Accelerating Medical Treatments for Serious Mental Illness

What it does

• •Directs the FDA to issue Commissioner's National Priority Vouchers to psychedelic drugs with Breakthrough Therapy designation to accelerate their review and approval.
• •Instructs the FDA and DEA to establish a pathway for eligible patients to access psychedelic drugs, including ibogaine, under the Right to Try Act with necessary Schedule I handling authorizations.
• •Allocates at least $50 million in existing HHS funds through the Advanced Research Projects Agency for Health to support state programs developing psychedelic drug treatments for serious mental illness.
• •Directs the Attorney General to initiate rescheduling review of Schedule I substances that complete Phase 3 clinical trials and receive FDA approval for serious mental health disorders.

Why it matters

• •Over 14 million American adults have serious mental illness, suicide rates increased 37 percent from 2000 to 2018, and veterans experience suicide rates more than twice the non-veteran population, creating a stated public health crisis the order seeks to address.
• •Psychedelic drugs have received FDA Breakthrough Therapy designations and show clinical potential for patients unresponsive to standard treatments, but the order aims to accelerate access to these experimental therapies.

Who is affected

• •Patients with serious mental illness, major depressive disorder, and substance abuse disorder, particularly veterans, who may gain earlier access to psychedelic drug treatments.
• •The FDA, DEA, Department of Health and Human Services, Department of Veterans Affairs, and state governments developing psychedelic treatment programs.

What happens next

The designated federal agencies must implement the order's directives consistent with applicable law and subject to appropriations availability.