Accelerating Medical Treatments for Serious Mental Illness
Federal Agencies Ordered to Speed Access to Psychedelic Treatments
What it does
Agencies must speed Food and Drug Administration review, expand patient access, fund state partnerships, and pursue rescheduling for certain psychedelic drugs.
Real-world impact
- Expedites Food and Drug Administration review and approval for certain psychedelic drugs.
- Creates patient access path under Right to Try, including Schedule I authorizations.
- Provides at least $50 million to help states advance psychedelic treatment programs.
Topics
Summary
This order directs federal agencies to speed development, review, and patient access to certain psychedelic drugs to treat people with serious mental illnesses and to help reverse rising suicide and relapse rates.
It requires the Food and Drug Administration to prioritize drugs with Breakthrough Therapy designation, directs the Food and Drug Administration and the Drug Enforcement Administration to create a Right to Try pathway (including Schedule I handling authorizations), and directs the Department of Health and Human Services to provide at least $50 million through the Advanced Research Projects Agency for Health to support state programs.
Questions, answered
Ask questions about this executive order and its implications. Try:
- “What agencies are affected by this order?”
- “How does this order change existing policy?”
- “What are the practical implications of this order?”