The FDA announced Friday it will offer ultra-fast review to three psychedelic drugs being developed to treat mental health conditions, including depression. President Trump signed an executive order directing the FDA and other federal agencies to speed research and loosen restrictions on psychedelics, a class of hallucinogenic drugs that remain illegal under federal law.
Voucher Awards and Fast-Track Timeline
The FDA awarded priority review vouchers to two companies studying psilocybin—the active ingredient in magic mushrooms—for hard-to-treat forms of depression. A third company received a voucher for methylone, a drug related to MDMA, for post-traumatic stress disorder. The FDA did not name the companies in its press release. FDA Commissioner Marty Makary stated: “We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency.” The vouchers don’t guarantee approval but mean regulators will try to shorten their reviews from months to weeks.
Political Support and Safety Considerations
The recent moves reflect growing popular support for psychedelics among Trump’s supporters, including combat veterans and followers of the Make America Healthy Again movement led by Health Secretary Robert F. Kennedy Jr. Last July, Kennedy told Congress his department aimed to make psychedelics available for hard-to-treat psychiatric conditions within one year. In a separate move, the FDA authorized initial testing of a drug related to ibogaine for alcohol use disorder. DemeRx is led by a Florida-based researcher who first began studying ibogaine as a treatment for cocaine addiction in the 1990s, before federal health officials pulled funding. Ibogaine is known to cause intense hallucinations, nausea, vomiting, tremors, and sometimes dangerous irregular heart rhythms.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.smdp.com/fda-plans-ultra-fast-review-of-three-psychedelic-drugs-following-trump-directive/