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  5. Questions and Answers: Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals
  1. Animal Drug User Fee Act (ADUFA)

Questions and Answers: Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals

Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) requires that animal drug companies annually report to FDA the amount of antimicrobial drugs they sell or distribute for use in food-producing animals. ADUFA 105 also requires FDA to issue annual summary reports of these sales and distribution data.

In 2014, FDA increased the amount of data included in its annual summary reports. FDA’s annual summary reports currently include additional data tables on the importance of each drug class in human medicine, the approved routes of administration for these antimicrobials, whether these antimicrobials are available over-the-counter or require veterinary oversight, and whether the antimicrobial drug products are approved for therapeutic purposes, or for production purposes or both therapeutic and production purposes. 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).

Why does the FDA collect this information?
Do the sales and distribution data in this report translate to actual use?
What information does the FDA include in the annual summary report?
Where can I find the FDA’s annual summary reports for past years?
How do the data in FDA’s annual summary reports compare to the estimates of antimicrobial drug sales or distribution data that have been reported by other organizations?
Why are drug sponsors that manufacture and distribute antimicrobial drugs not named in the summary report?
Because some antimicrobial drug products for food-producing animals are also approved for use in companion animals, how much of an effect does the use of these drug products in companion animals have on trends in the sales of certain antimicrobial classes, as reported in the Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals?
How much of the recent domestic sales as reported in the 2022 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals is likely attributable to drugs that are exported by distributors without the sponsors’ knowledge?
What is FDA’s Interactive Summary of Biomass-Adjusted Antimicrobial Sales Data, and what information does it provide that isn’t in the annual sales and distribution summary report?

Why does the FDA collect this information?

With the passage of the Animal Drug User Fee Amendments of 2008, Congress established specific reporting requirements for sponsors (i.e., manufacturers) of antimicrobial animal drugs. Section 105 of that legislation (ADUFA 105) requires such sponsors to annually report to FDA on the amount of each antimicrobial active ingredient in the drug products they sell or distribute for use in food-producing animals.

ADUFA 105 requires animal drug sponsors to list the target animals and production classes specified on the approved labels of the products in their annual reports but does not require them to break out the total sales or distribution data by individual food-producing species. In May 2016, the agency issued a final rule for drug sponsors of antimicrobials sold or distributed for use in food-producing animals which codified the reporting requirements in ADUFA 105 and established a new requirement for such sponsors to provide estimates of sales broken out by major food-producing species (cattle, swine, chickens, and turkeys). Information for each calendar year must be submitted to FDA by March 31st of the following year. In addition, consistent with ADUFA 105, the final rule provides for FDA to continue to prepare and make publicly available annual summaries of this sales and distribution information.

Do the sales and distribution data in this report translate to actual use?

These sales and distribution data only reflect the total quantity of antimicrobial drug product that enters the market, and does not represent how much or in what way these drugs are ultimately used. For instance, veterinarians and animal producers may purchase drugs in anticipation of using them but never actually administer them to animals, or they may use them in later years.

What information does the FDA include in the annual summary report?

The current report format contains various types of information, including data tables on the importance of each drug class in human medicine, aggregate data on the approved routes of administration for these drug products, as well as information about whether the drug products are available over the counter or require veterinary oversight, and whether they are approved for use for therapeutic purposes, or for production purposes or both therapeutic and production purposes. The report also contains sales and distribution information broken down by major food-producing species (cattle, swine, chickens, and turkeys).

Where can I find the FDA’s annual summary reports for past years?

Reports for previous years can be found on FDA's ADUFA Reports page.

How do the data in FDA’s annual summary reports compare to the estimates of antimicrobial drug sales or distribution data that have been reported by other organizations?

FDA’s annual summary report is not directly comparable to other reported estimates of antimicrobial drug sales or distribution. The summary report includes data on the quantity of antimicrobial drugs sold or distributed for use in all food-producing animal species for all purposes, both therapeutic and non-therapeutic, and includes all dosage forms. Other reported estimates have included different categories of antimicrobials and used different sources of information; thus, they cannot be directly compared to FDA’s annual summary report.

Why are drug sponsors that manufacture and distribute antimicrobial drugs not named in the summary report?

ADUFA 105 requires FDA to summarize sales and distribution data by antimicrobial drug class. As directed by Congress, no individual sponsors are publicly identified in the summary report in order to protect confidential business information. In addition, ADUFA 105 specifies that data from antimicrobial drug classes with fewer than three distinct sponsors only be included in aggregated form in this report.

Because some antimicrobial drug products for food-producing animals are also approved for use in companion animals, how much of an effect does the use of these drug products in companion animals have on trends in the sales of certain antimicrobial classes, as reported in the Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals?

Of the more than 127 medically important antimicrobial products approved for use in food-producing animals that were actively marketed in 2023, only 10 of these products are approved for use in both food-producing animals and companion animals. With the exception of two tetracycline medicated feed products, the other eight products are approved for use in dogs, cats, and/or horses (in addition to food-producing animals), and collectively represented 129,296 kg of active ingredient domestic sales in 2023. In contrast, there was a total of 6,127,991 kg of active ingredient domestic sales reported in 2023 for the medically important antimicrobial products. The two tetracycline medicated feed products are approved for use in psittacines (a subset of birds that includes parrots, macaws, and cockatoos), in addition to calves, cattle, chickens, sheep, swine, turkeys and ducks. However, we believe that the use of these products in psittacines is infrequent compared to use in the food-producing animal species. The use of these 10 drug products in companion animals likely has little to no effect on trends in the overall reported sales of antimicrobial drugs.

How much of the recent domestic sales as reported in the 2023 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals is likely attributable to drugs that are exported by distributors without the sponsors’ knowledge?

Antimicrobial animal drug sales and distribution data provided to FDA and summarized in the 2023 Summary Report are only for FDA-approved products labeled for use in the U.S. Although it’s possible that some products included in the domestic sales and distribution data may later be exported by distributors or customers, we don’t believe this to be a usual occurence. Many other countries have their own approval process for animal drugs, so animal producers in these countries would likely be using animal drug products that are approved and specifically labeled for use in their own country.

What is FDA’s Interactive Summary of Biomass-Adjusted Antimicrobial Sales Data, and what information does it provide that isn’t in the annual sales and distribution summary report? 

The interactive summary, launched in 2022, applies a biomass denominator to adjust FDA’s annual antimicrobial sales and distribution data for medically important antimicrobial drugs sold or distributed for use in U.S. food-producing animals. 

Animal biomass, in this case, is defined as the population of a given livestock species in the U.S., multiplied by the average weight of that species. FDA has used population and weight statistics from U.S. Department of Agriculture databases. In this method, a biomass denominator adjusts 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. 

Biomass-adjusted sales estimates allow for interpretation of antimicrobial sales trends relative to the U.S. livestock population and animal drug approvals.

 

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