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
Veterinary Feed Directive (VFD)
National Antimicrobial Resistance Monitoring System (NARMS)
Antimicrobial Drug Sales/Distribution Summary Data
The Pre-Approval Human Food Safety Assessment of Antimicrobial Drugs for Food-Producing Animals
Additional Resources
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:
- Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023 [PDF - 21 pages]
- A human food safety assessment for new antimicrobials (GFI #152),
- Guidance on judicious use (GFI #209),
- Guidance on phasing out production uses (GFI #213),
- Updates to the veterinary feed directive,
- Enhanced surveillance activities (NARMS),
- Education and outreach,
- Expanded research activities,
- Collaboration with international partners focused on resistance.
- CVM has limited the use of certain cephalosporins and withdrew the approval of fluoroquinolones for use in poultry.
- CVM has been actively engaged in identifying processes to acquire and analyze better antimicrobial use information.
Also see:
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):
- CVM GFI #209 - The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals
- CVM 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
Veterinary Feed Directive (VFD)
FDA has amended the new animal drug regulations to implement the veterinary feed directive (VFD) drugs section of the Animal Drug Availability Act of 1996 (ADAA). On June 3, 2015, the FDA published in the Federal Register the final rule revising the VFD regulations in 21 CFR Part 558. The final rule became effective on October 1, 2015. In September of 2015, FDA revised Guidance for Industry #120, Veterinary Feed Directive Regulation to reflect the VFD final rule. In March 2019 revised GFI #120 to provide additional information in response to questions that have been submitted by interested parties since 2015.
A VFD drug is intended for use in animal feeds, and such use of the VFD drug is permitted only under the professional supervision of a licensed veterinarian.
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 reports and interactive data displays, is available at the National Antimicrobial Resistance Monitoring System webpage.
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. Beginning with their reports covering the period of calendar year 2016, sponsors were required to report estimates of sales and distribution broken out by major food-producing species (cattle, swine, chickens and turkeys).
- FDA’s Proposes Biomass Method to Obtain Animal Antimicrobial Sales and Distribution Data based on Animal Species and Weight
- Final Rule to Collect Antimicrobial Sales and Distribution Information by Animal Species
- Questions and Answers: Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals
- 2020 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals
- ADUFA Reports
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 (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.
Additional Resources
- Antimicrobial Resistance Information from FDA
- FDA’s Take on the Executive Order and National Strategy to Combat Antibiotic-Resistant Bacteria
- FACT SHEET: Obama Administration Releases National Action Plan to Combat Antibiotic-Resistant Bacteria
- Extralabel Use and Antimicrobials
- Withdrawal of Enrofloxacin for Poultry
- CVM GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern
- From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process
- Interagency Task Force on Antimicrobial Resistance (ITFAR)
- Animation of Antimicrobial Resistance
- CDC: Antibiotic Resistance Threats in the United States, 2019
- Cephalosporin Order of Prohibition Questions and Answers
- FDA-TRACK: Progress on FDA’s Support of Antimicrobial Stewardship in Veterinary Settings