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New Study Recommends Overhaul of FDA

By Dan Flynn and Suzanna Schreck

A new study highlights the need for revamping the aging U.S. Food and Drug Agency, the organization in charge of monitoring the safety of 80 percent of the U.S. food supply. The 500-page study was requested by Congress in order to pinpoint the ways in which gaping holes in the efficiency of the FDA can be filled.  The report's central point is that the FDA is in dire need of a shift in focus "from a reactive approach to a risk-based approach."  The study's authors state that the agency can do this by centralizing FDA's limited resources towards the riskiest foods.  Robert Wallace, a member of the committee and professor at the University of Iowa, told the Canadian Medical Association that the FDA needs to "go where the problems are, and that's why you need good data." Improved data, he says, is "where they put inspection resources, where they put communication resources, where they put their scientific portfolio." "FDA uses some risk assessment and management tactics, but the agency's approach is too often reactive and lacks a systematic focus on prevention.  Our report's recommendations aim to help FDA achieve a comprehensive vision for proactively protecting against threats to the nation's food supply," he said. The report offers in-depth recommendations for achieving the goals the committee sets forth. The authors believe that the U.S. needs a single agency to handle all food safety areas, similar to the Canadian Food Inspection Agency established in 1996. Currently more than 15 separate agencies play a roll in U.S. food safety. The National Academies, a non-profit organization that helped generate the report, summarized part of the recommendations on its website:
"To enhance its efficiency, FDA should explore alternative approaches to regulating food safety, such as delegating food facility inspections to the states, the report says.  FDA should establish national standards for the intensity and frequency of these facility reviews and help states and local municipalities bring their safety programs up to those standards.  Once all programs are standardized, FDA should train and certify state inspectors with the goal of turning over the majority of inspections to them under the agency's supervision.  This change would build on current practices in which roughly 60 percent of inspections are already conducted by state inspectors under contract with FDA.  This integration and leveraging of resources would increase the quality of inspections and eliminate duplication of effort, the committee said." 
The report also recommends legislative action. The authors think the FDA should have more authority to conduct recalls, expanded access to records and testing results, and increase inspections at food facilities. The Food Safety bill currently before the Senate is in step with a number of these ideas.  The committee reported that each year over 76 million Americans are affected by foodborne illness. More than 300,000 of them require hospitalization and 5,000 die as a result of their illness. Over the past few years there have been a number of extremely high profile E. coli, Salmonella and Listeria outbreaks, resulting in massive amounts of recalled food. The report was well-received by both the FDA and Congress, both of which see it has a valuable resource to use in accomplishing the goal of providing the United States with a safer food supply. The study was conducted by the Committee on the Review of Food and Drug Administration's Role in Ensuring Safe Food, the Institute of Medicine, and the National Research Council.
A complete copy of the report can be purchased here.

Full post as published by Food Safety News on August 09, 2010 (boomark / email).