FDA's top drug regulator resigns, agency cites personal conduct

Robert Langreth, Bloomberg News on Nov 2, 2025

By clicking submit, I authorize Arcamax and its affiliates to: (1) use, sell, and share my information for marketing purposes, including cross-context behavioral advertising, as described in our Privacy Policy , (2) add to information that I provide with other information like interests inferred from web page views, or data lawfully obtained from data brokers, such as past purchase or location data, or publicly available data, (3) contact me or enable others to contact me by email or other means with offers for different types of goods and services, and (4) retain my information while I am engaging with marketing messages that I receive and for a reasonable amount of time thereafter. I understand I can opt out at any time through an email that I receive, or by clicking here

The U.S. Food and Drug Administration’s lead drug regulator George Tidmarsh resigned two days after being placed on administrative leave over personal conduct concerns, according to the U.S. Department of Health and Human Services.

Tidmarsh was appointed in late July to be the director for the Center for Drug Evaluation and Research. He didn’t immediately reply to a request for comment from Bloomberg News.

In an interview with the New York Times, Tidmarsh said he was placed on leave after he raised concerns over the legality of a program to speed up approval of some new drugs, which he believed “injected politics into the drug review program.”

The agency placed Tidmarsh on administrative leave on Friday after the Office of the General Counsel and the Office of Inspector General were notified of “serious concerns about his personal conduct,” an HHS spokesperson said.

On Sunday morning, Tidmarsh resigned, effective immediately, the spokesperson said, noting that HHS Secretary Robert F. Kennedy Jr. “expects the highest ethical standards from all individuals serving under his leadership.”

The department’s concerns were related to a September LinkedIn post where Tidmarsh criticized the FDA’s 2021 approval of voclosporin, which is marketed under the name Lupkynis and is used to treat lupus nephritis, according to two people familiar with the matter who weren’t authorized to speak publicly.

The post — which Tidmarsh later deleted — prompted shares of the drug’s maker Aurinia Pharmaceuticals Inc. to drop sharply after his comment.

Tidmarsh previously served as chief executive officer of La Jolla Pharmaceutical Co., whose then-chairman now serves as chair of Aurinia. Tidmarsh left La Jolla in 2019 “to pursue other interests,” according to a statement at the time.