FDA putting the brakes on antibiotic use

Apr 13, 2012

The U.S. Food and Drug Administration (FDA) announced last week that it would take steps with its final Guidance 209 and a draft proposed rule on veterinary feed directives to limit the use of antibiotics in animal production.

The three pieces FDA published in the Federal Register last week included:

• A final guidance for industry, 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 these drugs.

• A draft guidance, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels;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.

• A draft proposed Veterinary Feed Directive regulation, open for public comment, 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.

“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.”

“USDA worked with the FDA to ensure that the voices of livestock producers across the country were taken into account,” said Dr. John Clifford, USDA chief veterinary medical officer, “and we will continue to collaborate with the FDA, the American Veterinary Medical Association and livestock groups to ensure that the appropriate services are available to help make this transition.”

Based on a consideration of relevant reports and scientific data, 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, according to the FDA press release.

Under what FDA calls a voluntary initiative, certain antibiotics would not be used for 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.

According to Michael Taylor, deputy commissioner for foods, the reason FDA did not initiate a ban on the antibiotics in animal production was because drug companies and producers were willing to work with the agency.

National Cattlemen’s Beef Association (NCBA) was pleased that FDA resisted what they considered unscientific calls to completely ban the use of antibiotics and antimicrobials in cattle and other livestock species, but still voiced concern over the validity of the science behind FDA’s decision.

“NCBA raised concern with FDA’s Guidance 209 in 2010 because the agency lacked the necessary science in its recommendations. 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,” says Tom Talbot, a California beef producer, large animal veterinarian, and current chairman of NCBA’s Cattle Health and Well-Being Committee.

“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,” he added.

A recent study at Kansas State University (KSU) also adds another possible consumer link to FDA’s release.

According to KSU’s research, critics of antibiotic use in livestock production often overestimate the amount administered to animals.

While the study centers around pork production, KSU used data from a 2006 USDA swine survey, and a 2009 survey of swine veterinarians, showing 1.6 million pounds of antibiotics used annually in pork production for growth promotion/nutritional efficiency and disease prevention. A counter study, from 2001, from the Union of Concerned Scientists (UCS) claimed the pork industry used 10.3 million pounds per year.

Published in the March issue of Foodborne Pathogens and Disease, the KSU study found that 2.8 million pounds of antibiotics were used for growth promotion/nutritional efficiency, disease prevention and disease treatment.

This total is 368 percent less than the amount UCS claims pork producers used.

The study also sheds much needed scientific doubt on anti-ag groups’ claim that 80 percent of all antibiotics sold are used to promote growth in livestock. To date, there has been little data on this topic, but lots of media coverage, leading to a growing request from lawmakers to legislate the use of antibiotics in production agriculture.

National Pork Producers Council (NPPC) says FDA’s new plan will have a significant impact on pork producers. NPPC Chief Veterinarian Dr. Liz Wagstrom says that, while the guidance doesn’t have the force of law, it may be treated as such by FDA.

“On the call that FDA had with industry stakeholders today, they made it very clear that at the end of this three-year period when they evaluate what progress has been made with companies voluntarily giving up their labels—that if they aren’t satisfied with the movement away from growth promotional labels—they will take more action,” Wagstrom says. — Traci Eatherton, WLJ Editor


Corn planting began Feb. 24, 2012, in a field near Eudora in Chicot County, Arkansas. (University of Arkansas System Division of Agriculture photo by Gus Wilson.)