Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders. This week’s updates:
- Dr. Tidmarsh Out as CDER Director
- Leadership Developments in Key FDA Offices
- FDA Announces Reforms to Accelerate Biosimilars
- Second Round of Commissioner’s National Priority Review Recipients Announced
Dr. Tidmarsh Out as CDER Director
This week, several news outlets reported that Dr. George Tidmarsh, M.D., Ph.D., was placed on leave and resigned from his position as director of the Center for Drug Evaluation and Research (CDER). Dr. Tidmarsh was appointed CDER director in July to replace the retiring acting director, Dr. Jacqueline Corrigan-Curay, J.D., M.D. As of now, it is unknown who will replace Dr. Tidmarsh as CDER director.
According to reports, FDA recently began investigating certain conduct by Dr. Tidmarsh, which resulted in his being placed on leave by Commissioner Dr. Marty Makary, M.D., M.P.H. However, Dr. Tidmarsh told the New York Times and ABC News that he was placed on leave because he expressed concern about the legality of the Commissioner’s National Priority Voucher (CNPV) program. As we previously discussed, FDA awarded nine CNPVs in October as part of its first group of awardees.
Since the start of the year, FDA has experienced an unusual level of leadership turnover― leaders being fired, resigning after brief tenures, or even returning shortly after stepping down―along with significant staff departures. This degree of turnover creates uncertainty for stakeholders about the Agency’s regulatory or policy priorities and how it intends to carry them out.
Leadership Developments in Key FDA Offices
Last week, Agency IQ reported on a significant number of recent leadership departures within the Agency’s Office of the Chief Medical Officer. According to the publication, the list of personnel who have either willingly departed or been “forcibly transferred” from the office includes:
- Dionna Green, director of the Office of Pediatric Therapeutics
- Ann Meeker-O’Connell, director of the Office of Clinical Policy
- Daniel Singer, director of the Office of Public Health Preparedness and Response
- Sandy Retzky, director of the Office of Orphan Products Development (which we mentioned in our last Pulse)
Additionally, AgencyIQ reports that Dr. Mallika Mundkur, M.D., M.P.H., is the deputy chief medical officer and Scott Steele, Ph.D., who was acting director of the Center for Biologics Evaluation and Research before current director Dr. Vinay Prasad, M.D., M.P.H., is now the director of the Office of Public Health Preparedness and Response. Furthermore, Endpoints News reported last week that Dr. Mary Thanh Hai, M.D., is now the director of CDER’s Office of New Drugs after serving in an acting capacity following the dismissal of former director Dr. Peter Stein, M.D., during the April staffing cuts within the Agency.
FDA Announces Reforms to Accelerate Biosimilars
On October 29, 2025, FDA announced efforts intended to “make it faster and less costly to develop biosimilar medicines.” One action is the release of a draft guidance, in which FDA proposes a “framework for determining when a [comparative efficacy study] (CES) may not be necessary to support a demonstration of biosimilarity.” Under this guidance, if a comparative analytical assessment (CAA) shows that the proposed biosimilar is highly similar to its reference product, then a pharmacokinetic study and immunogenicity assessment may be sufficient to assess if there are clinically meaningful differences in safety, purity, or potency, rather than a CES.
In addition to announcing the release of the draft guidance, the press release notes that “FDA now generally does not recommend switching studies,” which the Agency states “can slow development and create public confusion about biosimilar safety.” Though no further detail was provided in the release about FDA’s “switching studies” recommendation, FDA Commissioner Marty Makary, M.D., M.P.H. mentioned in a related press conference that the Agency “is announcing its plans to issue final guidance on interchangeability. . .eliminating the bureaucratic switching studies that have been required.”
Second Round of Commissioner’s National Priority Voucher Recipients Announced
On November 6, the Agency announced an additional six recipients under the Commissioner’s National Priority Voucher pilot program:
- Zongertinib for HER2 lung cancer
- Bedaquiline for drug-resistant tuberculosis in young children
- Dostarlimab for rectal cancer
- Casgevy for sickle cell disease
- Orforglipron for obesity and related health conditions
- Wegovy for obesity and related health conditions
As with the initial nine voucher recipients announced on October 16, these recipients will receive an expedited “tumor board style” review (see our recent publication for more on this program).