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FDA completes step in fight against antimicrobial resistance

Agency also finds slowing rate of growth in drug sales, distribution

February 16, 2017

Christy Corp-Minamiji, DVM

The sales or distribution of antimicrobial drugs for use in food animals continues to rise, albeit at a slowing rate, judging from the U.S. Food and Drug Administration’s latest annual report on the subject.

Data in the 2015 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals show that 15,576,975 kilograms — 34,341,351 pounds — of active ingredient were sold or distributed domestically in 2015. That's an increase of 1 percent over the previous year.

By comparison, the amount of antimicrobial drugs sold or distributed in 2014 increased by 4 percent over 2013. During the period of 2009 to 2015, sales or distribution rose 24 percent.

Combating the rise of drug-resistant pathogens is a focused effort of the federal government and other governing bodies, which have adopted sweeping changes in the control and availability of antimicrobial drugs. California, the second-largest producer of food-animal products in the United States, has taken even more stringent measures than the federal government, including rolling out legislation mandating veterinary education in antimicrobial use and resistance.

Antimicrobial resistance happens when pathogens change such that a drug designed to kill them becomes less effective or ineffective. Overuse and misuse of antimicrobial drugs is believed to spur resistance.

Early this year, the FDA announced completion of a key step in its plan to curtail excessive antimicrobial use. Under Guidance for Industry #213 (GFI #213), any antimicrobial drugs that are labeled to be added to food or water of food animals no longer will be available over the counter. Now, these drugs are labeled for use only under a Veterinary Feed Directive (VFD).

That means livestock feed manufacturers need a VFD from a licensed veterinarian before adding antibiotics to feed for food animals. Although the final rule requiring VFDs went into effect in October 2015, the implementation of GFI #213 makes the VFD rule a practical reality.

The FDA is achieving the limits on use by eliciting the cooperation of drug companies to change the drugs’ labels. While a GFI is a guide rather than a mandate, the FDA reports that all 292 drugs affected by GFI #213 at the outset have been made compliant or withdrawn. “As a result of these changes, these products cannot be used for production (e.g., growth promotion) purposes and may only be used under the authorization of a licensed veterinarian,” the agency states.

This effort to curtail antimicrobial drug use in food animals has been underway for years and represents one of what the FDA calls its Key Initiatives for Antimicrobial Stewardship. Guidance previously released by the FDA, GFI #209, The Judicious Use of Medically Important Antimicrobials in Food-Producing Animals, lays out the rationale and framework for action.

As for GFI #213, an FDA representative told the VIN News Service this week that the new administration has not delayed or otherwise impacted its full implementation.

VIN News Service commentaries are opinion pieces presenting insights, personal experiences and/or perspectives on topical issues by members of the veterinary community. To submit a commentary for consideration, email

Information and opinions expressed in letters to the editor are those of the author and are independent of the VIN News Service. Letters may be edited for style. We do not verify their content for accuracy.


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