The news: Psychedelic drugs will get expedited FDA review and research under an executive order President Donald Trump signed this weekend. The order also directs $50 million in federal funding toward research on the psychoactive drug ibogaine, and calls on the FDA to establish a pathway for eligible patients to access treatments under the Right to Try Act.
For context, psychedelics have been illegal at the federal level since the Controlled Substances Act of 1970 was passed due to their high potential for abuse. Psychedelics have “no currently accepted medical use.” The FDA has approved only one psychedelic drug, Johnson & Johnson’s Spravato (a derivative of ketamine) to treat depression. In 2024, the FDA rejected Lykos Pharmaceuticals’ application for MDMA-assisted therapy for posttraumatic stress disorder.
Why it matters: While psychedelic drugs are gaining traction with consumers and drug developers, the medical and scientific community shows both measured optimism and concern.
Implications for healthcare providers and drugmakers: At least nine psychedelic candidates are in clinical trials currently, aiming for FDA review. They may now qualify for expedited review, cutting timelines from about 10 months to 1 to 2 months. FDA Commissioner Marty Makary said the first approvals could come as soon as this summer.
Trump’s order and new funding may speed up further research, development, and review. But rigorous clinical trials, evidence-based information, and healthcare professional oversight will remain key to both physician confidence and consumer uptake.
For providers, these drugs will likely remain tightly controlled, requiring in-office administration and supervision. New protocols for screening, consent, and follow-up care—and expanded training in therapy integration and managing psychological reactions—will be needed.
For drugmakers, faster approvals and potential breakthrough designations will bring added scrutiny around safety and abuse risk. Meeting payer expectations will require stronger real-world outcomes data and addressing concerns such as the cost of supervised visits.
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