WASHINGTON – President Trump moved Saturday to “reverse the serious mental illness crisis in America” by increasing access to psychedelic drugs in clinical settings. In an executive order, he directed the federal government to expedite access to treatment and reevaluate the drug’s status as a controlled substance.
The order directs the Food and Drug Administration to expedite the use of some psychedelics as breakthrough drugs and to allow their use through Right-to-Try laws, which allow terminally ill patients to try experimental drugs outside of normal regulatory channels.
Three serotonin 2a agonist and psychedelic drugs will be given priority review tickets next week, FDA Commissioner Marty McCulley said. He said a decision from the agency is expected later this summer.
The order also asks federal agencies to reconsider enforcement of federal laws against such drugs that have shown promise in clinical studies. The Drug Enforcement Administration and the Department of Justice will begin rescheduling the review after a successful Phase 3 clinical trial.
President Trump said rescheduling of approved drugs would happen “very quickly.”
It would also provide $50 million in funding to states to develop programs to further advance psychedelic treatments for mental illness.
The White House’s push for psychedelics comes amid a growing body of research suggesting they may be a promising treatment for many difficult-to-treat and common illnesses, from depression to opioid addiction to post-traumatic stress disorder.
The order comes as the White House is undergoing a politically sensitive review of its health care agenda as Republicans trail in midterm election polls. Notably, the weekend’s psychedelic promotion was at the behest of influential podcaster Joe Rogan and leaders of the “Make America Healthy Again” movement, part of the White House’s unconventional political coalition, which provides a large audience for the 2024 election.
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The president emphasized the treatment’s “life-changing potential” especially for veterans. “They’re going through a lot,” he said of the veterans. “We bring them new hope.”
From text messages to executive orders
The rush to change the government’s stance on drugs offers clues to top-down policymaking under President Trump, officials and advocates say.
Trump said he received calls from Logan, who attended the signing ceremony, and others who have taken psychedelic drugs about the need to open up access to drugs.
Logan said he texted President Trump about the research on ibogaine, and the president quickly replied, “Sounds great. Do you want FDA approval? Let’s do that.”
The president reportedly called a meeting of top health officials.
“I called Bobby, I called Oz, I called Marty and Jay,” the president said. “It was uniform support.”
Mehmet Oz, who heads the Centers for Medicare and Medicaid Services, said in a statement that the order was written within a week. “The president didn’t take no for an answer,” he said.
Even before signing the executive order, President Trump appeared to be urging government officials to act more quickly.
Jay Bhattacharyya, who led the National Institutes of Health and is currently the top official at the Centers for Disease Control and Prevention, emphasized the need for a better understanding of drugs and how they are used.
“I want to emphasize that this is something we are still researching and we must continue to research,” he said. “We have to find the right way to manage it, that it’s safe, and not take for granted that we already know everything, because we don’t know.”
“But if it’s good, you want it approved right away, right?” The president responded, noting that research could take a long time.
“Here’s a witness,” Trump said, pointing to the veterans behind him who had responded positively to treatment. “It’s a learning experience for me, isn’t it?”
The president was flanked by Republican congressman Morgan Luttrell of Texas, who has supported access to drugs, his brother Marcus Luttrell, a former Navy SEAL, other military veterans and top health officials.
Trump suggested that testimonies from those who were there should guide regulatory decisions, saying, “Frankly, to me, this is the best study of all.”
A win for drug developers and MAHA’s mom?
The move also comes over several regulatory and political hurdles to the clinical application of psychedelics.
Administration officials earlier this year vetoed an expedited approval process for psilocybin treatments. And in 2024, for example, Nora Borkow, director of the National Institute on Drug Abuse, who joined President Trump in the Oval Office for Saturday’s announcement, said ibogaine is unlikely to be approved due to concerns about heart side effects. (McQuarrie said the new order paves the way for the drug’s first human clinical trials.)
Still, advocates for expanded access to treatment, some of whom have been working behind the scenes for more than a year for the new federal action, applauded the move.
“Today’s executive order is a testament to the critical unmet medical need and the urgency for new, regulated, science-based innovation to address America’s mental health crisis,” John Costas, executive director of the Prescription Psychedelic Association, thanked the administration in a statement. “Psychedelics under development have undergone rigorous scientific research and clinical trials and show promise in the treatment of multiple psychiatric disorders.”
The government appears ready to act quickly, with authorities already considering ways to make such treatments more widely available and affordable.
Oz said the Center for Medicare and Medicaid Innovation is considering new models to lower the price of psychedelic treatments if there is research to support their further use. A pricing model could be announced by the end of the year, he said, noting that treatment would be a “completely different world” from, for example, daily doses of antidepressants, which in some cases would need to be administered by a medical professional.
The move could also be seen as a victory for the “Make America Healthy Again” movement, which some campaigners advocate for expanding the use of psychedelics in the United States, following a series of moves by the administration that have infuriated MAHA leaders.
Callie Means, who has served as a liaison between the MAGA and MAHA movements in the administration, said the order was in response to MAHA mothers’ calls for new treatments amid a growing mental health crisis.
“You know, MAHA, this is a big deal,” President Trump said.
Asked why he didn’t take action during his first administration, Trump suggested it didn’t occur to him, in addition to the lack of research available at the time.
“Frankly, no one told me about it,” he said.
