The U.S. Food and Drug Administration’s (FDA) action to prohibit the “extralabel” use of cephalosporin drugs in food-animal production became effective April 5. FDA specifically cites cattle, swine, chickens, and turkeys, as the “major species of food-producing animals.”

The order was announced on January 6 and was followed with a 60-day comment period in which the National Chicken Council argued that FDA presents no evidence demonstrating cephalosporin use in food-producing animals has actually caused the adverse event of antibacterial resistance, nor does the agency establish that such an event is likely to occur.  NCC also expressed concerns in whether about adequate time was provided to meaningfully comment on contemplated regulatory action before final decisions are made and regulations issued, especially in areas of emerging or complicated policy.

FDA officials reviewed the submitted comments and determined that the order of prohibition should go into effect on April 5, “without further revision or delay.” FDA officials say they are taking this action to “reduce the risk of cephalosporin resistance in certain bacterial pathogens” and to preserve the drug’s effectiveness in treating disease in humans.

Extralabel use is when a drug is used in a manner other than what is designated on a specific product’s label. FDA offers these guidelines as prohibited uses:

  • Using cephalosporin drugs at unapproved dose levels, frequencies, durations, or routes of administration.
  • Using cephalosporin drugs in cattle, swine, chickens, or turkeys that are not approved for use in that species (for example, cephalosporin drugs intended for humans or companion animals).
  • Using cephalosporin drugs for disease prevention.

Cephalosporin drugs may still be used as designated on a product’s label for the treatment of a specific disease within a species.

 

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