Mike Davis previously worked as clinical team leader at the FDA’s Division of Psychiatry before serving as chief medical officer for Usona Institute, a research organization advancing psychedelic science.
Mike Davis, a psychedelics-forward doctor who formerly served on the FDA’s Division of Psychiatry, will now serve as deputy director of the agency’s Center for Drug Evaluation and Research.
The news, first reported by Pink Sheet journalist Derrick Gingery on X, comes just days after CDER acting head Jacqueline Corrigan-Curay announced her retirement after nine years of service at the agency. She will stay with the center “for several more weeks” to help with the transition, according to an email she sent to colleagues.
Corrigan-Curay assumed leadership of CDER in January after its previous head, Patrizia Cavazzoni, departed. The FDA has yet to find a replacement for Corrigan-Curay, though BioCentury last week reported that Karim Mikhail, former Merck executive and current advisor to FDA Commissioner Marty Makary, could score the spot.
The CDER’s leadership page has not yet reflected any of these most recent staffing changes.
From October 2018 through December 2022, Davis worked as a clinical team leader at the FDA’s Division of Psychiatry. In this role, according to his LinkedIn page, he led a group of doctors that reviewed regulatory submissions, including Investigational New Drug filings and New Drug Applications. Davis also participated in developing guidance documents. Davis has updated his profile to reflect his appointment as CDER deputy director.
After departing the agency at the end of 2022, Davis then served as chief medical officer at Usona Institute, a medical research organization focused on what it calls “consciousness-expanding medicines.” According to its website, Usona seeks to advance psychedelic science by helping expand the tools available for researchers in this space, by identifying and developing effective and safe psychedelic medicines and by helping build manufacturing capabilities for these compounds. Usona no longer lists Davis as part of its executive team.
Health authorities in recent months have voiced support for the use of psychedelics in medicine. In an interview last month, for instance, Makary said the current “medical establishment” hasn’t been listening to doctors or patients regarding psychedelics and referenced patient reports of “curative” effects from these “plant-based therapies.”
“I’m not saying they’re effective, I’m not saying the evidence is strong. I’m saying we have to listen to doctors who have these experiences,” Makary said, adding that under his leadership, the FDA will be open to “expeditious and rapid” reviews of psychedelic therapies.
HHS Secretary Robert F. Kennedy Jr. has also been supportive of psychedelics in the past, even accusing previous FDA administrations of “suppressing” these compounds.
The industry has shown a keen interest in these types of therapies in recent years. While Lykos Therapeutics suffered a rejection of its MDMA-based therapy for post-traumatic stress disorder last August, Compass Pathways just this week reported Phase III data for its psilocybin drug for treatment-resistant depression that analysts speculated will support its eventual approval.
