George Tidmarsh, the former director of the FDA's Center for Drug Evaluation and Research, has filed a lawsuit alleging wrongful removal and defamation, according to GeneOnline. The filing, reported on Monday, escalates a months-long saga that began last fall when Tidmarsh was pushed out of one of the federal government's most consequential drug-regulation posts.
Tidmarsh was placed on administrative leave by the FDA on October 31, 2025, according to PharmExec. He stepped down days later, after being placed on leave amid an investigation into his conduct, as reported by STAT. At the time, an HHS spokesperson said the Office of the General Counsel and the Office of the Inspector General had been notified of serious concerns about his personal conduct, per the same PharmExec account.
Tidmarsh has denied wrongdoing, STAT reported. In the new lawsuit, he alleges that Vinay Prasad orchestrated his removal from the agency, with Prasad named as the primary architect behind the personnel change, according to the complaint as described by GeneOnline. That claim echoes what Tidmarsh told ABC News last fall, when he said his placement on leave was in retaliation for speaking out against Prasad.
Defamation Claims Target Aurinia and Board Chair
The lawsuit also accuses Kevin Tang and Aurinia Pharmaceuticals of defamatory conduct, per the complaint cited by GeneOnline, with Tidmarsh arguing the alleged conduct damaged his professional reputation. That dispute traces back to a separate legal fight: Aurinia, a Canadian drugmaker, filed suit over the fallout tied to a September LinkedIn post Tidmarsh wrote about the company's drug voclosporin, ABC News reported.
The reporting on that earlier Aurinia case is not entirely consistent. STAT described it as a lawsuit filed against Tidmarsh himself, and ABC News reported that Aurinia sued Tidmarsh, not the FDA, over the post. PharmExec additionally reported that the suit claimed Tidmarsh used his position to pursue a personal vendetta against Aurinia's board chair, Kevin Tang.
Tidmarsh's new filing also claims the dispute reaches further into the agency's leadership, detailing broader disagreements over the organization's leadership structure during Marty Makary's tenure, according to GeneOnline. Makary led the FDA during the internal conflicts described in the lawsuit, per the same report.
A Drug Center Churning Through Leaders
Tidmarsh's departure has become part of a larger pattern of turnover atop CDER. One report found that a subsequent leader, Høeg, was the fifth person to lead the center within the span of a year, according to PharmExec. That instability has reportedly made the job a hard sell internally: several longtime FDA employees said they were not interested in taking the CDER director position, The Guardian reported.
The lawsuit's allegations against Prasad, Tang, Aurinia and the broader leadership dispute under Makary have not been independently verified beyond the filing itself as described in the GeneOnline report, and the underlying court documents were not available for review. What is established across multiple outlets is the sequence that preceded it: Tidmarsh's October 2025 leave, his denial of wrongdoing as reported by STAT, and his public claim to ABC News that the move was retaliatory.
