FDA Issues Order of Prohibition for Extralabel Cephalosporin Use in Food Animals

By Dr. Lynne White-Shim, Assistant Director, Scientific Activities Division

FDA issued an Order of Prohibition on July 3 that would prohibit the extralabel use of cephalosporin antimicrobial drugs in food-producing animals.

Upon passage of the Animal Medicinal Drug Use Clarification Use Act (AMDUCA), veterinarians could utilize FDA-approved drugs in an extralabel manner that is consistent with protecting public health. The AMDUCA specified that the FDA could prohibit extralabel drug use (ELDU) of an animal drug or class of drugs if it found evidence that such ELDU has caused, or could cause, a public health risk. When the FDA issues a prohibition, the FDA must specify the nature and extent of the order and reasons for the prohibition.

The FDA cited cephalosporins as a class of antibiotics likely to contribute to the emergence of resistance. Considering the importance of cephalosporins in human medicine, FDA believes that preserving the effectiveness of cephalosporins is critical for treating human disease. The FDA intends to ban ELDU of cephalosporins in food animals because of its possible contribution to antimicrobial resistance in humans.

The AVMA supports the AMDUCA. However, within the AMDUCA, a provision exists that allows for FDA to limit ELDU. In weighing ELDU risks/benefits, animal health and welfare benefits should be considered along with possible public health risks. Any prohibitions should be narrow enough to limit public health risks directly and adequately, using a risk-based, scientific approach.

The AVMA is working to evaluate the current science regarding antimicrobial resistance. Together with its allied partners, the AVMA will also identify the impact of the ban on the practice of veterinary medicine, as well as any potential impacts on animal health and welfare and food safety.

Originally providing for a 60-day comment period and an October 1 effective date, the FDA has extended its comment period until November 1. The FDA has the authority to remove, modify, or implement its prohibition.

Do you have expertise to offer for AVMA consideration on this issue? Send your feedback to the Scientific Activities Division at ScientificIssues.