Food and Drug Administration:

Improvements Needed in the Foreign Drug Inspection Program

HEHS-98-21: Published: Mar 17, 1998. Publicly Released: Apr 24, 1998.

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Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) efforts to correct problems identified in earlier evaluations of its foreign drug inspection program, focusing on FDA's efforts to: (1) prepare inspection reports and take enforcement actions against foreign pharmaceutical manufacturers in a timely manner; (2) improve the consistency with which FDA evaluates the results of foreign inspections and conducts reinspections to verify that foreign pharmaceutical manufacturers have corrected serious deficiencies; (3) conduct routine inspections of foreign pharmaceutical manufacturers to monitor their compliance with U.S. quality standards; and (4) improve the management of data needed for planning inspections, monitoring inspection results, and taking enforcement actions.

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 for Executive Action

  1. Status: Closed - Implemented

    Comments: The Associate Commissioner of FDA issued a directive to district managers emphasizing their responsibility for ensuring that established time frames for submitting inspection reports are met. CDER has also been given two additional FTEs specifically for working on foreign drug inspections.

    Recommendation: To improve the effectiveness of FDA's foreign inspection program to ensure that only safe, pure, and high quality drugs are imported into the United States, the Commissioner of FDA should ensure that serious manufacturing deficiencies are promptly identified and enforcement actions are initiated by requiring investigators to prepare inspection reports and the Center for Drug Evaluation and Research to issue warning letters within established time periods.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  2. Status: Closed - Implemented

    Comments: Although FDA is checking the OASIS data base to identify foreign pharmaceutical manufacturers that have not received a periodic surveillance inspection, FDA does not intend to reassess its foreign inspection strategy until some unspecified time in the future. Moreover, FDA does not intend to reinspect all foreign manufacturers identified as having serious manufacturing deficiencies and that promised to take corrective action. Based on recent discussions, FDA is not expected to take any further action on this recommendation.

    Recommendation: To improve the effectiveness of FDA's foreign inspection program to ensure that only safe, pure, and high quality drugs are imported into the United States, the Commissioner of FDA should reexamine and revise FDA's foreign inspection strategy to provide adequate assurance that all foreign manufacturers exporting approved pharmaceutical products to the United States comply with U.S. standards. At a minimum, the strategy should include: (1) timely follow-up inspections of all foreign manufacturers that have been identified as having serious manufacturing deficiencies and that promised to take corrective action; and (2) periodic surveillance inspections of all foreign pharmaceutical manufacturers, not just high-risk manufacturers.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

 

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