Davis, Farchione and Colleagues Present FDA’s Psychedelic Drug Framework in NEJM

In a commentary published in the New England Journal of Medicine yesterday, FDA outlined what it describes as its “new framework for psychedelic drugs”.

The four agency staffers kick off the article by outlining the severity of the mental health crisis in the U.S., focusing on depression and PTSD in particular, before stating that FDA “is committed to meeting this moment with the urgency it deserves”, and noting that “[o]ne potential avenue for the development of better treatments includes psychedelic compounds.”

It then reviews, briefly, the arc of psychedelic use and research, as well as actions it has taken to catalyse psychedelic drug development in the U.S., like the issuance of Breakthrough Therapy designations to various candidates. The most recent of those was handed to Definium Therapeutics’ LSD candidate (DT120) for major depressive disorder (MDD), for example.

It also notes that it can offer rolling review and priority review to candidates in receipt of this designation. We know, for example, that Compass Pathways is undergoing a rolling review, expected to complete next quarter. We have reported, too, that we expect Usona Institute is also operating under this procedure, though it has not discussed the matter publicly.

“Despite this promise”, the agency authors write, “psychedelic therapies remain investigational, and our approach to integrating these complex programs into existing regulatory frameworks is still evolving.”

Part of that evolution is reflected in its guidance for industry, it suggested. It refined its initial 2023 draft guidance following the receipt of two hundred public comments and three further years of learning from drug development programs, as well as...