Top FDA Drug Regulator Resigns Amid Federal Probe into ‘Serious Concerns’

The recent resignation of Dr. George Tidmarsh, head of the FDA’s drug center, has raised significant concerns. His departure comes amidst an ongoing federal investigation into serious allegations regarding his personal conduct. Tidmarsh was appointed to this critical role in July.

Background on Dr. George Tidmarsh

Before his tenure at the FDA, Dr. Tidmarsh had a notable career in the pharmaceutical and biotech industries in California. He also held a position as an adjunct professor at Stanford University. His recruitment to the FDA followed a meeting with Commissioner Marty Makary.

Federal Investigation and Immediate Leave

Dr. Tidmarsh was placed on administrative leave last Friday after officials from the Department of Health and Human Services reviewed allegations against him. The HHS press secretary, Emily Hilliard, confirmed this action, stating that Secretary Kennedy expects high ethical standards from his team.

Lawsuit from Aurinia Pharmaceuticals

On the same day Tidmarsh resigned, Aurinia Pharmaceuticals filed a lawsuit against him. The company alleges that Tidmarsh made false and defamatory statements while serving at the FDA. This lawsuit highlights Tidmarsh’s involvement in what the company claims is a personal vendetta against its board chair, Kevin Tang.

Allegations of Targeting Competitors

The lawsuit also accuses Tidmarsh of using his position to aim at other drugs, including a thyroid medication produced by American Laboratories, where Tang is also the board chair. This suggests that his actions might have extended beyond personal grievances into broader industry practices.

Impact on Aurinia Pharmaceuticals

Following Dr. Tidmarsh’s unusual LinkedIn post, which criticized one of Aurinia’s kidney drugs, the company’s stock reportedly dropped 20%, resulting in a loss of over $350 million in shareholder value. Tidmarsh later deleted the post, claiming it was made in his personal capacity.

Leadership Challenges at the FDA

Dr. Tidmarsh’s resignation is part of a troubling trend of leadership instability at the FDA. Over the past year, the agency has seen significant turnover. More than 1,000 staff members have left due to layoffs or resignations, straining operations at the drug center, which is integral to the agency’s mission of ensuring drug safety and effectiveness.

Recent Leadership Changes

• Dr. Vinay Prasad, former director of the FDA’s vaccine and biologics center, resigned in July but rejoined two weeks later.
• The agency’s drug center is the largest division within the FDA.

These developments underscore a period of turmoil for the FDA, calling into question its leadership and operational stability.