Robert F. Kennedy Jr.’s mission to “Make America Healthy Again” appears to be facing significant challenges. The new “health czar” continues to oversee turmoil within some of America’s most critical health agencies—a development that does not bode well for the nation or its public health.
A recent example of this chaos unfolded over the weekend when the Food and Drug Administration (FDA) was thrown into disarray following the resignation of one of its top drug regulators, George Tidmarsh. Tidmarsh formerly headed the FDA’s Center for Drug Evaluation and Research.
The resignation came amid a lawsuit filed on Sunday by Aurinia Pharmaceuticals, a Canadian company, alleging misconduct by Tidmarsh. According to the lawsuit, Tidmarsh made defamatory statements on LinkedIn that caused a significant drop in Aurinia’s stock price. Specifically, Tidmarsh criticized voclosporin, Aurinia’s drug designed to treat lupus nephritis—an autoimmune disease—claiming that the drug had “not been shown to provide a direct clinical benefit for patients.” The lawsuit contends that these statements were false and defamatory.
Although Tidmarsh later deleted the LinkedIn post, the lawsuit asserts that Aurinia’s stock plummeted by 20 percent following his comments, as reported by ABC News.
The lawsuit further alleges that Tidmarsh engaged in a personal campaign against Aurinia’s board chairman, Kevin Tang, threatening over the course of six years to exact revenge. According to The New York Times, the suit claims Tidmarsh “attempted to extort” Tang, who is described as a “former business associate.”
In an interview with The New York Times, Tidmarsh denied all allegations.
Tidmarsh has faced previous criticism for shifting the FDA away from relying on expert advisory committees in the review of new drugs. CBS News reported that he described these meetings as “a tremendous amount of work for the company and for the FDA,” expressing a desire to focus resources on “the big questions” instead.
With Tidmarsh’s dramatic exit, the FDA is now in a state of flux. Text messages shared with Axios from FDA staffers reveal widespread dismay over the ongoing turmoil within the agency. Though the messages themselves were not made public, Axios reports that employees are “disturbed by the turmoil and increasingly motivated to leave,” exacerbated by the departure of many experienced career officials.
Axios also interviewed former FDA employees who echoed the sentiment. One former staffer reportedly said, “I don’t know that I’ve talked to anyone who’s happy there.”
Gizmodo reached out to the Department of Health and Human Services (HHS), the FDA, George Tidmarsh, and Aurinia Pharmaceuticals for comment.
In a statement to The New York Times, an FDA spokesperson said that before his resignation, Tidmarsh had been placed on administrative leave “after the office of the general counsel and the office of the inspector general were notified of serious concerns about his personal conduct.”
As the FDA navigates this turbulent period, the agency’s ability to effectively regulate critical health products remains under scrutiny—raising concerns about the future of public health oversight in the United States.
https://gizmodo.com/rfk-jr-s-fda-is-in-meltdown-mode-2000682180
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