The FDA's Continuing Incapacity on Livestock Antibiotics

26 Pages Posted: 18 Jan 2014 Last revised: 9 Oct 2014

Lisa Heinzerling

Georgetown University Law Center

Date Written: April 24, 2014

Abstract

The Food and Drug Administration (FDA) recently recommitted itself to its policy of addressing the profligate use of antibiotics in livestock by enlisting the voluntary participation of the drug companies that make the antibiotics. Two documents issued in December 2013 reveal the details of the agency’s current plans. The first is a final guidance document describing the FDA’s process for handling drug sponsors’ voluntary efforts to phase out certain uses of antibiotics in animal feed and water and to bring the remaining uses under the oversight of a veterinarian. The second is a draft rule relaxing the requirements for veterinarians in exercising this oversight. This article provides the first in-depth analysis of the several different strands of the FDA’s plan.

Together, the documents recently issued by the FDA guarantee little more than continued delay in tackling a public health risk that has bedeviled the agency for decades. The FDA’s decision to rely on voluntary action by drug companies and to continue to allow routine uses of antibiotics in whole herds and flocks of animals in order to prevent infections brought on by stressful conditions leave potentially gaping holes in the protection the agency purports to provide. The agency’s meager backup plans in case this endeavor does not work out as it hopes do little to comfort the skeptical. Moreover, the FDA’s proposal to weaken rules for veterinary oversight undermines the agency’s plan to place veterinarians at the front line of preventing agricultural overuse of antibiotics. In addition, after a small outburst of transparency at the very start of the process, this whole undertaking will move underground for three years while the FDA works things out privately with participating drug companies.

Rather than pursuing this doomed course, the FDA should do what a federal district court has already ordered it to do: complete regulatory proceedings to withdraw approvals for the mass administration of medically important antibiotics to food-producing animals. The FDA’s refusal to do so rests on the mistaken legal premise that such withdrawals must be preceded by formal, trial-type hearings; this premise ignores decades of developments in administrative law and misreads the agency’s own enabling statute.

Suggested Citation

Heinzerling, Lisa, The FDA's Continuing Incapacity on Livestock Antibiotics (April 24, 2014). Stanford Environmental Law Journal, Vol. 33, 2014. Available at SSRN: https://ssrn.com/abstract=2380115 or http://dx.doi.org/10.2139/ssrn.2380115

Lisa Heinzerling (Contact Author)

Georgetown University Law Center ( email )

600 New Jersey Avenue, NW
Washington, DC 20001
United States

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