U.S. Food and Drug Administration main campus building in Silver Spring, Maryland. Photo: ALM
The top drug regulator at the U.S. Food and Drug Administration resigned on Sunday while under review for what federal officials called “serious concerns about his personal conduct.”
Dr. George Tidmarsh, director of the agency’s Center for Drug Evaluation and Research, had been placed on leave last Friday pending an investigation by the HHS Office of Inspector General. “Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” HHS press secretary Emily Hilliard said.
Tidmarsh, who was named to the position in July, founded and led a several California pharmaceutical companies over several decades. On the same day he was placed on leave, Aurinia Pharmaceuticals, a drugmaker connected to one of Tidmarsh’s former business associates, filed a lawsuit alleging that he made “false and defamatory statements” during his time at the FDA.
The lawsuit alleged that Tidmarsh his position to pursue a “longstanding personal vendetta” against Kevin Tang, chair of the company’s board of directors. Tang previously served as a board member of several drugmakers where Tidmarsh was an executive, including La Jolla Pharmaceutical, and was involved in his ouster from those leadership positions, according to the lawsuit.
Tidmarsh posted on LinkedIn in September that a kidney drug from Aurinia Pharmaceutical had “not been shown to provide a direct clinical benefit for patients.” The company’s stock price dropped 20% after the post, according to the lawsuit, and more than $350 million in shareholder value was lost. The lawsuit, filed in U.S. District Court of Maryland, seeks compensatory and punitive damages and “to set the record straight,” according to the company
Tidmarsh told The New York Times that he believed the move was in retaliation for expressing concerns about the legal basis for the FDA’s new National Priority Voucher program aimed at to accelerating approval process of certain new drug applications. The first nine medications selected for the program were announced last month.
“The effort was going to basically change the entire paradigm of the legal underpinnings of drug approvals that have for decades supported the actions on the safety and effectiveness of drugs,” Tidmarsh said. “There was insufficient legal support for what they wanted to do, and so I didn’t agree.”
The FDA drug center that Tidmarsh oversaw is the largest FDA division and is responsible for the review, safety and quality control of prescription and over-the-counter medicines. The center has lost more than a thousand employees over the past year because of layoffs or resignations, according to agency figures.
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