The U.S. Food and Drug Administration said Monday it issued draft guidance aimed at reducing resistance to antimicrobial drugs used in animals raised and harvested for food.

The document outlines the agency's thinking on ways to assure the judicious use in animal agriculture of antimicrobial drugs that are important for therapeutic use in humans. FDA acknowledged past efforts by stakeholders to establish such guidelines, but said additional steps are required.

"The draft guidance summarizes a number of published reports on antimicrobial resistance and states that the overall weight of evidence available to date supports the conclusion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 medically important antimicrobial drugs for production or growth-enhancing purposes (i.e., non-therapeutic or subtherapeutic uses) in food-producing animals is not in the interest of protecting and promoting the public health," FDA said in a news release.

The draft guidance recommends phasing in measures that would limit uses to those that are considered necessary for animal health and that include veterinary oversight, thereby reducing the potential for antimicrobial resistance.

"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," Bernadette Dunham, director of FDA's Center for Veterinary Medicine, said in the release.

Dunham said FDA will work with animal drug sponsors, veterinarians and public health officials, animal agriculture and other stakeholders in developing a practical strategy to address antimicrobial resistance concerns.

FDA is seeking comments on the draft guidance, titled, "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals."

To view the document, click here. 

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