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Capitol Health Call
November 9, 2011

Foreign Drug Supply Chain

JAMA. 2011;306(18):1970. doi:10.1001/jama.2011.1603

The Food and Drug Administration (FDA) continues to have problems inspecting and obtaining information on foreign drug manufacturers, reported the Government Accountability Office (GAO) at a September 14 hearing before the Senate Committee on Health, Education, Labor, and Pensions (http://tinyurl.com/639ejv5).

In the report, the GAO said it had previously recommended that the FDA increase the number of foreign inspections it conducts to a frequency comparable with that of domestic establishments with similar characteristics. But in fiscal year 2009, the agency inspected only 424 foreign facilities compared with 1015 US establishments. The GAO indicated that the FDA would like statutory changes to the current requirement that the agency inspect domestic establishments every 2 years. The FDA indicated it would prefer rules implementing a risk-based inspection process, with flexibility to determine the inspection frequency with both foreign and domestic establishments.

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