FDA shuffles top drug, biologics leaders in latest shakeup

• CDER, which regulates prescription drugs, will see its fifth leader since January, with Karim Mikhail replacing Høeg who said she was fired
• The agency regulates products accounting for approximately 20% of U.S. consumer spending and has struggled with high turnover during Trump's second term
• The Trump administration plans to nominate a permanent FDA commissioner within weeks and is also working to fill other key health positions including CDC director and surgeon general

FDA Leadership Shakeup: Top Drug and Biologics Officials Replaced

The U.S. Food and Drug Administration conducted a major leadership reshuffle of its drug and biologics divisions, according to a memo obtained by CNBC. The changes come days after FDA Commissioner Marty Makary's departure, marking continued turbulence at the agency responsible for regulating products representing approximately 20% of U.S. consumer spending.

Key Personnel Changes

Tracy Beth Høeg, acting director of the Center for Drug Evaluation and Research (CDER), and Katherine Szarama, acting director of the Center for Biologics Evaluation and Research (CBER), were removed from their positions. Høeg confirmed on social media platform X that she was fired, while Szarama will remain with the agency in another capacity.

Karim Mikhail will replace Høeg at CDER, and Michael Davis will take over CBER. Lowell Zeta has been named acting chief of staff. The FDA website was updated Friday night to reflect these appointments.

Organizational Instability

The shake-up underscores significant turnover challenges at the FDA under the second Trump administration. CDER has seen five different leaders since January of the previous year, while CBER has experienced similar instability with multiple leadership changes over the past 12 months.

Broader Implications

The two affected divisions oversee prescription drugs, pills, and vaccines—critical healthcare products. The Trump administration plans to nominate a permanent FDA commissioner within weeks, requiring Senate confirmation. Meanwhile, other key health positions remain vacant, including the CDC director and surgeon general roles.

This latest reorganization raises concerns about regulatory continuity and stability at one of the government's most important public health agencies.