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FDA Drug-Review Chief George Tidmarsh Resigns as HHS Probes Conduct

Aurinia has sued, alleging a personal vendetta that damaged its share price and included an attempted solicitation of payments.

Overview

  • HHS said Tidmarsh was placed on administrative leave Friday after the Office of the General Counsel and the Inspector General were notified of serious concerns about his personal conduct, and he resigned Sunday.
  • Tidmarsh had led the FDA’s Center for Drug Evaluation and Research since July, overseeing the division responsible for prescription and over-the-counter medicine review and safety.
  • Aurinia’s complaint centers on a September LinkedIn post in which Tidmarsh questioned the benefit and safety of its lupus nephritis drug, Lupkynis, which the company says preceded a roughly 20% stock drop of about $350 million.
  • The lawsuit also alleges he targeted other companies linked to Aurinia board chair Kevin Tang and sought payments through a lawyer, claims Tidmarsh denies; court filings include texts and emails cited as evidence.
  • Tidmarsh says he was retaliated against for challenging a new rapid-review program he viewed as legally unsound and overly rushed, as federal health agencies face broader leadership turbulence under HHS Secretary Robert F. Kennedy Jr.