The US FDA is holding a public hearing on Monday to gather feedback on the potential therapeutic uses of psychedelic drugs, the latest step in a months-long effort by President Donald Trump’s administration to speed up the development of treatments for serious mental illness.
The hearings are part of a broader campaign launched in April when Trump ordered the U.S. Food and Drug Administration to focus on selecting psychedelic drug programs for its priority voucher program.
The order also directed the FDA to work with the Drug Enforcement Administration to allow some patients to receive experimental treatments under a law that allows some seriously ill patients to seek experimental treatments, and to expand collaboration with the Department of Veterans Affairs.
Since then, the FDA has issued priority vouchers to three companies developing psychedelic treatments: one for psilocybin for treatment-resistant depression, another for psilocybin for major depressive disorder, and a third for methylone for post-traumatic stress disorder.
The hearings focus on practical issues that could impact how psychedelic therapies are tested and implemented, including provider training and credentials, patient screening and monitoring, access and reimbursement, clinic capacity and long-term safety data collection.
The FDA said it does not seek opinions on individual drug applications, controlled substance scheduling or the legalization of psychedelics.
Doctors, veterans, pharmacists and therapists during the hearing called on the regulatory body to set clear standards for safety and access to psychedelic therapies.
Experts said any approved psychedelic treatment must include trained staff on the ward during sessions, as well as proper screening, aftercare and community support.
Robert Barrow, CEO of Definium Therapeutics, which is developing LSD-based therapies, told Reuters the hearings offered “an excellent opportunity to continue the public dialogue” between regulators, doctors and patients.
He said regulators and industry should treat psychedelics “as normal drug development, normal science, normal medicine,” rather than as an unusual new category requiring special treatment.
Just days before the hearing, senior FDA officials, including Michael Davis, head of the agency’s Center for Drug Evaluation and Research, published a journal article New England Journal of Medicine outlining a framework for the development and approval of psychedelic drugs and saying the agency is “meeting this moment” for difficult-to-treat conditions such as major depressive disorder and post-traumatic stress disorder.
The American Psychiatric Association said it “appreciates the FDA’s public hearings and coordination with federal partners on the potential therapeutic uses of psychedelics.”
“The FDA’s determination of safety and effectiveness… must remain the basis for any future clinical use.”
Jefferies analysts said the concept suggests the FDA is willing to consider flexible study designs to address concerns including “functional unraveling,” where a drug’s noticeable psychoactive effects show participants what kind of treatment they received.
The administration’s support has sparked renewed investor interest in the sector, with industry executives telling Reuters it could improve coordination between the FDA and the Drug Enforcement Administration and help reduce regulatory delays, even as researchers noted the treatment’s approval is likely still a long way off.
AtaiBeckley, Compass Pathways, Definium Therapeutics, Helus Pharma and GH Research should benefit from further alignment among regulators, clinicians and developers for safe and controlled implementation, analysts say.
Helus CEO Michael Halstead said that “science continues to evolve, and continued thoughtful engagement between regulators, researchers and clinicians is critical to advancing these promising new treatments.”
Published – September 16, 2026 02:55 pm EST.