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AHI Statement on U.S. District Court Decision on FDA Citizens Petitions

AHI Statement

U.S. District Court Decision on FDA Citizens Petitions

June 5, 2012


The decision by the U.S. District Court in New York adds confusion to FDA’s efforts to phase in veterinary oversight of antibiotics used in food animals while eliminating growth promotion uses.  The court has now ordered FDA to initiate two different, competing and resource intensive processes.

Animal health companies will continue to support and work with FDA on the stakeholder process to achieve its goals of veterinary oversight and elimination of growth uses for medically important compounds.  This cooperative process will help avoid the unintended consequences of increased animal disease that have resulted from legislated bans in Europe.

The opinion cites the lack of risk assessments as one basis for its action.  In fact, several risk assessments have been published in peer-reviewed journals, and FDA has performed its own risk assessment on one compound.  All these scientific assessments reached the same conclusion:  The actual human health risk of the use of antibiotic use in animals resulting in the inability of the drug to treat human disease is extremely small – in one instance, less than the risk of dying from a bee sting.  Research also shows antibiotics are one of the many tools used to enhance food safety.