AASV Submits Comments on FDA Order Banning the Extralabel Use of Cephalosporins

November 7, 2008 — 

The AASV submitted written comments to the US Food and Drug Administration (FDA) regarding the agency's order (Docket No. FDA-2008-N-0326) prohibiting the extralabel use of the cephalosporin class of antimicrobials in food-producing animals.

The association stressed the importance of maintaining the availability of these products for use in swine medicine and our concern that this order disregards the right of veterinarians to select the most appropriate therapy for their patients as assured under the Animal Medicinal Drug Use Clarification Act (AMDUCA). In our opinion, FDA's interpretation of the studies cited as justification for the ban is inaccurate and incomplete and does not show evidence of increased resistance in humans from the extralabel use of cephalosporins in swine. We also question the rationale for banning the use of a product approved for use in swine to treat a condition not listed on the label while allowing the extralabel use of a product not labeled for use in swine to treat the same condition.

The comment period has ended following a 60 day extension by the FDA. The agency will now consider the comments received to determine what, if any, action they will take regarding the order. They can choose to let the order stand as written in which case the ban will become effective on November 30, 2008. The other options are to rescind the order entirely or modify it in some way.