The head of the FDA’s drug regulation division stepped down on Sunday amid accusations of misusing his position to publicly criticize a treatment related to a former associate.
Dr. George Tidmarsh, who had a lengthy career in the pharmaceutical industry before joining the FDA in July, was put on administrative leave just days prior. Emily Hilliard, a spokesperson for the Department of Health and Human Services (HHS), confirmed that serious concerns about Tidmarsh’s conduct had been raised.
He officially resigned Sunday morning with immediate effect.
“Secretary Kennedy demands the highest ethical standards from his team and is committed to transparency,” Hilliard stated, referring to HHS Secretary Robert F. Kennedy Jr.
The lawsuit at the center of this issue comes from Aurinia Pharmaceuticals, which alleged that Tidmarsh made false and defamatory remarks about the company and its medications based on a “long-standing personal grudge” against board chairman Kevin Tan.
The FDA itself is not named in the lawsuit. Notably, the vicinity around Tidmarsh was the initial area developed for the FDA.
A federal court in Maryland received the lawsuit, claiming Tidmarsh targeted Tan and affiliates of Tan Capital.
The lawsuit references a LinkedIn post from September, wherein Tidmarsh criticized a drug for having minimal patient benefits and noted “significant toxicity.” He deleted the post later, clarifying it represented his personal opinion—not that of the agency. Aurinia subsequently defended its medication publicly.
Following Tidmarsh’s comments, Aurinia’s stock dropped over 20%, though it has since recovered somewhat.
The lawsuit accuses Tidmarsh of leveraging his authority to demand bribes from Tan, attempting to influence the FDA’s actions against Aurinia and its drug, voclosporin, used for a kidney-affecting type of lupus.
According to the complaint, Tidmarsh’s grudge against Tan dates back to 2019, when Tan was removed as president and CEO of La Jolla Pharmaceuticals and other companies where he held a board chairman position. Tidmarsh had left the company around that time for “other interests,” as stated in earlier remarks. The complaint implies Tan had asked him to resign.
Shortly after joining the FDA, Tidmarsh allegedly pressured the agency to restrict market access for top-selling products from American Laboratories, a company associated with Tan’s past leadership.
Following the FDA’s move, Tidmarsh’s attorney reportedly emailed Tan, seeking to extend an existing service contract for Tidmarsh’s related entities for another decade.
In discussions with the New York Times, Tidmarsh described a “toxic environment” at the FDA, alleging retaliation in response to his concerns about a new initiative by FDA Commissioner Marty McCulley that aimed to accelerate priority drug approvals. He expressed worry that scientific integrity might be sidelined for political motives.
This program aims to speed up the review process for key products aligning with the administration’s priorities, with more extensive criteria than previous priority review mechanisms. These criteria focus on addressing significant unmet medical needs, reducing healthcare costs, tackling public health emergencies, promoting domestic manufacturing, and enhancing medicine affordability.
Tidmarsh asserted he had “not sent anything” to Tan and denied any connection to the US lab’s interests.
His resignation adds to a series of high-profile departures during the Kennedy administration. Earlier this year, President Kennedy dismissed Peter Marks, the FDA’s leading vaccine authority, and Susan Monales was ousted shortly after just a month as director of the CDC.
The FDA has continued to face scrutiny for its controversial decisions regarding vaccines and fluoride treatments.
