Dr. George Tidmarsh, the Food and Drug Administration’s top drug regulator, was placed on leave Friday. File Photo by Jim Lo Scalzo/EPA
Dr. George Tidmarsh, the Food and Drug Administration’s top drug regulator, was placed on leave amid controversy over the drug approval process and a battle with a business foe.
The FDA claims Tidmarsh has resigned, but Tidmarsh maintains that he was placed on leave on Friday, according to ABC News and The New York Times. He was appointed to the position in July.
Emily Hilliard, a Health and Human Services spokesperson, said in a statement that Tidmarsh 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.”
STAT News reported Sunday that Tidmarsh was accused of trying to financially harm former colleague Kevin C. Tang, a board chair and investor at Aurinia Pharmaceuticals. Aurinia is a Canadian company that makes voclosporin, an immunosuppressant used as a treatment for lupus nephritis, a condition of the kidneys in people who have lupus.
Aurinia filed a lawsuit against Tidmarsh for a September LinkedIn post in which he criticized voclosporin as having little benefit and “significant toxicity.” The suit said the post cost Aurinia about $350 million in value, The New York Times reported.
The lawsuit also alleges that after Tang asked Tidmarsh to resign from some companies, Tidmarsh sent messages threatening revenge against Tang and that he solicited bribes from Tang through his lawyer.
In an interview with The New York Times, Tidmarsh said he doesn’t think about Tang. “He was irrelevant to me,” he said. He denied all allegations.
Tidmarsh said he is being pushed out because of his criticism of a new FDA process to speed up the process to review certain drugs. Tidmarsh said he voiced concern that the process might not be legal and that the reviews would bring politics into the process.
The review process normally takes months, but the new way would approve drugs within a day.
“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,” The Times reported Tidmarsh said. “There was insufficient legal support for what they wanted to do, and so I didn’t agree.”
Tidmarsh also described the FDA as a “toxic environment” because of Dr. Vinay Prasad, who oversees vaccine regulation at the FDA. Prasad was removed from his post in July but was brought back two weeks later.
