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