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:
- HHS finalizes certain layoffs after Supreme Court stays injunction
- New CDER Director
- FDA Releases CDER Employment Data
- FDA Establishes Two AI Councils
HHS finalizes certain layoffs after Supreme Court stays injunction
In our last Pulse, we discussed the Supreme Court's decision to stay an injunction that had paused the U.S. Department of Health and Human Services (HHS) and other agencies' restructuring and reductions-in-force (RIF) plans. At that time, HHS had not yet announced how it would proceed with RIFs and restructuring. However, on July 14, multiple news outlets reported that HHS sent emails to employees finalizing many of the previously halted terminations. According to the reports, HHS has confirmed that all staffing cuts implemented on April 1 are now complete, except those covered by a separate injunction issued in Rhode Island. That injunction applies to the FDA's Center for Tobacco Products, the Centers for Disease Control and Prevention, the Office of Head Start, and the Office of the Assistant Secretary for Planning and Evaluation.
The total number of employees terminated, or where they worked, has not been confirmed. HHS's restructuring plan initially called for the termination of 3,500 FDA employees. However, as we previously discussed, some employees who were originally terminated in April have since been rehired.
New CDER Director
On Monday, the FDA announced that Dr. George Tidmarsh, M.D., Ph.D., will be the next director of the Center for Drug Evaluation and Research (CDER). FDA's press release notes that Dr. Tidmarsh obtained both his M.D. and Ph.D. in cancer biology from Stanford University, and he has "led the successful clinical development of seven FDA-approved drugs and served as founder and CEO of multiple biopharmaceutical companies focused on oncology and critical care medicine." While Dr. Tidmarsh has extensive industry experience, he has not previously served at FDA. His appointment has the potential to change the direction of CDER following the retirements of the current acting director Dr. Jacqueline Corrigan-Curay and the previous CDER center director Dr. Patrizia Cavazzoni, both of whom were longstanding FDA employees (and followed Dr. Janet Woodcock's tenure as CDER director). We look forward to learning more about Dr. Tidmarsh's vision for CDER.
FDA Releases CDER Employment Data
In related news, this month, the FDA published quarterly net hiring data for CDER. According to the data, in fiscal year 2025, CDER lost 473 employees compared to the 120 it gained. During calendar year 2025, second and third quarter fiscal year data (covering January 1, 2025, through June 30, 2025) show that CDER lost 385 employees, substantially more than the 18 hired during the same period. These numbers offer valuable insight into departures that have occurred since the new FDA administration began. Importantly, this hiring data reports total hires for the centers, not just hiring related to user fee programs as required by the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Act (BsUFA III) reauthorizations. FDA says this data is "an effort to provide a more comprehensive overview of CDER's and CBER's hiring progress and status."
FDA Establishes Two AI Councils
Politico Pro reports that the FDA plans to establish "two cross-agency councils" focused on artificial intelligence (AI). One council will be devoted to FDA's internal use of AI, creating staff training and pilot programs. The other council will be tasked with developing policy regarding the use of AI in regulated products. According to the report, the Agency's chief AI officer, Jeremy Walsh, will be the chair of both councils, and Shantanu Nundy will manage the efforts of the AI policy council. The article describes Nundy as a "new agency hire" and "the former chief medical officer of a care navigator." The report notes that the existing AI councils in several of the Agency's divisions will remain, even with the creation of the new councils.
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.