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.

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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.
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    • 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: FDA reported that, in late 2011 and 2012, the Office of International Programs (OIP) revisited its strategic plan in light of the vision presented by the 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. This framework is a Results Oriented Management framework with a set of strategic outcomes cascading from a set of goals and objectives. OIP has vetted and refined this framework with its agency stakeholders and is now moving to operationalize the framework by the end of 2012. This process will include the formation of an OIP task force that will identify performance goals and measures related to the regulation of imported products, in coordination with the product Centers and ORA. By the end of 2012, OIP expects to have identified a set of core measures, to have published a narrative strategic plan, and to have implemented an annual operational planning process amongst its constituent offices.

    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: FDA agreed with this recommendation and, in 2012, reported a number of efforts to implement begin to this recommendation. 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. To achieve this goal, OIP embarked upon the Strategic Workforce Plan Initiative, with a goal of creating a comprehensive five-year plan to attract, retain, and develop its workforce. The objectives of this initiative are to: align FDA's global workforce with current and future program needs, develop long-term strategies to recruit, train, and retain staff, develop and implement a long-term Strategic Global Workforce Development Plan, develop new training and learning initiatives to address skill gaps, and develop global workforce competencies. In August 2011, FDA engaged a consulting firm to provide OIP with advisory and consulting services to support the Strategic Workforce Plan Initiative. These services include workforce assessment, planning, development and execution, and monitoring and evaluation solutions. A Demand Workforce Profiles Report was developed and is currently being finalized. The report is a result of analyzing the status of the current OIP workforce and the future demands of OIP's workforce requirements. This report provides an initial understanding and perception of OIP's workforce regarding workforce overview, workforce competencies, training needs and alignment, recruitment, retention and reintegration, and current and future workforce needs. The final output of this assessment will be a critical component of the OIP workforce assessment. In addition, FDA has taken other steps to further its efforts. Among other things, it instituted the Foreign Post Opportunity Development Pilot Program, a newly developed outreach initiative designed specifically for the FDA community. The program has been designed as a learning pathway that will ultimately cultivate the global knowledge, skills, and abilities of the FDA community, to meet the agency's mission abroad. OIP selected five participants in December 2011. The program consists of 4 workshops and two short-term (1-3 months) development assignments: One of these short-term assignments includes a rotation to OIP Headquarters. The second will be a 1-3 month temporary assignment to an FDA Foreign Post. In addition, in July 2011, OIP and ORA collaborated and established a program permitting staff to apply for temporary details to work as consumer safety officers (inspectors) at FDA Foreign Posts. This has given staff an opportunity to gain experience working overseas and has generated greater interest in the 2-year assignments. FDA has also identified competencies needed to work successfully overseas, piloted new customized training courses based on the skill set gaps identified by foreign post and OIP managers, and developed a guide on the selection and reassignment of staff to its foreign posts.

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