FDA Issues Draft Guidance on the Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals

By Ashley Shelton, Assistant Director

Draft guidance (#209) entitled "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals" was issued June 28, 2010, by the U.S. Food and Drug Administration (FDA). Antimicrobial resistance continues to be a growing concern for both the public health and animal health communities and this draft guidance outlines the FDA's current thinking on the use of medically important antimicrobial drugs in food-producing animals.

FDA hosted a stakeholder teleconference June 28th to discuss the draft guidance and answer questions. Presentations were made by Joshua Sharfstein, M.D., principal deputy commissioner of food and drugs, Bernadette Dunham, D.V.M., Ph.D., director of the FDA Center for Veterinary Medicine, and Dr. John Clifford, chief veterinary officer with the U.S. Department of Agriculture. Technical expertise was provided by Dr. William Flynn, senior advisor for science policy with the FDA Center for Veterinary Medicine. A replay of the briefing will be available until July 19, 2010, by dialing 1-800-666-8698; International callers can dial 203-369-3312.

FDA is also seeking public comment on the draft guidance for the industry. The new draft rules are available online at here. Additional information may also be obtained on FDA's website and from the Federal Register Notice.

AVMA is committed to working with FDA to reduce antimicrobial resistance and is grateful the FDA is looking to the experts—veterinarians—to help address this important issue. http://www.avma.org/press/releases/100629_antimicrobial_resistance.asp

Please contact Dr. Ashley Shelton at 202.289.3210 if you have questions or concerns.