FDA holds hearing on psychedelic drugs: 5 things to know

The FDA held a public hearing Sept. 14 on the potential future therapeutic use of psychedelic drugs, gathering input on issues that could shape how health systems eventually deliver this care, from provider credentialing to patient safety protocols.

Here are five things to know:

1. The hearing centered on two practical questions for the field: what provider training and credentialing should look like and how to promote patient safety, and how patients would access these treatments and how outcomes data should be collected and standardized. Both are foundational questions health systems would need answered before building any psychedelic-assisted therapy program.

2. The FDA has not approved any psychedelic drug for therapeutic use, and this hearing does not change that. The agency rejected Lykos Therapeutics’ MDMA therapy for PTSD in 2024, and it’s currently backing early-phase studies of psilocybin, methylone and ibogaine derivatives for serious mental illness.

3. Speakers included representatives from academic medical centers, veteran health organizations and companies already offering ketamine- and psychedelic-assisted therapy, suggesting the FDA is drawing on operators with real-world experience running supervised administration models — the kind of programs health system behavioral health leaders have weighed in on as both a clinical opportunity and a safety risk.

4. The hearing follows President Donald Trump’s April 18 executive order directing federal agencies to accelerate research, regulatory review and access to psychedelic drugs for serious mental illnesses, signaling continued federal momentum that could compress the usual approval timeline.

5. The FDA is accepting written comments on the hearing through the Federal Register until 11:59 p.m. ET Oct. 5. Health system leaders tracking behavioral health strategy may want to watch for how the agency incorporates safety and training standards into any future approval pathway, since those standards would likely determine what credentialing, facility and staffing requirements a health system would need to offer this treatment.