F.D.A. issues guidance on antimicrobial drugs

by Keith Nunes
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WASHINGTON — The U.S. Food and Drug Administration issued draft guidance on the judicious use of antimicrobial drugs in livestock raised for the purpose of food production. The paper 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 in food-producing animals is not in the interest of protecting and promoting the public health.

“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., the director of the F.D.A.’s Center for Veterinary Medicine. “F.D.A. 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 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 F.D.A. 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 agency said in a statement.

A copy of the draft guidance is available on the F.D.A. web site (www.fda.gov) and is titled “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals.”
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