Psychedelics research after Trump's executive order aims to speed FDA review

President Donald Trump signed an executive order directing the FDA to expedite review of certain psychedelics and asking the Attorney General and HHS to review rescheduling for products that complete late-stage clinical trials.

President Donald Trump signed an executive order directing the Food and Drug Administration to accelerate its review of certain psychedelic substances. The order targets therapies being studied for conditions such as PTSD, depression and addiction and asks the Attorney General and the Department of Health and Human Services to review rescheduling for products that successfully complete late-stage clinical trials. Researchers and experts quoted in coverage say the move could make it easier to obtain controlled substances for study, while emphasizing that safety and rigorous review remain important. Past small trials have reported some sustained benefits for substances like psilocybin in carefully supervised settings, but regulators and advisers have also noted safety and efficacy questions. Key points: - The executive order directs the FDA to expedite review of certain psychedelics and asks the Attorney General and HHS to review rescheduling for products that complete late-stage clinical trials. - Experts say rescheduling could ease researcher access to controlled substances, but they stress that established regulatory review and safety standards should not be bypassed. - Small clinical studies, including a 2022 Johns Hopkins trial and a 2025 veterans study, reported some lasting antidepressant effects from psilocybin for some participants, with varying durations of benefit. - A 2024 FDA advisory panel voted against recommending approval of a pharmaceutical MDMA therapy for PTSD, and the FDA later did not approve that combination; the executive order also named ibogaine and the record notes concerns about cardiac risks reported in earlier studies. Summary: The executive order is intended to speed regulatory review and to prompt rescheduling reviews that could reduce barriers for researchers studying psychedelics. Agencies named in the order will review products and potential rescheduling, while experts emphasize maintaining rigorous safety and efficacy assessment. Undetermined at this time.