[House Report 118-647]
[From the U.S. Government Publishing Office]


118th Congress }                                               {   Report
                        HOUSE OF REPRESENTATIVES
 2d Session    }                                               { 118-647

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

 
   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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.

           *       *       *       *       *       *       *