FDA Issues Draft Guidance on Use of Antimicrobial Drugs in Food Animals

On June 28, FDA issued draft guidance intended to help reduce the development of resistance to medically important antimicrobial drugs used in food animals. The draft guidance was issued in response to public and medical industry concern over the growing resistance to antimicrobial drugs in the global population. Relying on a number of published reports, FDA states that the weight of the evidence supports the conclusion that rampant use of antimicrobials for nontherapeutic purposes, such as enhancing animal growth, is contributing to the widespread failure of antimicrobial therapies in humans.

FDA is most concerned about the use of antimicrobial drugs that were approved prior to 1993, that are used in food producing animals for production purposes, are available over the counter, and are given continuously through feed or water or to large groups of animals. FDA recommends that antimicrobial drugs only be used judiciously, which it defines as when “necessary and appropriate.”

The guidance states only two principles:

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

In regards to the first principle, FDA states that it considers uses that are expressly associated with the treatment, control or prevention of specific diseases to be uses that are necessary for ensuring the health and safety of food animals. However, production based uses that do not target specific diseases and are instead intended to promote growth or improve feed efficiency are considered “injudicious” uses. The second principle merely reinforces the importance of veterinary oversight of the use of antimicrobial drugs in food producing animals.

In its Q&A, FDA states that it "does not want the recommendations to negatively impact animal health or disrupt the animal agriculture industry." Although it remains to be seen what effect these draft guidelines will have on the industry, it is likely to be small. Even if implemented, the principles have no teeth as they’re currently drafted and don’t mandate the industry to take any particular actions. That’s disappointing, particularly in light of the glut of available information that demonstrates the negative impact that current food production techniques are having on human health.

FDA is inviting comments on the draft guidance through August 30, 2010.

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