NY Judge: FDA Should Act on Animal Antibiotics
A federal judge has ordered the Food and Drug Administration to evaluate the safety risks to human health associated with the widespread use of antibiotics in food-producing animals, saying the agency has done "shockingly little" since proposing in the 1970s to order a substantial reduction in the use of antibiotics in animal feed.
U.S. Magistrate Judge Theodore Katz in Manhattan issued the order in a ruling filed on Monday. The decision largely agreed with the arguments of several health and consumer organizations that sued last year, saying the FDA violated federal law by failing to withdraw approval of using penicillin and tetracyclines in animal feed when animal health is not at stake.
Katz said the agency must evaluate the safety risks of the drugs and make a finding that they are unsafe - or explain why it is refusing to do so.
He rejected the agency's argument that it had addressed the threat from antibiotics by initiating a voluntary program that encourages the industry to use the drugs "judiciously" because public hearings would consume extensive periods of time and agency resources.
"By refusing to make findings as to the drugs' safety - or provide a statutorily based reason for refusing to make such findings - the agency avoided the Congressionally mandated scheme for addressing drugs not shown to be safe," Katz wrote. "For over thirty years, the agency has been confronted with evidence of the human health risks associated with the widespread ... use of antibiotics in food-producing animals, and, despite a statutory mandate to ensure the safety of animal drugs, the agency has done shockingly little to address these risks."