WASHINGTON — President Trump moved on Saturday to “reverse the crisis of serious mental illness in America” by boosting access to psychedelic drugs in clinical settings. In an executive order, he directed the federal government to rush access to treatments and reevaluate their status as controlled substances.
The order directs the Food and Drug Administration to expedite some psychedelics as breakthrough drugs, as well as allowing them to be used through right-to-try legislation, which allow terminally ill patients to try experimental drugs outside of usual regulatory pathways.
Marty Makary, the commissioner of the FDA, said three priority review vouchers would be given to three serotonin 2a agonists, psychedelics, next week. He said decisions from the agency could be expected later this summer.
The order also calls on federal agencies to rethink enforcement of federal laws for such drugs that are proving promising in clinical research. The Drug Enforcement Administration and Department of Justice will begin rescheduling reviews after successful phase-three trials.
Rescheduling of any drugs that are approved would go “very quickly,” Trump said.
It also provides $50 million in funding for states developing programs to further psychedelic treatments for mental illness.
The White House boost for psychedelics comes amid growing research suggesting they could be promising therapeutics for a host of hard-to-treat — and common — ailments, from depression to opioid addiction to post-traumatic stress disorder.
The order comes as the White House is in the midst of a politically sensitive reworking of its health policy agenda as Republicans lag in midterm election polls. Notably, the weekend psychedelics push came at the behest of influential podcaster Joe Rogan — who offered him a large audience ahead of the 2024 election — and leaders of the Make America Healthy Again movement, part of the White House’s unorthodox political coalition.
The president highlighted the “life-changing potential,” of the treatments, especially for veterans. “They’re having a hard time,” he said of veterans. “We’re bringing them new hope.”
From text message to executive order
The rush to change the government’s stance on the substances, described by officials and advocates, offers a window into the top-down policymaking under Trump.
Trump said he was called by Rogan and people who had taken psychedelics, who joined him at the signing ceremony, about the need to open access to the drugs.
Rogan said he texted Trump about research around ibogaine, and the president’s response was quick: “Sounds great. Do you want FDA approval? Let’s do it.”
The president marshaled his top health officials, he said.
“I called Bobby, I called Oz, I called Marty and Jay,” the president said. “It was uniform support.”
Mehmet Oz, who leads the Centers for Medicare and Medicaid Services, said during the announcement that the order was written in less than a week. “The president just would not take no for an answer,” he said.
Even before the order was signed, Trump appeared to push his agency heads to move faster.
Jay Bhattacharya, who leads the National Institutes of Health and is currently the top official at the Centers for Disease Control and Prevention, highlighted the need to better understand the drugs and how to use them.
“I do want to emphasize: this is something that we’re still studying, and we have to keep studying,” he said. “We have to figure out the right way to … administer it, that it’s safe, that we don’t just take it for granted that we already know everything — because we don’t.”
“But if it’s good, we want to get it approved fast, right?” the president responded, noting research can take a long time.
“I have a witness right here,” Trump said, pointing to veterans behind him who had responded positively to the treatment. “That, to me, is a study, right?”
The president was flanked by Morgan Luttrell, a Republican congressman from Texas who has supported access to the drugs, and Marcus Luttrell, his brother who served as a Navy SEAL, as well as other veterans — and his top health officials.
Trump suggested the testimonies of those in the room should guide regulatory decisions: “To me, that’s the best research of all, frankly.”
Leaders of companies developing psychedelic therapies told STAT after the announcement the scientific rigor needed for approval remained the same, emphasizing their commitment to producing strong 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, said in an interview after the order was signed.
Kabir Nath, CEO of Compass Pathways, which develops psychedelic therapies, said the scientists in the room emphasizing the need for high-quality research was reassuring.
“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.”
Win for drug developers — and MAHA moms?
The move also comes after some regulatory and political hurdles for clinical applications of psychedelics.
In 2024, for instance, Nora Volkow, the director of the National Institute on Drug Abuse — who joined Trump in the Oval Office for the Saturday announcement — said ibogaine was unlikely to receive approval because of concerns about cardiac side effects. (Makary said the new order would now offer a pathway for the first human trials of the drug.)
And administration officials vetoed a fast-track approval process for a psilocybin treatment from Compass Pathways earlier this year.
“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, the company’s CEO, 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.”
He and Barrow both declined to comment when asked whether their company’s treatments would be among the three getting fast-track FDA designations next week.
Advocates for broadening access to treatments, some of whom have been working behind the scenes for more than a year for new federal action, broadly praised the action. Barrow said it was “an incredibly big deal,” and Nath said it was “an encouraging sign” that could potentially shave months or more off the time needed to get 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 thanking the administration. “Psychedelics under development are undergoing rigorous scientific research and clinical trials, holding promise for treating multiple mental illnesses.”
The administration appears poised to move quickly — with officials already considering how they might make such treatments affordable for broader use.
Oz said the Center for Medicare and Medicaid Innovation was considering new models to cut down prices for psychedelic treatments, should research support further use. The pricing model could be announced by the end of the year, he said, noting it would be “a very different world” for treatment than a daily antidepressant, for instance — sometimes requiring medical professionals to administer it.
The move may also be seen as a win for the Make America Healthy Again movement — some of whom have advocated for expanded psychedelic use in the U.S. — after a series of moves from the administration that have riled MAHA leaders.
Calley Means, who has acted as a bridge between the MAGA and MAHA movements in the administration, said the order was a response to calls from MAHA moms for new treatments amid a growing mental health crisis.
“You know, MAHA — it’s a big deal,” Trump said.
Asked why he didn’t act during his first administration, Trump suggested — in addition to less research being available at the time — it hadn’t come up.
“Nobody told me about it, frankly,” he said.
