FDA swaps drug and biologics leaders in latest reshuffle
The Food and Drug Administration logo is seen before a news conference at Health and Human Services headquarters in Washington, April 22, 2025.
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The U.S. Food and Drug Administration is replacing its top drug and biologics regulators, according to a memo seen by CNBC days after the departure of former Commissioner Marty Makary.
Acting director of the FDA’s Center for Drug Evaluation and Research, Tracy Beth Høeg, and acting director of the Center for Biologics Evaluation and Research, Katherine Szarama, will resign their positions, according to the memo. The two departments are responsible for regulating prescription drugs, including pills and vaccines.
According to the memo, Szarama will remain with the agency. Høeg said in a post on X that she had been fired. Michael Davis will replace Høeg at CDER and Karim Mikhail will replace Szarama at CBER. Lowell Zeta becomes acting chief of staff. On Friday evening, an organizational chart on the FDA’s website was updated to reflect these changes.
The reorganization caps a tumultuous week at the FDA, which is responsible for regulating products that account for about 20% of U.S. consumer spending. Makary resigned after days of reports that President Donald Trump wanted to remove the commissioner. And it’s the latest change at an agency struggling with revenue problems under the second Trump administration.
Davis is one of several people who have led CDER since last January. CBER has also seen several faces in the post over the past year, including Vinay Prasad, who left the department, then returned and left again after a series of controversies.
The Trump administration hopes to name a new candidate for permanent commissioner in a few weeks, the senior administration official told CNBC this week. This person would have to be confirmed by the Senate. Meanwhile, the Trump administration is trying to fill healthcare vacancies, including director of the Centers for Disease Control and Prevention and surgeon general.
Correction: Michael Davis will replace Høeg at CDER and Karim Mikhail will replace Szarama at CBER. An earlier version misidentified their roles.
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