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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. (FDA, 2008a)
The FDA’s task is large. The FDA regulates products that comprise about 25 percent of consumer spending in the United States, which comes to more than $1 trillion in spending (Subcommittee on Science and Technology, 2007). The FDA’s 2008 budget authority was $1.87 billion; with user fees added to this number, the FDA’s total 2008 budget was $2.42 billion (Office of Budget, 2009). As stated by Wood (2008) in his article Playing “Kick the FDA”—Risk-free to Players but Hazardous to Public Health,
Between 1988 and 2007, additional FDA responsibilities were imposed by 137 specific statutes, 18 statutes of general applicability, and 14 executive orders (Subcommittee on Science and Technology, 2007). At the same time, the FDA received a 2007 federal appropriation of only $1.57 billion—less than 75% of the budget for the school district in its home county in Maryland.
For another comparison, Coca-Cola’s advertising budget in 2008 was $3 billion (Coca-Cola, 2009). The money spent to promote one company’s products in one year is greater than the money spent to ensure the safety of products purchased with one out of every four consumer dollars in the United States.
Recommendation 7.1 from the Institute of Medicine (IOM) report The Future of Drug Safety stated that “to support improvements in drug safety and efficacy activities over a product’s lifecycle, the committee recommends that the Administration should request and Congress should approve substantially increased resources in both funds and personnel for the Food and Drug Administration” (IOM, 2007b). Food safety is also a challenge because responsibilities are spread over multiple agencies (IOM, 1998). IOM reports on food safety have also pointed out the need for sufficient funding to support a science-based food safety system (IOM, 1998). The call for adequate resources to protect food and drug safety has also been sounded by the FDA’s Science Board in its report FDA Scienceand Mission at Risk (Subcommittee on Science and Technology, 2007). The challenges facing the FDA as its duties expand and its resources shrink have also been noted by IOM committees and workshops (IOM, 2007a, 2007b) as well as other entities (GAO, 2009b; IOM, 2007a, 2007b; Wood, 2008).
With its large task and small budget, the FDA faces criticism from many directions: when there is an outbreak of illness caused by a foodborne pathogen, when there are pervasive safety problems in food plants,