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Regulating in Real Time: Avandia and the Challenges of Making "Sound Decisions" Under Heavy Scrutiny

This article was originally published in RPM Report

Executive Summary

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.


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