For more than 60 years, antimicrobial drugs have been widely used to effectively fight bacterial infections in humans and animals. When bacteria develop resistance to an antimicrobial drug, that drug may be less effective in fighting infections caused by those bacteria. Using antimicrobial drugs in humans and in animals can contribute to the emergence of antimicrobial resistance in bacteria, thereby reducing the effectiveness of antimicrobial drugs for treating human disease.
The U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) has developed a multi-pronged, multi-year strategy designed to slow the emergence of resistance arising from the use of antibiotics in animals, while continuing to ensure the availability of safe and effective antibiotics for use in animals and humans. Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for FYs 2019 - 2023 serves as CVM’s action plan for guiding its activities over the next five years to combat antimicrobial resistance and help preserve the effectiveness of medically important antimicrobial drugs. The performance measures on this web page align with three overarching goals in CVM’s plan:
Veterinary Oversight of Medically Important Antimicrobial Drugs
Judicious use of antimicrobials is an integral part of good veterinary practice. We believe judicious use includes using antimicrobials only when it is necessary and in a manner that strives to provide effective therapy while minimizing the selection of resistant microorganisms.
The principles of FDA’s judicious use policy include ensuring medically important antimicrobial drugs are used under the supervision of licensed veterinarians and limiting uses of medically important antimicrobial drugs in food-producing animals to those considered necessary for assuring animal health.
Accomplishments: Implementation of 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, brought all 292 approved applications for medically important antimicrobials intended for use in the feed and drinking water of food-producing animals under veterinary oversight or voluntarily withdrew their approvals.
Based on the FDA 2017 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals, this represents approximately 95%, by weight, of all medically important antimicrobials sold/distributed for use in food-producing animals in the United States. The remaining 5%, by weight, of medically important antimicrobials includes products approved for routes of administration other than feed or drinking water.
Next Steps: To understand the impact of CVM’s actions, we aim to track label revisions for the medically important antimicrobial drugs that remain available over-the-counter as they transition to prescription marketing status.
Disposition of the remaining 94 approved applications is CVM’s target for the new effort being captured under Draft GFI #263, Recommendations for Drug Sponsors for Voluntarily Bringing under Veterinary Oversight All Medically Important Antimicrobial Drugs in Animals that Continue to be Available as Over-the-Counter Products. Of the 94 remaining approved applications available without a prescription or Veterinary Feed Directive (VFD) authorization, 76 are dosage forms other than feed or water administration (e.g., injectable, intramammary) marketed for food-producing animals, 2 are all dosage forms for companion animals, and 16 are all dosage forms for both food-producing and companion animals.
In Draft GFI #263, CVM is providing affected sponsors with a process to change the marketing status of the remaining over-the-counter products. As industry completes this process, updated labels will reflect the transition to veterinary oversight (prescription status). Alternatively, there may be cases where a sponsor decides to withdraw a product’s approval.
Once Draft GFI #263 is fully implemented, all medically important antimicrobials approved for use in animals (both food-producing and companion) will be under the oversight of a licensed veterinarian.
Duration of Use of Medically Important Antimicrobial Drugs
Another contributor to the development of antimicrobial resistance could be the administration of medically important antimicrobial drugs for undefined periods. The principles of antimicrobial stewardship, including judicious use, emphasize that medically important antimicrobial drugs should only be used to treat, control, or prevent a disease and be administered for an appropriately targeted period (that is, have a defined duration of use).
Our primary objective in defining durations of use is to update certain product dosage regimens to define when and for how long the drug may be used. Defining appropriately targeted durations of use for the approved applications that lack this information supports CVM’s ongoing efforts to slow the development of antimicrobial resistance.
Accomplishments: Since 2003, CVM has required all new unique indications for pioneer new animal drug approvals to include a defined duration of use. As a result, about 70% of all currently approved medically important antimicrobial drugs administered in the feed or water of food-producing animals already have a defined duration of use.
Next Steps: There are currently 85 approved animal drug applications that lack a defined duration of use. CVM will work over the next several years to establish targeted durations of use, so that veterinarians have clear labeling indications and instructions on how long to use a medically important antimicrobial drug.
