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BY THE NUMBERS

REGULATORY | November 28, 2007

Inspecting the Inspectors

GAO finds weaknesses in FDA's program for inspecting foreign drug manufacturers.

Nine years ago the U.S. Government Accountability Office found that the U.S. Food and Drug Administration needed to improve its foreign drug inspection program. A new GAO report presented to the House of Representatives at the beginning of November finds “fundamental flaws” in the agency’s foreign inspection program continue to persist. These foreign entities are responsible for producing as much as 80 percent of the bulk drug substances used by manufacturers in the United States to produce prescription drugs or finished drug products. Among other things, the GAO found the FDA continues to be hindered in its effort by weaknesses in its data system. The GAO said the agency doesn’t know how many foreign establishments are subject to inspection. It relies on several databases that were not created for this purpose with one identifying about 3,000 foreign establishments that could have been subject to its inspections in fiscal 2007 while another indicates the number is about 6,800. Overall, the FDA inspects relatively few foreign establishments, according to the GAO, which estimates the agency inspects about 7 percent of foreign establishments a year. It would take the FDA more than 13 years to inspect each foreign establishment once at that rate.


NUMBER OF FDA INSPECTIONS OF FOREIGN PRODUCERS OF DRUGS FOR THE U.S. MARKET (10 MOST INSPECTED COUNTRIES FISCAL 2002-2007)

Source: GAO analysis of FDA data.

2007 data may not be complete because the FDA provided it to the GAO September 26, 2007, four days prior to the end of the fiscal year. The number of establishments represents the number the FDA used to plan its fiscal year 2007 prioritized surveillance inspections.

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