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Safety

FDA’s Foreign Inspection Program Needs Overhaul

by Glenn Hess
November 3, 2008 | APPEARED IN VOLUME 86, ISSUE 44

Better data management and more inspections are needed to strengthen FDA’s foreign drug facility inspection program, according to congressional investigators. The Government Accountability Office says the agency isn’t sure how many foreign establishments produce drugs for the U.S. market (GAO-08–970). Using a list of 3,249 plants FDA developed in 2007 to prioritize foreign inspections, GAO estimates that FDA inspects only about 8% of facilities outside the U.S. each year. “At this rate, it would take FDA more than 13 years to inspect these establishments once,” GAO notes. Pharmaceutical plants in the U.S. are inspected on average every 2.7 years. “This report confirms that we have reason to be concerned about the safety of imported drugs,” says House Energy & Commerce Committee Chairman John D. Dingell (D-Mich.). “Foreign inspections are alarmingly low.” The report also indicates that FDA is failing to promptly conduct follow-up inspections after serious violations—such as product impurities or record-keeping problems—are found in foreign facilities. From 2002 through 2007, FDA issued 15 warning letters to foreign drug producers but reinspected only four of the facilities, the report notes.

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