The U.S. Food and Drug Administration (FDA) is soliciting comments from the public on antimicrobial drug use practices in companion animals and the potential impacts of such uses on antimicrobial resistance (AMR) in both humans and animals. The FDA is issuing this notice as part of their objective to engage with stakeholders to develop and implement a strategy for promoting antimicrobial stewardship in companion animals. Specific questions and information requests are included in this notice to help guide input from stakeholders and other members of the public. FDA’s Center for Veterinary Medicine (CVM) intends to use the information provided to assist in the development of strategies to promote antimicrobial stewardship in companion animals.

Questions for Consideration

1. Please describe if antimicrobial use practices in companion animals have impacted the development of antimicrobial resistance in bacterial pathogens of companion animals. Please provide information, data, and/or references to support your response.
2. Please describe if antimicrobial use practices in companion animals, including extralabel use, have impacted the development of antimicrobial resistance in human bacterial pathogens. If possible, please describe whether the impact was the result of direct or indirect contact between humans and the treated companion animals. Are there specific concerns about the development of antimicrobial resistance in human bacterial pathogens when particular antimicrobial drugs or drug classes are used in companion animals? Please provide information, data, and/or references to support your response.
3. How should the human medical importance of particular antimicrobial drugs or drug classes be considered when deciding whether, or under what conditions, to use such drugs in companion animals?
4. How can CVM best engage with our stakeholders on promoting antimicrobial stewardship for companion animals? Examples of stakeholders include other government agencies, the pharmaceutical industry, public health organizations (both public and private entities), veterinary professional organizations, veterinary schools, veterinarians, pet owners, and veterinary diagnostic laboratories.
5. How can CVM encourage the development of antimicrobial drugs consistent with the principles of antimicrobial stewardship for the treatment of infectious diseases in companion animals for which there are no FDA-approved animal drugs?
   1. What bacterial diseases affecting companion animals are most in need of an FDA-approved animal antimicrobial drug?
   2. What safety and effectiveness study design considerations present challenges for developing antimicrobial drugs to address specific infectious diseases in companion animals (e.g., Lyme disease, sepsis, or osteomyelitis)? Are there alternative study designs that would address these challenges? If not, what role(s) could the stakeholder groups identified in question 4 play in developing such alternative study designs?
   3. Are there specific infectious diseases in companion animals for which topical formulations of antimicrobial drugs (e.g., medicated shampoos, rinses, or ointments) may be a better alternative than using systemic antimicrobial drugs from the perspective of antimicrobial stewardship? If so, what role(s) could the stakeholder groups identified in question 4 play toward fostering the use of such topical antimicrobial formulations?
6. Labeling:
   1. What information on currently approved animal drug labeling helps the veterinarian prescribe or use an antimicrobial drug in a manner consistent with the principles of antimicrobial stewardship?
   2. What additional information could be added to the approved animal drug labeling to improve the veterinarian’s ability to prescribe or use an antimicrobial drug in a manner consistent with the principles of antimicrobial stewardship?
   3. Is there a need for materials containing labeling information and/or information about antimicrobial stewardship that veterinarians could provide to the client when they prescribe an antimicrobial drug (e.g., client information sheets or other educational handouts)?
7. With respect to the use of antimicrobial drugs in companion animals, what other actions should CVM consider taking to foster greater antimicrobial stewardship?

Please submit either electronic or written comments on the notice by June 16, 2022. For details on how to submit comments and additional information, please see the full statement here.