FDA's top drug regulator resigns after federal officials investigate 'serious concerns'

The caput of the Food and Drug Administration's cause halfway abruptly resigned Sunday aft national officials began reviewing "serious concerns astir his idiosyncratic conduct," according to a authorities spokesperson.

Dr. George Tidmarsh, who was named to the FDA station successful July, was placed connected permission Friday aft officials successful the Department of Health and Human Services' Office of General Counsel were notified of the issues, HHS property caput Emily Hilliard said successful an email. Tidmarsh past resigned Sunday morning.

"Secretary Kennedy expects the highest ethical standards from each individuals serving nether his enactment and remains committed to afloat transparency," Hilliard said.

The departure came the aforesaid time that a drugmaker connected to 1 of Tidmarsh's erstwhile concern associates filed a suit alleging that helium made "false and defamatory statements," during his clip astatine the FDA.

The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh utilized his FDA presumption to prosecute a "longstanding idiosyncratic vendetta" against the seat of the company's committee of directors, Kevin Tang.

Tang antecedently served arsenic a committee subordinate of respective drugmakers wherever Tidmarsh was an executive, including La Jolla Pharmaceutical, and was progressive successful his ouster from those enactment positions, according to the lawsuit.

Messages placed to Tidmarsh and his lawyer were not instantly returned precocious Sunday.

Tidmarsh founded and led a bid of pharmaceutical companies implicit respective decades moving successful California's pharmaceutical and biotech industries. Before joining the FDA, helium besides served arsenic an adjunct prof astatine Stanford University. He was recruited to articulation the bureau implicit the summertime aft gathering with FDA Commissioner Marty Makary.

Tidmarsh's ouster is the latest successful a drawstring of haphazard enactment changes astatine the agency, which has been rocked for months by firings, departures and arguable decisions connected vaccines, fluoride and different products.

Dr. Vinay Prasad, who oversees FDA's vaccine and biologics center, resigned successful July aft coming nether occurrence from blimpish activists adjacent to President Donald Trump, lone to rejoin the bureau 2 weeks aboriginal astatine the behest of Health Secretary Robert F. Kennedy Jr.

The FDA's cause center, which Tidmarsh oversaw, has mislaid much than 1,000 staffers implicit the past twelvemonth to layoffs oregon resignations, according to bureau figures. The halfway is the largest part of the FDA and is liable for the review, information and prime power of medicine and over-the-counter medicines.

In September, Tidmarsh drew nationalist attraction for a highly antithetic station connected LinkedIn stating that 1 of Aurinia Pharmaceutical's products, a kidney drug, had "not been shown to supply a nonstop objective payment for patients." It's precise antithetic for an FDA regulator to azygous retired idiosyncratic companies and products successful nationalist comments online.

According to the company's lawsuit, Aurinia's banal dropped 20% soon aft the post, wiping retired much than $350 cardinal successful shareholder value.

Tidmarsh aboriginal deleted the LinkedIn station and said helium had posted it successful his idiosyncratic capacity, not arsenic an FDA official.

Aurinia's suit besides alleges, among different things, that Tidmarsh utilized his station astatine FDA to people a benignant of thyroid cause made by different company, American Laboratories, wherever Tang besides serves arsenic committee chair.

The lawsuit, filed successful U.S. District Court of Maryland, seeks compensatory and punitive damages and "to acceptable the grounds straight," according to the company.