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  1. Antimicrobial Resistance

FDA’s CVM Key Initiatives for Antimicrobial Stewardship

Antimicrobial drugs have been widely used in veterinary medicine for more than 50 years. When used judiciously, antimicrobials can effectively fight infections and improve animal health. However, overuse of antimicrobials promotes the development of antimicrobial-resistant bacteria. Today, antimicrobial resistance is a worldwide phenomenon and growing problem. To slow the emergence of resistance and extend the useful life of antimicrobials, stewardship of antimicrobials in both human health and veterinary settings is essential.

The Food and Drug Administration (FDA) is committed to antimicrobial stewardship and supports several important principles that are critical to curbing or slowing the emergence of antimicrobial resistance. With respect to veterinary settings, these principles are 1) antimicrobial drugs should only be used when necessary to treat, prevent or control disease, and 2) when antimicrobials are used, these drugs should be administered in an optimal manner under the supervision of a licensed veterinarian.

Although FDA has broad authority to ensure the safety of antimicrobial animal drugs, there are some limitations to what we can do. Factors such as animal husbandry and biosecurity practices can have a significant impact on infectious disease incidence and, in turn, on the need for antimicrobials to treat, control, or prevent disease. Another critically important factor is the role the veterinary profession plays in overseeing when and how antimicrobials are used. Taking such factors into consideration is critical when developing and implementing comprehensive antimicrobial stewardship plans in veterinary settings. However, given that FDA does not generally regulate animal husbandry, farming activities, or the practice of veterinary medicine,1 our direct role in this area is limited.

Although FDA has taken a number of steps to support antimicrobial stewardship, effectively implementing stewardship principles in veterinary settings requires a collaborative effort that includes contributions from a broad interdisciplinary set of stakeholders. These include veterinary pharmaceutical manufacturers and distributors, feed manufacturers and distributors, veterinarians, animal producers, academic organizations, food safety advocacy groups, a number of Federal, State, and local agencies, and other key stakeholders.

To further advance antimicrobial stewardship, the Agency will focus on the following key initiatives over the course of the next five years: (1) Align antimicrobial drug products with the principles of antimicrobial stewardship in veterinary settings; (2) Support efforts to foster stewardship of antimicrobials in veterinary settings; and (3) Assess the impact of strategies intended to curb the emergence of antimicrobial resistance associated with the use of antimicrobial drugs in veterinary settings.

Key Initiative 1: Align antimicrobial drug products with the principles of antimicrobial stewardship in veterinary settings

In an effort to align all approved medically important antimicrobial drug products with the principles of antimicrobial stewardship, FDA is undertaking three important initiatives:

  • On an ongoing basis, FDA will continue to enhance our processes to support innovation and new product development, including encouraging the development and deployment of new antimicrobials and alternatives to antimicrobials for addressing animal health needs.
  • FDA will work with industry and other stakeholders to update the conditions of use for approved medically important antimicrobial drugs, as necessary, to align with the principles of judicious use.
  • FDA will develop a strategy for antimicrobial stewardship in companion animals.

Key Initiative 2: Support efforts to foster stewardship of antimicrobials in veterinary settings

As the regulatory agency responsible for ensuring that veterinary drugs are safe and effective, it is FDA’s role to take steps to promote antimicrobial stewardship, such as bringing medically important antimicrobials under veterinary oversight. These steps need to be supported with both education and compliance activities in order to ensure effective implementation.

  • FDA will continue to work with stakeholders to help coordinate the Agency’s actions with the broader effort to foster stewardship of antimicrobials in animals.
  • FDA will launch a multi-year effort to support education. This includes, but is not limited to, enhancing online access to information regarding antimicrobial use, working with State agencies and key stakeholders on disseminating information on stewardship, and assisting academic institutions in developing veterinary curricula that address antimicrobial stewardship principals.
  • FDA will finalize the VFD compliance program to ensure that veterinary professionals, feed mills and animal producers adhere to VFD requirements.

Key Initiative 3: Assess the impact of strategies intended to curb the emergence of antimicrobial resistance associated with the use of antimicrobial drugs in veterinary settings

Gathering information on how medically important antimicrobials are used in animals is essential to understand the drivers of resistance in animal agriculture and the success of interventions designed to reduce the emergence of antimicrobial resistance. This is accomplished by:

  • Enhancing the collection of antimicrobial drug use data in veterinary settings;
  • Enhancing the collection of data on antimicrobial resistance patterns
  • Increasing the exchange of information among stakeholders to aid in the monitoring of antimicrobial drug use practices and resistance.

FDA is committed to advancing efforts to implement good antimicrobial stewardship practices in veterinary settings. Fostering stewardship of antimicrobials used in animals is an essential component of the overall effort to combat the emergence of antimicrobial resistant bacteria and help preserve their effectiveness in both veterinary and human medicine.

While the focus of our key initiatives is on addressing antimicrobial resistance in the United States, FDA recognizes that antimicrobial resistance is a global problem and slowing the emergence and spread of resistance and extending the useful life of antimicrobials requires global solutions. Therefore, as we collaborate with our domestic partners, we will continue to engage our international partners in our efforts to promote animal health and extend the useful life of medically important antimicrobials.

If you have questions, please contact the Center for Veterinary Medicine at AskCVM@fda.hhs.gov.

1  We note, however, that the extralabel use of animal drugs is regulated by FDA, and that extralabel use must meet the requirements of sections 512(a)(4) and (5) of the Federal Food, Drug, and Cosmetic Act and FDA regulations at 21 CFR part 530. In implementing and enforcing the extralabel provisions of Federal law, we are regulating animal drugs, not regulating the practice of veterinary medicine. Although FDA does not generally regulate farming activities, we do regulate food and drugs given to food-producing animals.


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