FDA’s Top Drug Regulator Resigns Amid Conduct Investigation
The Food and Drug Administration (FDA) has recently witnessed a significant leadership shift following the resignation of Dr. George Tidmarsh, who headed the FDA’s drug center. His departure comes amid an investigation into serious allegations regarding his personal conduct.
Dr. George Tidmarsh’s Departure
Dr. Tidmarsh, who assumed his role at the FDA in July, was placed on leave on a Friday just before his resignation on Sunday morning. This decision followed a notification to federal officials from the Department of Health and Human Services (HHS) regarding concerns about his behavior. HHS press secretary Emily Hilliard emphasized the agency’s commitment to high ethical standards and transparency.
Legal Issues Involving Aurinia Pharmaceuticals
On the same day as Tidmarsh’s resignation, Aurinia Pharmaceuticals filed a lawsuit against him. The company claims that during his tenure at the FDA, Tidmarsh made “false and defamatory statements” that stemmed from a personal vendetta against its board chair, Kevin Tang.
- Tidmarsh allegedly pursued his vendetta due to prior professional conflicts with Tang.
- The lawsuit states that Tidmarsh’s actions caused Aurinia’s stock to plummet by 20%, resulting in a loss of over $350 million for shareholders.
Background on Dr. Tidmarsh
Dr. Tidmarsh has an extensive background in the pharmaceutical industry, having founded and led numerous companies over several decades. Before his appointment with the FDA, he was an adjunct professor at Stanford University. His recruitment to the FDA was facilitated by discussions with FDA Commissioner Marty Makary.
Impact on FDA and Recent Changes
Tidmarsh’s resignation highlights ongoing leadership turmoil at the FDA. The agency has experienced multiple recent departures, including that of Dr. Vinay Prasad, who resigned from the vaccine and biologics center in July but briefly returned after intervention from Health Secretary Robert F. Kennedy Jr.
The FDA’s drug center, the largest division of the agency, has faced significant staffing challenges, losing more than 1,000 employees due to layoffs and resignations over the past year. This instability raises questions about the center’s effectiveness in regulating prescription and over-the-counter medications.
Public Remarks and Controversies
In September, Dr. Tidmarsh attracted public scrutiny for his unusual LinkedIn post, where he remarked that a kidney drug from Aurinia had “not been shown to provide a direct clinical benefit for patients.” This was a significant departure from typical conduct expected from FDA officials, leading to further complications in his professional standing.
After deleting the post, Tidmarsh noted it was made in his personal capacity and not as a representative of the FDA. Nevertheless, the fallout from this incident contributed to the legal actions initiated by Aurinia Pharmaceuticals.
The resignation of Dr. George Tidmarsh serves as a critical moment for the FDA, shedding light on the challenges the agency faces amidst leadership changes and controversies surrounding its officials.
