Skip to Highlights

GAO was asked to review the Food and Drug Administration's (FDA) strategic planning and management. Leading practices in this area include developing strategies to address management challenges and results-oriented performance measures, aligning activities and resources to strategic goals, and enhancing the use of performance information. In this report, GAO examined the extent to which (1) FDA's Strategic Action Plan contains strategies to address its management challenges, and the progress FDA has reported in addressing those challenges; (2) FDA's annual performance measures are results-oriented; (3) FDA has aligned its activities and resources to support its strategic goals; and (4) FDA managers report using performance information in decision making and applying key practices to encourage that use. GAO surveyed FDA managers; analyzed reports on FDA to identify its management challenges; reviewed FDA and other documents, prior GAO work, and surveys of federal managers; and interviewed FDA officials.

Overall, while FDA is aware of its challenges and has taken steps to address them, the agency does not fully use practices for effective strategic planning and management. GAO identified five major management challenges that could affect FDA's ability to carry out its mission, and while FDA's 2007 Strategic Action Plan contains strategies to address these challenges, progress has been uneven. Through reviewing reports from GAO, the Institute of Medicine, the Department of Health and Human Services, and the FDA Science Board, GAO determined that FDA's management challenges include recruiting, retaining, and developing its workforce; modernizing its information systems; coordinating internally and externally; communicating with the public; and keeping up with scientific advances. GAO's 2009 survey asked FDA managers whether they thought the agency had made progress in addressing its management challenges. A minority of FDA managers responding to the survey reported that the agency was making great progress on meeting most of these challenges--the exception was for public communication. For example, less than one-half of FDA managers reported great progress in addressing workforce issues. GAO also found that FDA lacks an agencywide strategic human capital plan, which reduces the agency's ability to strategically strengthen its human capital. FDA's 48 annual performance measures for fiscal year 2010 are not as useful for decision makers as they could be because they are only partially results-oriented. The measures adhere to some of the key characteristics GAO identified in prior work that can help provide decision makers with useful information on an agency's results--for example, they are linked to agency goals. However, FDA's measures do not adhere to other key characteristics because they do not focus on outcomes, address important dimensions of agency performance, identify projected levels of performance for multiyear goals, or fully address identified management challenges. While FDA has taken steps to align its activities and resources to strategic goals, these efforts in its centers and offices are not clear, making it difficult to connect the agency's use of resources to the achievement of its goals. FDA has aligned its three main types of activities--pre-market review, production oversight, and post-market surveillance--and uses employee performance plans to link individuals' activities to its strategic goals. However, only four of eight centers and offices GAO reviewed clearly documented alignment of their activities to FDA's goals, and only two clearly linked their resources to goals, in part because several centers and offices do not track workload by goals. In GAO's survey, about one-third to one-half of FDA managers reported using performance information to a great extent in making management decisions--for example, to set program priorities. While training can develop agency capacity to use performance information, less than one-half of FDA managers reported receiving training that could improve and expand the use of performance information.

Skip to Recommendations


Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration 1. To more strategically manage its human capital, the Commissioner of FDA should develop a strategic human capital plan and issue an updated workforce plan.
Closed - Implemented
In FDA's 2012 update to GAO on the status of its recommendations, the agency said it completed actions to develop a strategic human capital plan and workforce plan, and FDA's performance tracking system reported that the agency finalized its work to develop a human capital plan and workforce plan in October 2012 through the delivery of an executive briefing on those plans. In June 2012, FDA provided GAO copies of its strategic human capital plan for 2010-2012 and updated workforce plan for 2011-2012.
Food and Drug Administration 2. To help decision makers more effectively gauge agency progress, the Commissioner of FDA should work to make FDA's performance measures more results-oriented.
Closed - Not Implemented
FDA has implemented an agency-wide performance tracking and management system called FDA-TRACK, which contains numerous performance measures. This system has the potential to put greater focus on performance management at FDA, and because data is posted online, increases transparency to stakeholders and the public. However, our review focused on the annual performance measures included in the President's yearly budget request for FDA, and our review of those measures shows no significant change in their results orientation. In addition, many performance measures in the new FDA-TRACK system are not results-oriented.
Food and Drug Administration 3. To more clearly demonstrate the alignment of activities to strategic goals, the Commissioner of FDA should direct each of the agency's main centers and offices to clearly align their program activities to FDA's strategic goals in documents, such as the budget request or center- and office-level documents.
Closed - Implemented
In its 2011 and 2012 updates on its response/implementation of recommendations from the report, FDA stated that it made overall alignment evident in its FY2011 and FY2012 performance budget submissions by including a new table that links each subprogram area to FDA's strategic goals. GAO verified this information in the agency's FY2011 budget request and in documentation provided by FDA in July 2012.
Food and Drug Administration 4. To more clearly demonstrate alignment of resources to strategic goals, once FDA creates a more results-oriented set of performance measures, the Commissioner of FDA should direct FDA's centers and offices to track their workload by strategic goals.
Closed - Not Implemented
FDA provided information to GAO on its efforts to estimate resources needed to address its medical product responsibilities, which could be useful to the agency in tracking some of their workload by strategic goals. However, the agency has not provided evidence that it is doing such tracking, and the information provided by FDA did not address tracking of its workload related to its responsibilities apart from those related to medical products (e.g. food or feed-related responsibilities).
Food and Drug Administration 5. To encourage greater use of performance information, the Commissioner of FDA should work to build FDA's capacity to collect and analyze performance information by expanding training for managers on topics related to performance information.
Closed - Implemented
In its 2012 update on its implementation of recommendations from the report, FDA stated that it had contracted with a provider for budget and performance training to provide classes in fiscal year 2012 on topics such as, "Using Performance Metrics to Improve Program Effectiveness," and "Analyzing the Budget Impact on Performance." FDA also provided information on the materials used in such classes.

Full Report