Accelerating Medical Treatments for Serious Mental Illness
Executive Office of the President
Over 14 million American adults suffer from serious mental illness, and existing psychiatric therapies do not work for everyone.
Recognizing this gap, federal policy is shifting to expedite the development and deployment of alternative treatments.
Psychedelic drugs, particularly ibogaine compounds, have shown clinical potential for complex cases, with several already receiving FDA Breakthrough Therapy designations.
To move these treatments out of the research pipeline and into clinical use, this order mandates sweeping coordination across federal health and law enforcement agencies.
The core directives reshape regulatory pathways for patients and researchers.
The FDA must issue National Priority Vouchers to appropriate psychedelic drugs holding a Breakthrough Therapy designation.
The FDA and DEA are directed to build a clear legal pathway for eligible patients to access psychedelics like ibogaine under the Right to Try Act. This includes authorizing Schedule I handling waivers for treating physicians.
The Department of Health and Human Services (HHS), through ARPA-H, will allocate at least $50 million from existing funds to support state governments already advancing psychedelic treatment programs.
HHS, the FDA, and the VA must collaborate with the private sector to boost clinical trial enrollment and share real-world evidence. Interagency data-sharing agreements are required to speed up FDA evaluations.
The Attorney General must prepare to review and potentially reschedule any Schedule I substance that successfully finishes Phase 3 trials for mental health disorders, ensuring swift availability upon FDA approval.
