Antibiotic Resistance and Agency Recalcitrance

by Lisa Heinzerling

February 06, 2013

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.

A federal district court in New York rejected the FDA’s decision.  In complex but compelling rulings, a magistrate judge held that the FDA was obliged to move forward with hearings on the safety of the routine administration of antibiotics to animals destined for the human food supply. The magistrate judge concluded that, with respect to two antibiotics, penicillin and tetracycline, the FDA had already -- in 1977 and beyond -- found that routinely administering these drugs to animals for the purposes of promoting growth and preventing infection was not safe. With respect to other antibiotics covered by the citizen petitions, the judge concluded that the agency must initiate withdrawal proceedings because its reasons for refusing to do so were arbitrary and capricious. The FDA appealed to the Second Circuit.

On Friday, the appeals court will hear oral argument in this case. The petitioners, led by the Natural Resources Defense Council, deserve to win for all of the reasons cited in the magistrate judge’s painstaking opinion. 

They also deserve to win for another reason (as I explain in detail in a new paper). The core legal premise of the FDA's decision -- its belief that it was legally obligated to hold formal hearings in the circumstances presented -- is simply mistaken. In making this argument, the FDA has ignored decades of developments in administrative law and has misread its own governing statute.  For decades, administrative agencies have -- with the active approval of the courts reviewing their actions -- moved away from formal process and trial-type hearings, and toward informal process and legislative rules. The FDA's unyielding legal position in the context of antibiotics fed to livestock -- that formal hearings must precede the withdrawal of approval for animal drugs -- is like an administrative-law time capsule, filled decades ago and untouched ever since.

In short, the FDA has the power under the law to act on antibiotics in animal feed without going through the years-long process of formal hearings.  The agency’s primary excuse for failing to act for all these years is based on a mistake of law.  Once that mistake is corrected, the agency must either act with expedition or explain the inexplicable: why it is choosing the slower, more process-intensive path to protecting the public health.

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Lisa Heinzerling is a Professor of Law at Georgetown University. 

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