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FDA Removes Acting Drug Center Director Dr. Tracy Beth Hoeg Amid Leadership Turmoil

5/16/2026, 10:48:17 PM

Recent Leadership Changes at the FDA

The FDA announced Friday that Dr. Tracy Beth Hoeg has been removed as acting director of the Center for Drug Evaluation and Research (CDER). Deputy director Dr. Mike Davis will serve as interim head. Hoeg’s exit follows the resignation of FDA Commissioner Marty Makary and the recent departure of Dr. Vinay Prasad, the former vaccine and biotech chief.

Hoeg’s Rapid Rise and Prior Experience

Hoeg joined the FDA in March 2025 and was promoted by Makary, a close ally of Health Secretary Robert F. Kennedy Jr., from special assistant to head of CDER in December, despite no prior government or management experience. A sports-medicine physician and public-health scientist, she previously criticized pandemic measures, co-authored papers with Makary and Prasad, and hosted the Vaccine Curious podcast, which promoted unverified claims about mRNA vaccines.

Controversial Investigations Conducted

During her tenure, Hoeg oversaw reviews of injectable RSV drugs for children, antidepressants, and COVID-19 vaccines. She led an analysis linking COVID-19 shots to ten reported child deaths, a finding shared in an internal memo from Prasad but presented without supporting data. Hoeg also examined a petition to add bold warnings to antidepressants about alleged pregnancy risks, including fetal abnormalities and autism, and sought to hire the petition’s author as a senior adviser, raising staff concerns about conflicts of interest.

Official Statements and Agency Response

In a social-media post, Hoeg announced she had been terminated and said she had learned a great deal and left without regrets. An internal FDA email confirmed her replacement by Davis. The agency has not issued a formal statement on the vaccine-injury analysis, and both the FDA and the Centers for Disease Control and Prevention have previously concluded that serious vaccine side effects are extremely rare.

Criticism and Opposition

Hoeg’s actions drew criticism from drug manufacturers, patient groups, and investors, contributing to Prasad’s resignation. Makary’s departure was linked to complaints from President Donald Trump’s allies, including anti-abortion groups and vaping lobbyists. FDA staff voiced unease about Hoeg’s lack of experience and her attempt to appoint a personal acquaintance as a senior adviser.

Conflicting Reports and Information Gaps

The “initial analysis” linking vaccines to child deaths lacks publicly available evidence and has not been formally released by the FDA. The agency has not clarified the methodology behind the analysis or the basis for the antidepressant warning petition. A federal judge in Boston temporarily blocked proposed changes to the child-vaccination schedule, and the administration plans to appeal the decision.

Verbatim Quotes

  • “I learned so much and leave with no regrets.” — Dr. Tracy Beth Hoeg, social-media post
  • “initial analysis” — Phrase used to describe Hoeg’s vaccine-injury review