Accelerating Medical Treatments For Serious Mental Illness

Suicide and serious mental health issues are rising, especially among veterans. Emerging psychedelic therapies show promise for patients unresponsive to existing treatments.

What the order does ​

• Directs FDA to prioritize review of breakthrough psychedelic drugs and issue priority vouchers.
• Orders FDA and DEA to streamline patient access to eligible psychedelics under the Right to Try Act, including handling of Schedule I substances.
• Requires HHS to allocate at least $50 million to support state-level psychedelic innovation programs.
• Mandates collaboration between HHS, FDA, VA, and private sector to boost clinical trials, share data, and fast-track drug approvals.
• Instructs Attorney General to quickly review and, if warranted, reschedule approved psychedelic products after successful Phase 3 trials.

Who it affects ​

• Patients with serious mental illnesses, including treatment-resistant depression and substance abuse disorders.
• Veterans at heightened risk of suicide.
• Physicians, researchers, and health care providers.
• State governments advancing psychedelic therapies.
• Drug manufacturers and private research entities.

Context ​

Psychedelic drugs with FDA breakthrough status may shift rapidly from research to wider clinical use if found safe and effective.