Undue Process at the FDA: Antibiotics, Animal Feed, and Agency Intransigence
Georgetown University Law Center
June 12, 2013
Vermont Law Review, Forthcoming
Georgetown Public Law Research Paper No. 13-016
For over 40 years, the Food and Drug Administration has been collecting evidence that the routine administration of antibiotics to animals destined for the food supply contributes to the development of antibiotic-resistant infections in the human population. For all these years, the FDA has put off acting with any force on this health risk. The agency’s explanation has been that the Food, Drug and Cosmetic Act requires it to hold time- and resource-intensive formal hearings before it can withdraw approvals for antibiotics used for the purposes of promoting growth and preventing infection in food animals. In so arguing, the FDA has ignored decades of developments in administrative law and has misread its own statute. The FDA has the discretion under the law to act on antibiotics in animal feed without going through the years-long process of formal hearings. At the least, the agency owes the public an explanation of why it has insisted on pursuing the longest possible path to protecting human health.
The FDA’s legal error is, in principle, simple enough to correct. Far less remediable are the habits of mind that entrench agency inaction, including institutional memory that privileges stasis over change and systematic acceptance of absurdly long timelines for addressing social problems. Equally immobilizing are statutory grants of epistemic authority to particular individuals within large bureaucratic institutions, which allow these institutions officially to deny certain facts about the world even while they report them as the truth.
Number of Pages in PDF File: 34
Keywords: FDA, antibiotics, animal feed, livestock, formal process, administrative lawAccepted Paper Series
Date posted: February 1, 2013 ; Last revised: June 13, 2013
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