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.