As animal health companies reach the compliance date of December 31, 2016 to remove production uses on antimicrobials important for treating human disease, the U.S. Food and Drug Administration has announced its’ next step in promoting judicious antibiotic use in agricultural animals.
The announcement states that the agency will be focusing on medically important antimicrobials administered via feed and water that have at least one therapeutic use without a defined duration for treatment. These antimicrobials are estimated to account for 32 percent of the products that will fall under Guidance for Industry #213, which limits the use of medically important drugs to therapeutic-use only.
FDA is actively seeking information from the public on establishing the appropriate duration of use for these animal drug products. Specifically, FDA stated in its’ press release that it is requesting information on the following:
- “The underlying diseases requiring these drugs for therapeutic purposes, and periods when livestock or poultry are at risk of developing these diseases;
- More targeted antimicrobial use regimens for these diseases and husbandry practices that may help avoid the need for these antimicrobials, or that may help make more targeted antimicrobial use regimens more effective; and
- Strategies for updating affected labeling of drug products that do not currently include a defined duration of use.”
All comments to the agency on this topic are due by December 13, 2016. Further information on the notice, and instructions for submitting comments is available here, and the FDA press release on the announcement is available here.
