In an effort to help address potential antimicrobial resistance concerns in humans, the U.S. Food and Drug Administration issued guidelines to extend veterinary oversight and phase out the sub-therapeutic use of antibiotics that are important to human medicine in food producing animals for growth promotion purposes. The new guidelines will be implemented over a three-year transition phase.
Historically, certain antibiotics have been used in the feed or drinking water of food producing animals for production purposes. Some of these antimicrobials are also used to treat human infection, thus prompting concerns about the potential contribution of this practice affecting antimicrobial resistance. Guidance 213 calls for animal pharmaceutical companies to voluntarily revise the FDA-approved labels for these products to remove growth promotion labels. FDA also proposes to change Veterinary Feed Directive regulations to move the over-the-counter status of the remaining appropriate therapeutic uses to require veterinary oversight when used to treat, control, or prevent health issues in animals.
Bernadette Dunham, director for FDA’s Center for Veterinary Medicine, said the steps taken by FDA will promote the judicious use of important antimicrobials to protect human health while ensuring sick and at-risk animals receive the care they need.
“Implementing this strategy is an important step forward in addressing antimicrobial resistance. The FDA is leveraging the cooperation of the pharmaceutical industry to voluntarily make these changes because we believe this approach is the fastest way to achieve our goal,” said FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor.
In a media statement, Zoetis came out in support of FDA’s new guidelines.
“Zoetis supports the FDA’s efforts to voluntarily phase-out growth promotion indications for medically important antibiotics in food producing animals. Zoetis plans to implement Guidances #209 and #213 and has already taken action. This reflects our continued commitment to antibiotic stewardship and represents the many ways that Zoetis promotes the responsible use of antimicrobial drugs in animals.
“We believe that veterinarians should be involved in decisions regarding antibiotic use in food animals for the health of the animal and for the safety of the food supply. We support the revisions to the Veterinary Feed Directive (VFD) regulation to guide veterinarians and farmers as they manage the health and welfare of animals.”