The head of the U.S. Food and Drug Administration’s drug division abruptly stepped down on Sunday after federal authorities began investigating “serious concerns” about his personal conduct, according to an agency spokesperson. Dr. George Tidmarsh, who took over the position in July, was placed on administrative leave Friday after officials in the Department of Health and Human Services’ (HHS) Office of General Counsel were alerted to the matter, said HHS press secretary Emily Hilliard in an email statement. Tidmarsh submitted his resignation two days later.“Secretary Kennedy expects the highest level of integrity from all officials under his leadership and remains fully committed to transparency,” Hilliard said.Top FDA Drug Regulator Resigns Amid Misconduct ProbeTidmarsh’s resignation coincided with a lawsuit filed by a pharmaceutical company tied to one of his former business associates. The company, Aurinia Pharmaceuticals, accused him of making “false and defamatory statements” while serving in his FDA role. The lawsuit claims Tidmarsh used his federal position to pursue a “personal vendetta” against Aurinia’s board chairman, Kevin Tang. Tang had previously sat on the boards of several biotech firms where Tidmarsh held executive roles, including La Jolla Pharmaceutical, and was allegedly involved in removing him from those posts.In September, Tidmarsh questioned the safety and effectiveness of Aurinia’s lupus medication, Lupkynis, in a LinkedIn post that he later deleted. Aurinia maintains the drug is both safe and effective, citing results from two large clinical trials and its full FDA approval in 2021.His exit comes amid a period of significant turnover within U.S. health agencies under Health Secretary Robert F. Kennedy Jr. Earlier this year, longtime vaccine official Peter Marks was dismissed, followed by gene therapy director Nicole Verdun.In another leadership shake-up, Dr. Vinay Prasad, head of the FDA’s vaccines and biologics division, resigned in July after facing criticism from conservative groups close to former President Donald Trump but rejoined the agency two weeks later at Kennedy’s request.Internal Strain at the FDAThe FDA’s drug division, previously overseen by Tidmarsh, has been struggling with heavy staff losses, more than 1,000 employees have reportedly left in the past year due to layoffs or resignations. The center is the agency’s largest branch, responsible for reviewing, approving, and monitoring the safety of both prescription and over-the-counter medicines.In September, Tidmarsh sparked widespread attention after posting publicly on LinkedIn that Aurinia’s kidney drug “had not been shown to provide a direct clinical benefit for patients.” It is highly unusual for an FDA official to single out a specific company or product on social media.Aurinia claims that Tidmarsh’s comments caused its stock to drop by 20%, erasing more than $350 million in shareholder value. Tidmarsh later deleted the post and stated that he had shared it in a personal capacity rather than as an FDA representative.The company’s lawsuit also alleges that Tidmarsh targeted another drug, a thyroid medication produced by American Laboratories, where Tang also serves as board chair.Filed in U.S. District Court in Maryland, the lawsuit seeks both compensatory and punitive damages, as well as a chance to “set the record straight,” according to Aurinia Pharmaceuticals.
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