FDA CBER acting director Mikhail pledges normalcy to staff
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- Karim Mikhail became acting director of the FDA's Center for Biologics Evaluation and Research and told staff at a June town hall that he was 'normal,' adding 'I am with you on planet Earth' and 'I understand very well what everybody is going through.'
- Vinay Prasad, the previous leader of CBER, is characterized in the article as 'decidedly outside the norm' — making Mikhail's deliberate normality pitch a direct contrast with his predecessor's leadership style.
- The article frames Mikhail's tenure as a push to help CBER 'steady itself after a stormy chapter,' using Mikhail's opening address as evidence of the new leadership tone.
- Mikhail's stated empathy for staff — acknowledging what 'everybody is going through' — is presented by the article as an unremarkable gesture made remarkable only because of what came before.
- The piece is a STAT+ exclusive examining the personnel and cultural transition at FDA's biologics center rather than a specific regulatory action.
Why it matters: CBER oversees vaccines, gene therapies, and blood products, so leadership turnover there ripples through every developer awaiting biologics review. Mikhail's 'normal' pitch is itself a signal that the prior era was exceptional, and the article uses the tone of his first address to flag how much stabilization staff may need.
