FDA Chief Drug Regulatory Officer George Tidmarsh Resigns Due to Investigation

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

WASHINGTON — George Tidmarsh, the top drug regulator at the U.S. Food and Drug Administration, has resigned after being accused of using his regulatory powers to cause financial harm to a former business associate, STAT has learned.

FDA Commissioner Marty Makary placed Tidmarsh on administrative leave after launching an investigation into Tidmarsh’s conduct in recent days based on a complaint filed against him by Kevin Tang, a San Diego-based healthcare investor and business owner. Aurinia Pharmaceuticals, one of Tang’s subsidiaries, filed a lawsuit against Tidmarsh on Sunday, citing a “long-standing personal vendetta against Kevin Tang.”

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

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