Court orders FDA to review antibiotic use

Jun 8, 2012

A federal judge ruled last Monday that the U.S. Food and Drug Administration (FDA) must reconsider previously denied petitions to ban certain antibiotics used in livestock production. This comes just after FDA issued a notice that it would appeal a March ruling determining the agency had broken the law by failing to act on petitions from 1977. The courts ordered FDA to follow through on the proposal it made decades ago that would ban the use of penicillin and two forms of tetracycline in animal feed.

The Natural Resources Defense Council and the other health and consumer advocacy groups that sued the government are happy with the rulings, calling it a “turning point” in a decade-long conflict over a public health threat.

“The FDA has just been dragging its heels, and until now, nobody has directed the agency to do something other than what it’s been doing,” said Avinash Kar, a lawyer at the Natural Resources Defense Council. The group said it finally “pushes the (FDA) one step closer to meaningful action to curb the dangerous overuse of antibiotics in animal feed.”

The court ruled last week that the agency still has the responsibility to review the safety of drugs and reconsider the merits of the petitions.

Food Safety News Dot Com says FDA has held up its new voluntary guidelines on promoting the judicious use of antibiotics in food animal production as part of its defense.

In last week’s ruling, Judge Theodore H. Katz said that FDA has known that the use of some antibiotics poses health risks for humans but that it has done “shockingly little” about it.

According to Katz, when FDA rejected two citizen petitions— filed in 1999 and 2005—it failed to weigh scientific evidence as required by law. Instead, the agency considered only the time and cost it would take to with draw the drug approvals and the fact that it was pursuing alternative regulatory proposals.

Although the two petitions generated 3,000 pages of court filings that contained numerous scientific studies, “the agency did not address or even mention the scientific evidence in its response,” according to Katz.

To date, FDA has not responded to the ruling, but has pointed to its new voluntary guidance promoting the judicious use of antibiotics in food animal production, 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 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.’” The Animal Health Institute (AHI) said the court’s recent rulings add confusion to FDA’s ongoing voluntary effort with producers.

On that front, the judge disagreed. Katz said FDA has failed to explain why its voluntary approach would be more effective than a formal ban.

“However, if any credence is to be given to the agency’s position that the drug industry intends to comply with the voluntary program,” Katz said, “then it is unclear why the industry would contest formal withdrawal notices or require time-consuming hearings.”

In April, FDA said that it would ask veterinary drug companies to change the labels on antimicrobials so that producers would be allowed to use the drugs only to prevent, control, or treat diseases and only under the supervision of a veterinarian, working towards the elimination of drug use for promoting growth or improving feed efficiency.

In the court’s decision last 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 agree to the proposed measures.”

AHI said 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.” — Traci Eatherton, WLJ Editor