During the recent Academy of Veterinary Consultants conference, William Flynn, DVM, MS, deputy director for science policy at FDA’s Center for Veterinary Medicine, updated veterinarians on the FDA’s efforts to ensure judicious use of antibiotics in food animals.
The key principles behind FDA’s policy direction, Flynn says, are:
- Limit the use of medically important antibiotics to those necessary for animal health.
- Increase veterinary involvement in decisions regarding antibiotic use in animals.
Toward those goals, FDA finalized its Guidance for Industry (GFI) 209 in April 2012, focusing on the judicious use of antimicrobials in food animals. The framework included the principles of phasing in such measures as 1) limiting medically important antimicrobial drugs to uses in food-producing animals that are considered necessary for assuring animal health; and 2) limiting such drugs to uses in food-producing animals that include veterinary oversight or consultation.
GFI 213, finalized in December 2013, provides a road map for implementing the principles in GFI 209, including guidance for drug sponsors to voluntarily withdraw performance uses from specific antimicrobials and combination products. The FDA-CVM website includes a list of affected products.
As of early July, all 26 drug manufacturers affected by GFI #213 agreed to fully engage in the strategy by phasing out the use of medically important antimicrobials in food-producing animals for food production purposes and phasing in the oversight of a veterinarian for the remaining therapeutic uses of such drugs. While GFI #213 specified a three-year timeframe (until December 2016) for drug sponsors to complete the recommended changes to their antimicrobial products, some sponsors have already begun to implement them.
Also in December 2013, FDA-CVM published a proposed Veterinary Feed Directive (VFD) rule, and a comment period on the proposed rule ended in March 2014. This rule will require producers to work through a veterinarian to obtain and file a VFD for use of medically important antimicrobials in feed. While the rule expands the list of VFD drugs, it intends to provide flexibility by revising the current VFD requirement for a valid veterinarian-client-patient relationship (VCPR), replacing it with veterinarian “supervision or oversight,” and saying veterinarians ordering the use of VFD drugs must do so “in compliance with all applicable veterinary licensing and practice requirements.”