FDA shuffles leadership following Makary’s exit

Additional high level shakeups have occurred at the U.S. FDA in the wake of commissioner Marty Makary’s departure last week.

Days after Makary resigned, Tracy Beth Høeg, acting director of CDER, was fired. Høeg announced her dismissal via a post on X, later telling media outlets that she was asked to resign, but refused. Michael Davis, who has been serving as CDER's deputy director, will take over in an acting capacity.

In addition, Katherine Szarama, who recently stepped in as CBER acting director role following the controversial departure of Dr. Vinay Prasad, will cease her duties at CBER. According to an internal FDA memo obtained by CNBC, Szarama will remain at the agency in a different capacity. Karim Mikhail, former Amarin CEO, will take over as acting director of CBER.

Høeg’s exit from CDER marks a string of recent leadership changes at the division. In January 2025 Patrizia Cavazzoni revealed her departure as head of CDER — announced as a retirement — ahead of Donald Trump’s inauguration. She was replaced in July 2025 by former biotech executive George Tidmarsh. Tidmarsh resigned abruptly in November 2025, after federal officials began probing concerns about his personal conduct. Dr. Richard Pazdur, founding director of the FDA’s Oncology Center of Excellence, was named Tidmarsh’s replacement. Weeks later, Pazdur announced his retirement and Høeg was named as his replacement.

CBER has also had its share of leadership drama. Prasad, a hematologist-oncologist, was named CBER director in May 2025, taking over for interim CBER head Scott Steele, who stepped in after Dr. Peter Marks resigned under pressure in March. In July 2025, Prasad resigned from CBER amid political controversy after becoming tangled in a public dispute with Sarepta. Criticism of Prasad’s stance on Elevidys later drew significant political backlash. He returned to the role several weeks after stepping down, only to depart again in March 2026. Høeg was named as his replacement.