Veterans and Servicemembers PTSD Emerging Treatment Review Act of 2026

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9547 Introduced in House (IH)]

<DOC>

119th CONGRESS
  2d Session
                                H. R. 9547

 To direct the Secretary of Defense to submit to Congress a report on
  emerging investigational treatment options for treatment-resistant
   post-traumatic stress disorder in veterans, members of the Armed
   Forces, and members transitioning to civilian life, and for other
                               purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             June 30, 2026

 Mr. Hamadeh of Arizona (for himself, Mr. Bacon, Mr. Crenshaw, and Mr.
   Moulton) introduced the following bill; which was referred to the
                      Committee on Armed Services

_______________________________________________________________________

                                 A BILL

 To direct the Secretary of Defense to submit to Congress a report on
  emerging investigational treatment options for treatment-resistant
   post-traumatic stress disorder in veterans, members of the Armed
   Forces, and members transitioning to civilian life, and for other
                               purposes.

    Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Veterans and Servicemembers PTSD
Emerging Treatment Review Act of 2026''.

SEC. 2. REPORT ON EMERGING TREATMENT OPTIONS FOR TREATMENT-RESISTANT
              POST-TRAUMATIC STRESS DISORDER.

    (a) Findings.--Congress finds the following:
            (1) Post-traumatic stress disorder often originates during
        military service and can have persistent effects on force
        health, medical readiness, retention, family stability, and
        successful transition from military service to civilian life.
            (2) Members of the reserve components and National Guard
        may also serve in civilian first responder roles, resulting in
        cumulative trauma exposure that may compound service-connected
        mental health burdens.
            (3) Existing therapies for post-traumatic stress disorder
        are not effective for all patients, and treatment-resistant
        cases may be associated with elevated risks of chronic
        impairment, substance misuse, suicidality, and reduced
        readiness.
            (4) Rigorous, ethical clinical research conducted in
        accordance with Federal law and force health protection
        standards is necessary to evaluate emerging treatments for
        service-connected mental health conditions where existing
        therapies have proven insufficient.
            (5) The State of Arizona has enabled regulatory and
        administrative support for clinical trials authorized by the
        Food and Drug Administration evaluating naturally derived,
        whole-mushroom psilocybin administered within a structured
        group-therapy setting for the treatment of post-traumatic
        stress disorder in veterans and first responders.
            (6) Private-sector innovators and public-private
        partnerships play a central role in developing, supplying, and
        evaluating federally lawful investigational products used in
        such clinical trials.
            (7) Clinical data from the randomized controlled Phase I
        Passage Trial and the Phase II Fortitude Trial sponsored by the
        State of Arizona may provide relevant information regarding
        safety, dosing, adverse events, feasibility, and operational
        considerations for future research involving veterans,
        servicemembers, and transitioning servicemembers.
            (8) Careful review by the Department of Defense of safety,
        dosing, feasibility, and continuity-of-care considerations
        associated with emerging investigational therapies is
        appropriate to inform future force health protection policy,
        medical readiness planning, suicide prevention efforts, and
        military-to-civilian transition support.
            (9) Any potential expanded access pathway or pilot activity
        involving an investigational Schedule I substance must be
        evaluated in accordance with applicable Federal law and
        regulations, including requirements administered by the Food
        and Drug Administration and the Drug Enforcement
        Administration, and applicable regulatory agencies should act
        in a timely manner to issue or update regulations, guidance,
        authorizations, and procedures necessary to enable lawful
        research and access for eligible patients, consistent with the
        Federal Right to Try Act, expanded access authorities, and the
        April 18, 2026, Executive Order titled ``Accelerating Medical
        Treatments for Serious Mental Illness,'' while maintaining
        appropriate safety, security, and diversion-control safeguards.
            (10) Congress has a responsibility to ensure that the
        Department of Defense assesses whether emerging clinical
        research may offer future benefit for active-duty
        servicemembers, reserve component members, veterans, and
        transitioning servicemembers with treatment-resistant post-
        traumatic stress disorder.
    (b) Report.--Not later than 180 days after the date of the
enactment of this Act, the Assistant Secretary of Defense for Health
Affairs shall submit to the congressional defense committees a report
on the operational relevance, safety, dosing, and feasibility of data
from the covered clinical trial as such data would apply to members of
the Armed Forces, including such members transitioning to civilian
life.
    (c) Elements.--The report under subsection (b) shall include the
following:
            (1) A summary of the safety, dosing, and adverse event data
        from the covered clinical trial that has been reviewed by any
        relevant department or agency of the Federal Government, or
        that is otherwise available to the Department of Defense, and
        an analysis by the Department of Defense of the applicability
        of such data to members of the Armed Forces.
            (2) An assessment of the implications of such data for
        force health protection, medical readiness, and suicide
        prevention strategies, including identification of any gaps in
        existing treatment options for members of the Armed Forces with
        treatment-resistant post-traumatic stress disorder.
            (3) A description of the legal and regulatory requirements
        for any potential expanded access pathway involving an
        investigational Schedule I substance, including coordination
        requirements with the Food and Drug Administration and the Drug
        Enforcement Administration.
            (4) An assessment of the applicability of the Federal right
        to try the pathway under section 561B of the Federal Food,
        Drug, and Cosmetic Act (21 U.S.C. 360bbb-0a) and under
        Executive Order No. 14401 (91 Fed. Reg. 21709; relating to
        accelerating medical treatments for serious mental illness) the
        for treatment-resistant post-traumatic stress disorder and
        associated comorbidities, including elevated suicide risk
        during post-deployment and transition periods.
            (5) An assessment of considerations necessary to ensure
        continuity of care for members of the Armed Forces
        transitioning from receiving health care at military medical
        treatment facilities to receiving health care furnished by the
        Veterans Health Administration, including--
                    (A) eligibility criteria;
                    (B) clinical treatment oversight;
                    (C) informed consent procedures;
                    (D) safety monitoring; and
                    (E) adverse event reporting.
            (6) An assessment of the financial resources, workforce,
        and infrastructure requirements, and a proposed timeline, for
        any potential pilot activities or expanded clinical research
        beginning in fiscal year 2027, and for any broader
        implementation occurring thereafter, as appropriate.
    (d) Coordination and Consultation.--The Assistant Secretary of
Defense for Health Affairs shall develop the report under subsection
(b) in coordination with the Director of the Defense Health Agency and
in consultation with the Secretary of Veterans Affairs, the Secretary
of Health and Human Services, the Commissioner of Food and Drugs, and
the heads of other departments and agencies of the Federal Government
the Assistant Secretary determines appropriate.
    (e) Form.--The report required under subsection (b) shall be
submitted in unclassified form, but may include a classified annex if
necessary.
    (f) Definitions.--In this section:
            (1) The term ``congressional defense committees'' has the
        meaning given that term in section 101(a)(16) of title 10,
        United States Code.
            (2) The term ``covered clinical trial'' means the clinical
        trial conducted in 2026 titled ``An Open-Label, Phase 1 Study
        of the Safety Pharmacokinetic Profile, and Preliminary
        Efficacy, of Organic Whole Psilocybin-Containing Mushrooms in
        Patients Suffering From PTSD''.
                                 <all>