FDA to 'Guide' Reduction in Non-Therapeutic Use of Antibiotics in Livestock

The Food and Drug Administration has issued a draft guidance recommending that antibiotics be administered to food-producing animals only in situations necessary to protect their health and under a veterinarian's supervision. And, the agency opened a 60-day period for public comment.

The Food and Drug Administration has issued a draft guidance recommending that antibiotics be administered to food-producing animals only in situations necessary to protect their health and under a veterinarian's supervision. And, the agency opened a 60-day period for public comment.

"The FDA acknowledges the efforts to date by various veterinary and animal producer organizations to institute guidelines for the judicious use of antimicrobial drugs, but the agency believes additional steps are needed," the agency said in a statement.

"This is the first step in FDA establishing a principle," said Joshua Sharfstein, FDA's principal deputy commissioner. "We can then move, if necessary, to other mechanisms of oversight, such as regulation…. I'm not ruling out anything we could do to accomplish these important public-health goals." Sharfstein said the guidance is nonbinding. "This doesn't tell people what to do," he said. "It establishes principles, and now we're seeking comment on how to achieve those principles."

"This is an urgent public health issue," Sharfstein said. "To preserve the effectiveness [of antibiotics], we simply must use them as judiciously as possible."

More than 50 percent of antibiotics produced in the United States are used on animals. And, the widespread use of these drugs has raised concerns that they are contributing to the increase in antibiotic-resistant bacteria as the organisms adapt to the drugs. 

Antibiotics are used in animal agriculture for three reasons: to promote animal growth, prevent illness and treat sickness. The Animal Health Institute, a trade association, estimates that 13 percent of agricultural antibiotics were used to promote growth, while the majority of agricultural antibiotics were given to healthy animals to prevent illness, not to promote growth. FDA officials have made it clear that they are most concerned about the use of antibiotics to promote growth — not to prevent or treat illnesses.

Rep. Louise Slaughter (D-N.Y.) has sponsored a bill (HR 1549) to restrict antibiotic use in food animals, although that proposal remains stalled in the legislative process. A companion Senate bill (S 619) introduced by the late Sen. Ted Kennedy (D-Mass.) has yet to have a hearing.

Rep. Frank Pallone Jr. (D-N.J.), chairman of the Health Subcommittee, plans a July hearing focusing on the effects of antibiotic use in animals on the development of resistant bacteria in humans "to determine the next steps forward on this issue."

The U.S. livestock industry questions the need and premise for FDA's move. Guidance on the use of antibiotics in livestock and poultry production could lead to the elimination or costly review of previously approved animal health products, says the National Pork Producers Council. "FDA didn't present any science on which to base this, yet it could have a tremendous negative impact on animal health and, ultimately, the safety of food," said NPPC President Sam Carney. "As we know, healthy animals produce safe food, and we need every available tool to protect animal health."

Concern about antibiotic resistance in humans has been growing for a number of years but it is not yet clear whether those who want to block the non-therapeutic use of antibiotics in the production of livestock will have the numbers to prevail at this time. What is clear is that the issue is unlikely to go away.

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