FDA issues priority review vouchers for three psychedelic drug trials following Trump executive order

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.

Health and Human Services Secretary Robert F. Kennedy Jr. said in a press release that the actions are a step in the right direction "to confront our nation's mental health crisis head-on, especially for our veterans." The AP reported that Kennedy told members of Congress in July that his department aimed to make psychedelics available for hard-to-treat psychiatric conditions within one year. Calley Means, a former Kennedy campaign staffer now serving as a senior health adviser, has previously written about the potential of psychedelics and has disclosed plans to invest in companies developing the drugs.

Nearly all psychedelics — including psilocybin, LSD, and MDMA — remain classified as Schedule I substances under federal law, a category for drugs considered high-risk with no currently accepted medical use. The AP reported that dozens of small drugmakers, many backed by Silicon Valley investors, have entered the race to win FDA approval for psychedelics. Tech investor Peter Thiel, who has made political donations to both Trump and Vice President JD Vance, has invested in AtaiBeckley, a company studying MDMA and other psychedelic compounds, according to the AP.

The FDA's priority voucher program is drawing scrutiny from Democratic members of Congress, who have noted — as the AP reported — that vouchers have gone to companies described as politically favored by the White House, including some that agreed to cut drug prices. The FDA press release emphasized that none of Friday's actions constitute full approval and that the agency will work closely with developers as clinical testing proceeds.