FDA accelerates review of psychedelic drugs under Trump directive

LEXINGTON, Ky. — The Food and Drug Administration announced Friday it will offer ultra-fast review to three psychedelic drugs being developed to treat mental health conditions, according to reporting from LEX 18 News. The move represents the latest step by the Trump administration toward possible approval of experimental treatments that remain illegal under federal law.

President Donald 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. 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 identify the companies in its announcement.

The vouchers do not guarantee approval but instead allow regulators to shorten their reviews from months to weeks. "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 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 development, the FDA authorized initial testing of a drug related to ibogaine, a powerful psychedelic made from an African shrub, for people with alcohol use disorder. Neurologist Deborah Mash, founder of the drugmaker DemeRx, said federal health officials rejected her grant proposals in the 1990s when she sought to study ibogaine for cocaine addiction. Mash said DemeRx's drug is a metabolite of ibogaine that avoids the same hallucinogenic effects and cardiac risks of the original substance.

The FDA's special treatment for psychedelics has renewed scrutiny of its Commissioner's National Priority Voucher program. Democratic members of Congress have noted that vouchers have gone to companies politically favored by the White House, including those that have agreed to cut medication prices. Virtually all psychedelics, including LSD and psilocybin, are classified as Schedule I substances, a category for high-risk drugs with no medically accepted use.