After less than three weeks on the job, Katherine Szarama is being replaced by Karim Mikhail as acting head of the Center for Biologics Evaluation and Research. Mikhail had previously spent more than 20 years at Merck and joined the FDA last year.
Katherine Szarama, ally of former biologics chief Vinay Prasad, is no longer the acting director of the Center for Biologics Evaluation and Research.
Szarama’s overall status at the FDA was unclear as of Friday. Citing an internal memo, CNBC reported that she will remain with the agency in a different capacity, while STAT News reported that she would be leaving the regulator.
On Monday, Pink Sheet reported that Szarama will stay at the FDA, where she will support product-related issues.
Szarama will be replaced as CBER head by Karim Mikhail, who had a long career in pharma before joining the FDA, according to his LinkedIn profile. Mikhail spent more than two decades at Merck before becoming President and CEO of Amarin Corporation, a cardiovascular disease-focused biopharma. He held that post for two years before he entered the FDA as a senior advisor in the Office of the Commissioner.
Like Szarama, Mikhail will serve as the CBER’s leader on an acting basis while the FDA searches for a permanent director. He will be the center’s fourth acting director and sixth leader since January 2025.
There has been a high-level cleanout at the FDA in recent weeks. The agency started the month without a biologics chief after Prasad, who formerly led CBER, stepped down at the end of April, when Szarama was tapped as his temporary replacement.
Former Commissioner Marty Makary followed Prasad out the door shortly after, resigning from the FDA last week to cap off a tumultuous term marked by controversial and inconsistent decisions.
“Makary oversaw what must be the most damaging period in FDA history,” analysts at Capital Alpha wrote in a May 12 note. Replacing him might be difficult, the firm added, arguing that “the administration might struggle to find a suitable candidate who will want the job.”
By the end of the week, Tracy Beth Høeg, acting director of the Center for Drugs Evaluation and Research, was also ousted. Høeg was one of many CDER chiefs under the second Trump administration, following Richard Pazdur, George Tidmarsh and Jacqueline Corrigan-Curay. Now, Michael Davis, deputy director of the center, has replaced Høeg as the CDER’s acting leader.
Finally, Jim Traficant, the chief of staff, was also ousted last week, according to reporting from The Guardian.
Editor’s note ( May 19): This story has been updated to include reporting from Pink Sheet stating that Szarama will remain at the FDA to support product-related issues.
