FDA’s Regulatory Approach to Preserving the Safety and Effectiveness of Medically Important Antimicrobials Used in Food-producing Animals

Introduction:  Medically important antimicrobials (MAs) are used in veterinary medicine to treat, control, and prevent diseases in food-producing animals (FAs).  In addition, some MAs are currently approved for production purposes (e.g., increased rate of weight gain or improved feed efficiency).  All antimicrobial uses carry a risk of antimicrobial resistance development; however, production uses may particularly be a contributing factor in the rise of antimicrobial resistance due to their frequent administration to entire FA herds or flocks at low doses and for prolonged durations.  FDA thinks that such production uses of MAs are not judicious.  

Purpose:  This presentation provides an up-to-date understanding of FDA’s regulatory activities surrounding MAs in FAs.  

Methods:  FDA’s current risk-based regulatory approach, as detailed in Guidance for Industry (GFI) #152, is to evaluate potential human health risks associated with proposed uses of antimicrobial drugs in FAs.  All production uses of MAs were approved prior to the publication of GFI #152; therefore, these products were not evaluated using the current approach with respect to antimicrobial resistance.  To begin a reconciliation of these concerns, FDA published GFI #209 and GFI #213.  GFI #209 provides the following framework to ensure judicious use of antimicrobials in FAs: 1) limit use of MAs in FAs to those that are considered necessary for assuring animal health, and 2) limit such uses in FAs through veterinarian oversight.  GFI #213 provides recommendations on how to implement the strategies outlined in GFI #209.  

Results:  To date, all sponsors of some 293 affected applications have confirmed their intent to comply with the recommendations outlined in GFI #213.  Additionally, 36 actions have been taken by sponsors on these affected applications.  

Significance:  In summary, FDA thinks using MAs judiciously is critical to minimize the selection and dissemination of antimicrobial resistance from FAs and to help preserve their effectiveness.