FDA’s high drug regulator resigns after federal officers probe ‘severe considerations’

Dr. George Tidmarsh, who was named to the FDA submit in July, was positioned on go away on Friday after officers within the Department of Health and Human Services’ Office of General Counsel had been notified of the problems, HHS Press Secretary Emily Hilliard stated in an e mail. | Photo Credit: Reuters

The head of the Food and Drug Administration’s drug centre abruptly resigned on Sunday (November 2, 2025) after federal officers started reviewing “severe considerations about his private conduct,” in response to a authorities spokesperson.

Dr. George Tidmarsh, who was named to the FDA submit in July, was positioned on go away on Friday after officers within the Department of Health and Human Services’ Office of General Counsel had been notified of the problems, HHS Press Secretary Emily Hilliard stated in an e mail. Mr. Tidmarsh then resigned on Sunday morning.

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

The departure got here the identical day {that a} drugmaker related to considered one of Mr. Tidmarsh’s former enterprise associates filed a lawsuit alleging that he made “false and defamatory statements” throughout his time on the FDA.

The lawsuit, introduced by Aurinia Pharmaceuticals, alleges that Mr. Tidmarsh used his FDA place to pursue a “longstanding private vendetta” towards the chair of the corporate’s board of administrators, Kevin Tang.

Mr. Tang beforehand served as a board member of a number of drugmakers the place Mr. Tidmarsh was an government, together with La Jolla Pharmaceutical, and was concerned in his ouster from these management positions, in response to the lawsuit.

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

Mr. Tidmarsh based and led a collection of pharmaceutical firms over a number of many years, working in California’s pharmaceutical and biotech industries. Before becoming a member of the FDA, he additionally served as an adjunct professor at Stanford University. He was recruited to hitch the company over the summer season after assembly with FDA Commissioner Marty Makary.

Mr. Tidmarsh’s ouster is the newest in a string of haphazard management adjustments on the company, which has been rocked for months by firings, departures and controversial choices on vaccines, fluoride and different merchandise.

Dr. Vinay Prasad, who oversees the FDA’s vaccine and biologics centre, resigned in July after coming beneath hearth from conservative activists near President Donald Trump, solely to rejoin the company two weeks later on the behest of Health Secretary Robert F. Kennedy Jr.

The FDA’s drug centre, which Mr. Tidmarsh oversaw, has misplaced greater than 1,000 staffers over the previous yr to layoffs or resignations, in response to company figures. The centre is the most important division of the FDA and is liable for the evaluation, security and high quality management of prescription and over-the-counter medicines.

In September, Mr. Tidmarsh drew public consideration for a extremely uncommon submit on LinkedIn stating that considered one of Aurinia Pharmaceutical’s merchandise, a kidney drug, had “not been proven to offer a direct scientific profit for sufferers.” It’s very uncommon for an FDA regulator to single out particular person firms and merchandise in public feedback on-line.

According to the corporate’s lawsuit, Aurinia’s inventory dropped 20% shortly after the submit, wiping out greater than $350 million in shareholder worth.

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

Aurinia’s lawsuit additionally alleges, amongst different issues, that Mr. Tidmarsh used his submit on the FDA to focus on a kind of thyroid drug made by one other firm, American Laboratories, the place Mr. Tang additionally serves as board chair.

The lawsuit, filed within the U.S. District Court of Maryland, seeks compensatory and punitive damages and “to set the report straight,” in response to the corporate.

Published – November 04, 2025 04:23 am IST

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