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The Government Accountability Office found breakdowns in the way the Food and Drug Administration evaluates drugs for rare diseases. The analysis came after an investigation by Kaiser Health News.
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Three decades ago, Congress set up a system to encourage drug companies to develop treatments for rare diseases. The law has worked, but at a high cost.
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Drugmakers have brought almost 450 orphan drugs to market and collected rich incentives by doing so. But nearly a third of the medicines aren't new or were repurposed many times for financial gain.