FDA Drug Center Chief George Tidmarsh Resigns Amid Ethics Probe and Industry Lawsuit
核心洞察
Dr. George Tidmarsh, head of the FDA's drug center, abruptly resigned Sunday after federal officials began reviewing "serious concerns about his personal conduct."
Aurinia Pharmaceuticals filed a lawsuit alleging Tidmarsh used his FDA position to pursue a "longstanding personal vendetta" against the company's board chair Kevin Tang (搜索).
The company claims Tidmarsh's LinkedIn post criticizing their kidney drug (搜索) caused a 20% stock drop, wiping out over $350 million in shareholder value.
Dr. George Tidmarsh, the head of the Food and Drug Administration's drug center, abruptly resigned Sunday after federal officials began reviewing "serious concerns about his personal conduct," marking the latest leadership upheaval at the agency. The resignation came just days after Tidmarsh was placed on administrative leave Friday following notification to Department of Health and Human Services (搜索) officials.
Ethics Investigation and Immediate Departure
According to HHS press secretary Emily Hilliard, officials in the Department of Health and Human Services (搜索)' Office of General Counsel were notified of issues regarding Tidmarsh's conduct, prompting his immediate placement on leave. "Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency," Hilliard stated.
Tidmarsh, who was appointed to the FDA position in July after meeting with FDA Commissioner Marty Makary, had previously founded and led several pharmaceutical companies over decades in California's pharmaceutical and biotech industries. He also served as an adjunct professor at Stanford University before joining the agency.
Industry Lawsuit Alleges Personal Vendetta
The resignation coincided with a lawsuit filed by Aurinia Pharmaceuticals alleging that Tidmarsh made "false and defamatory statements" during his tenure at the FDA. The company claims Tidmarsh used his regulatory position to pursue a "longstanding personal vendetta" against Kevin Tang (搜索), chair of Aurinia's board of directors.
According to the lawsuit filed in U.S. District Court of Maryland, Tang previously served as a board member of several drugmakers where Tidmarsh was an executive, including La Jolla Pharmaceutical (搜索), and was involved in Tidmarsh's removal from those leadership positions.
Controversial LinkedIn Post Triggers Market Impact
In September, Tidmarsh drew public attention for an unusual LinkedIn post stating that one of Aurinia Pharmaceutical's products, a kidney drug (搜索), had "not been shown to provide a direct clinical benefit for patients." Such public commentary targeting specific companies and products is highly unusual for FDA regulators.
The company's lawsuit alleges that Aurinia's stock dropped 20% shortly after the post, eliminating more than $350 million in shareholder value. Tidmarsh later deleted the LinkedIn post and claimed he had posted it in his personal capacity rather than as an FDA official.
The lawsuit also alleges that Tidmarsh used his FDA position to target a thyroid drug (搜索) manufactured by American Laboratories (搜索), where Tang also serves as board chair. Aurinia seeks compensatory and punitive damages and aims "to set the record straight," according to court documents.
Broader FDA Leadership Turmoil
Tidmarsh's departure represents the latest in a series of leadership changes that have disrupted the agency. The FDA has been affected by months of firings, departures, and controversial decisions regarding vaccines, fluoride, and other products.
Dr. Vinay Prasad, who oversees the FDA's vaccine and biologics center, resigned in July after facing criticism from conservative activists close to President Donald Trump, only to return two weeks later at the request of Health Secretary Robert F. Kennedy Jr.
The FDA's drug center, which Tidmarsh oversaw, has experienced significant staffing losses, with more than 1,000 employees departing over the past year through layoffs or resignations, according to agency figures. As the FDA's largest division, the drug center is responsible for reviewing, ensuring safety, and controlling quality of prescription and over-the-counter medicines.