FDA's Top Drug Regulator Resigns Amid Ethics Probe and Lawsuit
George Tidmarsh, head of the FDA's drug division, resigned following an ethics investigation and a lawsuit alleging misuse of his position against a former associate.
Dr. George Tidmarsh, appointed in July as the 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 misuse of his position.
The Department of Health and Human Services (HHS) placed Tidmarsh on administrative leave on Friday after its Office of General Counsel and Office of the Inspector General were notified of serious concerns regarding his personal conduct. 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."
On the same day as his resignation, Aurinia Pharmaceuticals filed a lawsuit accusing Tidmarsh of using his FDA position to pursue a personal vendetta against Kevin Tang, the company's board chair. The lawsuit alleges that Tidmarsh made false and defamatory statements about Aurinia's lupus drug, Lupkynis, leading to a significant drop in the company's stock value.
In September, Tidmarsh posted on LinkedIn that Lupkynis had "not been shown to provide a direct clinical benefit for patients," a statement that Aurinia claims caused a 20% decline in its stock price, erasing over $350 million in shareholder value. Tidmarsh later deleted the post, stating it was made in a personal capacity.
The lawsuit also alleges that Tidmarsh targeted a thyroid drug produced by American Laboratories, where Tang serves as board chair, as part of his alleged vendetta.
Tidmarsh's departure is the latest in a series of leadership changes at the FDA, which has experienced significant staff turnover and controversy in recent months. The agency's drug center has reportedly lost over 1,000 staffers in the past year due to layoffs or resignations.