To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to issue guidance on considerations for conducting clinical trials for psychedelic assisted therapy.
Last action on Feb 2, 2026Placed on the Union Calendar, Calendar No. 407.
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Summary
This bill requires the Food and Drug Administration (FDA) to issue guidance on considerations for conducting clinical trials for psychedelic assisted therapy, including how to request support from the FDA for related investigational use exemptions.
Lifecycle of the Bill
Committee Consideration and Mark-up Session Held
Dec 10, 2025
Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 26 - 15.
Dec 10, 2025
Reported (Amended) by the Committee on Ways and Means. H. Rept. 119-476.
Feb 2, 2026
Reported (Amended) by the Committee on Ways and Means. H. Rept. 119-476.
Feb 2, 2026
