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FDA Statement

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings

For Immediate Release:
Statement From:

Antimicrobial resistance is a global public health challenge. Antimicrobial drugs have been widely used in human and veterinary medicine for more than 60 years. When used judiciously, antimicrobials can effectively fight bacterial infections. However, we know that overuse or misuse of these drugs promotes the development of antimicrobial-resistant bacteria.

For all of these reasons, it’s critical that we implement good antimicrobial stewardship practices in human healthcare and veterinary settings. We must continue to take new steps to slow the development of resistance and extend the usefulness of these lifesaving drugs.

Combating antimicrobial resistance continues to be a top priority for the U.S. Food and Drug Administration (FDA).

To further these efforts, the FDA will soon implement a new, five-year blueprint for how the FDA plans to build on its current programs to advance antimicrobial stewardship in veterinary settings. We’ll expand on the FDA’s existing actions, and launch some new programs. Our aim is to reduce overuse of antimicrobial drugs and combat the rising threat of resistance.

As part of the FDA’s regulatory mission, our Center for Veterinary Medicine (CVM) is responsible for ensuring the safety and effectiveness of animal drugs, including antimicrobials. CVM has already taken important steps to update the approved conditions of use for medically important antimicrobials (i.e., antimicrobials important for treating human disease) to support judicious use in food-producing animals. While important progress has been made, we know that additional work is needed to address the complex challenge of antimicrobial resistance.

At FDA, we believe that the concept of antimicrobial stewardship encompasses several important principles of judicious use. These are critical to slowing the rate at which bacteria develop resistance to antimicrobial drugs. In simple terms, we believe medically important antimicrobial drugs should only be used when necessary to treat, control or prevent disease. In addition, when such use is necessary, these antimicrobials should be used in an optimal manner. They should only be used under the oversight of a licensed veterinarian.

Among the steps that CVM has already taken, perhaps the most significant action was implementation of Guidance for Industry #213. On Jan. 3, 2017, the FDA announced that it had completed implementation of GFI #213. This was the culmination of a process launched in 2013. The goal was to transition medically important antimicrobials that are used in the feed or drinking water of food-producing animals to veterinary oversight, and to eliminate the use of these products in animals for production purposes, such as for growth promotion.

Of the 292 new animal drug applications initially affected by GFI #213, 84 were completely withdrawn. Of the remaining 208 applications, 93 applications for oral dosage form products intended for use in water were converted from over-the-counter to prescription status; while another 115 applications for products intended for use in feed were converted from over-the-counter to veterinary feed directive status. Moreover, production indications (e.g., growth promotion) were withdrawn from all 31 applications that included such indications for use.

Last year, we also published a paper proposing the use of a biomass denominator to adjust annual data on the amount of antimicrobials sold or distributed for use in food-producing animals in the U.S. This adjusted estimate is intended to provide more insight into broad shifts in the amount of antimicrobials sold for use in food-producing animals and give the FDA a more nuanced view of why sales increase or decrease over time in a manner that is specific to U.S. animal production. The agency also recently launched the Resistome Tracker. This is an interactive research and data visualization tool for antibiotic resistance genes.

To build on the progress already made, we’re announcing that the FDA will shortly publish a blueprint on how we’ll press forward and implement additional steps to address antimicrobial resistance in veterinary settings. This blueprint will serve as the FDA’s new, five-year plan. We’ll include key goals, objectives and actions that CVM will focus on during fiscal years 2019 – 2023.

Our new activities will be aimed at addressing three key goals:

Aligning antimicrobial drug product use with the principles of antimicrobial stewardship; supporting efforts to foster better stewardship of antimicrobials in veterinary settings; and enhancing the monitoring of antimicrobial resistance and antimicrobial drug use in animals.

The specific objectives and actions will be outlined in our forthcoming plan.

Some of the important issues to be addressed in this new plan include establishing appropriate durations of use of medically important antimicrobials, and bringing all dosage forms of medically important antimicrobials under veterinary oversight. We are also developing and advancing new strategies for promoting antimicrobial stewardship in companion animals.

We’ll advance these goals in new guidance that the FDA will develop with broad stakeholder input. And we’ll enhance transparency and keep the public apprised of progress being made.

For example, we’ll shortly publish a list of all medically important antimicrobials labeled for use in animals that lack a defined duration of use on their labels. We’ll keep this list updated as we work to implement a science-based approach for addressing this important issue.

We’re also advancing new strategies to improve the collection and sharing of data on antimicrobial drug use and resistance. To advance evidence-based practices, we need to make sure that the entire community has access to good information. And we need to develop a long-term strategy for implementing a practical, efficient antimicrobial use monitoring and reporting system for veterinary settings. Our plan will address new ways to advance these goals.

Many stakeholders helped make our previous efforts a success. These include the animal pharmaceutical and feed industry; veterinary organizations; animal producer organizations; consumer organizations; various local, state and federal agencies; legislators; and other key stakeholders.

I look forward to releasing this plan shortly, and continuing to work collaboratively to promote stewardship and preserve the effectiveness of antimicrobials for human and animal health.

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Juli Putnam

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