A federal judge on Thursday ordered regulators to start proceedings to withdraw approval for certain antibiotics in animal feed, citing concerns that overuse is endangering human health by creating antibiotic-resistant "superbugs."
U.S. Magistrate Judge Theodore Katz ordered the U.S. Food and Drug Administration to begin proceedings unless makers of the drugs can produce evidence that their use is safe.
If they can't, then the FDA must withdraw approval for non-therapeutic use of those drugs, the judge ruled.
According to Liz Wagstrom, DVM, chief veterinarian with the National Pork Producers Council, "The ruling requires FDA to continue the process it began in 1977, to determine if subtherapeutic use of penicillin and tetracycline are unsafe. At the time these products were approved, there was no process to evaluate the implications of their use on antibiotic resistance. If there is a hearing on these products, any evidence, including the risk assessments that have been completed, are likely to be considered in determining the saftey of these uses."
The process that was started in 1977 never got completed.
"In the intervening years, the scientific evidence of the risks to human health from the widespread use of antibiotics in livestock has grown, and there is no evidence that the FDA has changed its position that such uses are not shown to be safe," Katz wrote.
The lawsuit was filed by environmental and public-health groups including The Natural Resources Defense Council, Center for Science in the Public Interest and the Union of Concerned Scientists in the Manhattan federal court in May.
The plaintiffs argued that using common antibiotics in livestock feed has contributed to the rapid growth of antibiotic-resistant bacteria in both animals and humans.
Antibiotic-resistant infections cost Americans more than $20 billion each year, the plaintiffs said, citing a 2009 study from the Alliance for the Prudent Use of Antibiotics and Cook County Hospital.
In his ruling, Katz ordered the FDA to follow through on the process it started in 1977 but only formally abandoned in December last year. The FDA said the proceedings were outdated and that it intended to pursue other regulatory strategies for coping with potential food-safety problems.
"The FDA has not issued a single statement since the issuance of the 1977 (notices) that undermines the original findings that the drugs have not been shown to be safe," Katz wrote.
The FDA could not be immediately reached for comment outside regular business hours on Thursday.
The case is Natural Resources Defense Council et al. v. FDA, in the U.S. District Court for the Southern District of New York, no. 11-3562.