Show summary Hide summary
An official who led the Food and Drug Administration’s drug center through a series of contentious safety reviews — including a recent probe into warnings for antidepressants — has been removed from her post, part of a rapid leadership shake-up at the agency. The change raises immediate questions about the direction of FDA policy and the stability of its review processes at a time when public trust and industry confidence are fragile.
An agency email obtained by The Associated Press named Dr. Mike Davis, previously the deputy director, as the acting head of the FDA’s largest center. The move follows a social media post in which the outgoing official, identified as Hoeg, said she had been “fired” and added that she was leaving with “no regrets.”
Who is stepping in — and who is moving on
Rockets’ playoff hopes wobble after shocking game 5 loss to Lakers
FDA reviewer of COVID vaccines and antidepressants exits: latest agency shake-up
Davis steps into the acting director role amid broader personnel changes. The agency also announced that Karim Mikhail, a longtime pharmaceutical executive brought into the agency last year, will serve as acting director of the vaccines center.
The departures come after the removal of the agency’s previous leader of the broader agency and the recent resignation of the vaccines and biotechnology chief, part of mounting pressure from political allies of President Donald Trump and other critics frustrated with the FDA’s recent course.
What Hoeg led and why her tenure drew scrutiny
Hoeg’s tenure at the FDA was brief but highly visible. Elevated rapidly from a special assistant role to the head of the drug center, her appointment broke with the agency’s usual pattern of naming directors with long federal careers and extensive regulatory experience.
During her time at the agency, Hoeg directed inquiries into several sensitive areas, including the safety of certain injectable treatments for children, post‑pandemic evaluations of COVID‑19 vaccines, and a formal petition seeking stronger pregnancy-related warnings on some antidepressants. Those actions reflected positions she had taken publicly before joining the FDA.
Hoeg first came to notice during the pandemic as a medical researcher who criticized interventions such as mask and school closure policies and questioned vaccine mandates. She co-authored papers with other critics who later entered the agency and maintained an active presence on podcasts and blogs that promoted skeptical views about mainstream vaccine safety claims.
- Leadership changes: Dr. Mike Davis named acting drug center director; Karim Mikhail to oversee vaccines as acting director.
- Controversial reviews: Hoeg led an “initial analysis” that linked COVID‑19 shots to a small number of pediatric deaths without releasing supporting data.
- Antidepressant review: The FDA has been examining a petition to attach new pregnancy-related warnings to certain antidepressants — a topic that has stirred debate inside the agency.
- Conflict concerns: Staffers raised issues after Hoeg tried to hire the author of the petition as a senior adviser, citing the candidate’s personal ties to Hoeg.
Evidence, internal debate and public confidence
Some of the analyses carried out under Hoeg’s watch were discussed internally but not formally announced by the FDA, and in at least one instance an internal memo circulated without full public documentation of the underlying evidence. Federal public health agencies have previously stated that serious adverse events from COVID‑19 vaccines are very rare, a conclusion reached after extensive monitoring and review.
The attempt to bring an external petitioner into a senior advisory role heightened concerns among agency staff about impartiality. According to people familiar with the matter, those concerns were amplified because Hoeg had repeatedly described the petitioner as a friend.
Observers say rapid personnel turnover at the agency can complicate ongoing reviews, delay decisions and unsettle both patients and industry stakeholders who rely on predictable regulatory pathways.
Why this matters now
The FDA regulates most prescription and over‑the‑counter medicines in the United States; leadership changes at the top of its largest center can influence how quickly and how rigorously safety questions are pursued. For clinicians, patients and drug developers, the current reshuffle may alter timelines for label changes, safety communications and approvals — and it comes at a moment when public debates over vaccines and drug safety remain highly charged.
Longer term, the episode underscores a tension within the agency between promoting new perspectives and preserving the institutional norms that many say help ensure scientifically grounded decisions. How the FDA balances those competing pressures will shape public confidence in its work going forward.
The Associated Press reported on the personnel memos and internal reactions; agency officials have not provided a full public explanation of the evidence behind some of the analyses carried out during Hoeg’s tenure.
