FDA's Top Drug Regulator, George Tidmarsh, Resigns Amid Probe

Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.

WASHINGTON — George Tidmarsh, the Food and Drug Administration’s top regulator of drugs, has resigned after being accused of using his regulatory authority to inflict financial harm on a former business associate, STAT has learned.

FDA Commissioner Marty Makary placed Tidmarsh on administrative leave after opening an investigation into his conduct in recent days based on a complaint filed against Tidmarsh by Kevin Tang, a San Diego-based health care investor and business owner. One of Tang’s affiliated companies, Aurinia Pharmaceuticals, filed a lawsuit against Tidmarsh on Sunday, accusing him of a “longstanding personal vendetta against Kevin Tang.”

In an interview with STAT, Tidmarsh confirmed he was placed on leave from his role as the director of the FDA’s Center for Drug Evaluation and Research. Makary informed him about Tang’s complaint on Friday, but Tidmarsh did not find out he had been placed on leave until he was locked out of his agency email account on Saturday. Tidmarsh denies any wrongdoing.

In a statement, a spokesperson for the Department of Health and Human Services, which oversees the FDA, said Tidmarsh resigned Sunday morning “effective immediately.”

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