FDA Ordered to Reconsider Petitions on Antibiotics

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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 guidance promoting 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. Read more…