The director of the U.S. Food & Drug Administration’s Center for Drug Evaluation and Research (CDER), George Tidmarsh, was placed on administrative leave on Friday, according to reports.
Tidmarsh, a top official overseeing most prescription and over-the-counter drugs, confirmed the move to The New York Times.
He told the newspaper he was placed on leave after raising internal concerns about the legal basis of a new program designed to rapidly approve certain new drugs.
While Tidmarsh pointed to his legal concerns, the Department of Health and Human Services (HHS) cited a separate issue, stating he was put on leave due to “serious concerns about his personal conduct.” Tidmarsh subsequently resigned on Sunday.
This abrupt exit of a senior regulator has raised questions about the FDA’s ethical standards, vetting process, and the increasing pressure to accelerate drug approvals.
