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ASI Files Antimicrobials Comments With FDA

The American Sheep Industry Association filed comments on Dec. 24, 2019, concerning the Food and Drug Administration’s Draft Guidance #263 for Industry providing Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products that Continue to be Available Over-the-Counter.

 

On Sept. 14, 2018, FDA unveiled a five-year action plan for supporting antimicrobial stewardship in veterinary settings. This plan builds upon the important steps the Center for Veterinary Medicine has already taken to support the judicious use of antimicrobials in animals, and is driven by the concept that medically important antimicrobial drugs should only be used in animals when necessary for the treatment, control or prevention of specific diseases. One action item included in this plan is to ensure that any medically important antimicrobial new animal drugs that continue to remain available as OTC products are brought under the oversight of licensed veterinarians. The purpose of this guidance is to provide sponsors with specific recommendations on how to facilitate voluntary changes to the approved conditions of use of these drugs to prescription marketing status. The voluntary process outlined in this guidance will help to ensure new animal drugs containing antimicrobials of human importance are administered only under veterinary oversight and only for therapeutic uses.

 

While ASI appreciates the public health concern that is presented with the development of resistance to antimicrobial drugs of importance to human medicine and the resulting loss of their effectiveness as antimicrobial therapies, it also appreciates that FDA is seeking a balance between this concern and the judicious use of medically important antimicrobial drugs necessary for assuring animal health.

 

Among ASI’s concerns is a shortage of large animal veterinarians, limited availability of products for use in sheep and extra-label use of products.

 

“The current situation regarding veterinary care for livestock in rural areas poses an animal welfare concern and is a major food supply concern,” read the conclusion to ASI’s comments. “Before finalizing the guidance document, we would like FDA to seek feedback from sponsors of antimicrobial new animal drugs that are considered medically important with approval for OTC marketing that are used in minor species, such as sheep, to see if any of these products may be in jeopardy of being removed from the market if changed to prescription only.

 

“If so, would the product’s loss be significant for the livestock industry? We would ask the FDA to consider that information and help develop a practical solution to ensure that this action will not pose a risk to the well-being of livestock or the viability of the nation’s food supply.

 

“Lastly, we would ask FDA to clarify two things. The first, will a prescription for antimicrobial new animal drugs with current approval as an OTC be per animal or per flock? And, the second, will extra-label use of antimicrobial new animal drugs be permitted?”

 

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