By Puyaan Singh and Kamal Choudhury
Sept 14 (Reuters) – The U.S. FDA is holding a public hearing on Monday to gather feedback on the potential therapeutic use of psychedelic drugs, the latest step in a months-long push by President Donald Trump’s administration to speed up development of the treatments for serious mental illnesses.
The hearing is part of a broader push launched in April, when Trump ordered the U.S. Food and Drug Administration to focus on qualifying psychedelic drug programs for its priority-voucher program.
The order also directed the FDA to work with the Drug Enforcement Administration on a pathway for some patients to obtain investigational treatments under a law, which allows certain seriously ill patients to seek experimental therapies, and to increase collaboration with the Department of Veterans Affairs.
Since then, the FDA has issued priority vouchers to three companies developing psychedelic-based 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 hearing focuses on practical issues that could shape how psychedelic therapies are tested and delivered, including provider training and credentials, patient screening and monitoring, access and reimbursement, clinic capacity and the collection of long-term safety data.
The FDA said it was not seeking views on individual drug applications, the scheduling of controlled substances or the legalization of psychedelics.
Doctors, veterans, pharmacists and therapists during the hearing urged the regulator to establish clear safety and access standards for psychedelic-assisted therapies.
Experts said any approved psychedelic treatment must include trained staff in the room during sessions, along with proper screening, follow-up care and community support.
Robert Barrow, CEO of Definium Therapeutics, which is developing an LSD-based therapy, told Reuters that the hearing offers “a nice opportunity for that continuing public dialogue” among regulators, clinicians and patients.
He said regulators and industry should treat psychedelics “like it’s normal drug development, normal science, normal medicine,” rather than as an unusually novel 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 paper in the New England Journal of Medicine outlining a framework for developing and approving psychedelic drugs and saying the agency was “meeting this moment” on hard-to-treat conditions such as major depressive disorder and PTSD.
The American Psychiatric Association said it “appreciates the FDA’s public hearing and coordination with federal partners on the potential therapeutic use of psychedelics.”
“The FDA’s determination of safety and effectiveness… must remain the foundation for any future clinical use.”
Jefferies analysts said the framework suggested the FDA was willing to consider flexible trial designs to address challenges including “functional unblinding,” when a drug’s noticeable psychoactive effects reveal to participants which treatment they received.
The administration’s support has stirred fresh 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 that approved treatments were still likely years away.
Continued alignment among regulators, clinicians and developers on a safe, supervised rollout should benefit AtaiBeckley, Compass Pathways, Definium Therapeutics, Helus Pharma and GH Research, analysts said.
Helus CEO Michael Halstead said “the science continues to advance, and continued thoughtful engagement among regulators, researchers and clinicians is critical to advancing these promising new treatments.”
(Reporting by Kamal Choudhury and Puyaan Singh in Bengaluru; Editing by Aurora Ellis and Shilpi Majumdar)
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