FDA Appoints Psychedelics Advocate as CDER Deputy Director Amid Leadership Changes

The U.S. Food and Drug Administration (FDA) has named Mike Davis, a physician with a background in psychedelic research, as the new deputy director of its Center for Drug Evaluation and Research (CDER). This appointment comes at a time of significant leadership transitions within the agency and growing interest in psychedelic therapies within the pharmaceutical industry.

CDER Leadership Shake-up

The FDA's CDER is undergoing a period of transition, with acting head Jacqueline Corrigan-Curay recently announcing her retirement after nine years of service. Corrigan-Curay, who assumed leadership of CDER in January following the departure of previous director Patrizia Cavazzoni, will remain with the center for several weeks to facilitate the transition.

As the search for a permanent CDER director continues, industry insiders have speculated that Karim Mikhail, a former Merck executive and current advisor to FDA Commissioner Marty Makary, may be a potential candidate for the position.

Davis's Background and Implications for Psychedelic Research

Mike Davis brings a unique perspective to his new role at the FDA. Prior to this appointment, Davis served as the chief medical officer at Usona Institute, a medical research organization focused on advancing psychedelic science. His experience at Usona, combined with his previous tenure as a clinical team leader in the FDA's Division of Psychiatry, positions him at the intersection of regulatory oversight and cutting-edge psychedelic research.

During his time at the FDA's Division of Psychiatry from October 2018 to December 2022, Davis led a team of physicians reviewing regulatory submissions, including Investigational New Drug filings and New Drug Applications. He also contributed to the development of guidance documents, providing him with extensive regulatory experience.

Shifting Attitudes Towards Psychedelics in Medicine

Davis's appointment reflects a broader shift in attitudes towards psychedelic therapies within the medical and regulatory communities. FDA Commissioner Marty Makary has recently expressed openness to "expeditious and rapid" reviews of psychedelic therapies, emphasizing the importance of listening to doctors and patients regarding these treatments.

Similarly, Health and Human Services Secretary Robert F. Kennedy Jr. has been supportive of psychedelics, even criticizing previous FDA administrations for allegedly suppressing these compounds.

This evolving perspective aligns with growing industry interest in psychedelic-based treatments. While challenges remain, as evidenced by Lykos Therapeutics' recent rejection of its MDMA-based therapy for post-traumatic stress disorder, other companies are making progress. Notably, Compass Pathways recently reported promising Phase III data for its psilocybin drug targeting treatment-resistant depression, sparking optimism about potential future approvals in this field.