A federal judge ruled this week that the U.S. Food and Drug Administration must reconsider previously denied petitions to ban certain medically important antibiotics used in animal agriculture.
The order comes just a few days after the FDA issued a notice that it will appeal a magistrate judge’s March ruling, which found that the agency unlawfully failed to act on its own 1977 proposal to ban penicillin and two types of tetracycline from animal feed despite evidence of a public health risk.
As part of its defense, the FDA has pointed to its new voluntary guidancepromoting the judicious use of antibiotics in food animal production — an approach the agency prefers because it requires less time and fewer resources than withdrawing individual animal drugs — but the court ruled that this approach does not excuse the agency from its duty to review the safety of the drugs and carefully consider the merits of the petitions.
“[T]he Agency has all but made a finding that the subtherapeutic use of antibiotics in food producing animals has not been shown to be safe,” reads the ruling by New York federal judge Theodore Katz. “In the course of this litigation, the Agency has conceded that ‘the phenomenon of antimicrobial resistance exists, [that] antimicrobial resistance poses a threat to public health, [and that] the overuse of antimicrobial drugs in food-producing animals can contribute to the development of antimicrobial resistance.'”
According to the most recent estimates, around 80 percent of all antibiotics sold in the United States – approximately 29 million pounds – are used to promote growth and control disease in food animal production each year.
The Natural Resources Defense Council — one of five advocacy groups that sued the agency after it failed to respond to petitions filed in 1999 and 2005 — called the ruling on Monday “another hugely important victory.”
The agency eventually denied both petitions last year, but the court ruled this week that the FDA did not provide proper legal justification for doing so. The court pointed out that the agency cited cost and time as key reasons not to move forward on the withdrawal proceedings, rather than focusing on safety and efficacy.
“This decision adds to the building momentum to end the unsafe use of antibiotics in livestock,” said NRDC staff attorney Avinash Kar.
The petitions filed by the coalition, which includes the American Academy of Pediatrics, the Union of Concerned Scientists, and the American Public Health Association, cover five classes of antibiotics, including penicillin and tetracyclines.
“Following the ruling, FDA must heed the science and make a decision about whether feeding antibiotics to healthy animals is safe for human health,” said Kar. “If FDA determines that such use is not safe, it must withdraw approval for the use of the antibiotics in animal feed.”
Robert Lawrence, director of the Johns Hopkins Center for a Livable Future, lauded the court’s decision.
“The rise of antibiotic resistance is a public health crisis. An important contributor to this grave public health threat is the continuing abuse of antibiotics in food animal production to make animals grow faster and prevent disease,” said Lawrence. “With this decision, a federal judge ruled that public health matters more than FDA’s excuses.”
Update: FDA said it is reviewing the decision, but the agency does not comment on pending litigation.
The Animal Health Institute, a veterinary pharmaceutical industry group, on Tuesday responded to the the court’s decision, saying it “adds confusion to FDA’s efforts to phase in veterinary oversight of antibiotics used in food animals while eliminating growth promotion uses.”
In April, FDA announced that it would ask veterinary drug companies to change the labels on antimicrobials so that farmers will be allowed to use the drugs only to prevent, control, or treat diseases and only under the supervision of a veterinarian — and not for promoting growth or improving feed efficiency.
In the court’s decision this week, the judge acknowledged FDA’s guidance program encourages the industry to use the drugs judiciously, but criticized the strategy, arguing that the agency did not present “hard evidence that the drug sponsors have agreed or will agreed to the proposed measures.”
AHI said that the industry supports FDA’s initiative and is working to move certain medically-important drugs under veterinary supervision.
“Animal health companies will continue to support and work with FDA on the stakeholder process to achieve its goals of veterinary oversight and elimination of growth uses for medically important compounds,” said AHI. “This cooperative process will help avoid the unintended consequences of increased animal disease that have resulted from legislated bans in Europe.”© Food Safety News