BioCentury
ARTICLE | Politics, Policy & Law

Amarin, Merck alum Karim Mikhail emerges as possible head of FDA’s CDER

The former Amarin CEO and Merck executive is serving as an adviser to Commissioner Makary

June 20, 2025 12:07 AM UTC

FDA Commissioner Marty Makary has hired former pharmaceutical executive Karim Mikhail as a senior adviser and is considering appointing him as director of the Center for Drug Evaluation and Research, current and former FDA officials told BioCentury.

The officials, who were granted anonymity because they are not authorized to speak to the press, said Mikhail recently joined the Office of the Commissioner as a senior adviser to Makary and has been vetted as a candidate for the CDER leadership post...