FDA Drug Chief Resigns Amid Explosive Defamation Lawsuit

UPDATE: Dr. George F. Tidmarsh, head of the U.S. Food and Drug Administration’s drug division, has resigned just one day before being named in a federal defamation lawsuit filed by Aurinia Pharmaceuticals Inc. in Maryland. The explosive lawsuit alleges Tidmarsh weaponized his position to settle personal scores, impacting multiple drugmakers.

This urgent development raises serious questions about the integrity of federal drug oversight at a time when public trust is paramount. The lawsuit claims Tidmarsh made damaging statements about Aurinia’s lupus nephritis drug, Lupkynis, which led to a staggering 20 percent drop in the company’s stock, erasing over $350 million in market value.

On November 2, 2025, Tidmarsh stepped down following an internal ethics investigation led by the Department of Health and Human Services (HHS). “Secretary Robert F. Kennedy expects the highest ethical standards from all individuals serving under his leadership,” said HHS spokesperson Emily Hilliard in a statement. Tidmarsh was placed on administrative leave two days prior to his resignation.

The 32-page lawsuit alleges Tidmarsh made “false and defamatory statements” in a now-deleted LinkedIn post on September 29, where he claimed Lupkynis “has not been shown to provide a direct clinical benefit for patients.” Aurinia contends these remarks contradicted the FDA’s own approval findings from 2021.

The fallout from Tidmarsh’s comments was immediate. Aurinia asserts that its pivotal Phase 3 studies, AURORA-1 and AURORA-2, demonstrated significant clinical benefits, and they stand firmly behind the drug’s efficacy.

Furthermore, the lawsuit details allegations of retaliation against Kevin Tang, Aurinia’s board chair. Tidmarsh reportedly threatened Tang in messages, stating, “The pain is not over.” This raises alarming questions about potential corruption at the FDA.

In one serious allegation, Tidmarsh is accused of soliciting a bribe from American Laboratories, a company linked to Tang. This solicitation followed an FDA notice targeting unapproved animal-derived thyroid products, which Tidmarsh allegedly expedited shortly after taking office. The lawsuit describes this as an attempt at extortion.

As the lawsuit progresses, both Aurinia and the FDA are under heightened scrutiny regarding transparency and accountability in drug regulation. The FDA oversees more than 20,000 approved drugs, and public confidence in its operations is essential.

“We have approved drugs with significant toxicity like voclosporin…that has not been shown to provide a direct clinical benefit for patients,” Tidmarsh wrote in his now-deleted LinkedIn post.

As the situation develops, the HHS Inspector General is currently reviewing Tidmarsh’s conduct. Stakeholders across the pharmaceutical industry are watching closely as this high-profile case unfolds, with implications that could resonate throughout the sector.

For now, the FDA’s ability to operate independently of personal vendettas remains under fire, and the public’s trust hangs in the balance as further details emerge from this contentious legal battle.