Issues Remain With FDA Foreign Inspections Despite Some Improvements, GAO Says
The Government Accountability Office reported some progress in the Food and Drug Administration's foreign offices and inspection operations in a new report (here). Since its previous report in 2010, "FDA has begun to take steps to enhance the agency’s strategic…
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planning for the foreign offices and has developed two performance measures," it said. Still, the agency is lacking in its measures of "effectiveness of the offices’ contributions," it said. Position vacancies in the foreign offices also remain too high, it said. "Given that one of the reasons for opening the foreign offices was to conduct inspections, the large number of vacant investigators is concerning," the GAO said. The GAO recommended that the FDA "assess the effectiveness of the foreign offices’ contributions by systematically tracking information to measure whether the offices’ activities specifically contribute to drug safety-related outcomes, such as inspections, import alerts, and warning letters," and establish foreign office staffing goals. The Department of Health and Human Services, which the FDA is part of, concurred with the GAO's recommendations and is taking "immediate steps to address them," the GAO said.