Experts urge FDA to set clear safety and access standards for psychedelic drugs

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. The agency was "meeting this moment" on hard-to-treat conditions such as major depressive disorder and PTSD, they 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, according to Jefferies analysts. 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, though treatments are likely still years away. "FDA's determination of safety and effectiveness ... must remain the foundation for any future clinical use," the American Psychiatric Association said. Agreement among regulators, clinicians and developers on a safe, supervised rollout should benefit AtaiBeckley, Compass Pathways, Definium Therapeutics, Helus Pharma and GH Research, according to analysts. "The science continues to advance, and continued thoughtful engagement among regulators, researchers and clinicians is critical to advancing these promising new treatments," said Helus CEO Michael Halstead. Doctors, veterans, pharmacists and therapists on Monday urged the U.S. Food and Drug Administration to establish clear safety and access standards for psychedelic therapies during a four-hour public meeting convened by the agency amid efforts to speed up their development. The hearing is the latest in a months-long push launched by U.S. President Donald Trump's administration in April to bring qualified psychedelic drug programs to market. Discussions at the meeting focused 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. Experts said any approved psychedelic treatment must include trained staff in the room during sessions — which could last six to 12 hours — alongside proper screening, follow-up care and community support. Speakers urged researchers to collect data on menstrual phases, pregnancy and postpartum status, perimenopause, menopause, hormonal status and concomitant medications, warning that aggregate results could obscure differences in efficacy or adverse events. "Important safety and treatment signals should not disappear inside population averages," said Melissa Lavasani, CEO of the Psychedelic Medicine Coalition. Treatments could also be inaccessible unless there was insurance coverage, the experts noted, adding that without adequate reimbursement for providers, clinics would either serve mostly wealthy patients or fail financially. "Approval alone is not access. A breakthrough therapy nobody can reach is not a breakthrough — it is a press release," said Lynn Watkins, a U.S. Air Force veteran associated with the Psychedelics and Pain Association.

Experts urge FDA to set clear safety and access standards for psychedelic drugs

FDA framework and investor interest in the sector

FDA hearing focuses on guardrails for psychedelic therapies

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