FDA response to commentary on studies involving the use of human critically important antimicrobials agents in veterinary species

The U.S. Food and Drug Administration’s Center for Veterinary Medicine is aware of concerns raised in response to a recent commentary published in the Journal of Veterinary Pharmacology and Therapeutics, entitled “The publication of studies involving the use of human critically important antimicrobial agents in veterinary species.” This article, a commentary regarding editorial policy of veterinary journals, included a co-author affiliated with FDA but authoring in her own capacity. As stated in a disclaimer on the article, the information in the article is not intended to, nor does it, represent the formal position of FDA.

FDA has long advocated for the judicious use of medically important antimicrobials. The principles of FDA’s judicious use policy include 1) limiting medically important antimicrobial drugs to uses in food-producing animals that are considered necessary for assuring animal health; and 2) limiting medically important antimicrobial drugs to uses in food-producing animals to those that include veterinary oversight or consultation.

FDA does not wish, nor is it our intent, to impede scientific exploration or interfere with the editorial policies of scientific journals. We recognize the need for scientists to perform and publish data from studies that further the understanding of how antimicrobial agents affect human and animal health. The agency also does not wish to interfere in the practice of veterinary medicine, provided that veterinarians follow all relevant aspects of the Federal Food, Drug, and Cosmetic Act and associated Acts, such as the Animal Medicinal Drug Use Clarification Act (AMDUCA), which outlines how veterinary practitioners may use FDA-approved drugs in an extralabel manner.

There has been no change in FDA policy on judicious use of medically important antimicrobials, or its view on the use of these products in the course of scientific exploration. Consistent with ongoing efforts, the agency is committed to an approach that emphasizes collaboration, stakeholder engagement, and broad public input when developing or implementing new or revised policies to reduce the impact of antimicrobial resistance.