Food and Drug Administration

As much as 80 percent of bulk pharmaceutical chemicals used by U.S. manufacturers to produce prescription drugs is imported. Although the Food and Drug Administration (FDA) has taken steps to address problems with its foreign inspection program, it conducts infrequent inspections of foreign manufacturers to ensure that they comply with U.S. quality control standards. Routine surveillance inspections of foreign pharmaceutical manufacturers occur with far less frequency than the two-year interval required for domestic manufacturers. In China and India, for example, as long as five years has elapsed between FDA inspections of drug manufacturers. Moreover, FDA is still experiencing delays in taking enforcement action against foreign pharmaceutical manufacturers. In one case, FDA allowed a manufacturer in India to continue exporting its products to the United States despite an investigator's finding that the manufacturer could not adequately test for impurities in its product and water system. Nearly two years passed before FDA determined that enforcement action had never been taken against this manufacturer.

GAO noted that: (1) FDA has taken several actions to address problems with its foreign inspection program that were identified in two previous internal evaluations; (2) although FDA has improved the timeliness with which investigators submit inspection reports, in fiscal year (FY) 1996, almost 60 percent were still submitted later than called for by agency standards, including half the reports that identified the most serious deficiencies in manufacturing quality; (3) during FY 1996 and FY 1997, headquarters review personnel continued to downgrade the classifications of inspections recommended by its field investigators who conducted the inspections; (4) most of the decisions to downgrade the classifications were based on foreign manufacturers' promises to implement corrective actions; (5) as a result, FDA conducted fewer reinspections of these facilities to verify that foreign manufacturers had corrected serious manufacturing deficiencies; (6) FDA conducts infrequent routine inspections of foreign manufacturers to ensure that they continue to comply with U.S. quality standards, although routine surveillance inspections constitute FDA's most comprehensive program for monitoring the quality of marketed pharmaceutical products; (7) most inspections of foreign pharmaceutical manufacturers are performed to approve the marketing of new products; (8) routine surveillance inspections of manufacturers producing approved pharmaceutical products already marketed in the United States accounted for only 20 percent of FDA's foreign inspections during FY 1995; (9) as a result, routine inspections of foreign pharmaceutical manufacturers occur with far less frequency than the 2-year interval required for domestic manufacturers; (10) FDA has been striving to improve its management of data needed for planning inspections, monitoring inspection results, and taking enforcement actions; (11) at present, FDA relies on 15 separate systems to identify foreign pharmaceutical manufacturers, plan foreign inspection travel, track inspection results, and monitor enforcement actions; (12) as a result, essential foreign inspection data are not readily accessible to the different FDA units that are responsible for planning, conducting, and reviewing inspections and taking enforcement actions against foreign manufacturers; and (13) FDA is developing a comprehensive, agencywide automated system to provide better data for managing its foreign inspection program.

Recommendations

Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.

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