Accelerating Medical Treatments for Serious Mental Illness

Key Points

• This executive order targets the 14 million Americans with serious mental illness who don't get better with standard treatments. It focuses on speeding up access to psychedelic drugs like ibogaine for conditions such as major depression and substance abuse disorder.
• The FDA is directed to give priority review vouchers to psychedelic drugs that have already earned Breakthrough Therapy status. This could significantly shorten the time it takes for these treatments to reach patients.
• The order creates a pathway for eligible patients to access psychedelic drugs under the Right to Try Act and directs the Attorney General to begin rescheduling any Schedule I psychedelic that completes Phase 3 clinical trials for a serious mental health disorder.
• At least $50 million from existing funds will go to ARPA-H to support states that have enacted or are developing programs to advance psychedelic treatments for serious mental illness.
• Veterans are a major focus. The VA, HHS, and FDA are directed to sign data-sharing agreements and work together to boost clinical trial participation and generate real-world evidence on psychedelic treatments, given that veteran suicide rates are more than double the non-veteran rate.