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GEN Poll

May 22, 2012

FDA Performance

Four recently released reports paint a decidedly mixed picture of FDA’s ability to bring drugs and biologics to market. California Healthcare Institute (CHI) and The Boston Consulting Group (BCG) fault FDA’s accelerated approval processes for favoring AIDS and cancer over diseases like diabetes, obesity, and heart disease. A Manhattan Institute report blames lack of development in these areas on the sky-high cost of Phase III trials, especially for heart-disease drugs. But a paper in NEJM suggests that FDA outstrips its European and Canadian counterparts in most areas of performance. And GAO concluded the agency met most of its performance goals between FY 2000 and FY 2010.

How much progress do you think FDA has made in reviewing drugs and bringing them to market faster?

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