The U.S. Food and Drug Administration (FDA) has advised manufacturers to stop indicating certain antibiotics for use as a growth aid in animal feed. The agency said the effects the practice can have on bacteria are harmful to human health. In final guidance to the animal-drug industry, the agency also recommended that drugmakers require veterinary oversight for the use of the antibiotics to treat or prevent disease in animals. Companies are asked to make the changes voluntarily, as the guidance is not legally binding.
Public health advocates have long expressed concern that the antibiotics used by producers to make cattle, poultry, hogs and other animals grow faster are making bacteria more resistant to treatment for illnesses and infections in people. FDA Deputy Commissioner Michael Taylor said in a statement:
Implementing this strategy is an important step forward in addressing antimicrobial resistance. The FDA is leveraging the cooperation of the pharmaceutical industry to voluntarily make these changes because we believe this approach is the fastest way to achieve our goal.
The FDA is currently locked in a battle with the Natural Resources Defense Council (NRDC) and other consumer groups about whether it should enforce a 1977 plan to pull certain antibiotics from the market.
The groups sued the FDA in 2011 after the agency formally shelved the plan, which was never implemented. A New York federal court ruled in August 2012 that the FDA must begin proceedings to withdraw approval of the antibiotics, but that the agency could follow its own proposed timeline. The FDA has appealed that ruling to the Second Circuit Court of Appeals. Companies are supposed to notify the FDA as to whether they will follow the guidance within three weeks. They would then have three years to meet its tenets. Avinash Kar, a lawyer for the NRDC, called the guidance “an early holiday gift to industry” and a “hollow gesture.” He said:
FDA has essentially followed a voluntary approach for more than 35 years, but use of these drugs to raise animals has increased. There’s no reason why voluntary recommendations will make a difference now, especially when FDA’s policy covers only some of the many uses of antibiotics on animals that are not sick.
The Animal Health Institute, a trade group for veterinary-drug makers, said it supported the policy. “It is important for consumers to know that within three years, all uses of medically important antibiotics in animal agriculture will be only for therapeutic, or targeted, purposes under the supervision of a licensed veterinarian,” the group said in a statement. The drugs that fall under the guidance include amoxicillin, several penicillins and other antibiotics the FDA considers important for treating human infections.
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