Following the recent departure of the top drug regulator at the US Food and Drug Administration (FDA), officials are working to identify a successor. This situation highlights internal tensions and challenges within the agency, which has historically been seen as stable.
The US Department of Health and Human Services (HHS) announced a new candidate for the Center for Drug Evaluation and Research (CDER) position. Richard Pazdur, a longtime FDA employee and oncology expert, was offered the role but declined. As a result, HHS began exploring alternative candidates for the leadership position.
This transition comes on the heels of George Tidmarsh’s resignation as CDER director, who left following accusations of retaliation against a former business partner and reports of internal conflict. Tidmarsh had recently opposed a proposed rapid approval program, raising questions about its legality. Tensions were also noted between Tidmarsh and Vinay Prasad, the agency’s chief medical and scientific officer, leading to further concerns about collaboration among top officials.
The HHS has not commented on the reported conflicts but confirmed Tidmarsh’s departure. Emily Hilliard, a press secretary for HHS, stated that the Secretary expects high ethical standards from those in leadership roles.
Prasad has had a tumultuous tenure as well; he was briefly removed from his position before being reinstated. These dynamics have raised concerns about the overall relationships among the FDA’s top officials. Some current employees expressed reluctance to consider the CDER director role due to the agency’s current instability.
The recruitment process for this critical leadership position reflects a significant departure from the FDA’s previous practices, leading to speculation about the agency’s future. Analysts have pointed out that maintaining stability is crucial for the FDA, particularly in fostering public trust in its drug evaluation processes. The ongoing internal strife could have implications for the agency’s credibility and its ability to effectively regulate the pharmaceutical industry.
Source: https://www.theguardian.com/us-news/2025/nov/15/fda-us-healthcare