	Background

FDA is responsible for ensuring the safety of food and medical products  marketed in the United States. To enhance FDA’s activities in  this regard, the centers and ORA also engage with foreign regulators and  industry through a variety of activities, such as conducting and attending  training workshops. The stated mission of the offices is to engage with foreign stakeholders to  develop information that FDA officials can use to make better decisions  about products manufactured in foreign countries for the U.S. market. In China and India, FDA also  placed investigators, who conduct inspections. FDA staff agreed to be posted overseas for an initial 2-year rotation. In a February 2010 report, we noted that FDA was not fully utilizing  practices for effective strategic and workforce planning. FDA’s Overseas Offices Have Taken Steps to Assist Regulatory Oversight, but Challenges Could Limit Their Effectiveness

FDA’s overseas offices are establishing relationships with foreign  stakeholders and U.S. federal agencies located overseas, gathering  information to assist regulatory decision making, conducting  establishment inspections, and providing capacity building to foreign  stakeholders in an effort to help ensure the safety of imported products. FDA officials said that prior to the  opening of the overseas offices, the agency had little knowledge of the  regulatory structures in some countries with which the overseas offices  interact or lacked points of contact with some of their regulatory  counterparts. Some of these officials  also told us that they have not been able to develop relationships with  foreign stakeholders to the same extent as their colleagues in the overseas  offices. Because of this, officials from other U.S. agencies located in  these countries said that FDA will probably have to establish relationships  with multiple layers of government officials. FDA officials said that they plan to obtain feedback on  these documents from centers and offices once they are complete. Officials from the India, China, Latin America, and Middle  East Offices have engaged in activities related to helping countries develop  their regulatory systems. FDA Is in the Early Stages of Long-Term Strategic Planning and Has Not Developed a Long- Term Workforce Plan for the Overseas Offices

FDA planning for the overseas offices initially focused on guiding early  activities and the agency is now developing a 5-year strategic plan, which  it expects to complete by October 2010. FDA has not yet developed a long- term workforce plan to help ensure that it is prepared to address potential  recruitment and retention challenges. FDA Has Not Developed a Strategic Workforce Plan to Prepare for Potential Staffing Challenges for Its Overseas Offices

FDA has not yet developed a long-term workforce plan to ensure that  future overseas office staffing needs are met. FDA staff and staff from other federal agencies with overseas staff have  identified potential challenges associated with staffing overseas offices  that could impact recruitment and retention. Although it is still early and the impact of the overseas offices on the  safety of imported products is not yet clear, overseas FDA staff, domestic  FDA staff, and foreign stakeholders have pointed to several immediate  benefits. Recommendations for Executive Action

To help ensure that FDA’s overseas offices are able to fully meet their  mission of helping to ensure the safety of imported products, we  recommend that the Commissioner of FDA take the following two actions:    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 ORA. 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. Food and Drug Administration: Opportunities Exist to Better Address  Management Challenges.
Why GAO Did This Study

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.

What GAO Found

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.

What GAO Recommends

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.