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Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed

GAO-10-961 Published: Sep 30, 2010. Publicly Released: Oct 25, 2010.
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Globalization has placed increasing demands on the Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), in ensuring the safety and effectiveness of drugs marketed in the United States. Drugs manufactured in more than 100 countries were offered for entry into the United States in fiscal year 2009. FDA inspects drug manufacturing establishments in order to ensure that the safety and quality of drugs are not jeopardized by poor manufacturing practices. In 1998 GAO identified weaknesses in FDA's foreign drug inspection program. In 2008 GAO found, among other things, that from fiscal years 2002 through 2007, FDA inspected relatively few foreign establishments each year. GAO also determined that, because of inaccurate information in its databases, FDA did not know how many foreign drug establishments were subject to inspection. In 2008 GAO recommended that FDA increase inspections of foreign drug establishments and improve information it receives to manage the foreign drug inspection program. This report examines FDA's progress since 2008 in (1) conducting more foreign drug inspections, and (2) improving its information on foreign drug establishments. GAO analyzed information from FDA databases, reviewed documents related to FDA's efforts to both improve these databases and supplement its existing information on foreign drug establishments, examined staffing and funding information, and interviewed FDA officials.

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BiologicsData integrityDatabasesDrugsFederal regulationsFood and drug lawFood and drug legislationImported drugsInspectionPharmaceutical industryProduct evaluationProduct safetyRequirements definition