AHI Statement on FDA Proposed Rule on Antibiotic Sales Data

Washington, D.C. – Animal health companies have been complying with the provisions of ADUFA Section 105 since 2008 by providing annual antibiotic sales data for food producing animals to the Food and Drug Administration. Today’s proposed regulation expands on those requirements.

The Animal Health Institute has always supported the collection and use of data that has a stated, scientific purpose and helps producers and veterinarians use antibiotics more wisely. We will review and comment on the FDA proposal with those principles in mind.

The FDA has been clear about the limits of sales data. Sales data do not well correlate to public health risk, as witnessed by the fact that recent sales reports show increased sales while recent reports from the National Antimicrobial Resistance Monitoring System (NARMS) show encouraging trends of declining antibiotic resistance in those pathogens that are foodborne, or potentially related to animal use. These data sets show that antibiotics can be and are being used carefully to protect animal health without adding to the human burden of antibiotic resistance.


Media Contact: Ron Phillips: (202) 637-2440