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Mike Mitka

JAMA. 2008;299(14):1657.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The Government Accountability Office (GAO) will review a drug approval process used by the Food and Drug Administration (FDA) that evaluates safety and efficacy based on surrogate end points in clinical trials.

The review comes at the request of Sen Chuck Grassley (R, Iowa), who said March 4 that the FDA had approved several drugs that appeared to have little to no effect in protecting lives and improving health. Grassley singled out bevacizumab (Avastin, Genentech), rosiglitazone (Avandia, GlaxoSmithKline PLC), and ezetimibe/simvastatin (Vytorin, Merck/Schering-Plough Pharmaceuticals). Grassley said the FDA had approved the drugs based on their effectiveness in achieving surrogate end point goals (such as limiting tumor growth) without determining whether the drugs improved health.

The Iowa senator wants the GAO to analyze such issues as the number of drugs that were approved by the FDA based on surrogate end points, the surrogate end points used for approval, and . . . [Full Text of this Article]