Despite almost a decade of funding and staff increases, “FDA reports that it cannot do all that is asked of it and our analysis of the agency’s activities confirms this,” the Government Accountability Office said in a June 19 report.
Despite almost a decade of funding and staff increases, “FDA reports that it cannot do all that is asked of it, and our analysis of the agency’s activities confirms this,” the Government Accountability Office said in a June 19 report.
The GAO concluded that the FDA is overwhelmed, partly because it is not asking for the resources it needs to fulfill its mission. It is not asking – because it does not know.
The GAO says the FDA needs to do a better job of tracking its resources and workload -- and correctly estimating its staffing and monetary needs of its medical product programs. Those programs cover human drugs, biologics, and medical devices that are marketed for sale in the United States.
Expanding workload
The FDA “faced a growing workload and was responsible for overseeing increasing numbers of marketed products and establishments,” the GAO notes in its report. “FDA officials…reported that rapid advances in science and technology, including the fields of genomics and nanotechnology, have increased the complexity of the medical products submitted to FDA for pre-market approval.”
In addition, the GAO found that new laws in the past decade – 11 of them specifically -- added to the FDA’s workload by expanding its medical-product oversight responsibilities.
The increasing workload has led the FDA to seek outside help to evaluate some new drugs and medical devices. Other investigations were put on hold as the government tried to catch up with the free market.
Normally, the FDA inspects domestic drug and device manufacturers as well as domestic blood banks every two years, but the GAO found that the agency has not been able to do that.
“FDA officials estimated that the agency, on average, conducts inspections of domestic drug manufacturers every 3 years, domestic device manufacturers every 3 or 5 years, and domestic blood banks every 2 years,” according to GAO.
Foreign manufacturers were inspected even less frequently, averaging an FDA checkup once every 12 years. In fact, the FDA only inspects foreign manufacturers of brand-name drugs. It ignores foreign makers of generic drugs, despite the prevalence of generic drugs in the United States.
These delays and failures occurred despite multi-million dollar increases in funding for the FDA.
Resource allocation problems
Funding and staffing for FDA's medical product programs increased between fiscal years 1999 and 2008, primarily as a result of increased user fees paid by industry, the GAO noted.
Total funding for FDA’s medical product programs increased 112 percent overall, from about $562 million in fiscal year 1999 to about $1.2 billion in fiscal year 2008, with user fees accounting for more than half of the increase.
While user fees help in some areas, activities not funded with user fees tend to suffer, the GAO report noted.
Staffing resources for FDA’s medical product programs also increased between fiscal years 1999 and 2008. The number of full-time employees supporting FDA’s medical product programs increased 14 percent from 4,925 in fiscal year 1999 to 5,626 in fiscal year 2008.
But again, the FDA noted that the staffing increase happened only in areas funded by user fees; the number of full-time employees funded by fiscal year appropriations (taxpayers) actually declined, limiting the agency’s ability to fulfill its medical product oversight responsibilities.
“FDA officials noted that they do not have enough staff to adequately perform duties that do not receive user-fee funding, such as the agency’s review of abbreviated new drug applications, oversight of product advertising and promotion, and inspections of establishments manufacturing marketed products. As a result, FDA officials noted that the agency’s work in these areas is increasingly backlogged,” the GAO reported.
The GAO found that the FDA’s reliance on user fees to fund certain activities, particularly those related to the review of new products, is a driving force behind which responsibilities FDA does and does not fulfill.
While approval of new products gets adequate funding, there is no parallel increase in funding for ensuring the continuing safety of products once they are on the market, the GAO said.
Basic management information lacking
The GAO said the FDA lacks information essential to getting the job done. For example, it “could not provide data showing its workload and accomplishments in some areas.” Also, the FDA lacks other “basic management information, such as the size of its contractor workforce.”
“Without this information, FDA does not have data to reliably estimate its resource needs—a problem we reported 20 years ago and which served as the basis of our recommendation that FDA collect such data,” the GAO said.
The GAO has previously recommended that the FDA improve the way it tracks its resources and workload, but the FDA has told the GAO it “lacks the resources to devote to this data collection and that it would detract from its oversight responsibilities.”
However, “without such basic data needed for managing its programs, FDA cannot develop sound and justifiable budget requests that reflect all the work that is vital to fulfilling its mission, including meeting its performance goals and its statutory requirements. It is also difficult for others to independently verify the extent to which FDA receives sufficient resources and whether the agency is appropriately utilizing and prioritizing the resources it receives.”
The GAO is once again recommending that the FDA commissioner establish complete and reliable estimates of the staffing and other resources it needs to fulfill its responsibilities.
In response, the FDA acknowledged that the GAO has identified some important issues regarding the challenges the agency faces in meeting its medical product responsibilities.