FDA seeks details on antimicrobial use, resistance in companion animals
Published: 10 Mar 2022
Food and Drug Administration officials want help collecting data on how antimicrobial administration to companion animals affects development of drug resistance.
A Feb. 15 announcement from the FDA Center for Veterinary Medicine indicates the FDA needs to better understand how drug use in animals such as dogs, cats, and horses might impact antimicrobial resistance in pathogens of animals and people.
Details on the request for comments are available at regulations.gov under docket number FDA-2021-N-1305. Comments are due June 16.
A Federal Register notice published Feb. 16 says FDA CVM officials want descriptions on how practices of antimicrobial use in companion animals may affect resistance development among bacterial pathogens of companion animals and of humans. Officials want to learn about concerns regarding resistance development related to particular antimicrobials or antimicrobial drug classes administered to companion animals, as well as how the importance of a drug to human medicine should be considered in decisions about whether to administer the drug to companion animals.
The notice also asks how the CVM can encourage greater antimicrobial stewardship that could help preserve drug effectiveness, how the center can encourage development of new antimicrobials, what study designs present or reduce challenges for developing needed antimicrobial drugs, and whether any specific infectious diseases are—from a stewardship perspective—best treated with topical antimicrobial formulations. The notice asks what information on drug labels helps veterinarians follow the principles of antimicrobial stewardship, what additional information could help, and whether veterinarians need drug stewardship information that they can provide to clients.
The CVM announcement indicates most of the FDA’s past animal-related antimicrobial stewardship efforts have focused on drug administration to food-producing animals. But the announcement also notes that agency officials awarded two grants in 2020 for five-year projects to develop and test methods of collecting data on antimicrobial administration to dogs and cats, and that data from the projects may aid investigations into associations between antimicrobial administration and resistance.
This is all part of the FDA CVM’s five-year action plan, “Supporting antimicrobial stewardship in veterinary settings: Goals for fiscal years 2019-2023.” The Federal Register notice is a step toward achieving one of the plan’s objectives, which is to engage with stakeholders to develop and implement a strategy for promoting antimicrobial stewardship in companion animals. The goal is “to help preserve the effectiveness of medically important antimicrobials for humans and companion animals.”
At the AVMA House of Delegates' regular winter session, held Jan. 7-8 in Chicago, delegates approved a new policy supporting the collection of antimicrobial use data to help combat drug resistance.
The AVMA Committee on Antimicrobials developed the new policy, “Support for the Collection of Antimicrobial Use Data for Antimicrobial Stewardship,” which states the AVMA recognizes the need to collect antimicrobial use data and is supportive of discussions to investigate how this should be accomplished, what should be considered during data analysis, and how the data might be used to inform and advance veterinary clinical decision making.
The AVMA plans to provide comments to the FDA.
The Association also has resources on antimicrobials, including veterinarians’ role in ensuring continued antimicrobial effectiveness and practical resources for use in daily practice.
AVMA members are encouraged to submit comments to the Association to help inform its response. They can do so by emailing email@example.com.