Accelerating Medical Treatments for Serious Mental Illness
Directs the acceleration of research and regulatory review for treatments of serious mental illness, including schizophrenia and treatment-resistant depression.
Section by Section
What each section does, and how they differ.
Addresses high suicide and serious mental illness rates in America, noting existing treatments prove insufficient for many patients; establishes policy that psychedelic drugs show potential in clinical studies for treating serious mental illnesses unresponsive to standard therapies.
Directs FDA Commissioner to issue National Priority Vouchers for psychedelic drugs with Breakthrough Therapy designation; directs FDA and DEA to establish pathway for eligible patients to access psychedelic drugs under Right to Try Act.
Directs HHS to allocate at least $50 million from existing funds to support state programs advancing psychedelic drugs for serious mental illness treatment.
Directs HHS, FDA, and VA to collaborate to increase clinical trial participation, data sharing, and real-world evidence generation regarding psychedelic drugs with Breakthrough Therapy designation.
Directs Attorney General to initiate and complete rescheduling review for Schedule I substances that complete Phase 3 clinical trials for serious mental health disorders, proceeding as quickly as practicable.
Standard boilerplate: preserves existing agency authority, conditions the order on appropriations, and creates no enforceable private rights.