Update on FDA antibiotics policy

 Resize text         Printer-friendly version of this article Printer-friendly version of this article

Vet manager 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:

  1. Limit the use of medically important antibiotics to those necessary for animal health.
  2. 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.”

FDA has been working on revisions to the proposed VFD rule based on public comments, including details such as the expiration date of a VFD, premises ID versus animal ID requirements, application of the rule to feed products containing combinations of VFD and over-the-counter drugs and options for electronic filing of VFD documents. Flynn anticipates a final VFD rule to be announced in the spring of 2015.

During a question and answer session, a veterinarian asked Flynn if, and how, FDA plans to measure the results of the new rules in terms of antibiotic resistance and animal health. He responded saying FDA plans to analyze trends in the quantity of antibiotics sold for use in food animals, looking for an overall decline once the rules are in place. He acknowledged there probably is only a limited relationship between the quantity sold and the actual risk of resistance, but says a reduction in use appears to be the primary goal of special-interest groups involved in the issue. He also points out the FDA’s National Antimicrobial Resistance Monitoring System (NARMS) will continue to track trends in resistance. Just this week, NARMS issued a new report showing some slight increases but also some declines in the occurrence of resistant pathogens.

Finally, Flynn says, FDA/CVM is developing, with input from industry, ideas for actually measuring the relationships between antibiotic uses and practices and resistance trends.

For more information:

FDA Guidance for Industry 209

FDA Guidance for Industry 213

FDA proposed veterinary feed directive rule


Prev 1 2 Next All



Comments (0) Leave a comment 

Name
e-Mail (required)
Location

Comment:

characters left