FDA Calls Off Ban on Animal Antibiotics

The Food and Drug Administration (FDA) said it would continue allowing the use of cephalosporin antimicrobial drugs in food-producing animals.

The FDA published its decision in the Nov. 26 Federal Register stating the agency received many comments and needed more time to review them.

This reverses a rule FDA issued banning cephalosporin use in food-producing animals in the July 3, 2008, Federal Register.

Up to this time, certain cephalosporins had been 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 urging the FDA to continue to allow cephalosporin use in sheep, the American Sheep Industry Association (ASI) put forward the argument that the FDA classifies sheep as a minor species, that the use of cephalosporin drugs in sheep would have little to no impact on antimicrobial resistance 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).

ASI was joined in its objection to the ban by groups such as the Animal Population Health Institute, the Kansas Health Department, the National Turkey Federation and the American Veterinary Medical Association, many commenting that the data on the human impact it used to support the ban were lacking.

"This is good news for the sheep industry," says Jim Logan, chair of ASI's Animal Health Committee. "There is no doubt that we would see higher culling rates and mortality if cephalosporins were banned for use in sheep."

The FDA's statement in the Nov. 26 Federal Register is available at http://edocket.access.gpo.gov/2008/E8-28093.htm

Staff contact: Paul Rodgers, 303-771-3500