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.

Status Legend:

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  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    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

    Status: Open

    Comments: In July 2013 FDA reported that, in late 2011 and 2012, the Office of International Programs (OIP) revisited its strategic plan in light of the vision presented in its Global Pathway for Product Safety and Quality report and the re-organization of OIP into the Office of Global Operations and Policy. OIP has since developed a revised strategic framework with a set of strategic outcomes flowing from a set of goals and objectives. Further, FDA reported that in 2012 and 2013, OIP has refined its strategic and operational processes in coordination with FDA Centers, and in alignment with the Office of Global Operations and Policy and ORA. In 2012, OIP developed the Strategy Map from the strategic framework developed in 2011 and the strategic plan developed in 2012. This OIP Strategy Map specifies strategic outcomes, the efforts to achieve those outcomes, and the operational and organizational foundations required to successfully carry out those efforts. OIP has also implemented an annual operational planning process and quarterly reporting process; formed a task force that completed a compendium of performance metrics related to the regulation of imported products, in coordination with the product Centers and ORA; and completed analysis of OIP efforts as identified in office operational plans mapped to the outcomes in the OIP Strategy Map. Although it has made progress, FDA reported that OIP will need to develop and refine performance goals and measures in conjunction with further refinement of the OIP operational plans. FDA recognized that the development of effective performance goals is a multi-year effort, and OIP expects to continue to integrate feedback from FDA's overseas offices and Centers/Offices to continue to refine the strategic and operational planning processes and subsequently identify a set of performance goals and measures that are outcome-driven and related to the safety of imported products.

    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

    Status: Open

    Comments: In 2013, FDA reported a number of efforts to begin to implement this recommendation. For example, in March 2011, the Office of International Programs (OIP) developed a formal Strategic Plan. One of the featured goals is to develop a plan for workforce recruitment, development, deployment, and retention. In addition, FDA has taken other steps to further its efforts. Among other things, it instituted the Foreign Post Opportunity Development Pilot Program. The one-year pilot program was designed as a learning pathway to ultimately cultivate the global knowledge, skills, and abilities of the FDA community, to meet the agency's mission abroad. OIP selected five participants and four participants successfully completed the requirements (workshops, domestic and foreign post development assignments, and presentations) in December 2012. OIP is in the final evaluation phase of the pilot program which involves finalizing and presenting findings and recommendations to senior management for their consideration. FDA has had challenges recruiting staff for overseas positions and obtaining visas for staff. To address these issues, OIP has continued an initiative to permit staff to apply for temporary details to work as consumer safety officers (inspectors) at FDA Foreign Posts by offering additional detail opportunities for 60-120 days. Due to the success of the program, OIP has incorporated into its formal internal recruitment process an option for the candidate to select detail assignments from 60, 90, or 120 days in addition to electing a 24-month overseas assignment. OIP has also selected several candidates for the international program and policy analyst (technical expert) and consumer safety officer (inspector) positions by continuing to use the open continuous recruitment bulletins internal to FDA as well as external bulletins for all U.S. citizens. FDA also hosts an annual forum to ensure interested employees are aware of the opportunities and know what is involved in a foreign assignment and maintains a distribution list that keeps employees informed of learning opportunities, seminars, and activities. Finally, a draft gap analysis report and a draft competencies (foundational, leadership, and global) document are in the process of being finalized. Deliverables will include training and learning initiatives to address the skill gaps identified in the report and learning pathways for each position category/series.

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