Tuesday, April 17, 2012

FDA proposed rules on antibiotics

FDA call on antibiotics could increase consumer confidence but hurt producers

New rules proposed last week by the Food and Drug Administration to limit use of antibiotics in livestock will likely increase consumer confidence but also bring additional strain to producers, an Ohio State University Extension expert said.

In a move designed to implement a three-year timetable for phasing out antibiotics, used to spur growth in food-producing animals, the FDA plan relies largely on getting the livestock and drug industries to voluntarily cut their use.

The plan calls for drug makers to stop using 200 drugs to promote growth and instead use them only to treat and prevent diseases. The companies would be required to change their drug labeling by removing growth promotion as a valid use for antibiotics that are primarily given to livestock through feed.

The relabeled antibiotics would then no longer be available to farmers over the counter. Instead, a veterinarian would have to prescribe the drugs, which would help to ensure they are being used to target specific diseases, FDA said.

While the FDA has a valid concern over the use of antibiotics in livestock, the plan could eventually impact the bottom line of producers, said John Grimes, beef coordinator for OSU Extension. The concern is whether using common human antibiotics, such as penicillin and tetracycline, in livestock could create drug-resistant "superbugs" that might threaten humans.

"It's a legitimate question that needs to be looked at," Grimes said. "If this plan is responsible to producers and means that we have more consumer confidence and reassures the public that we are doing the right thing, then that's good. But the problem is making sure that famers have adequate access to large-animal vets to get these prescriptions. For some producers, that could be a real issue."

About 28.6 million pounds of antibiotics were sold in 2009 for use in food-animal production, according to an FDA report. That number increased in 2010, when farm animals in the U.S. were given 29.1 million pounds of antibiotics.

Although the plan would allow antibiotics to be used only for sick animals, the guidelines leave room for "judicious" preventive uses for at-risk animals as well, said FDA Commissioner Margaret A. Hamburg.

"The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective," she said. "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."

While producers will have access to good antibiotics to treat a variety of issues in their animals when needed, the plan will mean that producers could also find themselves loaded down with more paperwork and extra steps and expenses to meet the new requirements, Grimes said.

"It's a complex issue," he said. "Do you view that as better than having the ability to use it as you see fit and give up animal performance to preserve drug usefulness?

"The production agriculture side will say we've got a growing population to feed, are concerned about the health of the animals and fear they could lose the efficiencies of production, which impacts their bottom line. The other side is the concern about disease resistance and the impact to humans. If we don't control disease X because we have resistance, what will it mean to humans? There's not really a clear answer."

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