NEJM Interview: Marcus Hughes on inconsistent oversight of psychedelic agents at the state and federal levels in the United States.

Both states and the US federal government have taken steps to expand opportunities for the use of psychedelic agents. But divergent approaches have produced an environment in which patients, clinicians, and policymakers may face conflicting expectations about access, safety, and clinical responsibility. I'm Stephen Morrissey, managing editor of the New England Journal of Medicine, and I'm talking with Marcus Hughes, an assistant professor of psychiatry at the Yale School of Medicine and an attending psychiatrist at Yale New Haven Psychiatric Hospital. Dr. Hughes has written a perspective article about balancing state and federal oversight of psychedelic agents. Dr. Hughes, which states have taken regulatory action related to psychedelic agents, and what types of use do they allow?

There are several different stances that have been taken by a variety of states. I think the most notable are Oregon and Colorado, which were kind of the first and the second state to implement kind of a structured pathway for psychedelics access. Both of those states do not permit what we consider medical use of psychedelics whereby you see a physician, you get a diagnosis, you get a prescription for a treatment. Those pathways exist kind of outside of that traditional medical system, but do permit experiences with psychedelics that are usually considered as therapeutic even though they exist outside of that model. And that was kind of done to try to increase access to these treatments that some might think are taking quite a while to get regulated in the traditional drug approval pathway that the FDA has stipulated. Other states such as New Jersey, Maryland, Washington, Utah, and many other states, actually most states have had some type of legislation around psychedelics either by setting up pilot research programs or some type of access way through medical pathways or non-medical pathways.

And then at the federal level, what has the Food and Drug Administration been doing with regard to psychedelics?

Well, it's been difficult. I think the FDA is quite cautious, specifically with psychedelics for several reasons. But they released a twenty-twenty three draft guidance actually on stipulating what they would like to see for clinical trialists who are producing evidence to potentially support the approval of a psychedelic drug or a psychedelic treatment, which has been very helpful for the field to kind of streamline the design of quality clinical trials. And so that has been encouraging for many of us in the field and signals to us that, "Hey, we are open to the federal regulation of a psychedelic treatment as long as you guys do it kind of in the manner that they stipulate." I think many of us were somewhat discouraged by the recent non-approval of MDMA for PTSD. Uh, it's a psychedelic agent or an agent considered a psychedelic by many that was up for recent FDA approval and was shot down due to a number of concerns that the FDA had. So on one hand, they're saying, "Hey, we're open. Produce some quality evidence, and we'll consider it." Many psychedelic drugs have been given breakthrough therapy designation by the FDA, which again signals that they are open to sort