In some cases, there may be significant scientific and technical challenges to establishing defined durations of use, such as the potential need to generate appropriate supporting data. CVM has issued a funding opportunity announcement and Request for Applications (RFA) for studies that can help target and define durations of use for certain medically important antimicrobial drugs approved for use in the feed of food-producing animals. We intend this funding to help generate publicly available data that sponsor(s) of affected approved animal drug applications can use to update product dosage regimens to better target when and for how long the drug may be used.
Additionally, CVM will publish a draft guidance that addresses establishing defined durations of use for affected new animal drug applications. This draft guidance will outline a proposed process and timeline for sponsors to revise approved conditions of use accordingly.
As with our approaches in GFI #213 and Draft GFI #263 to bringing medically important antimicrobial drugs under the supervision of licensed veterinarians, CVM will work with industry to update product labeling to provide for appropriately defined durations of use. We expect implementation timelines to vary by application. In some cases, sufficient data already may be available to establish appropriately defined durations of use, but in other cases, new studies may be needed to generate these data.
Enhancing Processes to Support New Product Development
CVM is responsible for ensuring that animal drugs are safe and effective for their approved conditions of use. To accomplish this, CVM conducts an extensive premarket review of the safety and effectiveness data for each animal drug and monitors the safety and effectiveness of each drug after it is approved for marketing.
While medically important antimicrobials are valuable tools for addressing certain animal health needs, identifying alternatives for managing animal disease can reduce reliance on such drugs and help slow the development of resistance.
Accomplishments: Since implementing GFI #152, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern, in 2003, CVM has assessed antimicrobial resistance risk for all new medically important antimicrobial products intended for use is food-producing animals. As part of CVM’s premarket antimicrobial resistance risk assessment, FDA ranks antimicrobial drugs according to their importance to human medicine following criteria in Appendix A of GFI #152.
Next Steps: FDA needs to update this human medical importance ranking to reflect current science and medical practice. Having an up-to-date GFI #152 in place is vital to ensure that as part of the animal drug approval process there is an effective process for assessing antimicrobial resistance concerns. Therefore, as part of our actions, we intend to re-examine the list of medically important antimicrobial drugs in GFI #152 and update the list and ranking process as necessary. FDA is considering soliciting public input in early 2020, prior to initiating the formal public comment process on draft guidance.
In addition to updating Appendix A of GFI #152 for assessing new animal drug applications, CVM will seek opportunities to facilitate alternative product development and focus on innovative methods to assess alternatives to antimicrobial drugs. CVM also advocates for non-drug alternatives when appropriate, such as changes in husbandry, biosecurity, vaccination, and other factors. Consistent with its mission, CVM is interested in exploring how new technologies and novel animal drug products could be used to address animal health needs and reduce reliance on medically important antimicrobials.
To ensure users of animal antimicrobial drug products have the information they need to use these products in accordance with applicable requirements and guidelines, CVM is undertaking three important objectives under Goal 2. These objectives balance educational and compliance activities. To foster antimicrobial stewardship in veterinary settings, CVM is working to make information associated with antimicrobial drug use more readily available to stakeholders. CVM is also strengthening compliance program activities by continuing to implement its phased compliance strategy for the VFD final rule. Additionally, CVM is committed to working with global counterparts and stakeholders to develop and implement antimicrobial stewardship policies.
This section of FDA-TRACK is under development and will report on performance against Goal 2 soon.
To develop a science-based and comprehensive understanding of antimicrobial drug use and resistance in veterinary settings, CVM is undertaking three important objectives under Goal 3. These objectives center on data collection and analysis of both antimicrobial drug use in animal agriculture and the ecology of antimicrobial resistance in bacteria pathogenic to humans. Additionally, CVM will continue to expand stakeholder engagement, data sharing, and collaboration to enhance monitoring of both antimicrobial resistance and antimicrobial drug use in veterinary settings.
This section of FDA-TRACK is under development and will report on performance against Goal 3 soon.
Note: The data provided on this website are produced on an ongoing basis for performance management purposes and are subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time.