Late last week, a federal judge in New York ruled that the Food and Drug Administration (FDA) must start proceedings to remove certain subtherapeutic antibiotics applications for food-animals, until drug makers can prove a product’s safety. If they can't prove safety, then FDA must withdraw the approval for use of those drugs, the judge ruled.
As his reasoning, U.S. Magistrate Judge Theodore Katz, cited concerns that “antibiotic overuse in food-animals is endangering human health” by resulting in antibiotic-resistant pathogens.
The judge sided with advocacy groups, including the National Resources Defense Council, Center for Science in the Public Interest and the Union of Concerned Scientists, which filed suit against FDA last May regarding a 35-year-old assessment that antibiotics use in food animals and their possible relationship to drug-resistant bacteria in people. Last December, FDA outlined its future plans, stating that the antibiotic directive was outdated and that it intended to pursue other regulatory strategies for coping with potential food-safety problems.
Katz ordered the FDA to follow through on the process it started in 1977. "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 in his decision.
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."
But others see this development differently. "It's about time," was the response from Rep. Louise Slaughter, D-N.Y., who has been a strong advocate against using antibiotics in food-animal production for reasons other than direct treatment. "The FDA has been dragging its feet on this for 35 years. We've all known that this is a public health issue for quite some time.”
Since 2007, Slaughter, a microbiologist, authored The Preservation of Antibiotics for Medical Treatment Act (PAMTA) legislation. “It is designed to ensure that we preserve the effectiveness of antibiotics for the treatment of human disease,” she says. “The legislation would prevent the overuse of seven classes of antibiotics, including penicillin and tetracyclines.”
Slaughter says the judge’s ruling is a start. "This is a good first step but to really get in front of this problem we must address all classes of antibiotics in farm animals that are important to human health. That's why I will continue to press for passage of PAMTA."
In its decision, the court noted: "Research has shown that the use of antibiotics in livestock leads to the development of antibiotic-resistant bacteria that can be--and has been--transferred from animals to humans through direct contact, environmental exposure, and the consumption and handling of contaminated meat and poultry products."
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.