HomeTop StoriesFDA shuffles top drug, biologics leaders in latest shakeup

FDA shuffles top drug, biologics leaders in latest shakeup

The logo for the Food and Drug Administration is seen ahead of a news conference at the Health and Human Services Headquarters in Washington, April 22, 2025.

Nathan Posner | Anadolu | Getty Images

The U.S. Food and Drug Administration is shuffling 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 leave their roles, according to the memo. The two divisions are responsible for regulating prescription drugs, including pills and vaccines.

Szarama will remain at the agency, according to the memo. Høeg in a post on X said she was fired. Michael Davis will replace Høeg at CDER and Karim Mikhail will replace Szarama at CBER. Lowell Zeta will take over as acting chief of staff. As of Friday night, an organization chart on the the FDA’s website had been updated to reflect those changes.

The shake up caps a tumultuous week at the FDA, which is responsible for regulating products that account for some 20% of consumer spending in the U.S. Makary resigned after days of reports that President Donald Trump wanted to oust the commissioner. And it’s the latest shuffle at an agency that’s struggled with turnover under the second Trump administration.

Davis becomes one of several people to lead CDER since last January. CBER has also seen multiple faces in the job over the past year, including Vinay Prasad, who left the division then returned only to leave again after a series of controversies.

The Trump administration hopes to name a new nominee for permanent commissioner in a matter of weeks, the senior administration official told CNBC this week. That person would need to be confirmed by the Senate. Meanwhile, the Trump administration is trying to fill health vacancies, including the director for the Centers for Disease Control and Prevention and the surgeon general.

Correction: Michael Davis will replace Høeg at CDER and Karim Mikhail will replace Szarama at CBER. A previous version incorrectly identified their roles.

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