FDA drug center head resigns amid misconduct review
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,” according to a government spokesperson, reports BritPanorama.
Dr. George Tidmarsh, who assumed the role in July, was placed on leave on Friday following notifications to the Department of Health and Human Services’ Office of General Counsel regarding the issues, as confirmed by HHS press secretary Emily Hilliard. Tidmarsh subsequently tendered his resignation on Sunday morning.
“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard stated.
This resignation coincides with a lawsuit filed the same day by a drugmaker linked to one of Tidmarsh’s former associates, accusing him of making “false and defamatory statements” during his tenure at the FDA.
The lawsuit, filed by Aurinia Pharmaceuticals, claims Tidmarsh used his position at the FDA to pursue a “longstanding personal vendetta” against the chair of the company’s board of directors, Kevin Tang. Tang, who previously served on the boards of several drugmakers where Tidmarsh had been an executive, is alleged to have played a role in Tidmarsh’s ouster from those leadership positions.
Efforts to reach Tidmarsh and his attorney for comment were unsuccessful late Sunday.
Prior to his FDA appointment, Tidmarsh founded and managed various pharmaceutical companies over several decades in California’s pharmaceutical and biotech sectors, also serving as an adjunct professor at Stanford University. He was recruited to the FDA after discussions with FDA Commissioner Marty Makary.
His departure follows several leadership shifts within the FDA, a trend marked by increasing contraventions, firings, and troubling decisions regarding vaccines, fluoride, and other regulated products.
In a notable incident in September, Tidmarsh attracted public scrutiny for a LinkedIn post in which he stated that one of Aurinia’s products, a kidney drug, had “not been shown to provide a direct clinical benefit for patients.” Such remarks from an FDA regulator about specific products are highly atypical.
The fallout from this post had immediate effects, as Aurinia’s stock reportedly fell by 20%, erasing over $350 million in shareholder value.
Aurinia’s lawsuit further alleges that Tidmarsh targeted a thyroid medication produced by American Laboratories, where Tang is also a board chair. Filed in U.S. District Court of Maryland, the lawsuit seeks compensatory and punitive damages while aiming “to set the record straight.”
Tidmarsh’s departure underscores an ongoing trend of instability within leadership at the FDA, which has lost over 1,000 staffers in recent times due to layoffs or resignations from its drug center, the largest division responsible for overseeing the review, safety, and quality control of medicines.
As regulatory bodies navigate the complexities of governance and ethical conduct in the pharmaceutical industry, attention remains focused on potential ramifications from Tidmarsh’s controversial tenure and the ongoing operations of the FDA.
