It has been 35 years since the U.S. Food and Drug Administration acknowledged that antibiotic overuse in farm animals posed a health risk to humans and announced its intention to withdraw approval for some types of uses of the antibiotics penicillin and tetracyclines. Back then, however, political pressure from the agriculture industry and drug companies, with a little help from our political leaders, made sure that those regulations went unenforced. A ruling by a federal judge in New York last week may change all that. The 55-page ruling requires the FDA to begin withdrawal proceedings for the two antibiotics, which are widely used in animal agriculture.
Antibiotic use in factory farming is, according to the Pew Commission on Industrial Farm Animal Production 2008 report, a growing public health threat and a known source of antibiotic resistance. Low- or sub-therapeutic doses of antibiotics have been given to farm animals since the 1940s to promote more rapid growth and to reduce the risk of disease outbreaks among livestock and other farm animals. According to the report, approximately “70% of all antibiotics used in the United States are used in farm animals” and farm animals consume up to 24 million pounds of antibiotics annually.
Last week’s ruling comes just a few months after the FDA sought to withdraw the unenforced 1977 policy. That change was quietly announced in the December 2011 Federal Register. According to the FDA, the regulation’s attempted withdrawal “should not be interpreted as a sign that FDA no longer has safety concerns or that FDA will not consider re-proposing withdrawal proceedings in the future, if necessary.” Instead, the agency claimed it was going “to focus its efforts for now on the potential for voluntary reform and the promotion of the judicious use of antimicrobials in the interest of public health.”
Now, contravening the FDAs December policy change, the court’s ruling says that the agency must give drug manufactures the opportunity to prove the drugs safe, but if “the drug sponsors fail to show that use of the drugs is safe, the Commissioner must issue a withdrawal order.” If, on the other hand, “drug sponsors demonstrate that the subtherapeutic use of penicillin and/or tetracyclines is safe, then the Commissioner cannot withdraw approval.”
If the ruling stands and subtherapeutic use of these antibiotics in animals is banned, this will be a great victory for public health. Congressional testimony in 2010 by leaders of the FDA, the Centers for Disease Control and Prevention, and the Department of agriculture acknowledged the “definitive link between the routine, non-therapeutic uses of antibiotics in food animal production and the crisis of antibiotic resistance in humans.” The FDA’s recent banning of another class of antibiotics, cephalosporins, for extra label use in food-producing animals, is also likely to help decrease antibiotic resistance and protect the public’s health. In that case, the agency also took action because “little is known” about cephalosporins’ “microbiological or toxicological effects” when used in cattle, swine, chickens, and turkeys.
But the impact of the ruling has deeper implications for how we raise animals for consumption. Because factory farms rely upon both the rapid growth of their animals and the ability to keep animals in close quarters, the removal of antibiotics from this equation may have unintended consequences. In the short term, without transforming the crowded conditions of the factory farm—including feedlots, tie stalls, gestation crates, battery cages, and veal crates—animals without antiobiotic protection may become more susceptible to infection.
Let’s hope that this will not be the case – and that all stakeholders, from politicians to government regulators to drug companies to farmers, can thoughtfully come together to find better ways to produce our food and to protect both the public’s health and the animals’ welfare.
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