A Strategy to Keep Antimicrobials Effective

By: Michael R. Taylor, J.D.

Over the past century, few innovations have been as important to public health as the development and use of antimicrobial drugs to treat bacterial infections. They have been successfully used for more than 50 years to treat, control, and prevent diseases in both humans and animals. But over the years, while physicians, veterinarians, and the livestock industry have been putting these important medications to their many uses, we’ve also learned a critical lesson:  they have to be used judiciously to ensure they remain effective.

Michael R. Taylor, J.D.There are complex reasons for this development, including the overuse of antimicrobial drugs in human medicine – a problem FDA and the medical community are working to address. But we also know that an additional factor contributing to antimicrobial resistance is the use of medically important drugs for feed efficiency or growth promotion (so-called “production” uses) in food-producing animals. For the FDA, an agency that’s responsible for protecting the health of the public, this fact requires a response to help preserve the continued effectiveness of these drugs for both humans and animals.

So FDA has settled on a strategy to phase out production uses of medically important antimicrobials and provide that they be used only for targeted, FDA-approved animal health purposes under the supervision of a veterinarian. The important sea change that will enable us to implement this strategy efficiently and expeditiously has been the willingness of many drug companies, veterinarians and animal producers to work collaboratively with FDA to ensure that medically important antimicrobial drugs are used in food-producing animals only when necessary to ensure their health. Many animal producers already work in this way, and we look forward to working closely with the animal production community to make judicious use of antimicrobials standard practice throughout the industry.

In developing our strategy, FDA’s Center for Veterinary Medicine has consulted extensively with our colleagues at the U.S. Department of Agriculture, with the agricultural and veterinary communities, with the animal drug and feed industries, and with public health and consumer advocates. And, as a result of that work, we have released three documents that outline a collaborative approach to keeping antimicrobials effective by limiting their food animal use to specific medical needs.

First, we are publishing a final guidance for industry on The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. This document establishes a framework for phasing out the use of these drugs for feed efficiency or growth promotion and phasing in veterinary consultation or oversight of their medical uses in food-producing animals.

Second, we are asking for public comments on a draft guidance to drug companies on how to revise their FDA-approved product labels for medically important antimicrobial drugs to no longer include use for feed efficiency or growth promotion, and include veterinary oversight or consultation.

And third, we are publishing a draft proposed regulation, also for public comment, to streamline and modernize the current regulation that governs veterinary authorization for the use of certain drugs in animal feed.

I know there will be those who question why we have not taken mandatory action to ban production uses of antimicrobials. The answer is that, with the willingness of drug companies and others in the animal production industry to collaborate in implementing our strategy, we can make changes more quickly than if we had to rely solely on a cumbersome regulatory process that would require us to seek change drug by drug, and labeled use by labeled use. Working together is how we will get good results in a timely manner.

In implementing our strategy, we want to avoid adverse impacts on animal health and disruptions to the agricultural industry. We anticipate that the phase out of production uses of antimicrobials and establishment of veterinary oversight of remaining ones will take three years. For that reason, in the draft guidance to drug companies we are proposing this timeframe for implementation. We intend to monitor progress after the three-year timeframe has elapsed to evaluate the rate of adoption of these changes. If progress is not what we expected, we will consider further action as warranted in accordance with existing provisions of the FD&C for addressing matters related to the safety of approved new animal drugs.

We know, and so do our colleagues at USDA, that change will be more challenging for small-scale and geographically remote animal producers. It will take time to ensure they have the veterinary support these changes will require and other technical assistance to adjust to the phase out. And we won’t forget about these unique needs.

Concerns about the use of antimicrobial drugs in humans and food-producing animals have been on FDA’s agenda for many years. We see the collaborative strategy we are announcing as a major step forward. It is designed to protect and promote the health of the American public while minimizing disruption to animal health and the animal agriculture industry. We look forward to the public’s comments and to the work ahead to achieve these important goals.

Mike Taylor is Deputy Commissioner for Foods at FDA

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