FDA’s high drug regulator resigns after federal investigation into ‘critical considerations’

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Dr. George Tidmarsh, who was appointed to the FDA submit in July, was positioned on administrative depart on Friday after officers within the Division of Well being and Human Companies’ Workplace of Normal Counsel had been notified of the matter, HHS spokeswoman Emily Hilliard stated in an e-mail. |Picture offered by: Reuters

The top of the Meals and Drug Administration’s Middle for Medicine abruptly resigned on Sunday (Nov. 2, 2025) after federal authorities started contemplating “critical considerations about his private conduct,” in keeping with a authorities spokesperson.

Dr. George Tidmarsh, who was appointed to the FDA submit in July, was positioned on administrative depart on Friday after officers within the Division of Well being and Human Companies’ Workplace of Normal Counsel had been notified of the matter, HHS spokeswoman Emily Hilliard stated in an e-mail. Mr Tidmarsh subsequently resigned on Sunday morning.

“Secretary Kennedy expects the best moral requirements from all people who serve beneath his management and stays dedicated to full transparency,” Hilliard stated.

The resignation got here on the identical day {that a} drug firm related to one in every of Mr. Tidmarsh’s former enterprise associates filed a lawsuit alleging that Mr. Tidmarsh made “false and defamatory statements” whereas on the FDA.

The lawsuit, filed by Aurinia Prescribed drugs, alleges that Tidmarsh used his place with the FDA to pursue a “long-standing private vendetta” towards Kevin Tan, chairman of the corporate’s board of administrators.

Based on the criticism, Mr. Tan beforehand served on the boards of a number of pharmaceutical firms the place Mr. Tidmarsh was an govt, together with La Jolla Prescribed drugs, and was concerned in Mr. Tidmarsh’s ouster from management positions.

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Messages left for Mr. Tidmarsh and his lawyer weren’t instantly returned late Sunday.

Mr. Tidmarsh spent a number of a long time in California’s pharmaceutical and biotechnology industries, founding and main a sequence of pharmaceutical firms. Previous to becoming a member of FDA, he was additionally an adjunct professor at Stanford College. He was scouted to affix the company over the summer time after assembly with FDA Commissioner Marty McCulley.

Tidmarsh’s sacking is the most recent in a sequence of haphazard management adjustments on the company, which has been rocked for months by firings, resignations and controversial choices about vaccines, fluoride and different merchandise.

Dr. Vinay Prasad, who oversees the FDA’s Middle for Vaccines and Biologics, resigned in July after criticism from conservative activists near President Donald Trump, however returned to the company two weeks later on the behest of Well being Secretary Robert F. Kennedy Jr.

The company’s drug middle, which Tidmarsh oversaw, misplaced greater than 1,000 workers to layoffs and retirements up to now 12 months, in keeping with FDA statistics. The middle is the FDA’s largest division and is liable for the evaluate, security, and high quality management of prescription and over-the-counter medicine.

In September, Tidmarsh attracted public consideration when he posted a extremely uncommon submit on LinkedIn stating that one in every of Aurinia Pharmaceutical’s merchandise, a kidney drug, “has not been proven to have a direct medical profit to sufferers.” It’s extremely uncommon for FDA regulators to call particular person firms or merchandise in on-line public feedback.

Instantly after the submit, Aurinia’s inventory value fell 20%, wiping out greater than $350 million in shareholder worth, in keeping with the corporate’s criticism.

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Tidmarsh later deleted the LinkedIn submit and stated he posted it in his private capability, not as an FDA worker.

Aurinia’s lawsuit alleges, amongst different issues, that Mr. Tidmarsh used his place on the FDA to focus on sure thyroid medicine made by one other firm, American Laboratories, of which Mr. Tan can also be chairman of the board.

The lawsuit, filed within the U.S. District Courtroom for the District of Maryland, seeks compensatory and punitive damages and “to set the file straight,” the corporate stated.

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