FDA Reshuffles Drug and Biologics Chiefs in Latest Leadership Shake

CNBC reported Friday that the U.S. Food and Drug Administration is replacing its acting heads of two critical regulatory divisions. The moves follow an already chaotic week for the agency.

FDA Leadership Shake Hits Drug and Biologics Divisions

The internal memo, obtained by CNBC, confirms that Tracy Beth Høeg, acting director of the Center for Drug Evaluation and Research, and Katherine Szarama, acting director of the Center for Biologics Evaluation and Research, are both stepping out of their current roles.

Høeg said on social media that she was fired outright. Szarama will remain employed at the agency in a different capacity.

Michael Davis steps in to lead CDER, while Karim Mikhail takes over CBER. Lowell Zeta has been named acting chief of staff. The FDA’s own organizational chart was updated Friday evening to reflect the new structure.

CDER and CBER jointly oversee prescription drugs, injectable biologics, and vaccines. Together, their regulated products account for roughly a fifth of all consumer spending in the United States.

A Week of Turmoil at the Top

The reshuffle lands days after Commissioner Marty Makary departed the agency. Makary’s exit followed persistent reports that President Donald Trump wanted him removed from the role.

The latest changes are not an isolated event. CDER alone has seen several different acting leaders since January of last year. CBER’s recent history has been equally unsettled. Dr. Vinay Prasad famously left the division, returned briefly, then departed again following a string of public controversies.

Also Read: Trump’s Second Term Is Reshaping U.S. Health Agencies

Vacancy List Grows Across Health Agencies

The FDA is not the only health body facing open leadership positions. The Trump administration is simultaneously working to fill the director role at the Centers for Disease Control and Prevention and the surgeon general post, both of which remain vacant.

A senior administration official told CNBC this week that a permanent FDA commissioner nominee could be announced within weeks. That nominee would face a Senate confirmation process before taking the role formally.

The continued churn raises questions about regulatory consistency at an agency whose decisions touch nearly every American consumer and patient. Investors tracking pharmaceutical and biotech equities have flagged leadership instability as a key watchpoint for approval timelines and drug-review calendars in 2026.

Read Next: What FDA Instability Means for Drug Approvals This Year