The FDA held a public hearing yesterday on the potential therapeutic use of psychedelic drugs, drawing testimony from doctors, veterans, pharmacists and therapists who called on the agency to establish clear safety and access standards for the treatments.
At the agency's White Oak Campus in Silver Spring, Maryland, the four-hour meeting addressed a range of practical issues, from how providers should be trained and credentialed to how patients would be screened and monitored, with additional discussion of clinic capacity, insurance reimbursement and long-term safety data collection, according to Reuters.
Experts told the hearing that psychedelic treatment sessions, which can run six to 12 hours, would need qualified staff on hand throughout, as well as robust patient screening beforehand and follow-up care and community support afterward, according to Reuters. Several speakers called on researchers to disaggregate data by factors including menstrual cycle phase, pregnancy and postpartum status, perimenopause, hormonal status and use of other medications, cautioning that lumping participants together could hide meaningful differences in how treatments work or what side effects they cause.
"Important safety and treatment signals should not disappear inside population averages," said Melissa Lavasani, CEO of the Psychedelic Medicine Coalition, according to Reuters.
Access and cost emerged as central concerns. Experts warned that without insurance coverage and sufficient provider reimbursement, clinics would be left to either cater exclusively to wealthier patients or shut down for financial reasons, according to Reuters.
"Approval alone is not access. A breakthrough therapy nobody can reach is not a breakthrough — it is a press release," said Amna Aslam, a representative from Radial, a brain medicine clinic network.
The hearing is part of a push launched by President Donald Trump's administration in April, when an executive order directed the Department of Health and Human Services and the FDA to support advances in psychedelic drug development and regulation, according to Biospace.
A few days before the hearing, Michael Davis, who leads the agency's Center for Drug Evaluation and Research, and other senior FDA officials co-authored a framework for psychedelic drug development and approval that appeared in the New England Journal of Medicine. The agency was "meeting this moment" on hard-to-treat conditions such as major depressive disorder and PTSD, they said.
The American Psychiatric Association said in a statement that the FDA's determination of safety and effectiveness "must remain the foundation for any future clinical use."
Written comments on the hearing may be submitted to the Federal Register through October 5, 2026, the FDA said.