Drug Safety Concerns Prompt GAO Probe Of FDA

Law360, New York (March 5, 2008, 12:00 AM EST) -- Amid recent safety concerns over two blockbuster drugs, the U.S. Government Accountability Office is set to investigate whether the U.S. Food and Drug Administration improperly cleared the medications without sufficient proof of their safety or effectiveness.

At the prompting of Sen. Charles Grassley (R-Iowa), the GAO – which is the investigative arm of Congress – has agreed to conduct an assessment of the method the FDA used to greenlight GlaxoSmithKline PLC's diabetes pill Avandia and Merck & Co. Inc. and Schering-Plough's cholesterol drug Vytorin.

Merck and...
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