
Research and Development Officer, Office of Research
and Development, Veterans Health Administration, U.S.
Department of Veterans Affairs; Dr. David Perry Chief
Officer, Workforce Management and Consulting, Veterans
Health Administration, U.S. Department of Veterans
Affairs; Mr. Jon Retzer, Assistant National Legislative
Director, Disabled American Veterans; Mr. Roscoe
Butler, Senior Health Policy Advisor, Paralyzed
Veterans of America; Ms. Brittany Elliot, Veteran
(USMC), Advocate; Ms. Melissa Bryant, Chair, Board of
Directors, Minority Veterans of America.
The following individuals and organizations submitted
statements for the record:
Wounded Warrior Project, Treat Now, Superior
Ambulance.
Subcommittee Consideration
On April 16, 2024, the Health Subcommittee met in an open
markup session, a quorum being present, and ordered H.R. 7347
to be reported favorably to the Full Committee by voice vote.
Committee Consideration
On May 1, 2024, the full Committee met in open markup
session, a quorum being present, and ordered H.R. 7347 be
reported favorably to the House of Representatives by voice
vote.
A motion by Ranking Member Takano of California to report
H.R. 7347 favorably to the House of Representatives was agreed
to by voice vote.
Committee Votes
In compliance with clause 3(b) of rule XIII of the Rules of
the House of Representatives, no recorded votes were taken with
ordering H.R. 7347 reported to the House.
Committee Oversight Findings
In compliance with clause 3(c)(1) of rule XIII and clause
(2)(b)(1) of rule X of the Rules of the House of
Representatives, the Committee's oversight findings and
recommendations are reflected in the descriptive portions of
this report.
Statement of General Performance Goals and Objectives
In accordance with clause 3(c)(4) of rule XIII of the Rules
of the House of Representatives, the Committee's performance
goals and objectives of H.R. 7347 are to provide a report to
Congress on the plans of the Department of Veterans Affairs to
include psychedelic drugs in the formulary.
Earmarks and Tax and Tariff Benefits
H.R. 7347 does not contain any Congressional earmarks,
limited tax benefits, or limited tariff benefits as defined in
clause 9 of rule XXI of the Rules of the House of
Representatives.
Committee Cost Estimate
The Committee adopts as its own the cost estimate on H.R.
7347 prepared by the Director of the Congressional Budget
Office.
Budget Authority and Congressional Budget Office Cost Estimate
H.R. 7347 would require the Department of Veterans Affairs
(VA) to report to the Congress whenever a decision is made
about whether to include on VA's prescription formulary,
psychedelic drugs that have been approved by the Food and Drug
Administration.
Under current law, VA publicizes its decisions about what
to include in the department's formulary, and to date, no
psychedelic drugs have been approved for medical use by the
Food and Drug Administration. CBO estimates that satisfying the
requirement to report to the Congress would cost less than
$500,000 over the 2024-2034 period.
The CBO staff contact for this estimate is Matt Schmit. The
estimate was reviewed by Christina Hawley Anthony, Deputy
Director of Budget Analysis.
Phillip L. Swagel,
Director, Congressional Budget Office.
Federal Mandates Statement
Section 423 of the Congressional Budget and Impoundment
Control Act (as amended by Section 101(a)(2) of the Unfunded
Mandate Reform Act, P.L. 104-4) is inapplicable to H.R. 7347.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act would be created by H.R.
7347.
Applicability to Legislative Branch
The Committee finds that H.R. 7347 does not relate to the
terms and conditions of employment or access to public services
or accommodation within the meaning of section 102(b)(3) of the
Congressional Accountability Act.
Statement on Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII of the Rules of the
House of Representatives, the Committee finds that no provision
of H.R. 7347 establishes or reauthorizes a program of the
Federal Government known to be duplicative of another Federal
program, a program that was included in any report from the
Government Accountability Office to Congress pursuant to
section 21 of Public Law 111-139, or a program related to a
program identified in the most recent Catalog of Federal
Domestic Assistance.
Section-by-Section Analysis of the Legislation
Section 1. Reporting of determination of the Secretary of Veterans
Affairs whether to include newly approved or licensed
psychedelic drugs in the formulary of the Department of
Veterans Affairs
This section would amend Chapter 81 of title 38, United
States Code, by inserting, a new section Sec. 8125A, which
would require, no later than 180 days after a psychedelic drug
is approved under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) or licensed under section 351 of
the Public Health Service Act (42 U.S.C. 262), the Secretary to
submit to the House and Senate Committees on Veterans' Affairs
a report regarding such drug, that includes the determination
of the Secretary whether to include such drug in the formulary
of the Department, and the justification of the Secretary for
such determination.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, existing law in which no change
is proposed is shown in roman):
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (new matter is
printed in italics and existing law in which no change is
proposed is shown in roman):
TITLE 38, UNITED STATES CODE
* * * * * * *
PART VI--ACQUISITION AND DISPOSITION OF PROPERTY
* * * * * * *
CHAPTER 81--ACQUISITION AND OPERATION OF HOSPITAL AND DOMICILIARY
FACILITIES; PROCUREMENT AND SUPPLY; ENHANCED-USE LEASES OF REAL
PROPERTY
* * * * * * *
Sec.
* * * * * * *
SUBCHAPTER II--PROCUREMENT AND SUPPLY
* * * * * * *
8125A. Reporting of determination whether to include newly approved or
licensed psychedelic drugs in the formulary of the Department.
* * * * * * *
SUBCHAPTER II--PROCUREMENT AND SUPPLY
* * * * * * *
SEC. 8125A. REPORTING OF DETERMINATION WHETHER TO INCLUDE NEWLY
APPROVED OR LICENSED PSYCHEDELIC DRUGS IN THE
FORMULARY OF THE DEPARTMENT
Not later than 180 days after a psychedelic drug is approved
under section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) or licensed under section 351 of the Public
Health Service Act (42 U.S.C. 262), the Secretary shall submit
to the Committees on Veterans' Affairs of the Senate and House
of Representatives a report regarding such drug, that
includes--
(1) the determination of the Secretary whether to
include such drug in the formulary of the Department;
and
(2) the justification of the Secretary for such
determination.
* * * * * * *