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 2007-11-01 monographic deposited born digital 28 p. GA 1.13:GAO-08-224T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-08-224T P0b002ee180376c86 f:d08224t DGPO 2010-08-12 2011-03-23 GAOREPORTS-GAO-08-224T machine generated eng fdlp REPORT GAOREPORTS-GAO-08-224T GAO-08-224T Accountability Data integrity Databases Food and drug legislation Foreign governments Imported drugs Importing Inspection International relations Investigations by federal agencies Pharmaceutical industry Prescription drugs Product safety Program management Risk assessment Program implementation Testimony A77892 Many drugs marketed in the United States are manufactured in foreign countries and the value of such products entering the country is increasing. 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. Foreign establishments that market their drugs in the United States must register with FDA and FDA inspects foreign establishments to ensure that they meet the same standards that are required of domestic ones. GAO reported 9 years ago that FDA needed to improve its foreign drug inspection program (GAO/HEHS-98-21). Questions remain as to whether FDA has improved its management of the foreign drug inspection program. This statement discusses preliminary information on (1) the extent to which FDA has accurate data to manage the foreign drug inspection program, (2) the frequency of foreign inspections and factors influencing the selection of establishments to inspect, and (3) issues unique to conducting foreign inspections. To address these issues GAO interviewed FDA officials; reviewed pertinent statutes, regulations, and guidance; and analyzed information from FDA databases. Because of the preliminary nature of our work, we are not making recommendations at this time. https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-08-224T/html/GAOREPORTS-GAO-08-224T.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-08-224T/pdf/GAOREPORTS-GAO-08-224T.pdf GAO-08-224T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-08-224T Testimony GAO-08-224T; Drug Safety: Preliminary Findings Suggest Weaknesses in FDA's Program for Inspecting Foreign Drug Manufacturers; Accountability Data integrity Databases Food and drug legislation Foreign governments Imported drugs Importing Inspection International relations Investigations by federal agencies Pharmaceutical industry Prescription drugs Product safety Program management Risk assessment Program implementation Volume 111 Page 2296 111 Stat. 2296 Public Law 105-115