Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives Have Potential, but Do Not Fully Address Weaknesses in Its Foreign Drug Inspection Program

United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 2008-04-22 monographic deposited born digital 23 p. GA 1.13:GAO-08-701T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-08-701T P0b002ee18038d51e f:d08701t DGPO 2010-08-12 2011-03-28 GAOREPORTS-GAO-08-701T machine generated eng fdlp REPORT GAOREPORTS-GAO-08-701T GAO-08-701T Accountability Data integrity Databases Drugs Food and drug legislation Foreign governments Imported drugs Importing Inspection International cooperation International relations Investigations by federal agencies Pharmaceutical industry Prescription drugs Product safety Program management Risk assessment program goals or objectives Program implementation Testimony A81830 Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives Have Potential, but Do Not Fully Address Weaknesses in Its Foreign Drug Inspection Program The Food and Drug Administration (FDA) is responsible for overseeing the safety and effectiveness of human drugs that are marketed in the United States, whether they are manufactured in foreign or domestic establishments. FDA inspects foreign establishments to ensure that they meet the same standards required of domestic establishments. Ongoing concerns regarding FDA's foreign drug inspection program recently were heightened when FDA learned that contaminated doses of a common blood thinner had been manufactured at a Chinese establishment that the agency had never inspected. FDA has announced initiatives to improve its foreign drug inspection program. In November 2007, GAO testified on weaknesses in FDA's foreign drug inspection program (GAO-08-224T). This statement presents preliminary findings on how FDA's initiatives address the weaknesses GAO identified. GAO interviewed FDA officials and analyzed FDA's initiatives. GAO examined reports and proposals prepared by the agency, as well as its plans to improve databases it uses to manage its foreign drug inspection program. https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-08-701T/html/GAOREPORTS-GAO-08-701T.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-08-701T/pdf/GAOREPORTS-GAO-08-701T.pdf GAO-08-701T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-08-701T Testimony GAO-08-701T; Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives Have Potential, but Do Not Fully Address Weaknesses in Its Foreign Drug Inspection Program; Accountability Data integrity Databases Drugs Food and drug legislation Foreign governments Imported drugs Importing Inspection International cooperation International relations Investigations by federal agencies Pharmaceutical industry Prescription drugs Product safety Program management Risk assessment program goals or objectives Program implementation