White House fast-tracks psychedelics for serious mental health crises
Published Date: 4/22/2026
Presidential Document
Summary
Millions of Americans, including many veterans, struggle with serious mental illnesses that current treatments don’t fully fix. This new order speeds up research and approval of promising new therapies, like psychedelic drugs, to help those who haven’t found relief yet. The government is committing resources now to bring better treatments faster and save lives.
Analyzed Economic Effects
5 provisions identified: 5 benefits, 0 costs, 0 mixed.
Right-to-Try Access Pathway
The FDA and DEA must establish a pathway so eligible patients can access psychedelic drugs, including ibogaine compounds, under the federal Right to Try Act (21 U.S.C. 360bbb-0a). The agencies will also address any necessary Schedule I handling authorizations for treating physicians and researchers consistent with 21 U.S.C. 823.
VA Collaboration to Boost Trials and Data
HHS and FDA will work with the Department of Veterans Affairs (VA) and, where appropriate, the private sector to increase clinical trial participation, data sharing, and real-world evidence around psychedelic drugs, prioritizing Breakthrough Therapy-designated drugs. HHS, FDA, and VA are directed to sign data-sharing memoranda to make clinical study data available to FDA to speed evaluation under section 505 of the Federal Food, Drug, and Cosmetic Act.
Faster Rescheduling After Phase 3 Success
The Attorney General, in consultation with HHS, must review any product containing a Schedule I substance that has successfully completed Phase 3 clinical trials for a serious mental health disorder so that rescheduling (under 21 U.S.C. 811) may proceed as quickly as practicable for products ultimately approved under section 505 of the Federal Food, Drug, and Cosmetic Act.
Faster FDA Review for Psychedelic Drugs
The FDA Commissioner will award Commissioner's National Priority Vouchers to appropriate psychedelic drugs that have received Breakthrough Therapy designation, speeding their review. This prioritization explicitly applies to psychedelic products meeting the National Priority Voucher Program criteria.
$50M Federal Support for State Programs
The Advanced Research Projects Agency for Health (ARPA-H) within HHS will allocate at least $50 million from existing funds to support and partner with State governments that have enacted or are developing programs to advance psychedelic drugs for serious mental illnesses. The funding can be used for federal funding, technical help, and data sharing as allowed by law.
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