Momentum Amidst Tumult: The FDA Reshuffle, Approval Timelines, and the Compass-Usona Race

Momentum Amidst Tumult: The FDA Reshuffle, Approval Timelines, and the Compass-Usona Race

Last week, I (the Editor, Josh Hardman) returned from a trip to the U.S. West Coast, visiting San Francisco for the American Psychiatric Association’s annual meeting and Palo Alto, where I caught up with researchers, investors, and others close to the psychedelics field.

While I was there, the Food and Drug Administration (FDA) generated several headlines, including the resignation of Commissioner Marty Makary and the ouster of Tracy Beth Høeg, the acting director of the Center for Drug Evaluation and Research; both darlings of the MAHA movement, at least initially. Ex-Usona Institute Chief Medical Officer Mike Davis has since filled the latter’s shoes.

Here, I share what the FDA reshuffle might mean for psychedelics, as well as recent comments from the agency’s Division of Psychiatry director Tiffany Farchione, a closer look at potential approval timelines, and a deep dive into the race to market for two psilocybin developers, Compass Pathways and Usona, which now appears too close to call.

Editor’s note: This is a lengthy (6,000-word) dispatch that is, in some respects, a few articles rolled into one broader report. It centres generally on topics related to the pursuit of FDA approval for psychedelics-based candidates. Later, we will share further coverage from the American Psychiatric Association’s annual meeting, as well as related reporting. As regular readers will be aware, our preference at Psychedelic Alpha is to publish our reporting as it’s ready, as opposed to holding content according to a content calendar. Note also that we published our first Field Note audio clip yesterday, which touches on some of the topics mentioned here.