FDA issues draft guidance for industry on judicious antimicrobial use

Posted 15 November 2010

The Food and Drug Administration recently issued a draft guidance entitled "The Judicious Use of Medically Important Antimicrobial Drugs in Food Producing Animals." The intent is to inform the public of the FDA's thinking on the use of these drugs in livestock. The document summarizes some of the key scientific reports on the use of antimicrobials in animal agriculture and outlines the FDA's current thinking on strategies for assuring that medically important antimicrobials are used judiciously in food producing animals to help minimize the development of antimicrobial resistance.

The guidance makes recommendations including 1) limiting medically important antimicrobial drugs to uses in food-producing animals that are considered necessary for assuring animal health and 2) limiting such uses to uses in food animals that include veterinary oversight or consultation.

The draft guidance does not specify which antimicrobial drugs the FDA considers medically important, nor does it define veterinary oversight or consultation. The draft guidance does, however, emphasize collaboration with the public and animal health communities on the development of these strategies to assure the protection of public health, while also assuring that animal health needs are addressed. The agency intends to issue further guidance to provide more specific information on the approaches for implementation of the recommendations outlined in the draft guidance.

The AVMA recognizes that any use of these drugs can result in increasing selective pressures and loss of effectiveness, potentially posing a threat to human and animal health. The AVMA also agrees that in order to effectively respond to public health concerns associated with antimicrobial resistance, it is important to broadly consider how medically important antimicrobials are being used. These drugs must be used judiciously in both humans and animals.

The Association asserts that reducing the overall quantity of antimicrobials used is only one of the means by which to evaluate successes or improvements in judiciousness, since microbes respond differently to reductions in selection pressure. Because reduction in overall antimicrobial use may not necessarily provide a human health benefit, we must remain cognizant of potential detrimental consequences to animal health and welfare that might accompany a reduction in use. Therefore, the AVMA cautions against overly broad limitations and recommends targeted interventions based on scientific quantitative risk assessments.

Furthermore, the documented ability of production use of an antimicrobial to improve human food safety should be a key consideration when assessing the judiciousness of a use. Additionally, production uses should not be categorically presumed to be injudicious, particularly if a veterinarian is involved in the decision-making process and FDA's own risk assessments have shown infinitesimally small risks. The American Veterinary Medical Association's comments to the draft guidance can be found here.

Additional resources on antimicrobials and antimicrobial use can also be found on the AVMA site here.

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