George Tidmarsh, the head of the FDA’s drug division, resigned on Sunday after he was placed on leave Friday, “after the Office of the General Counsel and the Office of the Inspector General were notified of serious concerns about his personal conduct,” Emily Hilliard, an HHS spokeswoman, told ABC News in a statement. Tidmarsh said in an interview that he believed the FDA’s new program for accelerated approval introduced politics into the drug review process. He also complained of a “toxic” work environment in an interview with ABC News. Tidmarsh told the New York Times that he believed these comments were the reason for his being placed on leave.
Silver Spring, MD, USA – June 25, 2022: The FDA White Oak Campus. Adobe Stock
Aurinia claims defamation
Aurinia Pharmaceuticals filed a lawsuit in Maryland federal court against Tidmarsh, claiming his criticism of one of its drugs in a LinkedIn post tanked their stock, which fell 20% after the post, wiping out more than $350 million in shareholder value. In the post, he claimed that Aurinia’s lupus nephritis treatment, Lupkynis, carries “significant toxicity” and it “has not been shown to provide a direct clinical benefit for patients.” Tidmarsh has since deleted the post.
Aurinia also claimed that Tidmarsh used his position in the FDA to pursue a “longstanding personal vendetta” against the chair of its board of directors, Kevin Tang. Tang has served as a board member of several pharmaceutical companies where Tidmarsh was an executive, and was involved in the departure of Tidmarsh from La Jolla Pharmaceuticals.
Aurinia cited text messages and emails from Tidmarsh to Tang and his associates, including one threatening to “expose” Tang, from 2019 to 2024, as evidence for Tidmarsh’s alleged personal vendetta. It also claims that Tidmarsh used his FDA position to advocate for the removal of desiccated thyroid extract (DTE) products from the market. American Laboratories is a major supplier of DTE, and Tang is its board chair. The complaint explains that the “request not only violated numerous federal laws” but “transparently reflects an attempt to extort and solicit a bribe from Mr. Tang in exchange for Dr. Tidmarsh using his power to reverse or otherwise mitigate the adverse impact on Mr. Tang, Tang Capital, and American Laboratories from FDA’s recent action to effectively remove DTE from the market.”
Aurinia is suing for defamation and injurious falsehood based on the LinkedIn post and is seeking damages in excess of $75,000 plus punitive damages.
An agency in chaos
This event further displays the instabilities of Robert F. Kennedy Jr.’s Health and Human Services department. In March, the HHS cut 4,700 jobs in the FDA and NIH. This was part of a “dramatic structuring” announced that month. In the announcement, Kennedy revealed plans to cut the workforce by 10,000 full-time employees, combined with early retirement to reduce the workforce from 82,000 to 62,000, as well as reduce the number of divisions from 28 to 15. The CDER, which Tidmarsh oversaw, lost over 1,000 staffers in the past year due to layoffs and resignations.
The department has also seen the resignation, or ousting, of several high-ranking leaders. CDC Director Susan Monarez was removed from her role in August, less than a month after she entered the position. The FDA’s chief science and medical officer, Vinay Prasad, whom Tidmarsh blamed for the “toxic work environment”, resigned from his role in July but was shortly reinstated.
Peter Marks, who led CBER (biologics center), resigned from his role in late March, suggesting that he had been forced out for refusing to give Kennedy access to the U.S.’ federal vaccine injury reporting system.
Filed Under: Regulatory affairs
