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AHI Statement on FDA Final Rule on Antibiotic Sales Estimates

Antibiotics are a critical tool to prevent, control and treat disease in animals. They make our food supply safer and people healthier.  In doing so, they also reduce the chance of bacterial transmission from animals to humans. For more than 40 years, the Food and Drug Administration (FDA) has approved the use of antibiotics in livestock and poultry. Veterinarians work with farmers to use these products in a judicious manner that provides consumers with the safest food possible.

AHI and its member companies are disappointed in today’s ruling from the FDA requiring species-specific sales estimates from drug sponsors. We believe this rule will result in an inaccurate representation of the data that will be misleading and not contribute to sound decision making. Asking drug sponsors to estimate sales data will lead to imprecise numbers that will be used as definitive measures of antibiotic use. Further, sales data does not correlate with antimicrobial resistance or public health.

We do believe in transparency and sound data regarding antibiotic usage that aids in both agency- and farm-level decision making.  That is why AHI voluntarily collected and published sales data before it was mandated by law and is working with agricultural, veterinary and public health groups in support of proposed funding for the U.S. Department of Agriculture to appropriately collect information and research that will aid in better understanding of antibiotic use.  A secure and confidential program like the USDA National Animal Health Monitoring System (NAHMS) is a more appropriate system for collecting this type of information.

We strongly encourage the FDA to reconsider this ruling and instead, develop a comprehensive plan for antibiotic data collection that is clear in its goals and provides information that will aid all users in making decisions about the use of antibiotics.