The U.S. Food and Drug Administration is undergoing a significant leadership shake-up, with top drug and biologics regulators Tracy Beth Høeg and Katherine Szarama being replaced, following the recent departure of Commissioner Marty Makary.
Michael Davis and Karim Mikhail will step into the key roles at CDER and CBER, respectively, amidst a period of high turnover and administrative vacancies under the second Trump administration.
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The U.S. Food and Drug Administration (FDA) is enacting a significant reorganization of its top drug and biologics regulators, according to an internal memo reviewed by CNBC. This comes just days after the controversial departure of former commissioner Marty Makary, capping a tumultuous period for the agency.
Acting Director of the FDA's Center for Drug Evaluation and Research (CDER), Tracy Beth Høeg, and acting Director of the Center for Biologics Evaluation and Research (CBER), Katherine Szarama, are both stepping down from their leadership roles. These critical divisions oversee the regulation of all prescription drugs, from pills to life-saving vaccines.
While Szarama will continue her tenure at the agency, Høeg publicly stated in a post on X that she was terminated. Filling these pivotal positions will be Michael Davis, who takes over Høeg's role at CDER, and Karim Mikhail, who will succeed Szarama at CBER. Additionally, Lowell Zeta has been appointed as the acting chief of staff. The FDA's official organization chart was promptly updated by Friday evening to reflect these changes.
This flurry of activity marks a turbulent week for the FDA, an agency with oversight of products representing an estimated 20% of all U.S. consumer spending. Makary's resignation followed days of reports indicating President Donald Trump's intent to remove the commissioner. This latest leadership shuffle underscores a persistent challenge of high turnover within the FDA during the second Trump administration.
Michael Davis is now one of several individuals to lead CDER since January, highlighting the instability within that division. Similarly, CBER has seen numerous leaders over the past year, including Vinay Prasad, who reportedly left, returned, and then departed again after a series of internal controversies.
A senior administration official revealed to CNBC this week that the Trump administration anticipates nominating a new permanent commissioner within a matter of weeks, a choice that will require Senate confirmation. Concurrently, the administration is actively working to fill other crucial health vacancies, including the director positions for the Centers for Disease Control and Prevention (CDC) and the U.S. Surgeon General.
