Protecting Antibiotics

The Food & Drug Administration is proposing that veterinary drug companies voluntarily change the labels on their antibiotics so that growth promotion in food-producing animals is no longer a valid use. The proposal is a response to the agency’s growing concern that the massive use of antibiotics in the agricultural industry is contributing to emergence of antibiotic-resistant diseases in humans.

Under the proposed plan, the use of veterinary antibiotics will still be allowed to prevent, control, or treat diseases in food-producing animals, but they will no longer be sold over the counter and must be prescribed by a veterinarian for a specific disease. But the proposal stops short of requiring the animal drug industry to make these changes. FDA believes a voluntary approach will reach the same result—reduced usage of the drugs—faster and with less disruption to the animal agriculture and drug industries than a formal ban, Michael Taylor, FDA Deputy Commissioner for Foods, said at an April 11 briefing.

The proposal drew mixed reactions from the veterinary drug and food industries. The Animal Health Institute, a trade group that represents manufacturers of veterinary drugs, says it supports the involvement of a veterinarian when antibiotics are given to food-producing animals. But the National Pork Producers Council says the effort will “disproportionately affect small producers, have a negative effect on animal health, and increase the cost of producing food, while not improving public health.”

According to the plan, the industry will voluntarily phase out the use of antibiotics for growth promotion in animals within three years. If a ban on the growth-promoting use of antibiotics were implemented, FDA would likely face decades of litigation and millions of dollars in related costs, Taylor stressed. Moreover, he says, the agency is confident that drug companies and animal producers are committed to making the changes.

Not everyone is convinced.

“We have no reason to believe that the veterinary pharmaceutical industry” will cooperate with FDA on a plan that could reduce industry profits, says Margaret Mellon, senior scientist at the Union of Concerned Scientists, an advocacy group. Likewise, Caroline Smith DeWaal, food safety director at the Center for Science in the Public Interest, calls the proposal “tragically flawed” because it relies on industry to act voluntarily in the interest of consumers.

FDA is accepting comments on the proposal and hopes to finalize it by early next year.