In a sudden turn of events, Dr. George Tidmarsh, the head of the Food and Drug Administration's drug center, tendered his resignation on Sunday
This unexpected move came on the heels of an investigation into "serious concerns about his personal conduct," as stated by a government spokesperson. Dr. Tidmarsh, who assumed his position at the FDA in July, was put on leave on Friday when the Department of Health and Human Services' Office of General Counsel was alerted to the issues. Emily Hilliard, the HHS press secretary, confirmed this in an email. Following this, Dr. Tidmarsh stepped down from his role on Sunday morning.
As reported by the Associated Press, Hilliard stated, "Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency." The timing of Dr. Tidmarsh's resignation coincides with a lawsuit filed by a pharmaceutical company linked to one of his former business associates.
The company, Aurinia Pharmaceuticals, accused Dr. Tidmarsh of making "false and defamatory statements," during his tenure at the FDA. The lawsuit alleges that Dr. Tidmarsh exploited his position at the FDA to settle a "longstanding personal vendetta" against Kevin Tang, the chair of Aurinia's board of directors.
Tang had previously served on the board of several pharmaceutical companies where Dr. Tidmarsh held executive positions, including La Jolla Pharmaceutical. According to the lawsuit, Tang played a role in Dr. Tidmarsh's removal from these leadership roles.
Dr. Tidmarsh, a veteran of the pharmaceutical industry, founded and led several pharmaceutical companies over the years. Prior to his stint at the FDA, he also served as an adjunct professor at Stanford University. He was brought on board the FDA after a meeting with FDA Commissioner Marty Makary.
However, his departure adds to the recent spate of leadership changes at the FDA, which has been grappling with a series of firings, resignations, and controversial decisions on vaccines, fluoride, and other products.
Dr. Vinay Prasad, who oversees the FDA's vaccine and biologics center, also resigned in July following criticism from conservative activists close to President Donald Trump. However, he returned to the agency two weeks later at the request of Health Secretary Robert F. Kennedy Jr.
The FDA's drug center, which was under Dr. Tidmarsh's supervision, has seen more than 1,000 staff members leave due to layoffs or resignations over the past year, according to agency figures. This division, the largest within the FDA, is responsible for the review, safety, and quality control of prescription and over-the-counter medicines.
In September, Dr. Tidmarsh drew public attention when he posted on LinkedIn that one of Aurinia Pharmaceutical's products, a kidney drug, had "not been shown to provide a direct clinical benefit for patients." Such public comments singling out individual companies and products are highly unusual for an FDA regulator. Following this post,
Aurinia's stock plummeted by 20%, erasing more than $350 million in shareholder value. Dr. Tidmarsh later removed the LinkedIn post and clarified that he had posted it in his personal capacity, not as an FDA official.
Aurinia's lawsuit also alleges that Dr. Tidmarsh used his position at the FDA to target a type of thyroid drug produced by another company, American Laboratories, where Tang also serves as board chair. The lawsuit, filed in the U.S. District Court of Maryland, seeks compensatory and punitive damages and aims "to set the record straight," according to the company.
As the dust settles on this unexpected resignation, the FDA will need to navigate these choppy waters while ensuring the safety and efficacy of the drugs it oversees.
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