FDA barraged with comments on extra-label use of cephalosporin in food animals; order could be delayed

Nov 06, 2008
Washington -- An FDA-ordered ban of extra-label use of cephalosporin antimicrobial drugs in food-producing animals could be delayed after nearly 300 comments poured in during an already extended public comment period.

"The agency is carefully reviewing the comments and evaluating any additional data that might have been submitted during the comment period to determine whether we need to revisit our conclusions," says Laura Alvey, U.S. Food and Drug Administration spokeswoman.

On July 3, FDA prohibited the extra-label use of cephalosporin antimicrobial drugs in food-producing animals "to help further protect consumers against antimicrobial-resistant strains of zoonotic foodborne bacterial pathogens."

The original order was to go into effect Oct. 1, but the public comment period was extended at the urging of several interested parties. The new comment period ended Nov. 3 with an effective date of Nov. 30.

"Once we have completed an initial review of the information submitted during the comment period, we will make a determination as to whether modifications to the order may be warranted or whether the order will go into effect on Nov. 30 as originally planned," Alvey says. "If a decision is made to delay or otherwise place in abeyance implementation of the order, FDA will issue a separate notice in the Federal Register to that effect prior to Nov. 30."

All of the food-animal groups took issue with the FDA ruling, including the American Association of Bovine Practitioners (AABP).

"The AABP has serious concerns about the scope and scale of the prohibition on extra-label drug use (ELDU) of cephalosporin drugs in food animals," according to the group's comment to the FDA. "We believe that the proposed inclusive ban on ELDU for the entire class of cephalosporin drugs and for all food-producing animals has not been scientifically justified. We believe that this is especially true for cephalosporin use in cattle. Furthermore, such a comprehensive ban would have a substantial adverse impact on cattle welfare."

To read more about this story, see the December issue of DVM Newsmagazine.