This Executive Order instructs federal agencies to accelerate research, review, and potential approval pathways for psychedelic drugs intended to treat serious mental illnesses, including major depressive disorder and substance abuse disorder. The EO directs FDA to prioritize review of qualifying products with Breakthrough Therapy designation through the National Priority Voucher Program and to facilitate access to psychedelic drugs under the federal Right to Try Act. The EO tasks HHS to allocate at least $50 million through ARPA‑H to support federal collaboration with states that have enacted or are developing psychedelic drugs for serious mental illnesses. It also instructs HHS, FDA, and the VA, in collaboration with the private sector, to increase clinical trial preparation, data sharing, and real‑world evidence generation regarding psychedelic drugs – prioritizing drugs with Breakthrough Therapy designation – and requires DOJ and HHS to expedite rescheduling review for products that successfully complete Phase 3 trials and receive FDA approval.
Accelerating Medical Treatments for Serious Mental Illness (Trump EO Tracker)
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