IOM Report Faults FDA for Piecemeal Approach to Risk Management
The Institute of Medicine (IOM) has issued a June 2010 report claiming that the Food and Drug Administration (FDA) “continues to be reactive, lacking a systematic focus on prevention.” According to a June 8, 2010, press release, IOM has advised FDA to adopt a “risk-based model” that involves increased coordination “with state and other federal agencies that share responsibility for protecting the nation’s food supply.” The institute has also called on Congress to amend the Food, Drug, and Cosmetic Act “to explicitly provide the authority FDA needs to fulfill its food safety mission.”
Enhancing Food Safety: The Role of the Food and Drug Administration apparently provides a blueprint for overhauling FDA, which IOM criticized in a report brief for continuing to address problems “on a case-by-case basis.” Its recommendations include integrating food safety programs and public education, enhancing the efficiency of the inspection process, and modernizing legislation in an effort to reorganize the food safety system.
In particular, IOM has urged government to (i) “establish a centralized food safety data center outside the regulatory agencies”; (ii) delegate food facility inspections to the states; (iii) implement national standards for state and municipal safety programs; and (iv) “detail FDA’s authorities in facility registration, preventive controls, risk-based inspection, mandatory recall, reporting of adulteration, and banning of food imports if the public’s health is at risk.” As the IOM report brief concludes, “Until the recommended changes are implemented, the FDA and the federal government will lack the process, capabilities, and structure needed to properly evaluate decisions that will ultimately ensure the safety of the nation’s food.”
