The US Food and Drug Administration (FDA) has selected Tracy Beth Høeg as its new head of drug research and evaluation – marking another leadership change in a tumultuous period for the agency.
Høeg’s appointment closely follows the sudden retirement of longtime FDA employee and previous Center for Drug Evaluation and Research (CDER) director, Richard Padzur, who only took the helm at the division less than a month ago.
Padzur was originally encouraged to take charge of CDER by FDA Commissioner Marty Makary after previous leader, George Tidmarsh, resigned following an investigation into his personal conduct revealing “serious concerns”.
Høeg is sports medicine physician and epidemiologist by training. She first joined the FDA as a special assistant to Makary in March 2025, and has since worked in two senior advisory positions within CBER and the Office of the Commissioner.
During her short time at the agency, Høeg has voiced her scepticism towards the safety and value of Covid vaccines – specifically focusing on mask mandates, as well as the approval of booster jabs for use in children.
Before her CDER appointment, Høeg was in the headlines for exactly this reason, as the Center for Biologics Evaluation and Research (CBER) leader, Vinay Prasad, claimed that research she headed had uncovered 10 children’s deaths linked to Covid vaccines.
While Prasad is yet to publicise proof of these claims, he used the point as leverage to push for tighter vaccine regulation alongside health secretary Robert F Kennedy (RFK) Jr, which has been a point of contention under the Trump administration.
Former FDA commissioners have stated their concern about the recent changes to vaccine regulation and recommendations, reflecting the disconnect between the current administration and previous leaderships.
In a self-written biography on not-for-profit hospital provider Dignity Health’s website, Høeg also expressed her special interest in orthobiologic medicine – specifically naming platelet-rich plasma, proliferative therapy and bone marrow aspirate concentrate.
Makary stated that Høeg is “the right scientist to fully modernise CDER,” while establishing a “culture of cross-centre coordination”.
US healthcare’s senior leadership changes
Høeg is now the fifth CDER head this year. Along with Pazdur and Tidmarsh, Patrizia Cavazzoni and Jacqueline Corrigan-Curay have also been in the role. Cavazzoni retired from the agency in January amid the incoming Trump administration, while Corrigan-Curay stepped down in June.
Outside of CDER, it has been a volatile year for the FDA, with many in leadership roles within the agency either retiring, resigning or being ousted.
This includes Prasad, who left his position as head of CBER just three months after assuming the role – only to rejoin two weeks later at the request of the FDA.
Before Prasad, Peter Marks headed the department, though he was forced to resign due to ongoing disagreements over vaccine policy with RFK Jr.
The FDA’s cell and gene therapy division was also subject to some leadership changes. Nicole Verdun, lead of the Office of Therapeutic Products (OTP) and her deputy, Rachel Anatol, were placed on administrative leave in June 2025.
Amid this turmoil, the FDA has also been subject to mass layoffs, while drug review delays caused by the recent government shutdown continue to cause issues.
