FDA issues guidelines to limit antibiotic use

WASHINGTON – The Food and Drug Administration called on drug companies Wednesday to help limit the use of antibiotics in farm animals, a decades-old practice that scientists say has contributed to a surge in dangerous, drug-resistant bacteria.

Antibiotic drugs like penicillin are routinely mixed with animal feed and water to help livestock, pigs and chickens put on weight and stay healthy in crowded feeding lots. Scientists have warned that such use leads to the growth of antibiotic-resistant germs that can be passed on to humans.

The FDA has struggled for decades with how to tackle the problem because the powerful agriculture industry argues the drugs are a key part of modern meat production.

Under the new FDA guidelines, the agency recommends antibiotics be used “judiciously,” or only when necessary to keep animals healthy. The agency also wants to require a veterinarian to prescribe the drugs. They can currently be purchased over-the-counter by farmers.

“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.

The draft recommendations by the FDA are not binding, and the agency is asking drug manufacturers to voluntarily put the proposed limits in place. Drug companies would need to adjust the labeling of their antibiotics to remove so-called production uses of the drugs. Production uses include increased weight gain and accelerated growth, which helps farmers save money by reducing feed costs.

The FDA hopes drugmakers will phase out language promoting nonmedical uses within three years.

“This is the most sweeping action the agency has undertaken in this area, as this covers all antibiotics used in meat and poultry production that are important to human health,” said Laura Rogers, director of the Pew Charitable Trusts’ campaign on industrial farming.

But some public health advocates said they do not trust the drug industry to voluntarily restrict its own products.

FDA officials said a formal ban would have required individual hearings for each drug, which could take decades.

“The process we would have to go through is a formal hearing process, product-by-product, that is extremely cumbersome,” said FDA Deputy Commissioner for Foods Mike Taylor. “There’s no point in going through those legalistic proceedings when companies are willing to make this shift voluntarily.”

Taylor said the FDA has consulted closely with drugmakers and expects them to support the measures.

An estimated 80 percent of all antibiotics sold in the U.S. wind up on animal farms. Neither industry nor the government track what percentage of those drugs is used to boost animal weight, but many experts believe the vast majority go toward nonmedical uses.

The debate over antibiotics has long pitted the benefits for producing safe, low-cost meat against the risk of contributing to dangerous antibiotic-resistant bacteria that can infect humans.

The National Pork Producers Council said Wednesday that the FDA “did not provide compelling evidence” that antibiotic use in livestock is unsafe.

But FDA officials said the scientific literature supports the role that indiscriminate use of antibiotics plays in reducing the effectiveness of antibiotics in humans.

“We think the science is very solid to support this effort to address these issues,” Taylor said.

The rollout from FDA comes at an unusual time in the agency’s attempts to curb antibiotic use in animals. Last month a federal court judge ordered the agency to take action on its own 35-year-old rule that would have banned nonmedical use of two popular antibiotics, penicillin and tetracycline, in farm animals.

The FDA issued the rule in 1977 but never enforced it, following vigorous pushback from members of Congress and lobbyists for farmers and drugmakers. Four public safety groups sued the agency to act on the regulation, winning the case handed down in the U.S. District Court of Southern New York on March 22. The agency was given 60 days to appeal the decision.

FDA’s Taylor said he believes the voluntary guidelines can achieve the same goal as the court ruling in less time.

The waning effectiveness of antibiotics has been a global health concern for several decades, attracting the attention of the World Health Organization, the Institute of Medicine and other medical groups. As bacteria have grown more resistant, new and more deadly forms of malaria, staph and other infections that were once easily treatable have emerged across the globe.

Experts say overuse of antibiotics in both animals and humans has contributed to the problem. Both medical societies and government agencies have launched educational programs designed to educate physicians on appropriate prescribing of antibiotics.