Accelerating Medical Treatments for Serious Mental Illness
The order directs FDA and the DEA to establish a Right to Try access pathway for psychedelic drugs — including ibogaine — so patients with serious mental illness can reach treatments that have cleared early-phase trials but lack full approval, and directs HHS to allocate at least $50 million to partner with states advancing similar programs.
It is the first executive order to push agencies to build a federal pathway specifically for psychedelic drugs aimed at serious mental illness, while directing the Attorney General to initiate rescheduling review for any psychedelic that completes Phase 3 trials — though the order itself does not reschedule any substance.
What this order does
What it orders
The order directs the FDA and DEA to establish a Right to Try pathway giving eligible patients access to psychedelic drugs, including ibogaine compounds, before full federal approval, including necessary Schedule I handling authorizations for treating physicians. It directs the FDA Commissioner to issue Commissioner's National Priority Vouchers to psychedelics holding Breakthrough Therapy designation. It requires HHS, through the Advanced Research Projects Agency for Health, to allocate at least $50 million from existing funds to states that have enacted or are developing psychedelic drug programs. HHS, FDA, and the Department of Veterans Affairs are directed to sign data-sharing memoranda to pool clinical trial data and accelerate drug evaluation.
The order also requires the Attorney General, in consultation with HHS, to initiate and complete rescheduling review for any Schedule I psychedelic substance that finishes Phase 3 clinical trials — but it does not itself reschedule any drug or change existing federal controlled-substance law. All actions are subject to applicable law and the availability of appropriations.
Who it affects
Patients with serious mental illness — including veterans — seeking access to psychedelic treatments not yet fully approved, state governments developing psychedelic drug programs, licensed physicians and researchers handling Schedule I substances, pharmaceutical companies developing Breakthrough Therapy psychedelics, and the FDA, DEA, HHS, VA, and DOJ.
Why it matters
Eligible patients gain a defined federal access pathway to psychedelic treatments still in trials. States developing such programs can compete for at least $50 million in federal funding. Veterans, who die by suicide at more than twice the rate of the general adult population, are a named priority for clinical trial participation and data sharing.
What must happen and when
How the order is supposed to work
The order works in sequential stages: FDA and DEA write the Right to Try access rules and Schedule I handling authorizations first; HHS deploys the $50 million state grant program through ARPA-H; HHS, FDA, and VA sign data-sharing memoranda to funnel clinical evidence to FDA for drug evaluation; and the Attorney General initiates rescheduling review only after a product completes Phase 3 trials. Each stage depends on agency rulemaking or negotiation, and actual patient access requires those downstream steps to be completed. No automatic enforcement mechanism or reporting deadline is specified.
Actions and deadlines
- Issue Commissioner's National Priority Vouchers to psychedelic drugs with Breakthrough Therapy designation meeting program criteria
- Establish a Right to Try access pathway for eligible patients to receive psychedelic drugs, including Schedule I handling authorizations
- Allocate at least $50 million from existing funds through ARPA-H to support state psychedelic drug programs
- Sign data-sharing memoranda among HHS, FDA, and VA to make clinical study data available to FDA for drug evaluation
- Initiate and complete rescheduling review for Schedule I psychedelics that successfully complete Phase 3 clinical trials