Approval and availability of antimicrobials for use in food-producing animals

Comment on this policy

The AVMA recognizes that the availability and effectiveness of antimicrobials, including medically important antimicrobials, are important for supporting the health and welfare of food-producing animals and ensuring food safety and public health. The AVMA supports a transparent drug approval process that is rigorous and based on substantial scientific evidence in support of the safety and efficacy of approved products. The AVMA believes that the Food and Drug Administration's (FDA) new animal drug application process provides a well-established scientific basis for animal drug approvals and supports ongoing commitment by the FDA to maintain scientific integrity while continuing to explore ways to streamline the regulatory process.

The AVMA supports the Food and Drug Administration's (FDA) use of scientific methods to approve antimicrobials, including medically important antimicrobials for therapeutic purposes to prevent, control, or treat diseases in food-producing animals in accordance with the Food, Drug, and Cosmetic Act. The process includes a number of pre- and post-approval safeguards such as target animal safety and effectiveness, human food safety, environmental impact, safety of the person administering the drug, and monitoring for antimicrobial resistance. The AVMA also promotes both the discovery and development of novel antimicrobials and the development of alternative drugs and technologies that would reduce the need for reliance on antimicrobial therapy in food-producing animals.

The AVMA supports the FDA's policy of eliminating the over-the-counter status of medically important antimicrobials. The AVMA also supports the requirement for veterinary oversight for on-farm therapeutic use of these drugs by requiring that a licensed veterinarian issue a veterinary feed directive, or a prescription, as appropriate, for the marketing status of the particular product. The AVMA emphasizes the important role of the veterinarian in an overall health program, establishment of the veterinarian-client-patient relationship, and the appropriate and judicious use of antimicrobials in food-producing animals. The AVMA believes restrictions on a veterinarian’s ability to access and utilize medically important antimicrobials detracts from efforts to promote antimicrobial stewardship under appropriate veterinary oversight.

The AVMA recognizes that more data are needed for guiding changes in antimicrobial availability and uses in food-producing animals and related efforts to protect public health. We urge the FDA, the USDA, and other public health agencies, as well as veterinarians, food animal producers, and pharmaceutical companies to cooperatively support scientific studies needed to evaluate public health impacts of the use of medically important antimicrobials in food-producing animals. All stakeholders should be advocates for risk-based policy concerning the approval, availability, and use of medically important antimicrobials in food producing animals.