By David Fairfield, Senior Vice President, Feed
The U.S. Food and Drug Administration (FDA) on Nov. 16 conducted a virtual public meeting to explain details and receive stakeholder feedback on the agency’s previously issued concept paper that outlines a potential revised process and criteria for ranking animal antimicrobial drugs based upon their importance in human medicine.
The concept paper explains a potential approach for updating the current list of antimicrobial drugs ranked by their importance in human medicine (commonly referred to as “Appendix A” of FDA’s Guidance for Industry #152) to reflect new understandings associated with antimicrobial resistance and other changes since the ranked list initially was established in 2003, including changes in available treatment options, changes in human clinical practices and other scientific advancements. Under FDA’s current policies, animal antimicrobials listed within Appendix A are deemed to be “medically important” to human medicine and only may be used in the feed or water of food-producing animals in accordance with the agency’s Veterinary Feed Directive regulations.
In developing the potential criteria for ranking antimicrobial drugs based upon their importance in human medicine, FDA stated during the meeting that it considered broad issues associated with the effectiveness of antimicrobial drugs in human medicine and factors influencing the development of antimicrobial resistance, including the availability of therapies from different classes of antimicrobial drugs to treat serious and non-serious human infections and the ease with which resistance develops and is transferred among organisms. In addition, given that the agency’s efforts to promote judicious use of antimicrobials are broadening to include all animals and not just food-producing animals, the revised medical importance criteria also consider other, non-foodborne exposure pathways that may affect the potential of the antimicrobial drug to select for antimicrobial resistance and adversely affect human health.
FDA released the concept paper to facilitate public comment on one potential approach to revising antimicrobial drug human medical importance rankings and intends to consider comments received before issuing draft guidance for additional public comment in the future.
Research Published on Systems to Collect Antimicrobial Use Data: Meanwhile, results of pilot projects conducted by researchers from the University of Minnesota and Kansas State University to develop systems for collecting and analyzing antimicrobial use data from U.S. beef feedlot, dairy, swine, turkey and chicken production settings were published on Nov. 17 in a special issue of Zoonoses and Public Health ̶ an international scientific journal that focuses on relationships between human and animal health.
The pilot projects primarily were funded by FDA’s Center for Veterinary Medicine through cooperative agreements awarded in 2016. Currently, researchers from the universities are in the fifth and final year of the cooperative agreements, with results from the first two years of data collection presented in the scientific journal, along with discussions related to challenges of collecting and reporting antimicrobial use data.
FDA’s stated goals and objectives for the pilot projects include development and testing of methodologies to collect detailed information (i.e. indication, dose, duration of use) on antimicrobial drug use in major food-producing species (cattle, swine, chickens and turkeys), annual collection and reporting of antimicrobial use data, and collection of data in a manner that protects disclosure of identity of participating producers, veterinarians and farms. FDA intends to use information obtained through the data-collection efforts to gauge the success of the agency’s antimicrobial stewardship efforts and assess associations between antimicrobial use practices and resistance.