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FDA Issues Guidance on Limiting Antibiotics in Livestock

WASHINGTON—In an effort to reduce the growing problem of drug-resistant bacteria that may be passed to humans, the U.S. Food and Drug Administration (FDA) announced a three-pronged approach to protect public health and promote the judicious use of medically important antibiotics in food-producing animals by targeting their use to only address diseases and health problems.

FDA is proposing a voluntary initiative to phase in certain changes to how medically important antimicrobial drugs are labeled and used in food-producing animals. The agency said the action is necessary to help preserve the effectiveness of medically important antimicrobials for treating disease in humans.

“It is critical that we take action to protect public health," said FDA 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."

Under the new voluntary initiative, certain antibiotics would not be used for so-called “production" purposes, such as to enhance growth or improve feed efficiency in an animal. These antibiotics would still be available to prevent, control or treat illnesses in food-producing animals under the supervision of a veterinarian.

FDA’s final guidance for industry, “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals" recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.

The agency also issued a draft guidance that will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels; adding, where appropriate, scientifically-supported disease prevention, control, and treatment uses; and changing the marketing status to include veterinary oversight. FDA anticipates drugmakers will phase out recommendations for those uses within three years. The draft guidance is open for public comment.

FDA also issued a draft proposed Veterinary Feed Directive regulation that outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient. The draft guidance is also open for public comment.

"Now you have a veterinarian who will be consulting and providing advice to these producers, and we feel that is an important element to assure that they are in fact using these drugs appropriately," said William Flynn, a deputy director in FDA's veterinary medicine center.

In 1977, FDA concluded that feeding animals low doses of certain antibiotics used in human medicine, namely penicillin and tetracyclines, for purposes of growth promotion and feed efficiency could promote antibiotic-resistant bacteria capable of infecting people. Despite this conclusion and laws requiring that the agency move on its findings, FDA failed to take action on penicillin and tetracyclines to protect human health for the last 35 years.

“We’re confident that it will result in significant reductions in agricultural antibiotic use and reductions in resistance pressure from dangerous bacteria" said Michael Taylor, FDA Deputy Commissioner for Foods.

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