FDA to offer ultra-fast review for three psychedelic therapies after Trump order
WASHINGTON — The Food and Drug Administration said Friday it will offer ultra-fast review to three psychedelic drug candidates for hard-to-treat mental health conditions, including major depression, following an executive order from President Donald Trump directing federal agencies to accelerate research and loosen restrictions on the substances.
The agency said it awarded priority review vouchers to two companies studying psilocybin, the active ingredient in so-called magic mushrooms, for forms of depression that are difficult to treat. 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 announcement. Psychedelics remain illegal under federal law. “We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency,” FDA Commissioner Marty Makary said in a statement.
The vouchers do not guarantee approval; instead, they are intended to shorten the agency’s reviews from a period of months to weeks. The moves reflect growing popular support for psychedelics among some of Trump’s supporters, including combat veterans and followers of the Make America Healthy Again movement spearheaded by Health Secretary Robert F.
Kennedy Jr. Last July, Kennedy told members of Congress his department aimed to make psychedelics available for hard-to-treat psychiatric conditions within one year. Some of his allies and staffers are proponents of the drugs; Calley Means, a former Kennedy campaign staffer now serving as a senior health adviser, has previously written about the “mind-blowing” power of psychedelics and his plans to invest in companies developing them.
The FDA’s special handling is likely to renew scrutiny of its speed-up mechanism, known as the Commissioner’s National Priority Voucher program. Democratic lawmakers have noted that vouchers have gone to companies viewed as politically favored by the White House, including firms that agreed to cut prices on their medications.
In a separate move, the FDA authorized initial testing of a drug related to ibogaine, a powerful psychedelic derived from an African shrub, for people with alcohol use disorder. Ibogaine is known to sometimes cause dangerous heart rhythms. The agency’s actions could accelerate timelines for several closely watched experimental therapies, while leaving the ultimate approval decisions to forthcoming reviews of safety and efficacy.