Katherine Szarama is no longer serving as the acting director of the Center for Biologics Evaluation and Research, according to a May 18 announcement. It remains unclear whether Szarama will continue working at the Food and Drug Administration in another capacity, with conflicting reports from CNBC and STAT News about her status.
The leadership change comes during a period of significant turnover at the FDA. The agency has seen multiple high-level departures in recent weeks, including former biologics chief Vinay Prasad and former Commissioner Marty Makary. These changes have left key positions unfilled or filled on an interim basis.
Szarama will be replaced by Karim Mikhail, who previously held executive roles in the pharmaceutical industry before joining the FDA as a senior advisor. Mikhail is set to become the fourth acting director and sixth leader of CBER since January 2025. He will serve on an interim basis while a search for a permanent director continues.
Other recent departures include Tracy Beth Høeg, who was ousted as acting director of the Center for Drugs Evaluation and Research (CDER), following several other chiefs under recent administrations. Michael Davis has taken over as CDER’s acting leader after Høeg’s exit. Additionally, Jim Traficant, chief of staff at the FDA, was also removed from his position last week.
Analysts at Capital Alpha said in a note that “Makary oversaw what must be the most damaging period in FDA history.” They also said that “the administration might struggle to find a suitable candidate who will want the job.”
The ongoing changes highlight continued instability within major divisions of federal health agencies.
