“The tenuous connections between Cephalosporin use and antimicrobial resistance do not justify the broad prohibition,” said the National Chicken Council in comments filed with the Food and Drug Administration (FDA) on March 2 in response to the final rule entitled “New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition.”

NCC 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 such an event is likely to occur.

“Although we recognize FDA’s responsibility to ensure drugs are administered to animals in a manner not likely to harm humans, we do not believe the circumstances justify the broad prohibitions the order imposes,” the comments state.

NCC also expressed concerns about adequate time to meaningfully comment on contemplated regulatory action before final decisions are made and regulations issued, especially in areas of emerging or complicated policy.

“Because of the complexity of extralabel new animal drug use, the agency should provide advance notice of any contemplated action that would potentially remove a significant drug in wide use in animals,” the comments continued.  “Doing so would ensure the agency is fully informed as to the consequences of its contemplated action as well as provide affected parties time to research and arrange alternative treatments for the animals in their care. In many instances, an agency order with a 60-day comment period and 90-day effective date simply provides too little time to ensure comments can have a meaningful impact on agency policy and for companies to arrange alternative treatments.”

The agency appears to overlook several practical considerations associated with cephalosporin use, which NCC also outlines in the comments.

A copy of the comments in their entirety is available here.