Following the departure of Vinay Prasad, M.D., former head of the Center for Biologics Evaluation and Research (CBER), the FDA has already tapped someone else to temporarily fill his shoes.
Freshly appointed Center for Drug Evaluation and Research (CDER) leader George Tidmarsh, M.D., Ph.D., will now take on the role of acting director of CBER as well, according to an internal letter from FDA Commissioner Marty Makary, M.D., to staffers that was viewed by Fierce.
Both departments fall under the FDA’s umbrella, with CDER covering most small-molecule and biological therapeutics while CBER oversees vaccines, cell and gene therapies and other blood products.
Tidmarsh is a veteran biotech executive who stepped into his federal leadership role at the beginning of last week.
"Promoting from within the technical staff is generally positive for maintaining a sense of respect and value for the rank and file the whole and is generally positive for continuity,” Leerink Partners analyst Mani Foroohar, M.D., said in an interview with Fierce Pharma regarding general expectations for a new CBER leader.
The letter also announced Scott Steele, Ph.D., and Brittany Goldberg, M.D., as deputy directors of CBER.
University of Rochester professor Steele has served as a senior advisor for CBER since 2022, while infectious disease physician Goldberg was the division's chief medical officer for 13 years. Both served as acting CBER directors before Prasad’s appointment.
The FDA did not respond to Fierce’s requests for comment about conducting a search for a permanent leader.
News of Prasad’s departure broke late Tuesday night, an exit that comes less than three months into his role.
Just last month, Prasad added on the additional titles of chief medical and science officer to his role at the agency. But his time with the FDA quickly soured, with his short tenure marked by controversies such as the messy regulatory back-and-forth with Sarepta Therapeutics about the company’s gene therapy Elevidys.
“The FDA was very fortunate to have Vinay’s expertise at CBER,” Makary’s letter to staff reads. “He implemented major reforms and designed new regulatory frameworks that will have an enduring impact.”
Angus Liu contributed to this report.