F.D.A., industry clamping down on antibiotic usage

by Keith Nunes
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WASHINGTON — The Food and Drug Administration, in conjunction with the medical drug community and animal producers, is taking steps to limit the use of antibiotics in animal production for treating and controlling diseases. The goal of the effort is to reduce the incidence of antimicrobial resistance, and the agency has published three documents to achieve its goals.

The documents published in the Federal Register include a final guidance for industry titled, “The judicious use of medically important antimicrobial drugs in food-producing animals” that recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of the drugs. The second document is a draft guidance, open for public comment, that will assist drug companies in voluntarily removing animal production uses of antibiotics from their F.D.A.-approved product labels; adding, where appropriate, scientifically-supported disease prevention, control, and treatment uses; and changing the marketing status to include veterinary oversight.

The final document is a draft proposed veterinary feed directive regulation that is open for public comment and outlines ways veterinarians may authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.

“It is critical that we take action to protect public health,” said F.D.A. Commissioner Margaret A. Hamburg, M.D. “The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective. We are also reaching out to animal producers who operate on a smaller scale or in remote locations to help ensure the drugs they need to protect the health of their animals are still available.”

Michael Taylor, deputy commissioner for foods, said the reason the F.D.A. did not initiate a ban for phasing out the antibiotics in animal production is due to the willingness of drug companies and animal producers to work with the agency. Mr. Taylor said through collaboration the process of limiting the use of antibiotics in animal production will be achieved more quickly.

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