The White House directive to put psychedelics on a regulatory fast track is at once welcome and worrisome. The attention to psychedelics is overdue, and there’s a real opportunity to build a stronger scientific base for a promising field.

Yet this area of medicine also demands extra care — or the U.S. risks unleashing complex therapies into an infrastructure unprepared to support them. Americans have already seen what happens when a promising therapy outpaces oversight.

Once on the fringes, psychedelics are drawing in a larger swath of Americans seeking relief from their mental health struggles. One analysis found that nearly 5% of American adults had used at least one psychedelic substance in 2023. And a new survey from RAND found a sizable chunk of psychedelics users are “microdosing” psilocybin, MDMA or LSD.

While some surely are using the drugs recreationally, many are convinced psychedelics are the answer to their anxiety, depression, PTSD and more.

Days after President Donald Trump signed an executive order to accelerate the development of psychedelics, the Food and Drug Administration said it had issued special vouchers to speed up the review of three such products.

If done right, this sharpened regulatory focus on psychedelics could shift the field away from claims of quick cures toward a more nuanced understanding of what psilocybin, MDMA and other therapies can — and, as importantly, cannot — offer people in need.

The question now is whether this FDA, which has in the past year made changes that run counter to the evidence, can get it right. The agency must move forward carefully.

Psychedelics have undergone a renaissance in recent years as researchers start to understand their potential to rapidly rewire brain circuitry. While conventional antidepressants might take weeks or even months to work, psilocybin and other therapies promise a more immediate effect. For people who have run out of other options, the appeal is hard to ignore.

But getting therapies through the formal regulatory process has been fraught. Among the challenges: It’s hard to do a randomized study of a hallucinogen, since people tend to know if they’ve taken a placebo. Researchers are developing better methods to pin down whether and by how much a given psychedelic helps. To that end, the FDA said it would soon offer updated guidance on the appropriate design for clinical trials.

What’s more, in their full doses, these aren’t pills a patient simply picks up at their neighborhood pharmacy. Patients need to be carefully monitored, and treatment is typically accompanied by psychotherapy to process the hallucinogenic experience. That leaves open the question of how much of the improvement seen in studies hinges on their environment and the quality of their interactions with providers — and whether both can be replicated in the real world.

And even in the most optimal settings, the clinical data suggest these therapies are not a panacea. “Hype doesn’t mean there’s not hope,” says Jonathan Alpert, chair of psychiatry and behavioral sciences at Montefiore Einstein. “But it needs to be backed up by really careful science and also a lot of thought about implementation.”

That implementation won’t be easy. Bringing psychedelics to market safely and at scale will be challenging — and is reason for the FDA to proceed with caution.

We’ve already seen how easily that can go wrong. The for-profit free-for-all with ketamine clinics has left consumers to navigate a vast marketplace where not all providers follow rigorous protocols. And while there’s a robust body of research supporting the use of small doses of ketamine for severe depression, many of those clinics are operating in areas where the evidence is sparse to nonexistent — all while asking consumers to pay handsomely for the privilege.

That has opened the door to abuse, both by providers and patients, says Steven Siegel, vice president for behavioral health at the University of Southern California. “The lesson with ketamine is if there’s money to be made, there’s going to be plenty of people out there that think you need it,” he says.

It’s not hard to imagine how that dynamic could play out with psilocybin, MDMA and other substances.

This risk should be top of mind at the FDA as it considers giving its stamp to the first psychedelics. It’s not enough for a provider to have expertise in, say, psilocybin. People with challenging conditions deserve care from professionals who understand their treatment history and personal needs. That’s especially critical given these therapies carry risks, and some people are particularly vulnerable to them — for example, those with a history of psychosis, says Alpert.

Moreover, patients deserve care from providers who anticipate what comes after the positive effects of a psychedelic start to wane — or if they don’t work at all. “With every single innovative treatment that has ever been developed, no matter how good they are, there’ll be a percentage — not a trivial percentage — of people who don’t respond, or who seem to respond initially and then relapse,” Alpert says.

There’s undeniable potential for psychedelics to help many people, potential that for too long was difficult to explore without health agencies’ full support. But in the zeal to meet the moment, regulatory authorities shouldn’t overlook the complexities of these treatments — and the very real risk of getting it wrong.

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This column reflects the personal views of the author and does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.

Lisa Jarvis is a Bloomberg Opinion columnist covering biotech, health care and the pharmaceutical industry. Previously, she was executive editor of Chemical & Engineering News.

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