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Open Minds on Avandia? A Defining Challenge for the New Regulatory Climate

This article was originally published in RPM Report

Executive Summary

The run-up to FDA's re-review of Avandia is becoming highly charged. There is a lot riding on the outcome of the agency's decision on how to deal with the diabetes therapy. Here are a number of considerations to think about going into FDA's advisory committee meeting.

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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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The Avandia advisory committee is a volatile event for GSK and the overall drug safety climate. The best and worst cases for the sponsor are not necessarily aligned with the best results for the industry overall. A look at three possible scenarios.

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Rosa DeLauro came to an Institute of Medicine meeting on regulatory science to praise FDA’s new leadership and to take credit for increasing its resources. But she also trashed the agency’s handling of Avandia. It isn’t clear that science has anything to do with that debate, but resolving it looks like a critical test for the agency and its new leadership this summer.

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