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FDA panel head shares lessons gleaned from Avandia hearing

August 10th, 2007 by Todd Hageman

The chair of last week’s FDA advisory meeting regarding Avandia, endocrinologist Chris Rosen, offered some lessons he learned about the drug approval process. Those lessons, which appear in the New England Journal of Medicine, were summarized by Pharmalot’s Ed Silverman:

Lesson One - Make sure you understand the disease, the studies used to evaluate the treatments are properly chosen and designed, and maintain approval standards at all cost. This is contrast to what was characterized as the “basic plot of the (Avandia) story: a new ‘wonder drug,’ approved prematurely and for the wrong reasons by a weakened and underfunded government industry subjected to pressure from industry has caused undue harm to patients.”

Lesson Two - Post-marketing observational studies, no matter how large or independent, can be inconclusive and are no substitute for the costly, but most likely, insightful safety and efficacy follow-up studies. “In the long run,” Rosen writes, “these efforts will save time, money and energy.”

Lesson Three - There’s an urgent need to change the ‘regulatory pathway’ for Type 2 diabetes drugs to make clinical outcomes, and not surrogates, the primary endpoints.

This should be common sense.  We’ll see if anyone takes heed.

If you or someone you know has been hurt as a result of taking Avandia, please call Simon Passanante attorney Todd Hageman toll free at 1-877-767-3108.

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