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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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FDA learned two important lessons from the Avandia debacle. First, the agency needs to be a better communicator—which means telling the public more about what it knows (and doesn’t know) about the safety of marketed products. But Avandia is also leading the agency to rethink what should be required to demonstrate safety, especially for chronic care therapies. Both could mean big changes for industry.

Lessons Learned: How Avandia is Changing the Way FDA Does Business

FDA learned two important lessons from the Avandia debacle. First, the agency needs to be a better communicator—which means telling the public more about what it knows (and doesn’t know) about the safety of marketed products. But Avandia is also leading the agency to rethink what should be required to demonstrate safety, especially for chronic care therapies. Both could mean big changes for industry.

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