Policy Watch: FDA moves to implement Trump order on psychedelic drugs

depression

In an executive order issued last weekend, President Trump directed the FDA and the Advanced Research Projects Agency for Health (ARPA-H) to speed up research and development of psychedelics, including psilocybin and ibogaine. The FDA responded by issuing Commissioner’s National Priority Vouchers to three companies developing psilocybin for treatment-resistant depression, psilocybin for major depressive disorder, and methylone for post-traumatic stress disorder.

Voucher Recipients and Timeline

The FDA has not elaborated on which three companies received the vouchers, but Compass Pathways announced it received one for its drug candidate COMP360, a synthetic psilocybin formulation. Endpoints News reported that Transcend Therapeutics and the Usona Institute were the other two recipients. The FDA has also green-lit a clinical trial for noribogaine, a derivative of ibogaine derived from the African Tabernanthe iboga shrub, to test its ability to treat alcohol use disorder. Tracy Beth Hoeg, acting director of the FDA Center for Drug Evaluation and Research, stated: “There is a growing recognition of the potential of psychedelic medications to address multiple different psychiatric conditions that are notoriously difficult to treat.”

Government Investment and Policy Direction

The White House order directs the Department of Health and Human Services to give $50 million to ARPA-H for new investments in psychedelics and orders the HHS, FDA, and U.S. Attorney General to collaborate to get patients access to new psychedelics as quickly as possible. The order makes good on an early promise from HHS Secretary Robert F. Kennedy Jr., who previously criticized the FDA for its “aggressive suppression of psychedelics.” A voucher does not necessarily serve as approval—the FDA rejected an early voucher recipient from a fast-track pathway in February, emphasizing that regulatory standards remain in place.


This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://cen.acs.org/policy/psychedelic-drug-mental-health-hydrogen-sulfide-catalyst-refiners-gras-climate-national-academies-nsf-hhs/104/web/2026/04?sc=230901_cenrssfeed_eng_latestnewsrss_cen