WASHINGTON — On Saturday, President Trump took steps to “reverse the crisis of serious mental illness in America” by enhancing access to psychedelic drugs in clinical settings. Through an executive order, he instructed federal agencies to expedite access to these treatments and reconsider their classification as controlled substances.
The executive order mandates the Food and Drug Administration (FDA) to hasten the approval of certain psychedelics as breakthrough therapies. It also supports their use under right-to-try legislation, which permits terminally ill patients to access experimental drugs outside standard regulatory processes.
FDA Commissioner Marty Makary announced that three priority review vouchers would be allocated to three serotonin 2a agonists, or psychedelics, in the upcoming week, with decisions from the agency anticipated later this summer.
The order further urges federal agencies to reassess the enforcement of federal laws concerning these drugs, given their promising results in clinical research. The Drug Enforcement Administration and the Department of Justice are expected to begin rescheduling reviews following successful phase-three trials.
Trump stated that the rescheduling of any approved drugs would proceed “very quickly.”
The order also allocates $50 million for states to develop programs aimed at advancing psychedelic treatments for mental health conditions.
The White House’s support for psychedelics arises amid increasing research indicating their potential as effective treatments for a variety of challenging and prevalent conditions, such as depression, opioid addiction, and post-traumatic stress disorder.
This initiative comes as the White House is undergoing a politically sensitive overhaul of its health policy agenda, with Republicans trailing in midterm election polls. The recent push for psychedelics was notably influenced by popular podcaster Joe Rogan, who offered Trump a broad audience leading up to the 2024 election, and leaders of the Make America Healthy Again movement, which is part of the president’s unconventional political coalition.
The president emphasized the “life-changing potential” of these treatments, particularly for veterans, stating, “They’re having a hard time. We’re bringing them new hope.”
From text message to executive order
The swift shift in the government’s stance on these substances, as described by officials and advocates, highlights the top-down policymaking style under Trump.
Trump mentioned that he was contacted by Rogan and individuals who had used psychedelics, who joined him at the signing ceremony, to discuss the necessity of expanding access to these drugs.
Rogan recounted texting Trump about research on ibogaine, to which the president quickly responded, “Sounds great. Do you want FDA approval? Let’s do it.”
The president then rallied his chief health officials, saying, “I called Bobby, I called Oz, I called Marty and Jay. It was uniform support.”
Mehmet Oz, head of the Centers for Medicare and Medicaid Services, noted during the announcement that the executive order was drafted in under a week. “The president just would not take no for an answer,” he commented.
Even prior to signing the order, Trump seemed to urge his agency leaders to accelerate their efforts.
Jay Bhattacharya, who leads the National Institutes of Health and is also the top official at the Centers for Disease Control and Prevention, stressed the importance of understanding these drugs and their proper application.
“I do want to emphasize: this is something that we’re still studying, and we have to keep studying,” he remarked. “We need to determine the safest and most effective way to administer these treatments without assuming we already know everything — because we don’t.”
The president replied, “But if it’s good, we want to get it approved fast, right?” pointing out that research can be a lengthy process.
“I have a witness right here,” Trump said, gesturing to veterans behind him who had positive experiences with the treatment. “That, to me, is a study, right?”
The president was accompanied by Morgan Luttrell, a Republican congressman from Texas who has supported drug access, and his brother Marcus Luttrell, a former Navy SEAL, as well as other veterans and top health officials.
Trump proposed that the testimonies from those present should guide regulatory decisions: “To me, that’s the best research of all, frankly.”
Executives from companies developing psychedelic therapies affirmed to STAT that the scientific standards for approval remain unchanged, emphasizing their commitment to producing robust data.
“Nothing about any of this should lower the bar or the requirements for getting drugs approved and reviewed,” Rob Barrow, CEO of Definium Therapeutics, stated in an interview following the order’s signing.
Kabir Nath, CEO of Compass Pathways, which develops psychedelic therapies, found reassurance in the emphasis on high-quality research from scientists present at the announcement.
“To me, that was an important component of today, and as Compass, we continue to believe that [building the right body of evidence] absolutely needs to be at the center,” he said.
Win for drug developers — and MAHA moms?
This initiative also follows various regulatory and political challenges faced by clinical applications of psychedelics.
For instance, in 2024, Nora Volkow, the director of the National Institute on Drug Abuse, who was present at the Oval Office announcement, expressed concerns about ibogaine’s approval due to potential cardiac side effects. Makary noted that the new order would now provide a pathway for the first human trials of the drug.
Earlier this year, officials had vetoed a fast-track approval process for a psilocybin treatment from Compass Pathways.
“There have been a lot of vocal advocates for the potential for psychedelics within and on the orbit of this administration for a long time,” Nath told STAT after the executive order was signed. “I’m not an expert in how political processes come to conclusions, so we’re just very happy that it has happened and that it’s happened now.”
Both he and Barrow declined to comment on whether their company’s treatments would be among the three receiving fast-track FDA designations next week.
Advocates for expanding treatment access, some of whom have been working behind the scenes for over a year to push for new federal action, widely applauded the move. Barrow described it as “an incredibly big deal,” and Nath called it “an encouraging sign” that could significantly reduce the time needed to deliver treatments to patients.
“Today’s Executive Order validates the critical unmet medical need to address the mental health crisis in America and the urgency for new and regulated, science-based innovations,” Jon Kostas, executive director of the Association for Prescription Psychedelics, said in a statement expressing gratitude to the administration. “Psychedelics under development are undergoing rigorous scientific research and clinical trials, holding promise for treating multiple mental illnesses.”
The administration appears ready to act swiftly, with officials already considering how to make these treatments affordable for broader access.
Oz mentioned that the Center for Medicare and Medicaid Innovation is exploring new models to reduce prices for psychedelic treatments, should research justify broader use. The pricing model could be announced by the end of the year, he said, noting that it would represent “a very different world” for treatment compared to daily antidepressants, as administration might sometimes require medical professionals.
This move may also be seen as a triumph for the Make America Healthy Again movement, which has advocated for expanded psychedelic use in the U.S., following several actions by the administration that have upset MAHA leaders.
Calley Means, who has served as a link between the MAGA and MAHA movements within the administration, said the order was a response to calls from MAHA moms for new treatments amidst a growing mental health crisis.
“You know, MAHA — it’s a big deal,” Trump remarked.
When asked why he didn’t take action during his first term, Trump suggested that it was due to less available research at the time, adding, “Nobody told me about it, frankly.”
