in effect
Executive Order 14401, signed April 18, 2026, directs multiple federal agencies to speed up research, clinical trials, and potential approval of psychedelic drugs — including ibogaine — as treatments for serious mental illnesses such as major depressive disorder. It does not legalize these substances outright, but rather creates pathways and funding mechanisms to move them faster through the existing regulatory system.
The FDA is directed to issue Commissioner’s National Priority Vouchers to qualifying psychedelic drugs that already hold Breakthrough Therapy designation, moving them to the front of the review queue. The FDA and DEA must establish a pathway for terminally or seriously ill patients to access these drugs under the existing Right to Try Act, including handling authorizations for physicians and researchers who would otherwise be blocked by Schedule I restrictions. HHS must direct at least $50 million in existing funds through ARPA-H to states that have enacted or are building psychedelic treatment programs. HHS, FDA, and the VA are directed to sign data-sharing agreements so that clinical trial data from across federal agencies flows to the FDA to support timely approval decisions. The Attorney General, working with HHS, must initiate a rescheduling review for any Schedule I psychedelic that completes Phase 3 trials and receives FDA approval, with the goal of completing that review as quickly as possible.
Patients with treatment-resistant serious mental illness — and particularly military veterans, who the order notes die by suicide at more than twice the rate of the general adult population — are the intended beneficiaries, gaining potential access to experimental psychedelic therapies through Right to Try before full approval. Pharmaceutical companies and researchers developing psychedelic drugs stand to benefit from faster FDA review and priority vouchers, while state governments running psychedelic treatment programs become eligible for new federal funding and technical assistance. Physicians and researchers who want to administer or study Schedule I substances will be able to seek handling authorizations through a new formal pathway that the FDA and DEA are required to create.