FDA’s Psychedelics Public Hearing Draws Broad Support but No Questions from Federal Panel

An FDA Part 15 public hearing on the potential therapeutic use of psychedelic drugs brought together about 300 attendees, 1,000 livestream viewers, and roughly 80 commenters, but none of the federal panellists asked questions. Speakers addressed provider training, patient safety, access, data standardisation, psychotherapy, preparation and integration, reimbursement, and the design of drug-specific REMS and labels. Debate centred on whether psychedelic treatments should include psychotherapy, how restrictive clinical requirements should be, and how to balance cautious rollout with equitable access. Several contributors highlighted weak evidence, small and functionally unblinded trials, inconsistent data collection, and the need for ongoing comparative-effectiveness research and public education. Most comments were supportive and familiar to industry participants, while criticism was limited. The hearing nevertheless signalled sustained FDA interest and suggested that psychedelic medicines may be moving toward entry into the US medical system. Written comments remain open until October 5.