The American Association of Swine Veterinarians submitted written comments to the U.S. Food and Drug Administration regarding the agency's order (Docket No. FDA-2008-N-0326) prohibiting the extra-label use of the cephalosporin class of antimicrobials in food-producing animals.
AASV's comments stressed the importance of keeping these products available for use in swine medicine, as well as the concern that the proposed FDA order disregards veterinarians' rights to select the most appropriate therapy 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 extra-label 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 extra-label use of a product not labeled for use in swine to treat the same condition," the AASV statement said.
The comment period has now ended after FDA extended it an additional 60 days. The agency will now consider the comments received to determine what, if any, action it will take regarding the order. FDA elect to let the order stand as written, in which case the ban will become effective on No. 30. The other options are to rescind the order entirely or modify it in some way.