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: FindLaw's Common Law

FDA Lacks Vision Needs Risk-based Approach

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The Food and Drug Administration needs more resources as well as major changes, according to a new expert report released this week.

Experts say that the FDA lacks the vision to protect the U.S. food supply. The Institute of Medicine issued a critical report on Tuesday submitting that the FDA's ability to discover threats to and prevent outbreaks of foodborne illnesses are hampered by impediments to efficient use of its limited resources. Further, the FDA's piecemeal approach to gathering and using information on risks presents further problems.

The Institute of Medicine believes the FDA should implement a risk-based approach to direct appropriate amounts of resources and attention to high risk areas and increase the chances of catching problems before they turn into widespread outbreaks.

Committee chair Robert Wallace, said that the "FDA uses some risk assessment and management tactics, but the agency's approach is too often reactive."

Recent major outbreaks, involving produce including tomatoes, lettuce, spinach, peppers and peanuts, have resulted in deaths and have been a source of major controversy among consumers.

The report also suggests establishing a federal centralized food safety data center to collect information and conduct rapid assessments of food safety risks and solutions. This would be a step toward consolidating food safety activities within a single agency, which many individuals and organizations have called for.

The Institute of Medicine also submits that the FDA should consider delegating food facility inspections to the states after creating national standards for the reviews. This type of risk-based approach could increase the quality of inspections and eliminate duplication of effort, the committee said.

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Full post as published by FindLaw's Common Law on June 11, 2010 (boomark / email).

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