The FDA has long maintained that resource constraints prevent it from meeting its responsibility to oversee the safety and effectiveness of medical products and devices. In a report issued in June, the Government Accountability Office (GAO) agreed.
But, while the FDA maintains it needs more help, the GAO said one of the main problems facing the FDA is that it does not have a handle on which resources it needs to fulfill its mission—a dilemma the GAO said has been plaguing the agency for 20 years. The problem is the FDA’s failure to improve the management and tracking of its resources and workload, according to the report, “FDA Faces Challenges Meeting Its Growing Medical Product Responsibilities and Should Develop Complete Estimates of Its Resource Needs.”
That failure, the GAO said, means the FDA “cannot develop sound and justifiable budget requests that reflect all the work that is vital to fulfilling its mission.”
Also the agency's mission continues to grow. New laws and a growing workload have increased the FDA’s oversight responsibilities concerning pharmaceuticals and medical devices.
For example, the GAO found that between 2002 and 2007, 11 new laws were enacted that specifically add to the FDA’s medical product oversight responsibilities. Between 1999 and 2009, the number of drug, biologic and device application materials submitted to the FDA grew by 30 percent--from 23,079 to 30,060. During the same period of time, the number of medical products the FDA approved or cleared for marketing grew by 55 percent.
Total funding (including fiscal year appropriations and user fee funding) for the FDA has increased—by 112 percent between fiscal years 1999 and 2008—but FDA officials reported there has been a decline in available funding for activities unfunded by user fees, such as the oversight of transfusion-related blood products, human tissues, device compliance and enforcement, as well as radiologic health.
The same phenomenon holds true for FDA staffing levels. The number of full-time employees supporting FDA’s medical product programs increased from 4,925 full-time employees in 1999 to 5,625 in 2008. But, almost all of that growth was attributable to user fee funding. The number of full-time employees funded by fiscal year appropriations actually declined by 7 percent during this same period of time.
All of this, the FDA says, has hindered its ability to fulfill its oversight responsibilities. For example, according to the report, the FDA failed to meet a requirement to complete certain inspections every two years. FDA officials estimated that they were only able to conduct inspections of domestic drug manufacturers every three years and domestic device manufacturers every three to five years.
The GAO recommended that the head of the FDA conduct a comprehensive assessment of the agency’s workforce, gather data on the work conducted to fulfill its congressionally mandated mission, determine the extent to which it is meeting those responsibilities and develop an evidence-based estimate on the resources needed to accomplish its mission.