FDA shuffles top drug, biologics leaders in latest leadership shakeup

The U.S. Food and Drug Administration is replacing its top drug and biologic regulators, days after the departure of former commissioner Marty Makary, according to a memo seen by CNBC.

According to the notice, Tracy Beth Høeg, acting director of the FDA’s Center for Drug Evaluation and Research, and Katherine Szarama, acting director of the Center for Biologics Evaluation and Research, will leave their positions. The two divisions are responsible for regulating prescription drugs, including pills and vaccines.

Szarama will remain with the agency, according to the statement. Høeg a to post X said he was fired. Karim Mikhail will replace Høeg at CDER and Michael Davis will replace Szarama at CBER. Lowell Zeta will take over as chief of staff. As of Friday night organization chart Information on the FDA’s website has been updated to reflect these changes.

Following a tumultuous week at the FDA, which is responsible for regulating products that account for about 20% of consumer spending in the United States, Makary resigned following days of reports that President Donald Trump wanted to oust the commissioner. And it’s the latest change at an agency that struggled with turnover under the second Trump administration.

Davis becomes the fifth person to lead CDER since last January. CBER has also seen more than one face in this business over the past year; these include Vinay Prasad, who left the department and returned only to leave again after a series of controversies.

The Trump administration hopes to name a new nominee for permanent commissioner within a few weeks, a senior administration official told CNBC this week. This person must be confirmed by the Senate. Meanwhile, the Trump administration is trying to fill vacant healthcare positions, including the director of the Centers for Disease Control and Prevention and the surgeon general.