The FDA holds a public hearing Monday afternoon on the potential future therapeutic use of psychedelic drugs, part of a Trump administration push to speed up research and approval of substances like psilocybin, LSD, and MDMA for treating serious mental illness. The hybrid hearing runs from 12:30 to 4:30 p.m. Eastern at FDA’s White Oak campus in Silver Spring, Maryland, and is also streaming online.
Why is the FDA holding this hearing now?
The hearing supports Executive Order 14401, “Accelerating Medical Treatments for Serious Mental Illness,” which President Trump signed in April 2026 directing federal agencies to speed up research, review, and approval of psychedelic drugs for conditions like treatment-resistant depression and PTSD. The FDA is using the session to gather public feedback on how psychedelic-assisted therapy should actually work in practice — questions like what supervised, supportive settings should look like, and how to handle drugs that require an in-session therapeutic experience rather than a pill taken at home. The same day the hearing was announced, the FDA also released its first final guidance for companies running clinical trials involving substances like psilocybin, LSD, and MDMA, giving drugmakers a clearer regulatory path for the first time.
What happens after Monday?
The hearing itself is just one input. The FDA is accepting written public comments through the Federal Register until 11:59 p.m. Eastern on October 5, meaning anyone who doesn’t get a chance to speak Monday still has three more weeks to weigh in formally. The finalized clinical trial guidance is likely the more consequential document long-term, since it’s what pharmaceutical companies will actually use to design and submit studies going forward — the hearing shapes policy discussion, but the guidance shapes what gets built.
Sources: U.S. Food and Drug Administration · Federal Register · Foley Hoag
