FDA Drug Center Head Resigns Amid Conduct Review and Drugmaker Lawsuit
Dr. George Tidmarsh, FDA's top drug regulator, resigned after federal review of his conduct and a lawsuit by Aurinia Pharmaceuticals over alleged defamatory statements.
Overview
- Dr. George Tidmarsh, who led the FDA's drug center, resigned from his position after federal officials initiated a review into concerns regarding his personal conduct.
- Dr. Tidmarsh was placed on administrative leave after issues were reported to the Department of Health and Human Services, directly preceding his resignation as the FDA's top drug regulator.
- Aurinia Pharmaceuticals sued Tidmarsh, alleging he made false and defamatory statements during his FDA tenure, specifically criticizing one of their FDA-approved kidney drugs.
- The lawsuit against Dr. Tidmarsh is reportedly connected to one of his former business associates, adding complexity to the controversy surrounding his departure from the FDA.
- Tidmarsh's resignation is part of broader leadership changes and controversies at the FDA, which has lost over 1,000 staffers from its drug center in the past year.
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Analysis
Center-leaning sources frame this story by highlighting Dr. Tidmarsh's "unusual" conduct and the allegations of a "personal vendetta" from a lawsuit. They use evaluative language like "rocked" to describe the FDA's broader instability, creating a narrative of a problematic official whose actions contributed to agency turmoil and led to his abrupt resignation.
"The departure came the same day that a drugmaker connected to one of Tidmarsh's former business associates filed a lawsuit alleging that he made "false and defamatory statements" during his time at the FDA."
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FAQ
Dr. George Tidmarsh was accused of personal conduct issues and of using his regulatory authority to inflict financial harm on his former business associate Kevin Tang; additionally, Aurinia Pharmaceuticals, affiliated with Tang, filed a lawsuit alleging Tidmarsh made false and defamatory statements about one of their FDA-approved kidney drugs.
Kevin Tang is a San Diego-based healthcare investor and business owner known for acquiring and closing struggling biotech companies; he filed a complaint that triggered the investigation into Tidmarsh and is affiliated with Aurinia Pharmaceuticals, which sued Tidmarsh over alleged defamatory statements.
FDA Commissioner Marty Makary placed Dr. Tidmarsh on administrative leave after a complaint by Kevin Tang, and an investigation into Tidmarsh's conduct was initiated; Tidmarsh resigned effective immediately following this process.
Dr. Tidmarsh denied any wrongdoing in response to the allegations and lawsuit and confirmed he was placed on leave after being informed by the FDA commissioner.
Tidmarsh's resignation is part of broader leadership changes and controversies at the FDA's Center for Drug Evaluation and Research, which has experienced significant staff losses, with over 1,000 personnel leaving in the past year.
History
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