File photo: U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland, November 4, 2009.
Jason Reid | Reuters
The head of the Food and Drug Administration’s Center for Drugs abruptly resigned on Sunday after federal authorities began considering “serious concerns about his personal conduct,” according to a government spokesperson.
Dr. George Tidmarsh, who was appointed to the FDA post in July, was placed on administrative leave on Friday after officials in the Department of Health and Human Services’ Office of General Counsel were notified of the matter, HHS spokeswoman Emily Hilliard said in an email. Mr Tidmarsh subsequently resigned on Sunday morning.
“Secretary Kennedy expects the highest ethical standards from all individuals who serve under his leadership and remains committed to full transparency,” Hilliard said.
The resignation came on the same day that a drug company connected to one of Mr. Tidmarsh’s former business associates filed a lawsuit alleging that Mr. Tidmarsh made “false and defamatory statements” while at the FDA.
The lawsuit, filed by Aurinia Pharmaceuticals, alleges that Tidmarsh used his position with the FDA to pursue a “long-standing personal vendetta” against Kevin Tan, chairman of the company’s board of directors.
According to the complaint, Mr. Tan previously served on the boards of several pharmaceutical companies where Mr. Tidmarsh was an executive, including La Jolla Pharmaceuticals, and was involved in Mr. Tidmarsh’s ouster from those leadership positions.
Messages sent to Mr Tidmarsh and his lawyer were not immediately returned late Sunday.
Tidmarsh founded and led a series of pharmaceutical companies involved in California’s pharmaceutical and biotechnology industries for decades. Prior to joining FDA, he was also an adjunct professor at Stanford University. He was scouted to join the agency over the summer after meeting with FDA Commissioner Marty McCulley.
Mr Tidmarsh’s sacking is the latest in a series of haphazard leadership changes at the agency, which has been disrupted for months by firings, resignations and controversial decisions about vaccines, fluoride and other products.
Dr. Vinay Prasad, who oversees the FDA’s Center for Vaccines and Biologics, resigned in July following criticism from conservative activists close to President Donald Trump, but returned to the agency two weeks later at the direction of Health Secretary Robert F. Kennedy Jr.
The agency’s drug center, which Tidmarsh oversaw, lost more than 1,000 employees to layoffs and retirements in the past year, according to FDA statistics. The center is the FDA’s largest division and is responsible for the review, safety, and quality control of prescription and over-the-counter drugs.
In September, Tidmarsh gained public attention when he posted a highly unusual post on LinkedIn stating that one of Aurinia Pharmaceuticals’ products, a kidney drug, “has not been shown to have a direct clinical benefit to patients.” It is highly unusual for FDA regulators to name individual companies or products in online public comments.
Aurinia’s stock price fell 20% shortly after the posting, wiping out more than $350 million in shareholder value, according to the company’s complaint.
Tidmarsh later deleted the LinkedIn post and said he posted it in his personal capacity, not as an FDA employee.
Mr. Aurinia’s lawsuit also alleges that Mr. Tidmarsh used his position at the FDA to target certain thyroid drugs made by another company, American Laboratories, of which Mr. Tan is also chairman of the board.
The lawsuit, filed in the U.S. District Court for the District of Maryland, seeks compensatory and punitive damages and “to set the record straight,” the company said.
