Psychedelic Therapy Review Acceleration
Advancing
In April 2026, following a Trump executive order directing federal agencies to expand access to emerging therapies, Dr. Marty Makary’s FDA moved to accelerate the review of psychedelic drug candidates. The agency issued new guidance and priority review vouchers for psilocybin aimed at treatment-resistant depression and an MDMA-like compound aimed at PTSD, and it approved an early clinical trial for noribogaine. Makary said the medications “have the potential to address the nation’s mental health crisis,” and he listed the psychedelics guidance among his top accomplishments in his resignation text.
Agency officials stressed at the time that these steps did not amount to approval of the drugs or a finding that they were safe and effective — they were procedural accelerations of the review pipeline. First approvals were reported as potentially coming as early as summer 2026.
Makary resigned on May 12, 2026, leaving the early outcomes of the program uncertain. Under acting commissioner Kyle Diamantas and with Heidi Overton’s nomination pending in the Senate HELP Committee as of early October 2026, it is not yet clear whether the expedited psychedelic review pathway will continue at the same pace.
Timeline
- April 2026: Following a Trump executive order on emerging therapies, Makary’s FDA issues psychedelic guidance and priority review vouchers (psilocybin for treatment-resistant depression, an MDMA-like compound for PTSD) and approves an early noribogaine trial.
- May 12, 2026: Makary resigns as FDA Commissioner, listing psychedelics guidance among his top accomplishments.
- Early October 2026: Kyle Diamantas remains acting commissioner; Heidi Overton’s nomination awaits a Senate HELP vote; early outcomes of the accelerated pathway remain uncertain.
