Psychedelic Therapy Has Real Promise. Bypassing the FDA Will Squander It.

Last week the President signed an executive order directing federal agencies to accelerate research into psychedelic medicines and expand access to them for serious mental illness, flanked at the signing by the Secretary of Health and Human Services and a podcaster. The science behind psychedelic-assisted therapy is genuinely exciting, perhaps the most promising development in psychiatric treatment in a generation, and yet the rollout being pushed by this administration risks turning that promise into something far less useful and considerably more dangerous.

The case for taking psychedelics seriously as medicine is grounded in a real clinical problem. Conventional psychiatric drugs, the antidepressants and mood stabilizers that anchor most mental health treatment in the United States, work by suppressing symptoms; patients take them every day, often for years, and the symptoms tend to return when the medication stops. For people living with severe depression, post-traumatic stress disorder, obsessive-compulsive disorder, or substance-use disorders, that pharmacological model has produced only modest, short-lived benefit, and millions of Americans cycle through medications without ever achieving stable recovery.

Psychedelic therapy operates on a different premise. A patient takes a compound. psilocybin from mushrooms, ibogaine from a West African shrub, or a synthesized molecule like MDMA or LSD. in one or a few structured sessions, with talk therapy before, during, and after. The compound creates a window of psychological openness during which deeply buried grief, shame, or trauma can be approached and processed in ways that ordinary clinical encounters rarely permit. A JAMA editorial framed it as a treatment that addresses the cause of symptoms instead of merely suppressing them, and the early data, though preliminary, are striking enough to justify substantial public investment.

The Right to Try Pathway Was Built for Different Patients

The executive order commits $50 million to ibogaine research and instructs the FDA to prioritize psychedelics holding Breakthrough Therapy designation, which is the right idea executed in a way I find troubling. The order also expands access through the Right to Try Act, a pathway designed for terminally ill patients who have exhausted approved treatments and want to try experimental therapies outside clinical trials. Using that mechanism for psychedelic therapy treats a population with serious but treatable mental illness as if they were dying, and it shifts patients out of the structured environments where we actually learn whether dosing protocols, therapy frameworks, and safety monitoring are working.

This administration has shown a recurring pattern of treating unproven compounds as ordinary consumer goods rather than medications, with the Secretary applying a similar approach to peptides and arguing that individual freedom matters more than safety and efficacy. There is real-world data on the safety of most psychedelics in recreational and ceremonial settings, and that data is genuinely useful. What it does not tell us is which dosing regimens, which patient populations, and which therapy structures produce reliable clinical benefit, and which produce harm.

The HIV/AIDS Activist Model Showed How to Do This Right

The argument that regulatory rigor and patient access are in tension is one I have heard for most of my career, and the historical record does not support it. The HIV/AIDS treatment activists of the late 1980s and 1990s, organizations like Treatment Action Group, understood that access and evidence were not opposing forces. They pushed the FDA to modernize trial designs, accelerate enrollment, and mobilize regulatory staff in ways that produced faster access to medical interventions that actually worked. Operation Warp Speed, whatever its political baggage, applied a version of the same lesson to Covid vaccines, compressing development timelines without abandoning the trials that told us whether the vaccines were safe and effective.

That is the model psychedelic therapy needs. The MDMA-assisted psychotherapy trial for PTSD published in Nature Medicine, despite its methodological critiques, demonstrates what serious research on these compounds can look like, and the field needs many more studies of that quality across a range of indications, dose schedules, and therapeutic frameworks. Bypassing the FDA in the name of urgency will give us a generation of patients who took psychedelics without learning whether the protocols they followed were the ones most likely to help them.

The promise of psychedelic medicine is that it could fundamentally change how we treat conditions that have resisted treatment for decades. Squandering that promise by skipping the work that turns a promising compound into a reliable therapy would be a public health failure measured in patients who took something hoping it would work and never found out whether it did.