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Highlights

An increasing volume of food and medical products marketed in the United States are produced in foreign countries. This globalization has challenged the Food and Drug Administration (FDA), which is responsible for ensuring the safety of these products. In late 2008 and early 2009, FDA established overseas offices comprised of 42 total staff covering particular countries or regions--China, Europe, India, Latin America, and the Middle East. The offices are to engage with foreign stakeholders to develop information that FDA officials can use to make better decisions about products manufactured in foreign countries, among other activities. GAO examined (1) the steps overseas offices have taken to help ensure the safety of imported products and (2) the extent to which FDA has engaged in long-term strategic and workforce planning for the overseas offices. GAO reviewed documentation of overseas office activities and planning. GAO also visited offices in China, India, and Latin America to interview FDA officials, officials from other U.S. agencies overseas, and foreign regulators and other stakeholders.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration 1. To help ensure that FDA's overseas offices are able to fully meet their mission of helping to ensure the safety of imported products, the Commissioner of FDA should ensure, as it completes its strategic planning process for the overseas offices, that it develops a set of performance goals and measures that can be used to demonstrate overseas office contributions to long-term outcomes related to the regulation of imported products and that overseas office activities are coordinated with the centers and Office of Regulatory Affairs (ORA).
Open
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 developed new performance measures for these offices along with a monitoring and evaluation plan 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 had to develop intermediate outcomes to link with final outcomes. In August 2020, the agency indicated 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.
Food and Drug Administration 2. To help ensure that FDA's overseas offices are able to fully meet their mission of helping to ensure the safety of imported products, the Commissioner of FDA should develop a strategic workforce plan for the overseas offices to help ensure that the agency is able to recruit and retain staff with the experience and skills necessary for the overseas offices and to reintegrate returning overseas staff into FDA's domestic operations.
Closed - Implemented
FDA finalized its strategic workforce plan in March 2016. The plan offers a strategic and long-term view of the issues facing the overseas offices and addresses the agency's plan to recruit, hire, retain, and develop employees with the skills and abilities to fulfill the agency's global mission, consistent with our recommendation. Among other things, it contains performance measures and a timeline for addressing its workforce planning challenges. It also includes key activities to be performed such as developing a hiring strategy, establishing a succession plan for anticipated vacancies, and working to maximize a returning foreign office employee's new skill set from his or her deployment. FDA's workforce plan also addresses reintegration challenges and determining how the agency can better leverage the skills staff develop while working abroad.

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