WASHINGTON — A U.S. Food and Drug Administration (FDA) official overseeing scrutiny of antidepressants, COVID-19 vaccines and other widely used therapies has been removed from her position leading the agency’s drug program.
Dr. Tracy Beth Hoeg will be replaced as acting director of the FDA’s drug center by Dr. Mike Davis, who previously served as deputy director, according to an internal email to staff obtained by The Associated Press.
Hoeg confirmed her departure in a social media post, saying she had been “fired” and adding: “I learned so much and leave with no regrets.”
Her removal is part of a broader leadership shake-up within the FDA, which has seen multiple senior officials leave or step down in recent months, including FDA Commissioner Marty Makary and vaccine and biotech chief Dr. Vinay Prasad.
The agency also named Karim Mikhail as acting director of its vaccines center.
Hoeg, a sports medicine physician and public health scientist, had led the FDA drug program since December after a rapid rise within the agency. She previously served as a special assistant to Makary and had no prior government leadership experience.
During her tenure, she oversaw reviews involving RSV treatments for children, antidepressants, and COVID-19 vaccines, including internal analyses that drew scrutiny and debate within public health circles.
She has also been known for publicly questioning pandemic-era policies such as masking and vaccine mandates, and has co-authored work with other officials now serving in or linked to the Trump administration.
Her removal adds to ongoing debate over the FDA’s direction and leadership stability, as the agency continues to face political pressure and internal restructuring while managing high-profile drug and vaccine policy decisions.