Just a few days after FDA Commissioner Makary resigned, ally Tracy Beth Høeg is also leaving the agency. Her departure comes amid reports of tension over a commissioner’s voucher for Sanofi’s diabetes drug.
Another domino has fallen at the FDA, with Center for Drug Evaluation and Research Acting Director Tracy Beth Høeg expected to exit, according to Reuters.
The interim drug center chief served in the role for about five months and was the fifth person to hold the post since President Donald Trump began his second term last January—a span of about 16 months.
The terms of her departure are unclear, with a spokesperson for the Department of Health and Human Services declining to comment on personnel matters to Reuters. BioSpace has also reached out to HHS for comment.
Høeg is known for her vaccine skepticism and allegiance to former FDA Commissioner Marty Makary, who resigned earlier this week amid rumors of his ouster. Makary faced several controversies, including pressure to approve flavored vapes, criticism surrounding the agency’s handling of several rare disease decisions, and concerns about the agency’s transparency actions and regulatory flexibility.
Høeg, who had replaced oncologist Richard Pazdur after his brief stint in the role, was embroiled in her own controversy. Earlier this week, Big Pharma Sanofi reportedly asked that the FDA remove teplizumab, or Tzield, from its Commissioner’s National Priority Review program after Høeg allegedly disagreed with staff who wanted to expand the label for the diabetes drug.
Now Høeg is leaving the agency, though the circumstances remain unclear. The FDA has not shared a release regarding the expected exit and hasn’t yet confirmed the departure with BioSpace.
Since Trump started his second term, the agency and its parent agency HHS have been rocked by deep workforce reductions and widespread resignations. But the past few weeks in particular have maintained a dizzying pace of FDA turnover.
In addition to Makary, Vinay Prasad, who led the Center for Biologics Evaluation and Research, recently exited the agency. Prasad was perhaps the most controversial figure at the FDA, known for injecting unpredictability and inconsistency into the regulator’s decision-making.
Katherine Szarama, a deputy to the now-departed Prasad, was tapped to take over his role in an acting capacity. Szarama was a director of clinical trials at billionaire-founded Arnold Ventures, according to her LinkedIn profile. Makary and Prasad are also tied to the venture firm, according to reporting from The Wall Street Journal.
