FDA's top drug regulator sued by Canadian pharmaceutical company
Dr. George Tidmarsh, the FDA drug regulator who was placed on leave and complained of a “toxic” work environment in an interview with ABC News, was sued Sunday night by a Canadian pharmaceutical company, which accused him of tanking its stock by criticizing one of its drugs in a post on LinkedIn.
Aurinia Pharmaceuticals filed the lawsuit in federal court in Maryland and described what it alleges was a drawn-out retribution campaign by Tidmarsh against Aurinia board chair Kevin Tang, who the lawsuit alleges removed Tidmarsh from an executive role at another company.
“Over the next six years, Dr. Tidmarsh repeatedly threatened that he would exact revenge against Mr. Tang,” the lawsuit said, citing texts and emails sent from Tidmarsh to Tang.
The lawsuit in large part centered around a LinkedIn post that Tidmarsh wrote in September about voclosporin, an Aurinia-produced drug that was approved by the FDA in 2021 to treat active lupus nephritis in adults.
Tidmarsh criticized the drug “despite knowing that voclosporin has demonstrated direct clinical benefit,” the lawsuit alleged.
Tidmarsh deleted the post, but not before Aurinia’s share price fell more than 20% and the company lost more than $350 million in market value, according to the suit.
The company alleged Tidmarsh engaged in a “stunning abuse of power” to “act on his longstanding personal grudge."
Asked about the lawsuit, Tidmarsh referred ABC News to his attorney Brad Bondi, who did not immediately respond to a request for comment.
The lawsuit came just days after Tidmarsh, who leads the FDA’s Center for Drug Evaluation and Research, was placed on leave Friday “after the Office of the General Counsel and the Office of the Inspector General were notified of serious concerns about his personal conduct,” Emily Hilliard, an HHS spokeswoman, told ABC News in a statement.
Tidmarsh denied the allegations in an interview with ABC News on Sunday night.
He claimed the move was in retaliation for his speaking out against Vinay Prasad, the FDA’s chief medical and scientific officer.
Tidmarsh said he had criticized a new regulatory process at the FDA designed to speed up the review process for certain drugs. Tidmarsh raised concerns about the legality of the arrangement, which uses a tumor board-style review process to fast-track approvals for “companies aligned with critical U.S. national health priorities,” according to an FDA description of the program.
He told ABC News the arrangement, as designed, would be “different than the entire history of decades of the FDA.”
“It circumvents rigorous scientific debate and puts Vinay Prasad in charge of every drug approval,” he said.
Hilliard, the HHS spokeswoman, did not respond to a question about Tidmarsh’s claims of retaliation.
“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” she wrote.
Though Hilliard said Tidmarsh had resigned on Sunday, Tidmarsh told ABC News he was still weighing whether to do so.
“I would resign from a place as toxic as the current environment,” he alleged of the FDA. “It’s toxic, it’s bad, it’s bad for the American people. Anybody with a right mind would get out of a situation like that."
