George Tidmarsh has resigned from the role of director of the FDA Center for Drug Evaluation and Research. According to media reports, the resignation follows an internal investigation into allegations around personal conduct. He was placed on administrative leave on Friday October 31.
He is also being sued by Canadian pharma company Aurinia Pharmaceuticals, which accuses Tidmarsh of using his authority to inflict financial harm through “false and defamatory statements.”
What does the lawsuit say?
In September, Tidmarsh reportedly published a now-deleted post on his personal LinkedIn discussing surrogate endpoints, where he made a direct comment about Aurinia’s drug voclosporin: “So we have approved drugs with significant toxicity like voclosporin that has not been shown to provide a direct clinical benefit for patients,” the post said. It also insinuated that Aurinia had failed “to perform the trials necessary to confirm actual clinical benefit” from voclosporin.
The drug was fully approved by the FDA in 2021 in combination with immunosuppressants to treat lupus nephritis. After the LinkedIn post, Aurinia’s stock dropped by 20%, wiping off more than $350 million off the company’s value.
The Washington Post has published a copy of the lawsuit filing. In it, Aurinia claims that Tidmarsh had a “longstanding personal vendetta” against Kevin Tang, who is currently the Chair of the Board of Aurinia, and that the LinkedIn post was made because Tidmarsh “wanted to continue retaliating against Mr. Tang.”
According to the lawsuit, Tang and Tidmarsh were both previously involved with La Jolla Pharmaceutical Company. As chair of the board of La Jolla, Tang asked Tidmarsh to resign from the position of President and CEO – and also asked him to resign from other companies where Tang was on the board, including at American Laboratories and Odonate Therapeutics.
The filing alleges: “Over the next six years, Dr. Tidmarsh repeatedly threatened that he would exact revenge against Mr. Tang over these ousters, writing in texts and emails to Mr. Tang and his business associates that he would “be exposed,” that there was “[m]ore bad karma to come,” that “[t]he pain is not over,” and that “I’m Not powerless.””
The filing also claims that Tidmarsh has targeted other companies associated with Tang, including American Laboratories.
Tidmarsh has told some reporters that he intends to fight to clear his name and credibility, and has also cited a “toxic” work environment at the FDA. In interviews, Tidmarsh suggests he was pushed out after criticizing a new review process at the FDA. There have also been media reports of tensions between Tidmarsh and Vinay Prasad.
Tidmarsh was appointed as CDER director in July 2025. Before joining the FDA, he had a long career in biotechnology and academic medicine. He founded and led several life sciences companies, including Horizon Pharma and La Jolla Pharmaceutical Company, and held faculty positions at Stanford University School of Medicine. His appointment to the FDA was viewed as part of a broader effort to bring industry experience to regulatory leadership roles.
