President Donald Trump signed an executive order on April 18 in the Oval Office — joined by HHS Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, CMS Director Mehmet Oz, Rep. Morgan Luttrell (R-TX), and podcaster Joe Rogan — directing the FDA to issue new guidance for clinical trials on psychedelics including psilocybin, ibogaine, LSD, and MDMA.
The order will “dramatically accelerate access to new medical research and treatments based on psychedelic drugs,” Trump said, by cutting bureaucratic hurdles, improving FDA-VA data sharing, and expediting rescheduling of FDA-approved psychedelics. The administration is also committing $50 million for state-level ibogaine research and opening a Right to Try pathway for the substance — a law from Trump’s first term.
On rescheduling, the order directs the Attorney General, in consultation with HHS, to initiate and complete review of Schedule I substances that complete Phase 3 trials for serious mental health disorders, under 21 U.S.C. 811, for products approved under section 505 of the Federal Food, Drug, and Cosmetic Act.
Kennedy pledged that HHS will coordinate with the DEA and Department of Justice on post-Phase 3 rescheduling reviews. “This executive order will remove legal impediments that block American researchers, scientists, physicians and clinicians from properly studying these medicines and, where appropriate, establishing protocols for their safe therapeutic use,” he said.
FDA Commissioner Makary announced three national priority vouchers for psychedelics and the first ibogaine investigational new drug clearance, which he said will “pave the way for the first-ever human trials in the United States” on the substance. “Under this new program in this administration, drugs can get approved in weeks—not a year or a year plus, but in weeks—if they are in line with our national priorities,” he said.
Luttrell, a veteran who attended the ceremony, said he can personally attest to ibogaine’s benefits. Psilocybin and MDMA already hold FDA “breakthrough therapy” designations; the order expedites further review of both.
Texas recently announced its own ibogaine clinical research program after failing to find a company to lead a consortium under a bill passed last year. The action comes four months after Trump separately directed the DOJ to move marijuana from Schedule I to Schedule III “in the most expeditious manner” — a process still unfinished.
Bipartisan lawmakers this session introduced legislation to provide $30 million annually for psychedelic-focused “centers for excellence” at VA facilities, offering veterans access to psilocybin, MDMA, and ibogaine treatments.
