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The Trump administration issued an executive order earlier this month to accelerate access to psychedelic medication for people with “serious mental illnesses”, but experts say the order is more likely to make a difference symbolically than legally.
“Policymakers and the medical field have long struggled to address the burden of suicide and serious mental illness rates in America,” the order reads, noting that some people do not respond to available treatments.
The order then lists provisions to accelerate access to psychedelic medications, including inter-agency collaboration with the Department of Veterans Affairs to share data and increase clinical trial participation, and timely rescheduling in the case that an illegal psychedelic receives FDA approval.
Mason Marks, a law professor at Florida State University and senior fellow for psychedelic projects at Harvard Law’s Petrie-Flom Center, said that while the concrete provisions of the order will likely have only “some minimal impact”, he added that “the overall order itself could have a pretty significant impact, just in terms of its symbolic value”. Marks noted that the order came with a lot of fanfare, including a press conference with Joe Rogan, a podcaster, and Marcus Luttrell, a former Navy Seal.
“It’s quite unusual for a president to be promoting psychedelic research in such a public way,” Marks said. During the conference, Rogan said that a text conversation between himself and the president inspired the executive order.
Cat Packer, director of drug markets and legal regulation at the Drug Policy Alliance, said the order is also a signal of “who is influencing the administration”, noting that Republican support for psychedelics is expanding and includes elected officials, veteran advocates like Luttrell and “high-profile public figures with proximity to the president”, such as Rogan.
“It’s a welcome sign that the federal government is taking psychedelic research and access seriously,” Packer said, before cautioning that the same framing that seems to have made psychedelic medications more popular with some Republicans could also limit who benefits from legal changes.
Packer continued: “The administration is clearly leaning into a medicalized, veteran-centered framework, rather than a broader rights-based or anti-criminalization approach. Without sustained investments in healthcare access, community-based treatment and housing – resources the Trump administration has continued to divest from – we cannot truly address America’s mental health crisis.”
Trump issued a similar executive order in December directing that cannabis be reclassified from a schedule I to a schedule III substance, which would remove restrictions on research as well as potentially easing some of the tax burdens that come with selling it. The Biden administration had initiated the rescheduling process in 2022.
Even after four years, and the support of two presidents, the acting attorney general, Todd Blanche, only just announced this week that the Department of Justice would be partly delivering on the promise to reschedule cannabis. In his X post announcing the change on Thursday, he wrote the justice department is “ordering a new, expedited hearing … to fully reschedule marijuana”, and “immediately rescheduling FDA-approved marijuana and state-licensed marijuana from schedule I to schedule IIl”. The FDA-approved part is a bit nonsensical, since anything FDA-approved is by definition not schedule I, as schedule I drugs are classified as having “no accepted medical use”.
“There’s already been some evidence of institutional resistance when it comes to cannabis rescheduling. President Trump himself has suggested that parts of his administration have stalled the process – likely reflecting the reality that the [US Drug Enforcement Administration] has historically resisted efforts to reschedule marijuana,” Packer said.
Marks echoed that sentiment: “The reason I think the psychedelic order is different is that we haven’t seen anything from the White House [concerning the cannabis rescheduling].”
There are a few other reasons that the psychedelics order is more promising. While the cannabis order had one essential provision – rescheduling – this one includes more straightforward directives, Packer said, like funding state-level research. Plus, Marks said, “there’s no question the FDA is very open to this. We are on the cusp of seeing FDA approval potentially for a handful of psychedelics. I would put that somewhere in the one-to-three-year range.” Drugs that are far along in the process include psilocybin for treatment-resistant depression.
That these drugs are already close to approval render some elements of the order somewhat meaningless. For example, while the order directs the Drug Enforcement Administration to reschedule any drug that successfully completes a phase 3 trial, Marks pointed out that the agency is already obligated to do that within 90 days. “You can’t get much faster than that,” Marks said.
The order also indicates that the FDA’s safety review process should be accelerated. Marks is concerned this provision will require reviewers to employ AI to help accelerate the process, which could lead to missed adverse events. Psychedelic clinical trials have already come under scrutiny for failing to report adverse events.
“The problem is that if they miss something, and then some adverse event crops up, after the drug is out in the market, it might have to be recalled, and that’s a horrible scenario, it really sets back everything,” Marks said.
Packer agreed, saying: “Faster review and expanded research can be positive, but only if they are paired with rigorous evidence, strong patient protections and a broader public-health approach. It’s also important to note that while these substances hold promise, they are not a panacea.”
