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Avandia's Black Box: FDA's Office of New Drugs Wins

This article was originally published in RPM Report

Executive Summary

The decision by FDA to add another "black box" warning to GalxoSmithKline's diabetes drug shows where the drug safety group stands on the agency's totem pole.

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The new group of Drug Safety & Risk Management Advisory Committee members comprises a lot of familiar faces. FDA has made use of its extensive outside academic connections, research grants and post-graduate training programs to bring in eight members for the Classes of 2013 and 2014. Most of them have been getting extensive on-the-job training with the advisory committee already.

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.

IoM Will Address Ethics in Safety Studies Prior To Avandia Advisory Committees

FDA is acting to create political and scientific cover for the second public review of Avandia safety issues in mid-July. A former top staffer to House Energy & Commerce Chairman Waxman is doing an internal study of agency post-marketing safety procedures to assure Capitol Hill that FDA takes the issue seriously; an IoM workshop is convening in early June to prepare a preliminary review on the ethical issues with post-market safety studies.

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