Food and Drug Administration
FDA Faces Challenges Meeting Its Growing Medical Product Responsibilities and Should Develop Complete Estimates of Its Resource Needs
GAO-09-581, Jun 19, 2009
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Twenty years ago, GAO reported that the Food and Drug Administration (FDA) was concerned that it lacked resources to fulfill its mission, which includes oversight of the safety and effectiveness of medical products--human drugs, biologics, and medical devices--marketed for sale in the United States. Since then, FDA, GAO, and others have raised concerns regarding FDA's ability to meet its oversight responsibilities. GAO was asked to review the resources supporting FDA's medical product oversight responsibilities. GAO examined trends in (1) FDA's funding and staffing resources for its medical product oversight responsibilities from fiscal years 1999 through 2008, and (2) FDA's medical product oversight responsibilities during this same period. GAO analyzed FDA data on the agency's resources and workload, reviewed relevant federal laws, and interviewed FDA officials. GAO also examined more-detailed data on FDA's fiscal year 2004 through 2008 resources and workload in four key areas, representing a range of FDA's oversight responsibilities, both before and after a medical product is marketed in the United States.
Funding and staffing resources for FDA's medical product programs increased between fiscal years 1999 and 2008, primarily as a result of increased user fees paid by industry, which are made available through appropriations acts to support the agency's processes for reviewing new medical products. Total funding increased from about $562 million in fiscal year 1999 to about $1.2 billion in fiscal year 2008, with user fee funding accounting for more than half of this increase. A large and growing portion of funding supported activities for which user fees are collected, resulting in a declining share of funding available for other activities. FDA officials said that this has seriously limited the agency's ability to fulfill its oversight responsibilities in some areas, particularly those not funded with user fees. FDA faced challenges fulfilling and managing its growing medical product oversight responsibilities, which agency officials attributed to resource constraints. FDA's statutory responsibilities grew during this period and a growing number of medical products subject to FDA oversight and establishments manufacturing these products for the U.S. market also added to the agency's workload. However, FDA could not provide data showing its workload and accomplishments in some areas, such as its review of reports identifying potential safety issues with specific medical products. Without such information, FDA cannot develop complete and reliable estimates of its resource needs. While FDA officials said that the funding amounts requested for and provided to FDA during the past 2 years will permit the agency to respond to its most urgent needs and priorities, officials also noted that they did not receive enough resources to meet some statutory requirements, such as biennially inspecting certain manufacturing establishments. Furthermore, officials said that the agency faces significant challenges fulfilling its mission to oversee the safety and effectiveness of medical products.
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Recommendations for Executive Action
Recommendation: The Commissioner of FDA should establish a comprehensive and reliable basis to substantiate the agency's estimates of its current and future resource needs in a manner consistent with the principles contained in our cost estimating and assessment guide. To do so, the Commissioner of FDA should conduct a comprehensive assessment of the agency's staffing resources, including its contractor workforce.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Open
Comments: In its agency comments on a draft of our recent report, FDA said that a comprehensive assessment of its staffing resources would provide useful information. It noted that it already had a staffing assessment process, which it started using in about January 2008 to assess the need for new staff. FDA indicated that, to implement our recommendation, it would expand this process to include both its contractor workforce and existing staff. FDA said it will also utilize this process to plan and assess future agency needs. In 2010 FDA said that it has a staffing assessment process in place that has been used for assessing needs for new staffing and backfills. This assessment has been conducted over the last 18 months. FDA plans to expand this process to include both contractor workforce and existing staff. It said it would also utilize this process to plan and assess future agency staffing needs.
Recommendation: The Commissioner of FDA should establish a comprehensive and reliable basis to substantiate the agency's estimates of its current and future resource needs in a manner consistent with the principles contained in our cost estimating and assessment guide. To do so, the Commissioner of FDA should gather data on the work the agency conducts to fulfill its responsibilities.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Open
Comments: In its agency comments on a draft of our recent report, FDA said that it plans to conduct a complete inventory of all regulatory work products by each of the FDA Centers, including those responsible for medical products. In 2010, it also indicated it plans to complete such an inventory but did not specifically update its efforts.
Recommendation: The Commissioner of FDA should establish a comprehensive and reliable basis to substantiate the agency's estimates of its current and future resource needs in a manner consistent with the principles contained in our cost estimating and assessment guide. To do so, the Commissioner of FDA should assess the extent to which the agency is meeting its responsibilities.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Open
Comments: In its 2010 update, FDA reiterated its commitment to completing an inventory of all regulatory work products generated in response to recommendation 2 above, and also noted it planned to identify and implement relevant measures for agency programs and offices which will allow it to determine how effectively it is meeting its responsibilities. FDA said that many measures of productivity are already in place in conjunction with user fees and related performance indicators. FDA also stated that the data collected and analyzed for these metrics will be used to inform FDA management about the effectiveness of specific programs in meeting the agency's responsibilities and inform management about whether or not changes to specific programs should be made. In 2011 FDA reported that a preliminary high-level assessment of the degree to which FDA is meeting its current medical product responsibilities was completed as part of itsresource estimation effort. However, a more systematic and thorough assessment has not yet been conducted.
Recommendation: The Commissioner of FDA should establish a comprehensive and reliable basis to substantiate the agency's estimates of its current and future resource needs in a manner consistent with the principles contained in our cost estimating and assessment guide. To do so, the Commissioner of FDA should develop an evidence-based estimate of the resources needed to fulfill all of its responsibilities.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Open
Comments: In its agency comments on a draft of our report, FDA said that, in addition to implementing performance management through the use of metrics across agency offices and programs, it plans to link these metrics to its budget and funding allocation. This approach will inform the agency about how well it is allocating its resources and additional resources it needs to fulfill its responsibilities. In its 2010 and 2011 recommendation status updates, FDA reported that, with the help of a contractor, it was developing evidence-based resource estimation models for each program area related to medical products. The resource estimation models and associated were scheduled to be completed in late August 2010. FDA reported that the resulting models will able to generate estimates that are reliable and repeatable and enable the agency to effectively plan for anticipated workload trends. FDA stated that these models should also inform future requests for additional resources needed to fulfill all of its responsibilities.