FDA drug unit chief resigns amid probe

Dr George Tidmarsh, the head of the Food and Drug Administration's drug division, resigned Sunday amid an investigation into criticism he aired publicly about a drug tied to a former business associate.

- CHRISTINA JEWETT

A sign outside the Food and Drug Administration's headquarters in White Oak, Maryland.

(REUTERS)

Dr Tidmarsh said he believed the review was opened in retaliation to concerns he raised last week about the legal basis of a new programme for the rapid approval of some new drugs.

Dr Tidmarsh, a drug industry veteran who joined the agency in July, said in an interview Sunday that he believed the new programme injected politics into the drug review process, superseding decisions based on science.

Late Sunday, a pharmaceutical company lodged explosive claims against Dr Tidmarsh in a lawsuit claiming that the regulator had acted vengefully against its board chair and investor, Kevin Tang, who had previously asked Dr Tidmarsh to leave several companies. The lawsuit claimed that Dr Tidmarsh attempted to extort him. Dr Tidmarsh denied the allegations, saying he had no interest in revenge against Mr Tang, a San Diego investor.

At the FDA, Dr Tidmarsh was placed on leave Friday pending the outcome of an investigation by the inspector general for the Department of Health and Human Services that is looking into some of the same claims.

On Sunday, he offered his resignation, and Emily Hilliard, an FDA spokesperson, said it had been accepted. Ms Hilliard said Sunday that the administrative leave had been imposed earlier "after the office of the general counsel and the office of the inspector general were notified of serious concerns about his personal conduct."

But Dr Tidmarsh continued to maintain Sunday evening that he was still on administrative leave.