Posted on January 29, 2014 by Lisa Heinzerling
The Food and Drug Administration recently recommitted itself to its feeble policy of addressing the profligate use of antibiotics in livestock by enlisting the voluntary participation of the drug companies that make the antibiotics. Peter Lehner discussed previous iterations of this policy in his ACOEL blog post of November 2012. 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. (In a new article, I provide an in-depth analysis of the several different strands of the FDA’s plan.)
Together, the documents recently issued by the FDA promise 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 leaves 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 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 courthas already ordered it to do: complete regulatory proceedings to withdraw approvals for the mass administration of medically important antibiotics to food-producing animals. As I have explained in a recent article, 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.