FDA Drug Evaluation Chief Resigns Amid Ethical Misconduct Allegations and Lawsuit

Dr. George Tidmarsh, who assumed the role of director at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) in July 2025, resigned on Sunday amid allegations of ethical misconduct and a lawsuit filed by Aurinia Pharmaceuticals. The Department of Health and Human Services (HHS) had placed Tidmarsh on administrative leave on Friday after being alerted to “serious concerns about his personal conduct,” according to HHS press secretary Emily Hilliard. ([apnews.com](https://apnews.com/article/19ed112b8e0e42347ba033f3b6f2c28c?utm_source=openai))

The lawsuit, filed by Aurinia Pharmaceuticals, accuses Tidmarsh of leveraging his FDA position to pursue a “longstanding personal vendetta” against Kevin Tang, the chair of Aurinia’s board and manager of Tang Capital Partners, the company’s largest shareholder. ([apnews.com](https://apnews.com/article/19ed112b8e0e42347ba033f3b6f2c28c?utm_source=openai))

In September, Tidmarsh posted a statement on LinkedIn questioning the safety and clinical benefit of Aurinia’s lupus drug, Lupkynis, describing it as having “significant toxicity.” This post, which was later deleted, led to a 20% drop in Aurinia’s stock, erasing over $350 million in shareholder value. ([apnews.com](https://apnews.com/article/19ed112b8e0e42347ba033f3b6f2c28c?utm_source=openai))

The lawsuit also alleges that Tidmarsh attempted to solicit a bribe from Tang. Specifically, after the FDA announced actions that could impact a product made by American Laboratories—where Tang is also a board chair—Tidmarsh’s personal lawyer reportedly emailed Tang, requesting that American Laboratories extend an existing financial agreement with a Tidmarsh-associated entity for another 10 years. ([washingtonpost.com](https://www.washingtonpost.com/health/2025/11/02/george-tidmarsh-resigned-aurinia-lawsuit/?utm_source=openai))

In response to these developments, HHS emphasized its commitment to ethical standards and transparency. “Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard stated. ([apnews.com](https://apnews.com/article/19ed112b8e0e42347ba033f3b6f2c28c?utm_source=openai))

Tidmarsh’s resignation marks another significant leadership change at the FDA, following the departure of other high-profile officials earlier this year. ([reuters.com](https://www.reuters.com/legal/litigation/us-fdas-drug-division-chief-resigns-amid-ethics-concerns-lawsuit-2025-11-03/?utm_source=openai))