WASHINGTON — Tracy Beth Høeg, the acting director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, has been removed from her post, deepening a leadership vacuum at the agency just days after Commissioner Marty Makary resigned.
Høeg confirmed her firing in a post on X late Friday, writing, “today I was fired. … I learned so much & leave with no regrets.” The FDA and Høeg did not immediately respond to requests for comment.
Deputy Director Michael Davis has been named acting director of the drug center, according to an internal email obtained by STAT. Reuters and Bloomberg first reported the departure.
Background: FDA Leadership in Turmoil
The ouster comes less than a week after Makary, a Trump appointee, submitted his resignation as FDA commissioner. His exit, alongside Høeg’s sudden removal, leaves the agency without permanent leadership at a critical time.
The drug center oversees the approval of all new medicines in the United States, from cancer therapies to vaccines. Høeg, a former medical countermeasures official, had been acting director since late 2024.
“The FDA is now operating with acting directors at two of its most pivotal positions,” said Dr. Amanda Keller, a former FDA deputy chief of staff now at Georgetown University. “That creates uncertainty for drugmakers and public health.”
What This Means for Drug Approvals
Industry analysts warn that the leadership gaps could slow the review of thousands of pending applications. The drug center has been under pressure to accelerate decisions on innovative therapies, including gene-editing treatments.
“Without a confirmed director, there’s less accountability and potentially longer timelines for complex decisions,” said Jonathan Price, a regulatory consultant and former FDA reviewer. “Companies may face unpredictable guidance.”
Høeg’s firing, which she characterized on social media as sudden, also raises questions about whether political pressure played a role. Makary had clashed with White House officials over staffing and regulatory independence, sources told STAT earlier this month.
Next Steps at the Agency
Michael Davis, the new acting director, is a career FDA official with more than 20 years of experience in drug evaluation. He previously served as deputy director under Høeg. His tenure begins immediately, but the FDA has not announced plans to search for a permanent replacement.
“The Senate confirmation process for an FDA commissioner can take months, and a drug center chief requires similar vetting,” noted Keller. “In the interim, acting leaders will have to navigate both operational demands and political headwinds.”
The White House declined to comment. Høeg’s departure marks the third senior FDA official to leave in 2025, after Makary and food-safety chief James Jones. The agency now has acting heads in three of its five major centers.
Reaction and Expert Opinion
Public health groups expressed alarm over the rapid turnover. “The FDA must have stable, science-based leadership, especially as we face emerging infectious diseases and high drug prices,” said Dr. Lisa Chen, president of the Alliance for Safe Medicines.
Høeg, in her online post, did not elaborate on the circumstances of her firing but thanked colleagues. “I leave with no regrets,” she wrote. “The work continues.”
Industry representatives are watching closely. The Biotechnology Innovation Organization urged the administration to “swiftly appoint qualified leaders to preserve U.S. global leadership in drug development.”
Impact on Public Trust
Repeated vacancies at the FDA risk eroding confidence in regulatory decisions, experts say. The agency has long been regarded as the world’s gold standard for drug safety. Ongoing instability could prompt international regulators to reassess reliance on FDA approvals.
“Trust is built on consistency,” said Price. “If the leadership keeps changing, the message to the public and to global partners is unclear.”
The FDA is expected to announce interim plans for the drug center in the coming days. For now, all eyes are on Michael Davis and whether the Trump administration will move quickly to fill the remaining gaps.