FDA’s Top Drug Regulator Has Resigned, Health Department Says

Dr. George Tidmarsh was head of the Food and Drug Administration’s Center for Drug Evaluation and Research.

Dr. George Tidmarsh, in this undated file photo. FDA via The Epoch Times

A top Food and Drug Administration official has resigned, according to the Department of Health and Human Services.

Dr. George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research since July, stepped down on Nov. 2, according to a spokesperson for the department headed by Health Secretary Robert F. Kennedy Jr.

Tidmarsh’s resignation came several days after he was placed on leave following officials at the department learning of “serious concerns about his personal conduct,” spokeswoman Emily Hilliard said in an email.

“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” she wrote.

Tidmarsh, who was still listed in the department’s online employee directory on Nov. 2, did not return a request for comment by publication time.

In a lawsuit filed in federal court on Nov. 2 by Aurinia Pharmaceuticals, the doctor was accused of targeting companies linked to an investor with whom he had previously worked.

That included a September post on LinkedIn in which Tidmarsh said that a drug called voclosporin, made by Aurinia and previously approved by the FDA, has “significant toxicity” and that it has not been shown to provide any clinical benefits for patients.

“These statements are not only baseless, but indefensible and totally at odds with the available evidence and the conclusions of experts and regulators, including FDA, the agency for which Dr. Tidmarsh works,” the lawsuit, lodged in federal court in Maryland, stated.

The FDA said in an analysis of trial data for voclosporin, which is taken by people with lupus nephritis, that the data showed “substantial evidence of effectiveness.”

Tidmarsh later deleted the post and said that his comments did not reflect the views of the government.

The concerns about Tidmarsh’s personal conduct are related to the post, according to the Department of Health and Human Services.

Tidmarsh also sought payments from Kevin Tang, the investor, the suit alleges. It seeks compensatory and punitive damages.

A lawyer representing Tidmarsh did not respond to an inquiry by publication time.

Tidmarsh has, over the years, founded and headed multiple pharmaceutical companies. At one point, he was an executive at a company called La Jolla Pharmaceutical, where Tang was a board member.

Tidmarsh joined the FDA over the summer at the invitation of FDA Commissioner Dr. Marty Makary.

The head of another FDA division, Dr. Vinay Prasad, earlier in the year left the agency after resurfaced reports of his positive comments about Democrats. Prasad returned to the FDA in August.