U.S. Health Secretary Robert F. Kennedy Jr. told lawmakers he expects the Food and Drug Administration to authorize at least one form of clinical psychedelic therapy within 12 months, marking the most aggressive federal timetable yet for substances such as MDMA and ibogaine that remain classified as illegal Schedule 1 drugs. FDA Commissioner Marty Makary has labeled the evaluation of psychedelics a "top priority" and outlined measures that could shrink review times to as little as one month and relax certain trial requirements. The agency is reconsidering MDMA for post-traumatic stress disorder after rejecting the treatment under the Biden administration for data flaws. The push has galvanized veterans organizations and allies including former Texas governor Rick Perry. Texas last month set aside $50 million—the largest U.S. government grant of its kind—to study ibogaine’s potential to treat opioid addiction and PTSD, adding state-level momentum to the federal effort. Researchers and industry figures are split on the accelerated approach. Advocates say faster approval will expand options for patients with hard-to-treat conditions, while critics warn that bypassing rigorous placebo-controlled studies could jeopardize safety and discredit the nascent field if therapies are rushed to market or become closely tied to Kennedy’s controversial health record.
For decades, proponents of psychedelic drugs have come to Washington with a provocative message: Illegal, mind-altering substances like LSD and ecstasy should be approved for Americans grappling with depression, trauma and other hard-to-treat conditions. https://t.co/dVgLA1Ukrl
Will RFK Jr.’s push for psychedelic therapy help or hamper the emerging field? https://t.co/dEwbZ59Owr https://t.co/okqhAjVuDD
Will RFK Jr.'s push for psychedelic therapy help or hamper the emerging field? https://t.co/f3p5D4iRiL