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.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Complete Online Safety Training Courses

    Deliver state-of-the art, online safety training courses to your organization with IndustrySafe Training Management Software. Generate reports to track training compliance and automatically notify learners of upcoming or overdue classes.

  • Easy to Use Safety Inspection App

    Conduct inspections on the go with IndustrySafe’s mobile app. Complete safety audits at job sites and remote locations—with or without web access.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Analyze Incident Data and Maintain OSHA Compliance

    Collect relevant incident data, analyze trends, and generate accurate regulatory reports, including OSHA 300, 300A, and 301 logs, through IndustrySafe’s extensive incident reporting and investigation module.

  • Industry Safe
comments powered by Disqus