Consumer groups sue FDA's Center for Veterinary Medicine over subtherapeutic uses of antibiotics

New York

— Consumer groups filed a lawsuit against FDA's Center for Veterinary Medicine for allowing low-dose antibiotics to be used as growth promoters in livestock.

Specifically, the coalition, led by the National Resources Defense Council (NRDC), is asking the U.S. District Court for the Southern District of New York to force FDA to withdraw its approvals for the subtherapeutic uses of penicillin and tetracycline.

The groups charge that the Food and Drug Administration (FDA) shirked its public responsibilities for more than 30 years by allowing low-doses of antibiotics to be used for growth promotion in livestock, according to the suit filed last week.

Veterinary and industry groups have not yet commented on the claims outlined in the lawsuit, but it comes at time when there is increasing regulatory scrutiny over the uses of antimicrobials due to fears associated with the emergence of antibiotic resistance. In fact, FDA stated in a June 2010 guidance document that "it is in the interest of both human and animal health that we take a more proactive approach to considering how antimicrobial drugs are being used, and take steps to assure that such uses are appropriate and necessary for maintaining the health of humans and animals. Using medically important antimicrobial drugs as judiciously as possible is key to minimizing resistance development and preserving the effectiveness of these drugs as therapies for humans and animals."

The document goes on to advise 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, FDA called for a "phase-out" of antimicrobial use for growth promotion in food animals -- a measure applauded by the American Veterinary Medical Association (AVMA), which has pledged to be at the forefront of the antimicrobial debate.

Last month, AVMA announced a new partnership with FDA, with the association creating a new steering committee that will provide veterinary input to federal regulators charged with crafting new antimicrobial use guidelines.Still, NRDC contends its not enough.

“The agency has known for more than 30 years that mixing human antibiotics into animal feed poses a risk to human health. It first confirmed that connection back in 1977,” charges Peter Lehner, executive director of the NRDC, one of the four plaintiffs in the case. “Yet despite laws that compel the agency to act on its own findings, the FDA has done little to protect Americans from this threat. Nor has it provided a final response to two petitions urging action: these petitions have now been pending for six and 12 years.”

NRDC filed the lawsuit with the Center for Science in the Public Interest, Food Animal Concerns Trust and the Union of Concerned Sciences. The complaint asks the court for a judgment declaring that FDA’s failure to withdraw approvals of subtherapeutic uses of penicillin and tetracyclines in animal feed and delay in issuing responses to petitions about antibiotic use in livestock violate its own administrative rules, as well as the Federal Food, Drug and Cosmetic Act.

While consumer groups have been actively lobbying against antimicrobial use in animal feeds, this issue is currently being examined and debated within the veterinary and medical communities.

“The lawsuit will have no bearing on the use of antibiotics for treating sick animals," Lehner says. "We simply want to end the practice of giving these critical disease fighters to healthy livestock when it’s not medically necessary.”