Advocacy in action: Guidance #209 and you (July 2012)

Advocacy in Action

Guidance #209 and you

The US Food and Drug Administration (FDA) recently published the final draft of Guidance for Industry (GFI) #209 entitled The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. In short, this document outlines how FDA plans to move forward with its effort to restrict the use of medically important feed-grade antimicrobials for production purposes (ie, growth promotion and feed efficiency) in livestock. The FDA defines “medically important” as drugs considered important for therapeutic use in humans. While not legally binding, guidance documents define the agency’s current thinking on a particular topic and generally provide a roadmap for how the agency plans to conduct itself in the future regarding this topic.

Citing agency concerns regarding the development of antimicrobial resistance in humans resulting from the production use of antimicrobials, FDA is proposing a voluntary initiative (as opposed to regulatory) to phase in certain changes to how medically important antimicrobial drugs are labeled and used in food-producing animals. The agency contends that the intent of this action is to help preserve the effectiveness of medically important antimicrobials for treating disease in humans.

According to an FDA news release, GFI #209 is intended to guide veterinarians, farmers, and animal producers on the judicious use of medically important antibiotics in food-producing animals by targeting their use to address only diseases and health problems. Under this new voluntary initiative, certain antibiotics would not be used for so-called “production” purposes, such as to enhance growth or improve feed efficiency in an animal. These antibiotics would still be available to prevent, control, or treat illnesses in food-producing animals under the supervision of a veterinarian. There will be a 3-year “phase-in” period before these changes will become effective. It is unclear when this phase-in period will begin.

So how will implementation of GFI #209 impact swine veterinarians? The FDA is working with drug manufacturers to remove the growth-promotion claims from medically important feed-grade antimicrobials. This means that, since there is no legal extra-label use of feed-grade antimicrobials, administration of these products for production purposes will cease. The products will remain available for the control, prevention, or treatment of any labeled indications at the dose, duration, and frequency described on the label. The agency has indicated that they are willing to work with manufacturers on a process to facilitate the addition of medically valid indications to the existing label claims.

It is the ultimate objective, however, of the FDA to decrease the overall use of these products and to increase veterinary oversight of their use. In response to questions regarding what mechanisms the agency would use to evaluate the effectiveness of these actions, the agency noted that antimicrobial resistance-monitoring surveys, such as the National Antimicrobial Resistance Monitoring System, would be a source for such evaluation. The FDA acknowledged, however, that the multi-year ban on the use of fluoroquinolones in poultry has not resulted in a measureable decrease in campylobacter resistance in humans.

A PDF of GFI #209 can be downloaded from the FDA website at http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM216936.pdf.

In addition to GFI #209, the FDA also published the following documents in the Federal Register:

• Draft Guidance #213, New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf), which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels; adding, where appropriate, scientifically supported disease prevention, control, and treatment uses; and changing the marketing status to include veterinary oversight.

• A draft-proposed regulation modernizing the Veterinary Feed Directive (VFD) (https://www.federalregister.gov/articles/2012/04/13/2012-8844/veterinary-feed-directive-draft-text-for-proposed-regulation). This document outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.

The FDA is currently accepting comments on Draft Guidance #213 and on the VFD document. I encourage you to take the time to review these documents and to submit comments by the July 12, 2012 deadline. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

— Harry Snelson, DVM
AASV Director of Communications