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

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.