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: Published: Jun 19, 2009. Publicly Released: Jul 20, 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.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: In response to our recommendation, FDA launched a study to develop an evidence-based approach to resource estimation focused on medical products. In addition to developing a tool to enable the agency to make accurate and repeatable estimates of the resources needed to fulfill its responsibilities, FDA's resource estimation contractor also examined future trends that were likely to affect FDA's resource utilization. Among other things, this analysis considered shifts in workforce changes, advances in science and technology, changes in the agency's regulatory authority, and globalization. This analysis provided FDA with an estimate of resources needed through fiscal year 2015. FDA also said that its resource estimation models were used to support requests for additional funding for the agency, inform the agency's Medical Device User Fee Act negotiations, and provide the foundation for implementing new legislation. The agency's final presentation on the results of its study used to brief the FDA Commissioner specifically cited our recommendation as the motivation for its actions.

    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

  2. Status: Closed - Implemented

    Comments: In response to our recommendation, FDA launched a study to develop an evidence-based approach to resource estimation focused on medical products. As part of FDA's resource estimation study, the agency contracted with a consulting firm to create a modeling tool that would enable the agency to develop accurate and repeatable estimates of the resources needed to fulfill all of its responsibilities. An analysis was also conducted to identify gaps in the agency's ability to meet its responsibilities by medical product center. The agency's final presentation on the results of its study used to brief the FDA Commissioner specifically cited our recommendation as the motivation for its actions.

    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

  3. Status: Closed - Implemented

    Comments: In response to our recommendation, FDA launched a study to develop an evidence-based approach to resource estimation focused on medical products. As part of FDA's resource estimation study, the agency contracted with a consulting firm to catalog the range of FDA's responsibilities related to medical products. A framework was then constructed which included over 1,600 responsibilities derived from statutes, regulations, performance and budget documents. These responsibilities were then cross-walked to more than 200 work activities performed by FDA in the execution of these responsibilities. In addition, a benchmarking study was performed to validate the resources needed by comparing FDA to other organizations with comparable responsibilities. The agency's final presentation on the results of its study used to brief the FDA Commissioner specifically cited our recommendation as the motivation for its actions.

    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

  4. Status: Closed - Implemented

    Comments: In response to this recommendation, FDA contracted with a consulting firm and launched a study to develop an evidence-based approach to resource estimation focused on medical products. This study was initiated to develop a process to estimate the labor, facilities, equipment, materials, and contracted services required to fulfill the agency's statutory and non-statutory responsibilities related to the regulation of medical products. The study included a variety of analyses including an examination of the agency's responsibilities, a baseline assessment of resources needed, a gap analysis, a benchmarking review, and a trend analysis. The agency's final presentation on the results of its study used to brief the FDA Commissioner specifically cited our recommendation as the motivation for its actions.

    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

 

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