FDA action buys more time to mull extra-label ban of cephalosporins

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FDA action buys more time to mull extra-label ban of cephalosporins

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Nov 26, 2008
By dvm360.com staff
Washington -- The federal order banning extra-label use of cephalosporins in food-producing animals has been revoked -- at least for now.

The Food and Drug Administration (FDA) received more than 300 letters during the public comment period, which was enough for the agency to revoke its implementation date of Nov. 30. The action gives the agency more time to consider all of the information.

"We think that is a really positive step as far as the profession being able to work with the FDA and other regulatory agencies," says Gatz Ridell, executive vice-president of the American Association of Bovine Practitioners (AABP). "The food-animal profession would be hiding our heads in the sand if we didn't worry about antimicrobial issues and how they might effect people. After re-investigating, if the FDA were to come back with some other order of prohibition that targets cephalosporins as extra-label usage that could definitely impact public health, I think the profession would be very willing to provide additional comment and work with that." 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 food-borne 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, including the American Association of Bovine Practitioners (AABP). The new comment period ended Nov. 3 with an effective date of Nov. 30.

"If after considering the comments and other relevant information, FDA decides to issue another order of prohibition addressing this matter, FDA will follow the procedures that provide for a public comment period prior to implementing the order," according to the agency.

Ridell says following the regular rule-making process, instead of pushing a prohibition through as an emergency, such as what happened with the cephalosporin ban, will ensure professional groups and practicing veterinarians are able to provide scientific-based information to assist the FDA with its decision.