Makary Support Vouchers for Psychedelic Therapies
FDA commissioner Marty Makary says the agency will deploy its new “national priority voucher” program to significantly shorten drug review timelines for three psychedelic therapies at the center of president Donald Trump’s executive order signed over the weekend (see earlier story). The vouchers could reduce review periods to roughly 40 to 50 days, compared to the typical timeline of nearly a year, he says. “This is about moving faster without compromising safety,” Makary said on Fox Business, noting that FDA has already issued 18 such vouchers across therapeutic areas and plans to issue additional ones soon.
The administration is also committing at least $50 million in funding to support psychedelic research through federal-state partnerships coordinated by HHS. The initiative builds on growing bipartisan interest in alternative mental health treatments, including support from Health secretary Robert F. Kennedy Jr.
The executive order was a move influenced in part by podcaster Joe Rogan. According to accounts of the Oval Office meeting over the weekend, Rogan shared information with Trump about ibogaine — a psychoactive compound increasingly discussed among veterans and conservative policymakers — and later texted the president about the drug. Trump responded: “Sounds great. Do you want FDA approval? Let’s do it,” underscoring the informal but direct role Rogan played in elevating the issue.
The executive order directs federal agencies to “dramatically accelerate” access to potential psychedelic therapies, including ibogaine, which remains classified as a Schedule I controlled substance under federal law. Despite that designation, the administration is taking steps to ease research barriers and expand clinical study pathways for conditions such as severe depression and PTSD.
Advocates, including veterans groups, argue that ibogaine may offer benefits for hard-to-treat conditions such as PTSD and opioid addiction. Former Navy SEAL Marcus Luttrell, who attended the White House event, told Trump the therapy “absolutely changed my life for the better.”
However, the policy shift comes with notable scientific and safety concerns. Ibogaine has been associated with serious cardiac risks, including irregular heart rhythms, and has been linked to more than 30 deaths in published medical literature. The National Institutes of Health previously funded research into the drug but halted those efforts decades ago due to concerns about cardiovascular toxicity.
Makary acknowledged the risks but emphasized that the FDA will continue to require robust clinical evidence. The agency is also moving to enable the first human trials of ibogaine in the U.S. under the investigational new drug pathway.
More broadly, no psychedelic therapy has yet been approved in the U.S., though substances such as psilocybin, MDMA and LSD are currently being evaluated in late-stage clinical trials. All remain federally illegal, though states including Oregon and Colorado have legalized certain forms of psychedelic-assisted therapy.
Despite the uncertainties, Trump framed the initiative as a potentially transformative step. “If these turn out to be as good as people are saying, it’s going to have a tremendous impact,” he said during the signing ceremony.