Top FDA Drug Regulator Leaves, Agency Cites Personal Conduct (2)

The US 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 US Department of Health and Human Services.

The resignation comes the same day Tidmarsh was sued for defamation by Aurinia Pharmaceuticals Inc., which accused him of harboring “a longstanding personal vendetta” against the company’s chairman. In late September, Tidmarsh published, then deleted a post on LinkedIn calling a lupus drug manufactured by Aurinia toxic that sent the drugmaker’s shares plummeting.

Tidmarsh said in an interview with the New York Times that he believes he was actually placed on leave after he raised concerns over the legality of a program to speed up approval of some new drugs. Tidmarsh said he thought the program injected politics into the drug review process. Tidmarsh was appointed in late July to be the director for the Center for Drug Evaluation and Research.

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.”

Tidmarsh and a lawyer representing him didn’t immediately reply to requests for comment from Bloomberg News.

Aurinia shares have since recovered from their slide after Tidmarsh’s late September LinkedIn post and were up 2.4% at the start of regular trading in New York on Monday. The company’s chairman, Kevin Tang, and Tidmarsh have a long professional history.

Tidmarsh previously served as chief executive officer of La Jolla Pharmaceutical Co., where Tang was chairman at the time. Tang asked Tidmarsh to resign from the company in 2019 “due to growing concerns over” Tidmarsh’s management, according to the Aurinia lawsuit. A statement at the time said Tidmarsh left La Jolla “to pursue other interests.”

Around the same time, Tang also asked Tidmarsh to resign from positions at two other companies where Tang served as chairman, American Laboratories Holdings and Odonate Therapeutics Inc., according to Aurinia’s complaint. The drugmaker alleged Tidmarsh formed a “vendetta” against Tang after being ousted.

Aurinia claimed in its lawsuit Tidmarsh sent harassing and threatening messages to Tang after he left La Jolla in 2019. Once he got to the FDA, Tidmarsh “targeted multiple companies” affiliated with Tang, and pushed the agency to remove thyroid drugs American Laboratories made the active ingredient for from the market, according to the complaint.

The FDA didn’t immediately comment on its role in taking action on the thyroid drugs.

After the FDA announced action against the thyroid drugs in August, Tidmarsh then made “an attempt to extort and solicit a bribe” from the Tang-associated company that made the thyroid drug ingredients, which failed, Aurinia alleged. Later Tidmarsh made the “indefensible” and “defamatory” LinkedIn post about Aurinia’s drug.

Tidmarsh wrote the lupus drug voclosporin made by Aurinia has “significant toxicity” and hasn’t been shown to help patients, sending shares of the drugmaker down about 20%. The medicine is marketed under the name Lupkynis and used to treat lupus nephritis, a disorder that causes the body’s immune system to damage the kidneys. Tidmarsh later clarified that his earlier post reflected “my own personal views” and not those of the agency.

Read More: Aurinia Sinks After FDA Official Questions Its Drug in Post

(Updates with shares in sixth paragraph.)

To contact the reporter on this story:
Robert Langreth in New York at rlangreth@bloomberg.net

To contact the editors responsible for this story:
Cynthia Koons at ckoons@bloomberg.net

Shelly Banjo, Kelly Gilblom

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