GAO Report Blames Drug Shortages on Manufacturing Problems

Wall Street Journal (12/14/11) Burton, Thomas M.
A new report from the US Government Accountability Office (GAO) finds that the growing problem of drug shortages is caused by manufacturing problems, and that the US Food and Drug Administration (FDA) should be given more authority to act in response. There are some that say the source of the problem is thin profit margins of generic drugs and other economic issues, but GAO says manufacturing problems, many of which led to manufacturing shutdowns, are the source. There were also disruptions in the supply of raw materials, which also were caused by factory problems and manufacturing delays. FDA should be able to make stronger laws to force companies to notify the government when there are manufacturing problems and shortages, which would allow the government to take steps such as allowing foreign drugs into the country to alleviate the problem, the report concludes. It should also be able to allow drugs with quality problems to be sold if the problem is fixed by the manufacturer before it is sold.

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