CVM Antimicrobial Stewardship in FY 2023 and Beyond

By Bill Flynn, DVM, MS, Deputy Director of FDA’s Center for Veterinary Medicine

Today, we kick off Antimicrobial Awareness Week, held every year from November 18-24.  This recognition is a great opportunity to reflect upon what we at FDA’s Center for Veterinary Medicine (CVM) are doing to address antimicrobial resistance (AMR) and preserve the effectiveness of these critical and life-saving drugs. In this post, I’m mainly going to focus on what we accomplished in FY 2023.

Some of what CVM did in FY 2023

OTC to Rx

One of the biggest achievements during 2023 was the full implementation of Guidance for Industry (GFI) #263, under which animal drug sponsors voluntarily changed the approved marketing status of certain medically important antimicrobial drugs for animals from over the counter (OTC) to prescription (Rx).   

The result: all medically important antimicrobials approved for use in animals now require the authorization of a licensed veterinarian. This means the veterinarian is involved in helping their clients select the most appropriate treatment for their animals. This is an important milestone in FDA’s efforts to promote judicious use of antimicrobials in animals.

We applaud all affected drug sponsors for working with us to voluntarily make this change and appreciate the efforts of veterinarians and producers to adjust practices in response. 

Defining Durations of Use

Another key accomplishment was the release of draft GFI #273, which provides recommendations on how animal drug sponsors can voluntarily establish a defined duration of use for certain approved medically important antimicrobials that lack such information on the product label.  A duration of use specifies how long a drug is used for a particular indication. 

The objective of this initiative is to revise the use conditions of affected products to better target when and for how long a drug may be used to effectively treat, control, or prevent the disease(s) for which the product is indicated. Updating this label information is intended to provide for the continued effective use of these products while minimizing the extent of antimicrobial drug exposure. 

If you have input to share on draft GFI #273, there’s still time to comment.

Biomass Denominator

Near the beginning of FY 2023, we launched a data visualization dashboard that applies a biomass denominator to the sales and distribution data FDA publishes annually. Animal biomass is defined as the population of a given livestock species in the U.S. multiplied by the average weight of that species. In this method, a biomass denominator adjusts FDA’s annual antimicrobial sales data to account for the size of the population of a given livestock species in the U.S. potentially being treated with those drugs. Animal population and average weight statistics used to calculate animal biomass come from U.S. Department of Agriculture databases. Biomass-adjusted sales estimates allow for interpretation of antimicrobial sales trends relative to the U.S. livestock population and animal drug approvals.

Exploring Feasibility of Collecting Data on Antimicrobial Use in Animals

And finally, a recap of key FY 2023 AMR activities at CVM would be incomplete without mentioning our ongoing efforts to track trends in antimicrobial use in animals. In August, we presented a possible framework for establishing a public-private partnership to collect and analyze data on antimicrobial use in food-producing animals. The framework was laid out in a report generated by Reagan-Udall Foundation. The report incorporated stakeholder feedback obtained by the foundation in focus groups and through comments shared in a docket and at an FDA public meeting. More to come on this issue as we consider comments received and consider next steps. We believe antimicrobial use information, which could provide more context on why and how antimicrobials are used, could better inform FDA’s judicious use policies, and serve as a resource for veterinarians and animal producers to inform antimicrobial stewardship strategies.

What CVM intends to do next 

Last month, CVM released “Supporting Antimicrobial Stewardship in Veterinary Settings, Goals for Fiscal Years 2024-2028.” This five-year plan builds upon the progress of our previous plan for FY 2019-2023. 

The plan is intended to provide stakeholders with a transparent roadmap of actions that correspond to FDA’s three main veterinary stewardship goals:

1. Align antimicrobial drug product use with the principles of antimicrobial stewardship
2. Foster stewardship of antimicrobials in veterinary settings
3. Enhance monitoring of AMR and antimicrobial drug use in animals

To see how we perform and to follow our future progress, visit our dashboard: FDA-TRACK: Progress on FDA’s Support of Antimicrobial Stewardship in Veterinary Settings.

I look forward to sharing more details regarding our antimicrobial stewardship efforts sometime in 2024.