FDA Takes Voluntary Approach to Limiting Animal Antibiotics

The agency is issuing a final guidance document that explains how animal pharmaceutical companies can work with it to voluntarily remove growth enhancement and feed efficiency indications from the approved uses of their medically important antimicrobial drug products.

The U.S. Food and Drug Administration announced it is implementing a voluntary plan with industry to phase out the use of certain antibiotics for cattle, hogs, poultry, and other food-producing animals. These antibiotics are added to feed or water to help the animals gain weight faster or use less food to gain weight, but they contribute to the development of antimicrobial resistance.

FDA is working to address the use of "medically important" antibiotics in food-producing animals for production uses; they're considered important because they are also used to treat human disease and might not work if the bacteria they target become resistant to the drugs' effects. "We need to be selective about the drugs we use in animals and when we use them," said William Flynn, DVM, MS, deputy director for science policy at FDA's Center for Veterinary Medicine. "Antimicrobial resistance may not be completely preventable, but we need to do what we can to slow it down."

The agency is issuing a final guidance document that explains how animal pharmaceutical companies can work with it to voluntarily remove growth enhancement and feed efficiency indications from the approved uses of their medically important antimicrobial drug products and also shift the therapeutic uses of the products from over-the-counter availability to a marketing status requiring veterinary oversight.

"This action promotes the judicious use of important antimicrobials, which protects public health and, at the same time, ensures that sick and at-risk animals receive the therapy they need," said Bernadette Dunham, DVM, Ph.D., the center's director. "We realize that these steps represent changes for veterinarians and animal producers, and we have been working to make this transition as seamless as possible."

The agency is asking animal pharmaceutical companies to notify it within the next three months of their intent to voluntarily make the recommended changes. "Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort," said Michael R. Taylor, FDA's deputy commissioner for foods and veterinary medicine.

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