FDA Reshuffles Drug and Biologics Leadership in Fresh Shakeup
CNBC reported Friday that the U.S. Food and Drug Administration has replaced the acting heads of its two most prominent regulatory divisions, compounding what has been an extraordinarily turbulent week for the agency.
The changes follow the exit of former FDA Commissioner Marty Makary, who stepped down amid reports that President Donald Trump sought his removal.
New Names Take Over Drug and Biologics Divisions
According to an internal memo obtained by CNBC, Michael Davis will take over as acting director of the Center for Drug Evaluation and Research, replacing Tracy Beth Høeg. Karim Mikhail will step in to lead the Center for Biologics Evaluation and Research, replacing Katherine Szarama.
CDER and CBER together oversee the approval and safety of prescription medications, pills, and vaccines. Their decisions affect products that collectively touch roughly one-fifth of all U.S. consumer spending.
Szarama is expected to remain at the agency in a different capacity. Høeg, however, stated on X that she was fired. Lowell Zeta was also named acting chief of staff. By Friday evening, the FDA’s official organizational chart had already been updated to reflect all three appointments.
A Pattern of Instability at the FDA
The FDA leadership shakeup is not an isolated event. The agency has cycled through multiple leaders at both CDER and CBER since the start of the second Trump administration in January 2025.
CBER’s recent history is particularly volatile. Vinay Prasad led the division, departed, returned, and then left again following a string of public controversies. Davis now becomes at least the third person to hold the top CDER post in little over a year.
The broader federal health apparatus faces similar strain. The Trump administration is still seeking a permanent director for the Centers for Disease Control and Prevention and has yet to fill the surgeon general role.
What Comes Next for the Agency
A senior administration official told CNBC this week that a nominee for permanent FDA commissioner could be announced within weeks. That candidate would still require Senate confirmation before assuming the role.
In the interim, the agency that regulates everything from cancer treatments to flu vaccines is operating under a patchwork of acting officials with no confirmed leader at the top.
Markets and pharmaceutical executives will be watching closely. Personnel instability at the FDA can affect drug approval timelines, clinical guidance, and the broader pipeline of treatments awaiting regulatory clearance.
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