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

  • Safety Metrics Guide

    Is your company leveraging its safety data and analytics to maintain a safe workplace? With so much data available, where do you start? This downloadable guide will give you insight on helpful key performance indicators (KPIs) you should track for your safety program.

  • Job Hazard Analysis Guide

    This guide includes details on how to conduct a thorough Job Hazard Analysis, and it's based directly on an OSHA publication for conducting JHAs. Learn how to identify potential hazards associated with each task of a job and set controls to mitigate hazard risks.

  • A Guide to Practicing “New Safety”

    Learn from safety professionals from around the world as they share their perspectives on various “new views” of safety, including Safety Differently, Safety-II, No Safety, Human and Organizational Performance (HOP), Resilience Engineering, and more in this helpful guide.

  • Lone Worker Safety Guide

    As organizations digitalize and remote operations become more commonplace, the number of lone workers is on the rise. These employees are at increased risk for unaddressed workplace accidents or emergencies. This guide was created to help employers better understand common lone worker risks and solutions for lone worker risk mitigation and incident prevention.

  • EHS Software Buyer's Guide

    Learn the keys to staying organized, staying sharp, and staying one step ahead on all things safety. This buyer’s guide is designed for you to use in your search for the safety management solution that best suits your company’s needs.

  • Vector Solutions

OH&S Digital Edition

  • OHS Magazine Digital Edition - June 2022

    June 2022

    Featuring:

    • SAFETY CULTURE
      Corporate Safety Culture Is Workplace Culture
    • HEAT STRESS
      Keeping Workers Safe from Heat-Related Illnesses & Injuries
    • EMPLOYEE HEALTH SCREENING
      Should Employers Consider Oral Fluid Drug Testing?
    • PPE FOR WOMEN
      Addressing Physical Differences
    View This Issue