Op-Ed: The FDA Is Moving Faster on Psychedelics — Now Washington Must Do More
By Peter J. Pitts
Every 11 minutes, an American dies by suicide. Millions more struggle to manage their mental health, cycling through medications, therapy, and hospital visits without finding relief.
In April, the FDA took a decisive step toward addressing this prolonged health emergency. In response to President Trump’s recent executive order, the agency announced plans to expedite review of certain psychedelic medicines for serious mental health conditions.
It’s about time.
America’s mental health crisis condemns millions to daily suffering. 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 affects one in five adults — a historic high.
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.
At least 30% of patients with major depressive disorder don’t respond to multiple courses of antidepressant treatment. About half of patients receiving antidepressants reported being dissatisfied with the results.
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 clinical trials under strict federal oversight. The FDA granted breakthrough therapy designation to several psilocybin-based treatments in 2018 and 2019. Today, there are more than 120 clinical trials underway.
The New England Journal of Medicine recently published the results of the largest-ever clinical trial for psilocybin-based medicine. A single dose of the medicine led to a significant improvement in depressive symptoms in just three weeks.
Skepticism is understandable. Psychedelics carry cultural baggage, and patients may have questions about safety. But the public debate around these compounds too often conflates recreational drug use with regulated medical use.
The psilocybin medicines under review would not pave the way to casual access. If approved, they would be prescribed by licensed clinicians, administered in controlled healthcare settings, and subject to the same high standards that govern any FDA-approved drug.
There is plenty of precedent for this approach. A ketamine-derived medicine is legally available for certain patients with treatment-resistant depression — but only in approved clinical settings. 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.
None of this requires lowering scientific standards. It demands that regulators and researchers apply those standards without bias — evaluating new medicines based on evidence, not assumptions.
For too long, America’s mental health system has forced patients to endure a trial-and-error treatment process that often leads nowhere. The FDA’s announcement offers a different way forward that takes the urgency of this crisis and the potential of new science seriously.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest. A version of this column was first published in the Washington Examiner.
