FDA Fast Talk: Health Advisories with Unclear Advice
This article was originally published in RPM Report
Executive Summary
FDA is trying to get safety messages out to consumers more rapidly. A recent warning on Nexium and Prilosec shows how complicated these early warnings can be.
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Avandia and the Commercial Impact of FDA's Credibility Gap
GlaxoSmithKline's diabetes drug Avandia survived a perilous FDA advisory committee review. The real question is whether the industry can survive the damage to FDA's credibility.
The Agency that Cries Wolf
FDA is being more proactive about issuing safety warnings. But, as GSK's experience with Advair shows, what looks like bad news to Wall Street may not matter as much to physicians. FDA is well aware of the limitations of its risk communication techniques, but for now the agency is commited to transparency.