Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency’s structure and stakeholder interactions. This week’s updates are as follows:
- CBER Director Resigns from FDA
- Commissioner Makary’s Recent Remarks on FDA Staffing Cuts
- Newly Released CBER Hiring Data
- Additional Leadership Developments
CBER Director Resigns from FDA
On July 29, multiple news outlets reported that Dr. Vinay Prasad, M.D., M.P.H., director of the Center for Biologics Evaluation and Research (CBER), resigned from FDA just a few months into his tenure. Dr. Prasad also served as the chief medical and scientific officer at the Agency. According to reports, Dr. Prasad’s resignation followed increased political criticism of his appointment and controversy over FDA requesting that Sarepta Therapeutics stop shipping its gene therapy drug for Duchenne muscular dystrophy, after potential links to patient deaths. Notably, on Monday, July 28, FDA recommended lifting the voluntary hold to allow shipments for ambulatory patients, having determined that a child’s death was unrelated to the product―the hold for non-ambulatory patients is still in place.
Dr. George Tidmarsh, M.D., Ph.D., who was recently announced as the director of the Center for Drugs Evaluation and Research (CDER), has been selected as acting director of CBER. In related news, changes to CBER’s structure could be forthcoming, as InsideHealthPolicy and Politico report that the Trump administration is considering dividing it into two centers, with one dedicated to vaccine products and the other to therapeutics.
Commissioner Makary’s Recent Remarks on FDA Staffing Cuts
The broader issue of FDA’s overall staffing and hiring was a topic of discussion in Politico’s recent interview with FDA Commissioner Marty Makary, M.D., M.P.H. Although the U.S. Department of Health and Human Services (HHS) reorganization plan initially called for FDA to cut 3,500 employees, Dr. Makary clarified that the actual number of terminations was closer to 2,000 and that “a quarter to a third” of these have since been reversed. In the interview, Dr. Makary emphasized that scientific reviewers and inspectors were not impacted by the staffing cuts. Instead, according to Dr. Makary, FDA “consolidated” certain offices, including human resources, information technology, and procurement. In response to a question about whether additional terminations are necessary, Dr. Makary stated he believes the Agency is in a good place and is actively working to hire more scientists, noting there are numerous job postings.
Newly Released CBER Hiring Data
In our most recent Pulse, we discussed FDA’s release of quarterly hiring data for CDER, which revealed that the center has lost substantially more employees than it gained since the start of the year. Similar numbers have been released for CBER. Second- and third-quarter fiscal year data (January 1, 2025 through June 30, 2025) shows that CBER gained just 25 employees while losing 106. Importantly, this CBER and CDER data represents total hiring, including hires reported under BsUFA III and PDUFA VII―providing insight into the centers’ overall workforce changes during this year.
Additional Leadership Developments
In other leadership news, Politico reports that Sonja Fulmer, Ph.D., the acting director of the Digital Health Center of Excellence office in the Center for Devices and Radiological Health, will be leaving FDA. Fulmer has held this position since the departure of the previous director, Troy Tazbaz, in January. Additionally, Sridhar Mantha has succeeded Craig Taylor as the acting chief information officer.
Venable will continue to monitor all changes regarding the FDA and report any critical developments. If you have questions about how the contents of this article may impact you or your business’s interactions with the FDA, please contact the authors today.