Dr. Tracy Beth Høeg, acting director of the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), is leaving her post as part of a broader leadership shakeup at the agency according to multiple reports.
Key Takeaways
FDA's acting drug chief Dr. Tracy Beth Høeg leaves her post amid leadership changes at the agency. Her departure follows that of former Commissioner Marty Makary and comes after she claimed to have been fired. Michael Davis will replace her, while Karim Mikhail takes over another key division.
Høeg had served since December overseeing drug approvals. Her departure comes days after former FDA Commissioner Marty Makary resigned following internal tensions, particularly over the recent approval of flavored e-cigarettes. According to CBS News, sources familiar with the matter stated that Makary left due to disagreements over this policy.
Høeg's exit follows a tumultuous period at the FDA marked by high turnover. Dr. Vinay Prasad, who previously led vaccine approvals, also departed last month after briefly leaving and returning in 2023. Høeg’s appointment had drawn controversy due to her history of vaccine skepticism.
According to Fox News, Høeg claimed she was fired rather than resigning voluntarily. In an interview with MD Reports published Friday, she stated that she did not want to resign and would not sign a resignation letter if it wasn't her choice. She indicated the decision came from higher up in the administration.
Michael Davis will replace Høeg at CDER, while Karim Mikhail takes over the Center for Biologics Evaluation and Research (CBER), according to an FDA memo seen by CNBC. The Trump administration plans to nominate a permanent commissioner within weeks as the agency continues to face challenges with high turnover.
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