APRIL 24, 2026
FDA issues priority review vouchers for three psychedelic drug trials following Trump executive order
The Food and Drug Administration announced Friday it would award priority review vouchers to three companies developing psychedelic-based treatments for mental health conditions, including psilocybin for depression and methylone for PTSD. The announcement came six days after President Trump signed an executive order directing federal agencies to accelerate research and expand access to psychedelic therapies. The vouchers shorten review timelines from months to weeks but do not guarantee approval or indicate the drugs have been found safe or effective.
The FDA on Friday issued priority review vouchers to two unnamed companies studying psilocybin — the active ingredient in magic mushrooms — for treatment-resistant depression and major depressive disorder, and to a third company studying methylone, a drug related to MDMA, for post-traumatic stress disorder. The agency also authorized an early-phase clinical study of noribogaine hydrochloride, a metabolite of ibogaine, as a possible treatment for alcohol use disorder. The companies were not named in the FDA press release.
FDA Commissioner Marty Makary created the national priority voucher program last summer to reduce drug approval times for products addressing what he described as an "unmet public health need" or a national security priority. In a statement Friday, Makary said the agency owes "it to our nation's veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency," and stressed that development must be "grounded in sound science and rigorous clinical evidence."
The executive order Trump signed the previous Saturday was accompanied by an Oval Office event that included podcaster Joe Rogan, retired Navy SEAL Marcus Luttrell, and Americans for Ibogaine CEO W. Bryan Hubbard, among others. According to the AP, Rogan said he texted Trump about ibogaine, and the president responded: "Sounds great. Do you want FDA approval? Let's do it." Rogan's endorsement of Trump before the November 2024 election was described by White House aides, as reported by the AP, as a key factor in his victory.