FDA seeks comment on proposed guidelines for judicious use of antimicrobials


On June 28, the U.S. Food and Drug Administration issued draft guidance intended to help reduce the development of resistance to medically important antimicrobial drugs used in food-producing animals.

The draft guidance outlines the FDA’s current thinking on strategies to assure that antimicrobial drugs that are important for therapeutic use in humans are used judiciously in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The draft guidance summarizes a number of published reports on antimicrobial resistance and states that the overall weight of evidence available to date supports the conclusion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.

The document recommends phasing in measures that would limit medically important antimicrobial drugs to uses in food-producing animals that are considered necessary for assuring animal health and that include veterinary oversight or consultation. These steps would help reduce overall use of medically important antimicrobial drugs, thereby reducing the pressure that generates antimicrobial resistance.

The FDA recognizes the importance of antimicrobial drugs for addressing the health needs of animals. Antimicrobial drugs have been widely used in human and veterinary medicine for more than 50 years with benefits to both human and animal health. The development of resistance to these drugs, and the resulting loss of their effectiveness, poses a serious public health threat.

“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., Ph.D., 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.”

The agency invites comments on the draft guidance, available online and titled The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. Although comments are accepted any time, the FDA recommends that comments are sent before August 30, 2010.

Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.

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