January 5, 2024

While the guidance offers sponsors the option to include boilerplate “resistance mitigation statements,” such as “Feed this drug only to the number of animals necessary to treat, control, or prevent the indicated disease in accordance with the approved conditions of use,” the agency does not suggest that the risk of resistance should be considered in establishing an expected or maximum duration of. [...] Concerns with GFI 273 CSPI’s primary concerns with the draft GFI are the recommended indefinite, non-time-bound language for the expected duration of use and the resultant lack of a request for scientific justification for the expected duration of use. [...] As described above, the guidance encourages sponsors to take an approach that will leave the maximum duration as the only definite, time-bound duration of use on labels, even though CVM acknowledges that this duration "should not be the duration veterinarians would routinely order.” Failing to provide a definite, time-bound duration of use for the expected course of treatment, which is what most v. [...] Even without this guidance, antimicrobial drug sponsors and salespersons are financially motivated to promote the drug to veterinarians and producers at the longest duration of use approved in the label, creating additional encouragement for the maximum duration of use. [...] Requested Changes to GFI 273 Considering the aforementioned issues with the draft GFI, we recommend the following changes be made: First, the section “Defining the Expected Duration of Use” should be amended to advise manufacturers to provide a definite, time-bound expected duration of use for each indication in the label, supported by evidence.