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As of October 25, 2020, there are 4812 open recommendations, of which 473 are priority recommendations. Recommendations remain open until they are designated as Closed-implemented or Closed-not implemented.
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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. These efforts include the development of 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 an assessment of the foreign offices to help set their objectives and ensure the right balance of personnel, skillsets, and resources. However, FDA still had to develop intermediate outcomes to link with final outcomes. In an August 2020 written response, the agency reported that because of a reorganization and strategic planning effort for its Office of Global Policy and Strategy, it was still revising and updating its measures and its approach to evaluating impact in 2020 to align with a five-year strategic plan completed in March 2020. The agency indicated that the recommendation should remain open, and GAO will continue to monitor the implementation of this recommendation.
