Agencies would speed research and review of psychedelic treatments

The FDA Commissioner shall provide National Priority Vouchers to qualifying psychedelic drugs, and the FDA and DEA shall facilitate a Right to Try pathway. This covers psychedelic drugs, including ibogaine compounds, that have Breakthrough Therapy designation and meet the voucher program’s criteria, plus eligible patients and authorized doctors or researchers. Access must follow the Right to Try Act, controlled-substance law, and other applicable law. Schedule I handling authorizations and any waivers must meet legal requirements.

The HHS Secretary shall allocate at least $50 million from existing funds to support and partner with participating State governments. The funding covers States that have enacted or are developing programs for psychedelic drugs used to address serious mental illnesses. Support may include Federal funding, technical assistance, and data sharing. The work must follow applicable law and depends on available funds.

HHS, the FDA, and the VA shall increase clinical-trial participation, data sharing, and real-world evidence collection for psychedelic drugs. The work covers psychedelic drugs, with priority for drugs that have Breakthrough Therapy designation, and may include private-sector partners. Data sharing must follow the Privacy Act, HIPAA, and other applicable law. Agencies shall share relevant study data with the FDA to help evaluate drugs that meet legal approval standards.

The Attorney General shall begin and finish a review of covered Schedule I products. This covers products containing a Schedule I substance that successfully completed Phase 3 trials for a serious mental health disorder and are ultimately approved by the FDA. Rescheduling may proceed only if appropriate under the Controlled Substances Act. The order does not itself reschedule or approve any product. The review applies after successful Phase 3 trials and concerns products ultimately approved under the Federal Food, Drug, and Cosmetic Act.