FDA Drug Chief Resigns Amid Explosive Defamation Lawsuit

BREAKING: Dr. George F. Tidmarsh, head of the U.S. Food and Drug Administration’s drug division, resigned on November 2, 2025, just one day before facing a federal defamation lawsuit filed by Aurinia Pharmaceuticals in Maryland. The lawsuit alleges Tidmarsh used his position to carry out a personal vendetta against a former business associate while negatively impacting multiple drugmakers.

This explosive lawsuit raises critical questions about the integrity of the FDA and its ability to operate free from personal bias. With public trust in federal drug regulation at stake, the implications of Tidmarsh’s actions could resonate far beyond one individual’s reputation.

After only four months in office, Tidmarsh’s tenure as director of the FDA’s Center for Drug Evaluation and Research (CDER) ended abruptly following an internal ethics investigation initiated by the Department of Health and Human Services (HHS). HHS spokesperson Emily Hilliard stated, “Secretary Robert F. Kennedy expects the highest ethical standards from all individuals serving under his leadership.” Tidmarsh was placed on administrative leave just two days prior to his resignation.

The 32-page complaint, titled Aurinia Pharmaceuticals Inc. et al. v. George F. Tidmarsh, accuses Tidmarsh of posting “false and defamatory statements” regarding Aurinia’s lupus nephritis drug, Lupkynis, on LinkedIn while he was in office. His September 29 post claimed that Lupkynis “has not been shown to provide a direct clinical benefit for patients,” contradicting the FDA’s previous full approval of the drug in 2021. This post was deleted shortly after concerns were raised by FDA ethics officials.

Following Tidmarsh’s remarks, Aurinia’s stock plummeted by 20 percent, resulting in a staggering loss of over $350 million in market value. Aurinia firmly asserts that its clinical studies demonstrate significant benefits of Lupkynis, emphasizing the drug’s importance for patients with lupus nephritis, a severe autoimmune condition.

The lawsuit further alleges a pattern of retaliation against Kevin Tang, Aurinia’s board chair, who had previously requested Tidmarsh’s resignation from other companies. Texts and emails revealed Tidmarsh allegedly threatened revenge against Tang, including a chilling message stating, “The pain is not over.”

In a serious twist, the lawsuit claims Tidmarsh attempted to solicit a bribe from American Laboratories, a company linked to Tang. This request reportedly occurred after the FDA issued an enforcement notice against unapproved thyroid products, a move Tidmarsh allegedly championed shortly after taking office.

As the lawsuit unfolds, both Aurinia and the FDA are under intense scrutiny for their transparency and accountability. The FDA oversees more than 20,000 approved drugs, and the integrity of this oversight is now in question.

“I gave up everything to go into government,” Tidmarsh stated on November 2. “I pursued the thyroid medications because they were marketed without FDA approval.”

The HHS inspector general is currently reviewing Tidmarsh’s conduct, with the outcome potentially influencing the future of federal drug regulation.

As this story develops, the implications of Tidmarsh’s resignation and the ongoing lawsuit will be crucial to watch, as they may redefine the standards of ethical conduct within the FDA.