FDA Shakeup Continues: Høeg Fired, Davis Named Acting CDER Head

• Tracy Beth Høeg, acting CDER director, was fired on May 16 after refusing to resign; the fifth person to lead the center in 16 months
• The FDA now has no permanent commissioner, deputy commissioner, or permanent heads of its two major drug and biologics centers

The FDA lost three more senior officials in a single week, capping a rapid-fire leadership collapse that now leaves the agency’s two largest centers, responsible for drug and biologics review, in the hands of acting directors with no confirmed replacements in sight.

Tracy Beth Høeg, who had served as acting director of the Center for Drug Evaluation and Research (CDER) for five months, says she was fired on May 16 after declining to submit a resignation letter. “I said I’m not signing a letter of resignation if it’s not my choice,” Høeg told MD Reports in an interview published Friday. She added that those delivering the news told her “it was from someone above them, from someone way above their pay grade.” Høeg posted on X that evening: “Today I was fired. … I learned so much & leave with no regrets.”

Her exit follows the resignation of Commissioner Marty Makary on Tuesday, and lands alongside two other departures the same week: Katherine Szarama, who had been acting director of the Center for Biologics Evaluation and Research (CBER) for just 10 days following Vinay Prasad’s exit, and Chief of Staff Jim Traficant, who had joined the agency last March as former chair and CEO of Citadel Sciences, according to the Guardian. An FDA email to staff, obtained by the Associated Press, confirmed that Høeg’s former deputy, Dr. Michael Davis, will serve as acting CDER director. Karim Mikhail, previously CEO of pharmaceutical company Amarin, will temporarily head CBER, the Guardian reported.

Høeg was the fifth person to run CDER since Trump began his second term in January 2025 — a span of roughly 16 months. Her tenure was marked by controversy: she considered relabeling COVID-19 vaccines to indicate risks outweighed benefits for men ages 12 to 24, raised safety questions about approved RSV treatments from Merck, Sanofi, and AstraZeneca, and disagreed with FDA scientists who recommended approving Sanofi’s Type 1 diabetes drug teplizumab. A dispute that prompted Sanofi to ask the FDA to remove the drug from a pilot accelerated approval program, Reuters reported.

The broader shake-up is being driven in part by Chris Klomp, who sits just below HHS Secretary Robert F. Kennedy Jr., according to Reuters. Klomp has been pushing to remove controversial appointees and replace them with more traditional picks following Makary’s departure. A number of lower-level FDA officials brought in by Makary, including deputy chief of staff Samuel Doran and associate director of policy and research strategy Sanjula Jain-Nagpal, are also expected to leave, Reuters reported.