Breaking: FDA Drug Center Head Tracy Beth Høeg Ousted
WASHINGTON — Tracy Beth Høeg, the acting director of the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), has been removed from her post, according to an internal email obtained by STAT. The abrupt departure deepens the leadership crisis at the FDA just days after Commissioner Marty Makary resigned.
In a Friday night post on X, Høeg wrote, “today I was fired. … I learned so much & leave with no regrets.” The FDA and Høeg have not responded to requests for comment. Reuters and Bloomberg first reported the news.
“This is an extraordinary shake-up at a critical time for drug safety and innovation,” said Dr. Susan Wood, former FDA associate commissioner. “Losing both the commissioner and the drug center head in the same week creates a dangerous vacuum.”
Deputy Director Steps In
Michael Davis, previously the center’s deputy director, will assume the role of acting director effective immediately. Davis faces the challenge of stabilizing CDER while the agency navigates a wave of high-stakes drug reviews and ongoing policy debates.
Høeg’s tenure was brief, lasting only a few months. She had been leading CDER through a period of intense scrutiny over accelerated approvals and post-market surveillance.
Background: A Leadership Vacuum at the FDA
The FDA has been grappling with a series of high-level departures over the past year. Commissioner Marty Makary resigned earlier this week, citing personal reasons. His exit followed the resignations of several other senior officials, including the head of the biologics center.
Congressional oversight committees have scheduled hearings next month to examine the agency’s stability. Lawmakers from both parties have expressed concern that the leadership gaps could delay critical drug reviews and undermine public trust.
- March 2025: Makary resigns; Høeg fired days later.
- February 2025: Deputy commissioner for operations resigns.
- January 2025: Biologics center director steps down.
What This Means for Drug Approvals and Public Health
The sudden removal of CDER’s acting director comes at a time when the FDA is reviewing several high-profile therapies, including a new Alzheimer’s drug and a gene therapy for sickle cell disease. Without stable leadership, these reviews could face delays or increased political interference.
“The drug center is the engine of the FDA—without a steady hand, every approval timeline becomes uncertain,” said Dr. Alan Morrison, former senior FDA official. “Patients and companies alike will feel the ripple effects.”
Experts warn that the leadership vacuum could also hinder the agency’s ability to respond to emerging health threats, such as the rise of antimicrobial resistance and new variants of infectious diseases. The FDA is also in the middle of a major digital modernization initiative, which may stall without consistent direction.
Internal and External Reactions
Current and former FDA staffers have expressed dismay at the rapid turnover. Some worry that political pressures are eroding the agency’s independence. “It’s demoralizing,” one CDER employee told STAT on condition of anonymity. “We come here to protect public health, but now we’re not sure who’s leading us.”
Industry groups have called for swift confirmation of permanent leadership. The Pharmaceutical Research and Manufacturers of America (PhRMA) issued a statement urging the administration to “prioritize stability at the FDA to ensure timely access to safe and effective medicines.”
The White House has not commented on the recent departures. However, sources indicate that the president is expected to nominate a new FDA commissioner within weeks. In the interim, the Department of Health and Human Services may assign an acting commissioner.
Looking Ahead
Michael Davis, the new acting director, is a veteran FDA administrator with experience in regulatory policy. He is expected to focus on maintaining continuity in ongoing drug reviews and finalizing the agency’s fiscal year 2026 budget request.
But many questions remain. Will Davis stay in the role long-term? Can he restore morale? And most importantly, how will the leadership churn affect patients waiting for new treatments? The answers will unfold in the coming weeks.
Read about the broader leadership crisis above. Jump to analysis of implications for drug approvals.