Office of New Drugs Director John Jenkins recommended against new restrictions on GlaxoSmithKline's type 2 diabetes therapy Avandia. He was over-ruled in this case, but his meditation on the difficulties of making regulatory decisions in a highly charged environment-and measured judgment about the tradeoffs in FDA's new regulatory authority-serves as a testament to the dilemmas facing regulators in the current era.
By John Jenkins
Jenkins is director of the Office of New Drugs in FDA's Center for Drug Evaluation & Research. This article is an excerpt from his Sept. 2 memo on Avandia.
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