Every 11 minutes, an American dies by suicide. Millions more struggle to manage their mental health, cycling through medications, therapy appointments, and hospital visits without ever finding relief.
In late April, the FDA took a decisive step toward addressing this prolonged health emergency. In response to President Donald Trump’s recent executive order, the agency announced plans to expedite the review of certain psychedelic medicines for serious mental health conditions.
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It’s about time.
FDA FAST-TRACKS PSYCHEDELIC DRUG RESEARCH FOLLOWING TRUMP EXECUTIVE ORDER
The U.S.’s mental health crisis currently condemns millions to daily suffering, with little hope of relief. Given just how few effective treatments exist, the government should not let psychedelic medicines languish in regulatory limbo. Science-backed psychedelic treatments should be evaluated with the same urgency as other promising medicines.
Nearly a quarter of U.S. adults suffer from a mental illness. Depression alone now affects 1 in 5 adults — a historic high, according to a recent Gallup poll.
For many patients, particularly those with severe or treatment-resistant depression, today’s standard of care often falls short. Most widely prescribed medications rely on mechanisms developed decades ago and often take weeks to produce modest effects, if they work at all.
By one estimate, at least 30% of patients with major depressive disorder don’t respond to multiple courses of antidepressant treatment. Even among those who do respond, remission is far from guaranteed. According to one recent literature review, about half of patients receiving antidepressants reported being dissatisfied with the results. Nearly one-third tried switching medications.
It is against this backdrop that a new class of treatments — psychedelic compounds such as psilocybin — has begun to attract serious scientific and regulatory attention.
Once dismissed as fringe, researchers are now investigating these medicines in rigorous clinical trials at leading academic institutions and under strict federal oversight. The FDA first granted breakthrough therapy designation to several psilocybin-based treatments back in 2018 and 2019. And today, more than 120 clinical trials are underway involving these compounds.
In a growing number of studies, a single or small number of supervised psilocybin administrations has led to rapid and sustained reductions in symptoms of depression, including among patients who had not responded to other treatments.
Results have been striking in larger studies as well. The New England Journal of Medicine recently published the results of the largest-ever clinical trial for psilocybin-based medicine. The study found that just a single dose of the medicine administered under the supervision of a clinical professional led to a significant improvement in depressive symptoms in just three weeks — a response that continued for as long as 12 weeks in some patients.
Skepticism is understandable, of course. After all, psychedelics carry cultural baggage, and patients may have questions about psilocybin’s safety. But the public debate around these compounds too often conflates recreational drug use with the separate matter of regulated medical use.
That’s a mistake.
The psilocybin medicines now under review would not pave the way to legalization or casual access. If approved, they would be prescribed by licensed clinicians, administered in safe, controlled healthcare settings, and subject to the same high standards that govern any FDA-approved drug.
There is plenty of precedent for this approach. For instance, there is already a ketamine-derived medicine that is legally available for certain patients with treatment-resistant depression — but only in approved clinical settings.
Seen in this light, the FDA’s decision to expedite review of psychedelic medicines is both appropriate and long overdue.
But faster FDA review is only part of the equation. Once the FDA approves a psychedelic-based medicine, the Drug Enforcement Administration must reschedule the substance before it can become available to patients — another step in the process that should happen swiftly and in coordination with the FDA.
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None of this requires lowering scientific standards. On the contrary, it demands that regulators and researchers apply those standards consistently and without bias — evaluating new medicines based on evidence, not assumptions.
For too long, America’s mental health system has forced suffering patients to endure a trial-and-error treatment process that often leads nowhere. The FDA’s recent announcement offers a glimpse of a different way forward — one that takes both the urgency of this crisis and the possibility of new science seriously.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
