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FDA’s top drug regulator resigns after investigation into ‘serious concerns’ about his conduct
Taking melatonin while you sleep could be silently harming your heart, scientists warn.

FDA’s top drug regulator resigns after investigation into ‘serious concerns’ about his conduct

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WASHINGTON (AP) — The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government spokeswoman.

Dr. George Tidmarsh, who was appointed to the FDA in July, took leave Friday after officials with the Department of Health and Human Services’ Office of General Counsel were notified of the issue, HHS spokeswoman Emily Hilliard said in an email. Tidmarsh resigned on Sunday morning.

“Secretary Kennedy expects the highest ethical standards from all individuals who work under his leadership and is committed to maintaining complete transparency,” Hilliard said.

The departure comes on the same day that a pharmaceutical company linked to one of Tidmarsh’s former business associates filed a lawsuit alleging that he made “false and defamatory statements” while working for the FDA.

The lawsuit filed by Aurinia Pharmaceuticals alleges that Tidmarsh used his FDA position to pursue a “long-standing personal vendetta” against Kevin Tang, chairman of the company’s board of directors.

Tang previously served as an executive at several pharmaceutical companies, including La Jolla Pharmaceutical, and was involved in his ouster from those leadership positions, according to the lawsuit.

Messages left for Tidmarsh and his attorney were not immediately returned as of late Sunday.

Tidmarsh founded and led a series of pharmaceutical companies over several decades in California’s pharmaceutical and biotechnology industries. Before joining the FDA, he also served as an adjunct professor at Stanford University. He was recruited to join the FDA over the summer after meeting FDA Commissioner Marty Makary.

Read more: Controversial FDA vaccines chief leaves agency after less than three months

Tidmarsh’s firing is the latest in a series of chaotic leadership changes at an agency that has been rocked for months by layoffs, resignations and controversial decisions on vaccines, fluoride and other products.

Dr. Vinay Prasad, who oversees the FDA’s Center for Vaccines and Biologicals, resigned in July following criticism from conservative activists close to President Donald Trump, but rejoined the agency two weeks later at the request of Health Secretary Robert F. Kennedy Jr.

The FDA’s drug center, which Tidmarsh oversaw, lost more than 1,000 employees through layoffs or resignations over the past year, according to agency figures. The center is the largest division of the FDA and is responsible for the review, safety and quality control of prescription and over-the-counter drugs.

Last September, Tidmarsh captured public attention with a highly unusual post on LinkedIn saying one of Aurinia Pharmaceutical’s products, a kidney drug, “has not been shown to provide direct clinical benefit to patients.” It is highly unusual for FDA regulators to single out individual companies and products in online public comments.

Aurinia’s stock fell 20% immediately after the post, wiping out more than $350 million in shareholder value, according to the company’s lawsuit.

see: What ousted CDC Director Monarez revealed about RFK Jr. during a Senate hearing

Tidmarsh later deleted the LinkedIn post and said he posted it in his personal capacity and not as an FDA official.

Aurinia’s lawsuit also alleges, among other things, that Tidmarsh used his position at the FDA to target a type of thyroid drug made by another company, American Laboratories, of which Tang serves as chairman of the board.

The suit, filed in the U.S. District Court for the District of Maryland, seeks compensatory and punitive damages and to “set the record straight,” according to the company.

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