The Psychedelic Horizon: Federal and State Shifts Reshaping Behavioral Health Law and Practice

Healthcare attorney Shalyn Watkins wrote an article for the American Health Law Association about the historic transformation underway in the legal regulation of psychedelic substances in the U.S. For more than half a century, the Controlled Substances Act (CSA) consigned psychedelics to Schedule I, foreclosing them to research and development as well as any practical clinical uses. However, Ms. Watkins says, that posture is now shifting, driven by Executive Order 14401 directing federal agencies to accelerate psychedelic drug access, U.S. Food and Drug Administration (FDA) actions including priority review vouchers and finalized clinical trial guidance, and a growing patchwork of state laws ranging from decriminalization to fully regulated therapeutic frameworks. Ms. Watkins' article surveys the current landscape and identifies the key legal and compliance challenges healthcare attorneys must confront as psychedelic-assisted therapy moves toward mainstream clinical practice, including U.S. Drug Enforcement Administration (DEA) scheduling, prescriber licensing, clinical trial infrastructure, reimbursement, patient safety and equitable access for underserved communities.

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