FDA's Top Drug Regulator Resigns Amid Ethics Investigation and Lawsuit
Dr. George Tidmarsh, head of the FDA's drug division, resigned following an ethics probe and a lawsuit alleging misconduct related to his comments on a pharmaceutical company's product.
Dr. George Tidmarsh, director of the Food and Drug Administration's Center for Drug Evaluation and Research, resigned on Sunday amid an ethics investigation and a lawsuit alleging misconduct. Appointed in July 2025, Tidmarsh was placed on administrative leave after the Department of Health and Human Services' Office of the General Counsel and the Office of the Inspector General were notified of serious concerns about his personal conduct.
The resignation coincided with a lawsuit filed by Aurinia Pharmaceuticals, a Canadian company, accusing Tidmarsh of making false and defamatory statements about their lupus nephritis drug, Lupkynis (voclosporin). In a September LinkedIn post, Tidmarsh criticized the drug's efficacy, stating it had "not been shown to provide a direct clinical benefit for patients." The post was later deleted, but Aurinia claims it led to a 20% drop in their stock value, erasing over $350 million in market capitalization.
The lawsuit further alleges that Tidmarsh used his FDA position to pursue a personal vendetta against Kevin Tang, Aurinia's board chairman and a former business associate. According to the complaint, Tidmarsh attempted to extort Tang and sought to remove a top-selling product made by another company where Tang is a significant shareholder.
In response to the resignation, HHS press secretary Emily Hilliard stated, "Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency."
Tidmarsh's departure is the latest in a series of leadership changes at the FDA under Health Secretary Robert F. Kennedy Jr., including significant staff reductions and restructuring efforts aimed at streamlining operations within federal health agencies.