FDA to fast-track review of three psychedelic drugs after Trump directive

Summary

The U.S. Food and Drug Administration said it will use an “ultra-fast” review process for three psychedelic drugs being developed to treat mental health conditions, expanding the Trump administration’s push to speed research into psychedelics that remain illegal under federal law. FDA Commissioner Marty Makary said in a statement that the agency owes “to evaluate these potential therapies with urgency,” as it announced priority review vouchers tied to the FDA’s review-speed program.

The FDA said the reviews apply to three psychedelic therapies: two companies studying psilocybin, the active ingredient in magic mushrooms, for hard-to-treat forms of depression, and a third company studying methylone, a drug related to MDMA, for post-traumatic stress disorder. The FDA said the companies were not named in its press materials.

The agency said the vouchers do not guarantee approval. Instead, the FDA said the program is designed to try to shorten FDA review timelines from months to weeks, allowing it to move faster through the regulatory process for some psychedelic drug applications.

The FDA’s decision came after President Donald Trump signed an executive order last weekend directing federal agencies to speed research and loosen restrictions on psychedelics. The announcement reflects how far the administration has pushed the drug class toward the front of its agenda, including through support from Trump backers tied to mental health and veterans’ issues.

The FDA’s priority-review voucher program is also likely to bring renewed scrutiny, according to Democratic members of Congress who have said vouchers have gone to companies politically favored by the White House, including those that have agreed to cut prices on medications. FDA’s special treatment for psychedelics, the AP reported, is expected to reignite questions surrounding how the voucher system is used.

Separately, the FDA authorized initial testing of a drug related to ibogaine for people with alcohol use disorder. The AP reported that ibogaine has been embraced by some combat veterans as a way to treat trauma and addiction, though it is also known to sometimes cause dangerous irregular heart rhythms.

The drugmaker DemeRx is leading the ibogaine-related effort, and the AP reported that it is led by neurologist Deborah Mash. Mash told AP that every grant proposal she submitted to the National Institute on Drug Abuse was rejected in the past, and she said that federal funding shortfalls prevented the work from advancing earlier.

The AP reported that ibogaine is known to cause intense hallucinations, nausea, vomiting, tremors and sometimes dangerous irregular heart rhythms, and Mash said her company’s drug is a metabolite of ibogaine that does not carry the same hallucinogenic effects or risks as the original substance. The FDA’s authorization for initial testing means researchers can begin early evaluations under regulatory oversight rather than proceeding without FDA review.

The White House’s recent push for psychedelics also included a Saturday event where Joe Rogan—who appeared at the Oval Office event—discussed ibogaine and said he texted Trump about the drug. The AP reported that Rogan said Trump responded, “Sounds great. Do you want FDA approval? Let’s do it,” and tied his endorsement to his earlier discussions of the substance on his podcast; Rogan said he learned about ibogaine from Ed Clay, who runs retreats using it in Mexico.