Phaseout Set for Antibiotics in Animal Feed, FDA Says

The practice of giving low-dose antibiotics to farm animals to promote weight gain will be phased out gradually under a voluntary, cooperative program with food producers, the FDA said Wednesday.

Over the next 3 years, according to Michael Taylor, the FDA’s deputy commissioner for foods, the agency will work with industry to eliminate such “production” uses of antibiotics while increasing the role of veterinarians in directing the use of antibiotics to treat illness in livestock.

The FDA issued three nonbinding guidance documents outlining the agency’s intentions, including one each for food producers, drug companies, and veterinarians that work with the agriculture industry.

During a telephone briefing for reporters, FDA officials said the guidance plan predated a federal court order issued last month that directed the agency to start formal proceedings to revoke approvals for production use of antibiotics, pursuant to notices the FDA had issued in 1977 but never enforced.

Taylor said on the press call that the agency believes a voluntary approach will achieve better results sooner.

“I know there will be those who will ask why we have not taken mandatory action to ban production uses of antimicrobials,” he said.

“The answer is that, with the willingness of drug companies and others in the animal production industry to collaborate in implementing our strategy, we can make changes more quickly than if we had to rely solely on a cumbersome regulatory process that would require us to seek change, regulatory change, drug by drug, labeled use by labeled use.”

He said that if production uses of antibiotics have not ended within 3 years, the agency would reevaluate the strategy and consider other steps to put a stop to the practice.

With regard to the federal court order, Taylor said the government had not yet decided whether to appeal it.

Taylor said a major goal of the cooperative program was to preserve food producers’ ability to have antibiotics available for treating infections, and one of the three draft guidance documents released today outlines procedures by which veterinarians can authorize the use of specific anti-infective drugs in animal feed.

Another draft guidance is aimed at antibiotic drug producers, advising on how to voluntarily seek to have approvals removed for production uses of their drugs while keeping authorization for disease treatment. The guidance also spells out how drug firms can amend the products’ labels to include veterinarian oversight.

Tying the program together is a final guidance, called “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,” which provides “a strategic framework” for phasing out production uses, Taylor said.

However, the FDA came under attack from both sides of the issue.

The National Pork Producers Council called the guidances “problematic for producers,” arguing that animal health would suffer while increasing the cost of food. It said that requirements to have veterinarians authorize antibiotics for farm animals would be especially burdensome to small operators who may not have ready access to veterinarians.

Meanwhile, the Natural Resources Defense Council, one of the plaintiffs in the suit leading to Judge Katz’s order, also blasted the FDA’s plan but for different reasons.

“This is an ineffective response to the real and sobering threat of rising antibiotic resistance, which threatens human health,” wrote NRDC staff attorney Avinash Kar in an online statement.

He noted that the guidances are nonbinding and therefore unenforceable.

“We may hear the right kind of noises from industry, but there is no assurance that improvements will actually follow,” Kar wrote. “Once again, FDA is making much ado about nothing; pretending to act while barely acting at all.”

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By John Gever, Senior Editor, MedPage Today