The U.S. Food and Drug Administration today issued draft guidance intended to help reduce the development of resistance to medically important antimicrobial drugs used in food-producing animals.

Today’s draft guidance outlines the FDA’s current thinking on strategies to assure that antimicrobial drugs that are important for therapeutic use in humans are used judiciously in animal agriculture. The FDA acknowledges the efforts to date by various veterinary and animal producer organizations to institute guidelines for the judicious use of antimicrobial drugs, but the agency believes additional steps are needed.

The document recommends phasing in measures that would limit antimicrobials such as penicillin and tetracycline to uses in food-producing animals that are considered necessary for assuring animal health. According to FDA, these steps would help reduce the pressure that generates antimicrobial resistance.

The draft guidance summarizes a number of published reports on antimicrobial resistance and states that the overall weight of evidence available to date supports the conclusion that using antimicrobial drugs for non-therapeutic or subtherapeutic uses in food-producing animals is not in the interest of protecting and promoting the public health.

The draft guidance includes the principles of phasing in such measures as:

  • Limiting medically important antimicrobial drugs to uses in food-producing animals that are considered necessary for assuring animal health
  • Lmiting such drugs to uses in food-producing animals that include veterinary oversight or consultation.

According to the document, the FDA recognizes the importance of antimicrobial drugs for addressing the health needs of animals. The development of resistance to these drugs, and the resulting loss of their effectiveness, poses a serious public health threat, according to the FDA.

FDA has established a 60-day comment period after which the agency will put forward next steps.

“Using medically important antimicrobial drugs as judiciously as possible is key to minimizing resistance development and preserving the effectiveness of these drugs as therapies for humans and animals,” said Bernadette Dunham, D.V.M., director of the FDA’s Center for Veterinary Medicine. “FDA is committed to working with animal drug sponsors, the veterinary and public health communities, the animal agriculture community, and all other interested stakeholders in developing a practical strategy to address antimicrobial resistance concerns that is protective of both human and animal health.”

Read the draft guidance.

Questions and Answers.

Source: FDA