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FDA Statement

Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s 2017 report on declining sales/distribution of antimicrobial drugs for food animals, a reflection of improved antimicrobial stewardship

For Immediate Release:
Statement From:
Scott Gottlieb, M.D.

Every year, at least two million Americans are sickened by serious infections caused by antimicrobial-resistant (AMR) pathogens, such as MRSA. And, at least 23,000 people die as a direct result of these infections. AMR is the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug. It’s a serious, complex and costly public health problem.

Optimizing how medically important antimicrobial drugs are used and limiting their use to only when necessary to treat, control or prevent disease will help to preserve the effectiveness of these drugs for fighting disease in both humans and animals. While it’s impossible to completely outrace antimicrobial resistance, we can take important steps now to slow its pace and reduce its impact on both human and animal health.

Earlier this year, I announced the FDA’s 2019 Strategic Approach for Combating AMR. This comprehensive plan is part of an ongoing, agency-wide initiative to build on our past efforts, and to coordinate policy and external partnerships to help confront AMR as it relates to a variety of FDA-regulated products, including biologics, medical devices, as well as human and veterinary drugs.

Today, I’d like to focus on how we’re addressing AMR in the context of veterinary antimicrobial drugs and their use in food-producing animals. The FDA’s Center for Veterinary Medicine (CVM), along with our industry partners and veterinarians, have made great strides over the past year to support antimicrobial stewardship in animals. A new CVM report issued today suggests that our efforts are paying off.

I’m pleased to share the 2017 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals. This report highlights a 33 percent decline between 2016 and 2017 in domestic sales and distribution of all medically important antimicrobials intended for use in food-producing animals.

The report also shows a decline of 43 percent since 2015, the peak year of sales/distribution since the FDA began issuing these annual reports, and a decline of 28 percent since the first sales report which summarized the sales/distribution data for 2009. These reductions are an indication that our ongoing efforts to support antimicrobial stewardship are having a significant impact.

It’s important to note that this year’s report is the first to include sales/distribution data submitted after all medically important antimicrobial drugs administered to food-producing animals in their feed or water were no longer allowed to be used for growth promotion and could only be obtained through a veterinarian’s order. This sea change was a direct result of the roadmap that the FDA provided to animal drug sponsors in Guidance for Industry (GFI) #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. This guidance included recommendations for industry on how to eliminate production uses (e.g., growth promotion, feed efficiency) of medically important antimicrobials in the feed and drinking water of food-producing animals. The guidance also explained the importance of bringing the remaining therapeutic uses of these drugs under veterinary oversight.

The successful implementation of changes, such as those outlined in GFI #213, depend heavily on the commitment of our key partners and stakeholders, including animal pharmaceutical and feed industries, the animal agriculture community, the veterinary community, and other federal and state agencies, such as the U.S. Department of Agriculture. At the FDA, we continue to renew our commitment to work in consultation with all of our stakeholders and across government to identify ways to develop and disseminate information on antimicrobial stewardship. This ranges from collaborating with consumer groups to providing information to animal producer groups and veterinarians on good stewardship practices, to working with veterinary medical associations and academic institutions to create veterinary curricula with the most up-to-date information on antimicrobial stewardship.

The data summarized in the 2017 Sales/Distribution report is collated from estimates of antimicrobial animal drug product sales for that year provided by the drug manufacturers and can’t be substituted for actual usage data. For example, veterinarians and animal producers may purchase antimicrobial drugs, but never actually administer them to animals, or they may administer the drugs in later years. The sales trends reflected by the 2017 report are very encouraging, and I’m pleased to see that the sales and distribution of these antimicrobial drugs has declined significantly the past two years. Although the 2017 sales/distribution data being made available today can’t be used to forecast numbers for the upcoming year, we hope that this downward trend will continue.

While I’m very pleased with the results of the report, and the efforts by all of our stakeholders thus far to improve antimicrobial stewardship, our work isn’t yet done when it comes to fighting antimicrobial resistance.

CVM’s five-year action plan, unveiled in September, outlines additional steps that the FDA intends to take to continue fostering our momentum in antimicrobial stewardship across veterinary settings.

The plan involves a broad set of actions intended to combat antimicrobial resistance and preserve the effectiveness of antimicrobial drugs. This includes, for example, applying a risk-based approach to evaluate new and currently approved antimicrobial products for animals. It also calls for further collaboration with key stakeholders to support stewardship of these products and facilitates the collection of data on resistance and antimicrobial use to monitor the effectiveness of this action plan in slowing the development of resistance.

The items outlined in the action plan will be initiated in phases over the next five fiscal years (2019 – 2023). This phased approach will allow for adjustments to be made based on critical, science-based analysis, public health impact, feedback from stakeholders and resource availability. Down the road, we will continue to engage our stakeholders and the public as we develop and implement strategies for addressing individual actions and goals identified in this plan.

This action plan is an integral piece to our 2019 Strategic Approach for Combating AMR in both veterinary and human health care settings, including efforts to facilitate product development to ensure a robust pipeline of safe and effective treatments that can combat resistant organisms. I’m confident that our present efforts, and additional steps we’ll take in the future, will help us advance antimicrobial stewardship across human and animal health to slow the development of antimicrobial resistance.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.



Lindsay Haake

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