Issues that matter: FDA issues new antibiotic guidance

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The U.S. Food and Drug Administration issued a new guidance on the use of antibiotics in livestock production, drawing mixed responses from livestock organizations and groups opposed to antibiotics in agriculture.

The final Guidance 209 calls for voluntary suspension of non-therapeutic use of certain antibiotics in livestock.

“Under this 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,” said the FDA in a statement. “These antibiotics would still be available to prevent, control or treat illnesses in food-producing animals under the supervision of a veterinarian.”

FDA also issued a draft proposed rule, which would encourage pharmaceutical companies to remove production uses of certain antibiotics from their FDA-approved product labels.

“NCBA raised concern with FDA’s Guidance 209 in 2010 because the agency lacked the necessary science in its recommendations,” says Tom Talbot, a California beef producer, large-animal veterinarian and current chairman of NCBA’s Cattle Health and Well-Being Committee. “Antimicrobial resistance is a multifaceted, extremely complex issue that cannot be adequately addressed solely by focusing on the use of antibiotics in animal agriculture. Prudent and responsible evaluation of this issue must consider animal, human and industrial use of antibiotics. While we appreciate the agency working with industry on the implementation of Guidance 209, we remain committed that a strong science foundation is critical before moving forward with this guidance.

“The goal of giving veterinarians greater oversight of antibiotic use in food animals is commendable, but cattlemen are concerned with the feasibility of implementing the veterinary feed directives given practical hurdles, including a current shortage of veterinarians in many rural areas throughout the country and the increased recordkeeping burden it could have on the day-to-day requirements veterinarians currently face. We are pleased FDA has committed to working with farmers and ranchers, veterinarians and with the U.S. Department of Agriculture to seek additional information and address these concerns, specifically to ensure family-owned farms and ranches are not negatively impacted by this regulation.”

“It sounds to me that it is the expected guidance we knew was coming,” says Steve Kopperud, government affairs counsel for the American Feed Industry Association. “It looks like they are heading in the right direction. It is critical this remains collaborative rather than a formal rule-making process.”

A statement from the Animal Health Institute, which represents animal-health companies, agreed with the collaborative approach that FDA is taking with the various stakeholders.

“The veterinarian is critically important in animal-care decisions and, ultimately, in protecting food safety and human health,” the AHI said. “We strongly support responsible use of antibiotic medicines and the involvement of a veterinarian whenever antibiotics are administered to food producing animals.

“Implementation of this policy means all medically important antibiotics used in animal agriculture will be used only for therapeutic purposes — disease treatment, control and prevention — under the supervision of a licensed  veterinarian. This policy will assure these medically important medicines are used in animal health in much the same way they are used in human health — under the supervision of a licensed professional and only to address disease challenges at various stages,” the AHI said.

Advocates of stronger regulation of antibiotics in livestock expressed disappointment that the guidance relies on voluntary cooperation within the industry.


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