Updated
Updated · STAT · Jul 15
Karim Mikhail Promises Stability at FDA Biologics Center After 1 Stormy Leadership Chapter
Updated
Updated · STAT · Jul 15

Karim Mikhail Promises Stability at FDA Biologics Center After 1 Stormy Leadership Chapter

1 articles · Updated · STAT · Jul 15

Summary

  • Karim Mikhail told FDA biologics staff in a June town hall that he was “normal” and understood what employees were going through, signaling a reset as acting director.
  • The message landed because Mikhail has taken over the Center for Biologics Evaluation and Research after Vinay Prasad, whose tenure staff viewed as unusually turbulent and outside the norm.
  • CBER oversees biologics regulation, so Mikhail’s early emphasis on steadiness points to an effort to calm internal disruption and restore routine leadership at a key FDA center.

Insights

Is a 'normal' leader enough to fix an FDA facing a massive workforce crisis and a deep trust deficit?
With leadership in constant flux, can the FDA's ambitious plans to modernize drug development actually succeed?