FDA removes Dr. Tracy Beth Hoeg as head of drug regulation division

The U.S. Food and Drug Administration has removed Dr. Tracy Beth Hoeg from her role leading the agency’s drug regulation division, the Center for Drug Evaluation and Research, in the latest personnel change amid a broader leadership shakeup. Hoeg was replaced as acting drug center director by Dr. Mike Davis, the FDA said, citing an internal email to staff. Hoeg said on social media late Friday that she had been fired.

Hoeg’s departure comes days after FDA Commissioner Marty Makary resigned earlier in the week, and after Dr. Vinay Prasad, the FDA’s vaccine and biotech chief, stepped down last month. The FDA also announced Friday that Karim Mikhail would take over as acting director of the vaccines center.

Hoeg had served as acting head of CDER since December, overseeing the FDA’s review of prescription and over-the-counter drugs. FDA staff typically fill such roles with career scientists, according to descriptions of the position. Hoeg had no prior government or management experience before joining the agency last March, when she began leading inquiries into the safety of several products and treatment areas, including injectable respiratory syncytial virus drugs for children,...