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Food and Drug Administration: Response to Heparin Contamination Helped Protect Public Health; Controls That Were Needed for Working With External Entities Were Recently Added

GAO-11-95 Published: Oct 29, 2010. Publicly Released: Nov 09, 2010.
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In early 2008, the Food and Drug Administration (FDA) responded to a crisis involving the contamination of heparin, a medication used to prevent and treat blood clots, when the agency received multiple reports of adverse events involving severe allergic reactions. The crisis took place from January 2008 through May 2008, during which time FDA took several actions in its response to the crisis. GAO was asked to review FDA's management of the heparin crisis. This report examines (1) how FDA prevented additional contaminated heparin from reaching U.S. consumers, (2) how FDA coordinated its response to the contaminated heparin crisis, and (3) FDA's monitoring and analysis of adverse events associated with heparin. To conduct this review, GAO reviewed relevant FDA documents, regulations, and guidance; analyzed FDA data; and interviewed FDA officials and other experts involved in the crisis and knowledgeable about drug quality standards.

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ContaminationFederal regulationsImportingInspectionInvestigations by federal agenciesMonitoringPrescription drugsProduct evaluationProduct recallsProduct safetyPublic healthRegulatory agenciesRisk managementConsumer protectionAgency evaluationEmergency responseContaminantsSafety regulationInternal controls