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.
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
Comments: In August 2015, FDA reported that every office in its Office of International Programs (OIP), including the overseas offices, develops an Operational Plan for each fiscal year and updates these plans quarterly. These Operational Plans map the overseas office priorities to OIP's strategic priorities, and link to OIP's strategic planning tools. These plans are intended to help OIP to track each office's performance and measure its contributions toward its goals throughout the year. FDA also reported that OIP is working with a contractor to develop a set of performance measures to assess and manage the performance of the food safety-related activities conducted by OIP Offices, with a special emphasis on the foreign posts. The performance measures will link to the OIP Strategy Map and Operational Plans, as well as other food-related management frameworks. According to FDA, when developed, the metrics will allow for the tracking of performance and contribution of activities to results expected from the various food safety activities identified under the OIP operational and strategic planning process; a set of measures for evaluating the impact of these activities and linking them to the desired strategic outcomes; and a method for implementing a data-driven management system. The indicators will be used to track OIP overseas office contributions towards results and to analyze and report on the impact of OIP Offices? food safety activities. The approach will provide senior managers in FDA with a tool for managing OIP effectively using performance measures linked to the results framework. While all OIP Offices are involved in the metric development process, FDA stated it would place particular emphasis on ensuring that the metrics developed are applicable for the Latin America and China Offices, given the high volume of food imports from these countries. However, FDA's response did not contain any mention of its efforts to develop performance goals and measures related to the safety of medical 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
Comments: In August 2015, FDA reported that its Office of International Programs (OIP) is continuing to develop a forward-looking strategic Workforce Plan (WFP) for 2015 through 2020. According to the agency, the WFP Team has made significant progress over the past year and is on-track to complete the first phase of the WFP by September 2015. OIP continues to use contract support for expertise in strategic workforce planning and has prepared the WFP and outline to include multiple sub-plans, including interviews and focus groups with OIP leadership and subject matter experts on international food and drug regulation, supply and demand analysis, workforce gap analysis, a learning and development strategy, a recruitment and retention strategy, succession plan, and a performance management plan. FDA said that extensive background research has been completed, including review of recent legislative requirements and internal initiatives. Specifically, the WFP Team is developing a strategic alignment pathway to ensure that human resource needs associated with the transition toward specialized, commodity-based expertise among FDA investigators are addressed. The OIP WFP will also make recommendations for training of overseas staff. In addition, FDA said that OIP, in collaboration with the Office of Human Resources, FDA University and its workforce analysis staff have retrieved historical personnel data records from 2010 through 2015. They are analyzing multiple workforce dimensions, including trends in gains and losses among occupational series and other demographic characteristics to produce predictive forecast models for the next 5 years. In addition, the WFP team is analyzing archival Employee Viewpoint Survey data to determine drivers of employee engagement and turnover intentions. Finally, the WFP Team has prepared draft interview questions for OIP leadership and subject matter experts, which will provide the critical insight needed to develop the WFP strategy. Interviews are currently being scheduled and will be completed throughout summer 2015.
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