FDA lists two principles for “judicious” antimicrobial use

FDA strongly acknowledges that effective antimicrobials are critically important for combating infectious disease in both humans and animals.

With the new veterinary feed directive (VFD) rule, the agency says, it is striving for what it calls more “judicious” antimicrobial use to minimize the development of resistance and preserve antimicrobial effectiveness.

FDA has applauded efforts by veterinary and producer organizations to institute guidelines for responsible antimicrobial use. Still, the agency wants everyone to be clear on its two guiding principles.[i]

Principle 1: The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that are considered necessary for assuring animal health.

Using medically important antimicrobials solely to improve production of food animals, such as promoting growth or improving feed efficiency, constitutes “injudicious” use, FDA says.

However, the agency says, using medically important drugs to treat, control or prevent specific diseases — including administration of the drugs in feed or water — is necessary to ensure the health of food-producing animals.

Although concerns have been expressed about using medically important drugs to prevent disease in food animals, FDA believes some indications for prevention are necessary and judicious when their use is based on professional veterinary judgment.

As an example, the agency cites the prevention of necrotic enteritis — a common and potentially costly intestinal disease in broilers. In this case, preventive use of an antimicrobial is important to manage the disease “in certain flocks in the face of concurrent coccidiosis.”

If animals are not at risk for a specific disease, administration of a medically important antibiotic would be considered injudicious use by FDA.

Antibiotics that are not used in humans and are not considered medically important by FDA — bacitracin and bambermycins for poultry — will be allowed to retain their performance claims.

Principle 2: The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation.

Veterinarians, FDA says, can play a critical role in the diagnosis of disease and in the decision-making process regarding the treatment, control and prevention of disease in food animals. However, the agency recognizes that the nature of veterinary involvement can vary due to numerous factors such as geographic location and animal-production setting.

For example, some animal disease events require immediate attention. In some cases, veterinarians may be directly diagnosing and administering therapies, while in other cases — the more likely scenario for poultry veterinarians — they are visiting and consulting with producers periodically to establish customized disease-management protocols for a flock. “Of key importance to FDA is the fact that, in both of these cases, the veterinarian is involved in the decision-making process regarding antimicrobial drug use,” FDA says.

[i] #209 Guidance for Industry. The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. FDA. April 13, 2012.