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.

Bill: 118-hr-4242
Sponsor: full_name: Rep. Crenshaw, Dan [R-TX-2]
Introduced: 2023-06-21
Policy area: Health
Subjects: Administrative law and regulatory procedures

Alternative treatments

Department of Health and Human Services

Drug therapy

Drug, alcohol, tobacco use

Medical research
Latest action: action_date: 2023-06-23
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2023-06-21
action_desc: Introduced in House
text: <p>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.</p>

tv_txt: I 118th CONGRESS 1st Session H. R. 4242 IN THE HOUSE OF REPRESENTATIVES June 21, 2023 Mr. Crenshaw (for himself, Mrs. Miller-Meeks , and Mr. Khanna ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL 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.

1. Guidance on considerations for conducting clinical trials for psychedelic assisted therapy The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall— (1) not later than 180 days after the date of enactment of this Act, issue for public comment draft guidance on considerations for conducting clinical trials for psychedelic assisted therapy, including how those seeking an investigational use exemption for such clinical trials should request interactive support by the Food and Drug Administration; and (2) not later than 180 days after issuing such draft guidance, finalize such guidance.