FDA Drug Center Chief Resigns Amid Misconduct Review

Washington, Nov 3 (AP) — On Sunday, the head of the Food and Drug Administration's drug center, Dr. George Tidmarsh, unexpectedly resigned amid a review by federal officials into "serious concerns about his personal conduct," as reported by a government spokesperson.

Dr. Tidmarsh, who had taken up the FDA position in July, was placed on leave last Friday. This action followed a notification to the Department of Health and Human Services' Office of General Counsel regarding these issues, as stated by HHS press secretary, Emily Hilliard, in an email. Tidmarsh opted to resign on Sunday morning.

"Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency," Hilliard noted.

The resignation coincided with a lawsuit filed by Aurinia Pharmaceuticals, a drugmaker linked to one of Tidmarsh's former business collaborators, claiming he made "false and defamatory statements" during his tenure at the FDA.

Aurinia Pharmaceuticals alleges in the lawsuit that Tidmarsh exploited his position at the FDA to enact a "longstanding personal vendetta" against Kevin Tang, the chair of Aurinia’s board of directors.

Tang was a former board member at several pharmaceutical companies where Tidmarsh held executive roles, including La Jolla Pharmaceutical, where Tang was allegedly involved in Tidmarsh's removal from leadership roles, based on the lawsuit's claims.

Messages for comment left with Tidmarsh and his legal counsel were not returned immediately by late Sunday.

Tidmarsh has a long history as a founder and leader of multiple pharmaceutical companies in California's pharmaceutical and biotech sectors. Prior to his FDA role, he also held a position as an adjunct professor at Stanford University. He joined the FDA over the summer after discussions with FDA Commissioner Marty Makary.

His resignation adds to the series of erratic leadership changes at the agency, which has been dealing with a wave of departures, firings, and contentious decisions concerning vaccines, fluoride, and various other products over recent months.

Dr. Vinay Prasad, previously in charge of the FDA's vaccine and biologics center, resigned in July amid pressure from conservative figures aligned with President Donald Trump, only to return to the agency two weeks later at the request of Health Secretary Robert F. Kennedy Jr.

The FDA’s drug center, under Tidmarsh’s purview, has experienced a loss of over 1,000 employees in the past year due to layoffs and resignations, according to agency data. This center is the FDA's largest division and is tasked with the review, safety, and quality control of both prescription and over-the-counter medications.

In September, Tidmarsh gained public attention due to an unusual LinkedIn post criticizing Aurinia Pharmaceutical’s kidney medication, stating it "had not been shown to provide a direct clinical benefit for patients." Such public remarks regarding specific companies and products are uncommon for FDA regulators.

Following this post, the lawsuit claims Aurinia's stock fell by 20%, resulting in a loss of over USD 350 million in shareholder value. Tidmarsh subsequently deleted the LinkedIn post, stating it was made in a personal capacity and not as an official of the FDA.

Aurinia's lawsuit also claims that Tidmarsh targeted a thyroid drug from American Laboratories, where Tang holds the position of board chair, during his tenure at the FDA. The lawsuit filed in the US District Court in Maryland seeks compensatory and punitive damages and aims “to set the record straight,” as stated by the company.

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