Antibiotic Resistance and Agency Recalcitrance

Eighty percent of the antibiotics used in this country are given not to humans, but to animals destined for the human food supply. Most of these antibiotics are given to the animals not for the purpose of treating active infections, but for the purposes of promoting growth and preventing infection in the microbe-rich environment of the modern factory farm. For over 40 years, the Food and Drug Administration (FDA) has been collecting evidence that this agricultural practice contributes to the development of antibiotic-resistant infections in the human population. Based on such evidence, in fact, the agency proposed to withdraw its prior approvals for two antibiotics used in animal feed due to the risks they posed to human health. The agency promised to hold hearings on the matter. That was over 35 years ago. On Friday, the future of this issue will be debated in oral arguments in a key case before the Second Circuit Court of Appeals. In the last 35 years, the FDA has continued to accumulate evidence of the link between administering subtherapeutic doses of antibiotics to food animals and the development of antibiotic-resistant infections in the human population. Indeed, the agency itself has repeatedly acknowledged the link between herd- and flock-wide administration of antibiotics to food animals and the development of antibiotic-resistant disease in humans. But still it has done nothing to take the drugs off the market. Not surprisingly, after watching the FDA sit still for decades, public health and environmental organizations eventually grew restless, and petitioned the agency to hold the hearings and to withdraw the relevant approvals. In 2011, almost 35 years after finding that using antibiotics in animal feed was linked to antibiotic resistance in humans, the FDA finally answered the petitions. It denied them. The agency explained -- without a trace of irony -- that the process for withdrawing these approvals would simply take too long and that the agency was thus instead encouraging the animal feed industry to take voluntary measures to address the overuse of antibiotics. The FDA argued that the process for withdrawing approvals would take too long because the agency thought itself legally bound to offer formal, trial-type hearings on the question whether the relevant antibiotics were "safe" within the meaning of the relevant statute, the Food, Drug and Cosmetic Act.