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: In September 2014, FDA reported it is utilizing its strategic and operational planning continuum to help plan, prioritize and track performance and accomplishments in more measureable and aligned ways. FDA said that its Office of International Programs (OIP) works closely with the Office of Global Operations and Policy (GO) and the Office of Regulatory Affairs (ORA) to assure alignment with FDA strategic priorities. FDA stated that OIP has made significant progress in enhancing strategic planning efforts as demonstrated by the following key accomplishments: (1) An updated OIP Strategic Plan; (2) the establishment of six FY14 OIP Strategic Priorities; (3) the tracking of SES plan elements in office operational plans; and (4) the development of a GO/OIP/ORA planning calendar to delineate timing and deadlines for key processes, including strategic and operational planning and performance management. FDA acknowledged that OIP is in the early stages of monitoring and evaluation. According to FDA, there is a wealth of information being tracked, with access to regularly updated performance data through tools and processes. At this stage, OIP is exploring options for a path forward to measure results-oriented goals. Although it has made progress, FDA has not yet reported any specific performance goals and measures that are outcome-oriented and clearly related to the contributions made by the overseas offices to enhance 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 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: In September 2014, reported that its Office of International Programs (OIP) is currently working on enhancing workforce planning efforts that are linked to the OIP Strategic Plan. Over the next year, OIP plans to develop the first phase of a forward-looking strategic Workforce Plan (WFP) for FDA?s Foreign Offices. The WFP?s first phase will focus on OIP and will also include engagement from FDA?s Office of Regulatory Affairs. To facilitate the process, OIP has developed a preliminary strategic Workforce Planning Framework based on the workforce planning model and best practices recommended by the U.S. Office of Personnel Management. In the next phase, the WFP effort will link with recommendations presented by the Department of Health and Human Services Global Health Service Career Track working group, formed in 2013 for the purpose of strengthening workforce recruitment, retention, deployment, and specialized training for foreign service. The recommendations of this interagency working group will assist in FDA?s agency-wide workforce planning efforts. OIP plans to continue to focus on developing a skilled and knowledgeable workforce in recruitment, retention, and reintegration; leadership development; proactive management and succession planning; and cultural and linguistic competency. FDA stated that the OIP Strategic Workforce Plan should be completed by September 2015. FDA also provided information on steps it has taken to improve recruitment and retention, such as by utilizing more temporary duty assignments to meet increased inspection needs until permanent positions can be filled. TDYs increased in FY 2013 by 50 percent and in FY 2014 by an additional 11 percent to date, standardizing position descriptions across offices, and instituting individual development plans as a voluntary option for staff. OIP has also created a recruitment initiative to cycle vacancy bulletins biannually for non-supervisory positions. FDA also explained that its Office of Human Resources and OIP work closely when recruiting and placing individuals at Foreign Posts. In an effort to document important human resources processes, its Office of Human Resources is leading a collaborative effort to produce a FDA Foreign Post reintegration standard operating procedure, the first part of which was issued in March 2014. According to FDA, it has successfully reintegrated about 30 employees who were assigned to overseas postings and were eligible to exercise their reemployment rights.

    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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