September 5, 2008
September 5, 2008 - "We urge the Food and Drug Administration (FDA) to grant an exception to allow the extra-label use of cephalosporins in sheep."
This was the culminating statement put forth by the American Sheep Industry Association (ASI) in its comments to the FDA on its decision to prohibit the extra-label use of cephalosporin antimicrobial drugs in food-producing animals. The FDA issued this final rule in the July 3, 2008, Federal Register stating concern that the extra-label use of cephalosporins in food-producing animals is likely to lead to the emergence of cephalosporin-resistant strains of foodborne bacterial pathogens. If these drug-resistant bacterial strains infect humans, it is likely that cephalosporins will no longer be effective for treating disease in those people, the rule stated.
Certain cephalosporins were approved for use in a number of animal species. One of the approved uses includes the treatment of respiratory disease in sheep, goats, cattle and swine, as well as acute bovine interdigital necrobacillosis, acute metritis and clinical and sub-clinical mastitis.
In its comments, ASI put forward the argument that the FDA classifies sheep as a minor species and pointed out that there are few antimicrobial drugs with label approval for use in sheep. There are a limited number of clinical conditions for which these approved antimicrobials are permitted. Such is the case with the approved use of the cephalosporin class of products in sheep. A prohibition of the extra-label use of cephalosporins will leave the U.S. sheep industry with nearly no tools to treat gram-negative bacterial infections (mastitis being an example). There is no doubt that there will be significant pain, suffering, mortality and financial loss as a result of this action.
"ASI appreciates FDA's diligence in taking actions to protect human health," stated Burdell Johnson (N.D.), ASI president. "The sheep industry has invested heavily in educational efforts with its producers regarding the proper use of antimicrobials."
The rule becomes effective Oct. 1, 2008. Staff contact: Paul Rodgers, 303-771-3500