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Committee Reports that FDA Has Insufficient Personnel, Resources to Meet Mission

By Jennifer Nuzzo and Michael Mair, December 7, 2007

A recent report issued by the Federal Drug Administration (FDA) Science Board’s Subcommittee on Science and Technology has concluded that FDA can no longer fulfill its mission without substantial and sustained additional appropriations. The report, which is entitled FDA Science and Mission at Risk, was completed at the request of FDA Commissioner Andrew von Eschenbach, MD.1

The Subcommittee, which was composed of three members of the FDA’s Science Board and “other experts representing industry, academia, other government agencies, and included individuals with extensive knowledge of cutting-edge research,” was charged specifically with identifying “the broad categories of scientific and technologic capacities that FDA needs to fully support its core regulator functions and decision making throughout the product life cycle, today and during the next decade.”1

The Subcommittee concluded that “science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” Specifically, the Subcommittee found that:

• “The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
• The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
• The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.”1

Although the Subcommittee “was asked to review gaps in scientific expertise and technology and not to assess available resources, it became apparent that gaps were so intertwined with two decades of inadequate funding that it was impossible to assess…[the gaps] without also assessing resources.” The Subcommittee concluded that FDA can no longer fulfill its mission without substantial and sustained additional appropriations.1

Independent analyses by the Institute of Medicine and the Grocery Manufacturers/Food Products Association have estimated that it could take $350 million to $450 million to restore the FDA’s scientific capability and capacity, whereas the Coalition for a Stronger FDA (co-chaired by the last three HHS Secretaries and endorsed by a number of former FDA Commissioners), have called for a “15 percent increase in appropriations per year during the next five years.” However, the Subcommittee concluded that such “increases would still be an insufficient amount to allow the FDA to initiate and support all of the changes necessary to fulfill its mission.” To that end, the “Committee strongly recommends that the most immediate increases be used to address those critical gaps identified in its report.”1

Reference

1. FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology. Prepared for the FDA Science Board. November 2007. http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf. Accessed December 7, 2007.