FDA scraps 12-year-old petition to pull antibiotic approvals for food animals

ROCKVILLE, MD. — Twelve years after filing a petition calling for the phase-out of non-medical uses of antibiotics in food animals, the U.S. Food and Drug Administration (FDA) recently denied these petitions by saying withdrawing approvals for certain antimicrobial uses in food animals would consume too much of the agency's time and resources.

Petitions were filed by the Center for Science in the Public Interest (CSPI) in 1999 and again in 2005, both asking FDA to withdraw approvals for herd-wide uses of antibiotics in chickens, swine and beef cattle for the purposes of growth promotion and disease prevention.

FDA issued its responses for both petitions Nov. 7, saying that while it shares the group's concern about the use of medically important antimicrobial drugs in food-producing animals, lengthy and costly legal battles can result from withdrawing drug approvals. The agency cites the withdrawal of nitrofuran—initiated in 1971 and not finalized until 1991—and enrofloxacin—which took five years and cost FDA about $3.3 million to settle.

FDA says it will continue to work with animal-drug sponsors, the veterinary and public-health communities, and the animal agricultural community to address antimicrobial resistance concerns.

"We are disappointed that after 12 long years the FDA rejected our petition and a more recent petition to ban non-medical uses of antibiotics in animals. The industry's irresponsible use of antibiotics in livestock increases the prevalence of antibiotic-resistant pathogens, and those germs can cause infections in humans that are difficult or impossible to treat," says CSPI Executive Director Michael F. Jacobson in a Nov. 9 statement on the FDA's denials. "The industry has long failed to cooperate voluntarily, and the FDA should take binding action. Consumers cannot afford another decade of delay."

In June, CSPI, along with the National Resources Defense Council and a number of other consumer groups, filed suit against FDA in the U.S. District Court for the Southern District of New York. The suit asks the court to force FDA to withdraw its approvals for subtherapeutic uses of penicillin and tetracycline, charging that FDA shirked its public responsibilities for more than 30 years by allowing low-doses of antibiotics for growth promotion in livestock, according to the lawsuit filed last week.

FDA issued an advisory in June 2010 stating that antimicrobial use in food animals should be restricted to uses that are necessary to assure the animal's health and administered under veterinary supervision. At the same time, the agency called for a "phase out" of antimicrobial use for growth promotion in food animals—a measure applauded by the American Veterinary Medical Association (AVMA). Additionally, AVMA and FDA have formed a partnership with AVMA creating a new steering committee that will provide veterinary input to federal regulators charged with crafting new antimicrobial-use guidelines.