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Recommendation: To help ensure that FDA's foreign offices are able to fully meet their mission of helping to ensure the safety of imported products, as the agency continues to test performance measures and evaluate its Office of International Programs (OIP) strategic workforce plan, the Commissioner of FDA should 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.
Agency: Department of Health and Human Services: Food and Drug Administration Status: Open Priority recommendation
Comments: In June and July 2018 FDA reported on its recent efforts to assess the effectiveness of the foreign offices' contributions to drug-safety related outcomes. Among other things, the agency has developed new performance measures for these offices along with a monitoring and evaluation plan; strengthened communications and collaboration between the foreign offices and FDA program centers and its Office of Regulatory Affairs; and conducted an assessment of the foreign offices to help set their objectives and ensure the right balance of personnel, skillsets, and resources. However, FDA still needs to develop intermediate outcomes to link with final outcomes and intends to address this step in fiscal year 2019.