Food and Drug Administration:

Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed

GAO-10-960: Published: Sep 30, 2010. Publicly Released: Oct 25, 2010.

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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.

FDA's overseas offices have engaged in a variety of activities to help ensure the safety of imported products, but officials report challenges that could limit their effectiveness, due to an increasing workload and other factors. A primary activity for the offices has been establishing relationships with foreign stakeholders (such as foreign regulators and industry) and U.S. agencies overseas. FDA officials and foreign stakeholders said they had limited contact prior to the opening of the offices, and each noted that the overseas offices are beneficial for relationship building, although relationship building can be time consuming. FDA overseas officials have also gathered information about regulated products and shared it with U.S. officials to assist with decision making. Although FDA has used some of this information to take regulatory actions, some FDA overseas officials told us that they lack feedback regarding the utility of much of the information that they submit to the agency. FDA's offices in China and India include investigators who inspect foreign establishments. In these two countries, as of June 2010, the overseas investigators conducted 48 inspections since they were posted overseas. The FDA overseas officials have also started to provide training, responses to queries, and other assistance to foreign stakeholders to help them improve their regulatory systems and better understand FDA regulations. These officials said, however, that an increasing interest in this type of assistance from foreign stakeholders, while important, could lead to an unmanageable workload. Although FDA staff and others have pointed to several immediate benefits of the offices, it is early and their impact on the safety of imported products is not yet clear. FDA is in the process of long-term strategic planning for the overseas offices and has not developed a long-term workforce plan. FDA expects to complete a 5-year strategic plan to manage office activities by October 2010. Officials said that they intend to include performance goals and measures for the offices in the strategic plan, but that it will be difficult to quantify office contributions toward long-term outcomes. Also, coordination of the overseas offices with other parts of FDA has been a challenge, and strategic planning efforts can help ensure this coordination. FDA has not yet developed a long-term workforce plan to help ensure that it is prepared to address potential overseas office staffing challenges. Overseas staff agree to 2-year rotations, and workforce planning has focused on preparing to fill any 2011 vacancies. FDA has experienced challenges staffing some office locations and officials from FDA and other agencies with overseas staff have identified potential recruitment and retention challenges that could affect FDA's mission. They said that recruiting staff with language skills and reintegrating returning staff into domestic operations may be difficult. Certain FDA staff experienced a reduction in their pay when they went overseas. Workforce planning could help FDA prepare for potential staffing challenges. GAO recommends that the Commissioner of FDA take steps to enhance strategic planning to ensure coordination between overseas and domestic activities and develop a workforce plan to help recruit and retain overseas staff. FDA agreed with GAO's recommendations.

Recommendations for Executive Action

  1. Status: Open

    Comments: FDA's Office of International Programs (OIP) contracted with Management Systems International (MSI) to develop a set of performance metrics. MSI delivered its final report to the agency assessing the performance of OIP's food safety-related activities, with a focus on FDA's overseas offices. MSI put special emphasis on ensuring that the metrics would be applicable for the Latin America and China Offices, given the high volume of food imports from these areas. However, OIP believes it is appropriate to begin applying these metrics-to the extent appropriate-to the India and Europe Offices as well, but not to medical products. FDA is also in the process of standardizing how the foreign offices report information about their activities. This reporting on the foreign offices' activities is designed to align with the performance measures and the linkage of these measures to the strategic outcomes that OIP has sought. OIP believes this will enable FDA senior officials to use a data-driven system for effectively managing OIP. OIP also anticipates that this approach has the potential to allow OIP to track the contributions of the overseas office towards meaningful results and to analyze the overall impact of the activities of OIP Offices on the safety of FDA-regulated products. GAO is continuing to monitor FDA's progress as part of an ongoing engagement.

    Recommendation: 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).

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

  2. Status: Open

    Comments: The Office of International Programs (OIP) has developed a strategic Workforce Plan (WFP) for 2016 through 2020. The WFP, which OIP may modify each year, as necessary, includes a lengthy list of actions that OIP is scheduled to complete by the end of each quarter of fiscal year 2017. Many of these actions are specifically designed to enhance FDA's ability to successfully 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. In addition to these actions, the WFP has 4 performance measures in areas of workforce planning that OIP believes are among the most important for the overseas offices if they are to maximize their ability to contribute to ensuring the safety of FDA-regulated products entering the United States. Nonetheless, as GAO reported in January 2015, FDA continues to experience high vacancy rates in its foreign offices. GAO is continuing to monitor FDA's progress as part of an ongoing engagement.

    Recommendation: 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.

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

 

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