Animal & Veterinary

Antimicrobial Resistance

Antimicrobial resistance is recognized as a growing global threat. In 2014, the White House announced the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB), underscoring the need to address antimicrobial resistance. FDA has and continues to be integral in these efforts.

Antimicrobial use in animals can contribute to the emergence of antimicrobial resistance in bacteria that may be transferred to humans, thereby reducing the effectiveness of antimicrobial drugs for treating human disease. FDA CVM has developed a multipronged strategy designed to limit or reverse resistance arising from the use of antibiotics in food-producing animals, while continuing to ensure the availability of safe and effective antibiotics for use in animals and humans.


What is FDA CVM Doing to Address Antimicrobial Resistance?
Judicious Use
National Antimicrobial Resistance Monitoring System (NARMS)
The Pre-Approval Human Food Safety Assessment of Antimicrobial Drugs for Food-Producing Animals
Antimicrobial Drug Sales/Distribution Summary Data


What is FDA CVM Doing to Address Antimicrobial Resistance?

FDA/CVM is engaged in numerous activities to address the threat of antimicrobial resistance arising from the use of medically important antimicrobials in food-producing animals. These activities include:

Also see:

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Judicious Use

Judicious use of antimicrobials is an integral part of good veterinary practice. Judicious use refers to drug use practices aimed at maximizing therapeutic efficacy while minimizing the selection of resistant microorganisms.

The principles of FDA’s judicious use policy include 1) limiting medically important antimicrobial drugs to uses in food-producing animals that are considered necessary for assuring animal health; and 2) limiting medically important antimicrobial drugs to uses in food-producing animals to those that include veterinary oversight or consultation.

More information, including progress updates, can be found on CVM’s Judicious Use of Antimicrobials webpage. Additionally, FDA has published two guidance documents (Guidance for Industry, GFI):

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National Antimicrobial Resistance Monitoring System (NARMS)

Antimicrobial resistance is directly related to the safety and efficacy of FDA-regulated products. As such, FDA coordinates the NARMS program, a surveillance system that collects information on antibiotic resistance in foodborne bacteria. The NARMS program was established in 1996 as a partnership between the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Agriculture (USDA). The purpose of NARMS is to track resistance trends to help in the pre-approval evaluation of new animal antibiotics, to identify emerging resistance hazards and to measure interventions aimed at limiting resistance. To do this, NARMS monitors antimicrobial susceptibility in enteric bacteria from humans, retail meats, and food-producing animals. Detailed information regarding the NARMS program, including comprehensive annual reports, is available at the National Antimicrobial Resistance Monitoring System webpage.

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The Pre-Approval Human Food Safety Assessment of Antimicrobial Drugs for Food-Producing Animals

In order to assess the risks to human health from the consumption of animal-derived food products, such as meat or milk, FDA requires animal drug sponsors to provide information to the FDA about their product prior to approval. When the proposed use is in a food-producing animal species (for example, poultry, swine, or cattle), this information details potential risks to public health from consumption of edible food products from those animals. FDA evaluates risks associated with any proposed antimicrobial drug, including risks associated with development of antimicrobial-resistant bacteria of public health concern in the food supply.

FDA uses data from the National Antimicrobial Resistance Monitoring System (NARMS) and other sources to reach an overall risk estimation for the proposed use of an antimicrobial drug in food-producing animals. This risk estimation is used to guide FDA’s decision to approve or deny the use of an antimicrobial drug in food-producing animals. FDA may also limit a drug’s conditions of use based on this risk estimation to lessen the risk of antimicrobial resistance development.

In 2003, FDA published a guidance document for the animal drug industry to evaluate the potential development of antimicrobial resistance resulting from the use of antimicrobial new animal drugs in food-producing animals. This FDA guidance is available at GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern (PDF - 290KB) (en Español).

FDA also evaluates the effects of antimicrobial residues in animal-derived foods on the intestinal flora of human consumers. This FDA guidance on pre-approval safety assessment of drugs for food-producing animals is available at GFI #159, VICH GL36 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI (PDF - 533KB)

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Antimicrobial Drug Sales/Distribution Summary Data

The Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA) amended section 512 of the Federal Food, Drug, and Cosmetic Act (FFDCA) to require antimicrobial drug sponsors to annually report to FDA the amount of antimicrobial active ingredient in their drugs that have been sold or distributed for use in food-producing animals. ADUFA 105 also requires FDA to prepare summary reports of the sales and distribution information received from drug sponsors each year to provide those summary reports to the public. The 2012 summary report incorporates a new, more detailed format than was previously available.

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Page Last Updated: 06/12/2015
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