Court Orders FDA To Act On Antibiotics

A federal court has again ordered FDA to protect public health from the overuse of antibiotics in animal feed. On June 1, the U.S. District Court for the Southern District of New York directed FDA to reconsider two citizen petitions, filed in 1999 and 2005, that urge the agency to revoke approvals for all nontherapeutic use of antibiotics in livestock production. FDA rejected the petitions last year, saying it would be less costly and more efficient to ask the industry to voluntarily limit the practice. Farm groups argue that drugs such as penicillin and tetra­cycline are needed to hasten animal growth and compensate for unsanitary and overcrowded feedlots. But Judge Theodore H. Katz noted that for more than 30 years, FDA has been aware of evidence that overuse of antibiotics in animal feed is endangering human health by creating antibiotic-resistant bacteria. “Despite a statutory mandate to ensure the safety of animal drugs, the agency has done shockingly little to address these risks,” Katz wrote. In a related decision in March, Katz ordered FDA to stop farmers from mixing antibiotics into animal feed, unless the practice can be proven safe (C&EN, April 2, page 9).