FDA Chief Resigns Amid Explosive Lawsuit Over Allegations

UPDATE: The head of the U.S. Food and Drug Administration’s drug division, Dr. George F. Tidmarsh, has resigned just hours ago amid a growing legal storm, following allegations of defamation and personal vendetta against a former business associate. The explosive lawsuit, filed by Aurinia Pharmaceuticals Inc. in Maryland, claims Tidmarsh misused his position to target the company and its lupus drug, Lupkynis.

This urgent development raises significant concerns about the integrity of federal drug regulation. At stake is not only Tidmarsh’s reputation but also public trust in the FDA’s ability to operate free from personal conflicts. The lawsuit claims Tidmarsh made damaging statements about Lupkynis in a now-deleted LinkedIn post, asserting that the drug “has not been shown to provide a direct clinical benefit for patients” and accusing Aurinia of inadequate trials. These claims, made while he was the top drug regulator, led to a dramatic 20 percent drop in Aurinia’s stock, erasing over $350 million in market value.

On November 2, 2025, Tidmarsh resigned, a day before the lawsuit was publicly announced. He was placed on administrative leave as the Department of Health and Human Services (HHS) initiated an internal ethics investigation. HHS spokesperson Emily Hilliard stated, “Secretary [Robert F.] Kennedy expects the highest ethical standards from all individuals serving under his leadership.”

The lawsuit details a troubling pattern of alleged retaliation against Aurinia’s board chair, Kevin Tang. Tidmarsh reportedly sent threatening messages to Tang, vowing that “the pain is not over.” Furthermore, the complaint alleges Tidmarsh attempted to solicit a bribe from American Laboratories, a company linked to Tang, shortly after issuing an FDA enforcement notice against unapproved thyroid products. Tidmarsh has denied all allegations, claiming he is dedicated to public service.

The fallout from Tidmarsh’s actions could have lasting implications for regulatory practices at the FDA, an agency responsible for overseeing over 20,000 approved drugs. As the lawsuit progresses, both Aurinia and the FDA will face increased scrutiny over their transparency and accountability.

Dr. Tidmarsh’s now-deleted LinkedIn post raised eyebrows due to its stark criticism of Lupkynis, an immunosuppressant used to treat lupus nephritis. His comments contradict the FDA’s previous endorsement of the drug in 2021, sparking concerns about the motivations behind his statements.

As this urgent situation unfolds, the HHS inspector general is reviewing Tidmarsh’s conduct. The implications of this investigation could resonate throughout the pharmaceutical industry and alter how the FDA engages with drugmakers.

Stay tuned for more updates on this developing story as it continues to evolve, impacting both the FDA’s reputation and the future of drug regulation in the United States.