Overview
- President Trump signed an executive order directing agencies to speed clinical access to certain psychedelics, reevaluate their controlled status, and provide $50 million for state programs and ibogaine research.
- The FDA, Commissioner Marty Makary said, will issue three priority review vouchers next week for serotonin 2A agonists, with decisions on applications possible this summer.
- The order instructs the DEA and Justice Department to begin rescheduling reviews after successful Phase 3 trials so approved drugs can move off Schedule I.
- The plan opens a Right-to-Try pathway for eligible patients and tasks federal health systems, including the VA, to coordinate studies and share data.
- Industry leaders praised the urgency, with Compass Pathways pointing to Phase 3 psilocybin results, while scientists and policy critics warned that ibogaine can cause dangerous heart rhythm problems and must be used only under strict clinical controls.