New FDA Biologics Chief Vows to Be 'Normal' After Prasad Era

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- Karim Mikhail became acting director of the FDA's Center for Biologics Evaluation and Research (CBER), succeeding the previous leader Vinay Prasad
- At a June town hall meeting, Mikhail told CBER staff "I am with you on planet Earth" and "I understand very well what everybody is going through," framing himself as a relatable, on-the-ground leader
- STAT+ characterizes Mikhail's unusual self-description as "normal" as a deliberate contrast to his predecessor, who was "decidedly outside the norm"
- Vinay Prasad's CBER tenure was turbulent enough that Mikhail's plain-spoken opening is framed as noteworthy rather than routine
Why it matters: CBER oversees vaccines, gene therapies, and blood products — high-stakes categories where leadership turbulence can ripple into drug approval timelines and industry confidence. Mikhail's explicit pitch to staff as a "normal" boss signals the center is actively working to restore internal morale and predictability after a contentious chapter.




