Antibiotic Resistance Concerns FDA

Antibiotics, available over-the-counter at farm supply stores, are typically added into livestock feed to promote growth and prevent illness in crowded, unsanitary living conditions. According to the U.S. Food and Drug Administration (FDA): “With these agricultural production uses, typically no disease is present and no outbreak is anticipated to occur. These drugs are given to animals to enhance the production of animal-derived food products.” In the United States alone, the FDA estimates approximately 30 million pounds of antibiotics were given to livestock in 2010.

With such widespread distribution, the development of human antibiotic resistance by ingesting food and water associated with livestock production is a growing concern. Resistance will cause crucial antibiotics to lose their effectiveness, meaning more patients will be prescribed stronger antibiotics with potentially severe side effects or be left with no treatment option at all. The U.S. Centers for Disease Control and Prevention declares antibiotic resistance as one of its “top concerns’ and the World Health Organization estimates 38 Americans die each day from hospital acquired antibiotic-resistant infections. A 2003 report published in the National Academies Press (NAP) and edited by Dr. Margaret A. Hamburg, the present Commissioner of the FDA, pointed out if the drivers of antibiotic resistance are not addressed, including the overuse of antibiotics in livestock, the “specter of untreatable infections—a regression to the pre-antibiotic era—is looming just around the corner.”

Surprisingly, despite the NAP report’s call for action in 2003, decades of warning from the scientific community and pressure from numerous health and environmental organizations, the FDA announced last Wednesday that they will solely issue a non-binding “guidance” for the livestock industry to follow regarding antibiotic use on their animals. Under The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, the livestock industry is allowed to decide whether to voluntarily follow the recommendations or simply ignore them.

“The FDA is implementing a voluntary strategy to promote the judicious use in food-producing animals of antibiotics that are important in treating humans,” the agency explained on their website, “The goal of the strategy is to protect public health and help curb the development of antimicrobial resistance and in turn help to reduce the number of infections in humans that are difficult to treat because existing antibiotics have become ineffective.”

Though the FDA states the guidance “establishes the framework for phasing out production uses of antimicrobials that are important in treating humans”, in order to comply with the recommendations, much of the livestock industry would have to voluntarily transition out of a cheap, high-yield system for a health issue they claim is not a public threat.

“Our industry doesn’t know whether we’re part of the problem because there is no science linking antibiotics in food animals to antibiotic resistance,” National Pork Producers Council (NPPC) spokesman Dave Warner said. “All antibiotic use means safer meat, and that’s our bottom line.”

And considering FDA data calculates 80% of antibiotics in the U.S. are administered to livestock, pharmaceutical companies also do not seem keen to accept an extensive financial hit in the name of human antibiotic resistance prevention.

“There is no scientific evidence that antibiotics used in food animals have any significant impact on the effectiveness of antibiotics in people,” stated the Animal Health Institute, which represents major pharmaceutical companies like Bayer Healthcare and Pfizer.

The FDA “does not want the recommendations to negatively impact animal health or disrupt the animal agriculture industry”, according to the guidance, and will not evaluate “the rate of voluntary adoption of the proposed changes’ until 2015. But the National Resources Defense Council (NRDC) argues the FDA’s decision goes against their mandate “to protect our food, our health and our families’ as well as a federal court-issued legal obligation. In late March 2012, United States Magistrate Judge for the Southern District of New York Theodore H. Katz ordered the FDA to withdraw approval of the use of penicillin and tetracycline antibiotics in animals unless drug makers are able to show they are safe. Approximately 14 million pounds, nearly half of the total antibiotics administered to livestock in 2010, were penicillins and tetracyclines. The FDA has 60 days to appeal the ruling.

“Not only is [the guidance] not what the law requires of FDA, it does nothing to ensure that antibiotic use in livestock is actually reduced to slow the rise of antibiotic resistance,” said Avinash Kar, an attorney with NRDC’s Health Program.