IBOGAINE Act

(a) Program. The Secretary of Health and Human Services (in this section referred to as the Secretary), in collaboration with the Secretary of Veterans Affairs, shall carry out a program to collaborate with the private sector to increase clinical trial participation, data sharing, and real-world evidence generation regarding psychedelic drugs.

(b) Prioritizing breakthrough therapies. In carrying out the program under subsection (a), the Secretary shall prioritize collaboration regarding psychedelic drugs that are designated as a breakthrough therapy under section 506(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)).

(c) Provision of HHS and VA data from clinical studies to FDA

(1) Interagency agreement. Subject to paragraph (2), the Secretary of Health and Human Services, the Secretary of Veterans Affairs, and the heads of other Federal departments and agencies, shall enter into agreements to provide data from federally conducted or supported clinical trials to the Food and Drug Administration to facilitate the timely evaluation and approval or licensure (as applicable) of drugs (including biological products) under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) or section 351 of the Public Health Service Act (42 U.S.C. 351).

(2) Applicable provisions. The provision of data under paragraph (1) shall be subject to other applicable law, including any privacy restrictions under the Privacy Act of 1974 (5 U.S.C. 552a) and the Health Insurance Portability and Accountability Act of 1996 (Public Law 104–191).