FDA’s next focus: Antibiotics without defined duration of use

In a notice published in the Federal Register, the agency requests information from the public about how to establish appropriately targeted durations of use for the approximately 32% of therapeutic products affected by GFI #213 with no defined duration of use in order to foster stewardship of medically important antimicrobial drugs in food-producing animals and help preserve the effectiveness of these antimicrobials in animal and human medicine. Specifically, for certain species and disease indications as listed in the FR notice, the FDA wants to obtain additional information on: 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.