For Industry

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 the sales and distribution data.

In 2014, FDA increased the amount of data included in its annual summary reports. FDA’s annual summary reports have expanded to 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 data for calendar year 2016, sponsors were required to report species-specific sales and distribution estimates. The 2016 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals is FDA’s first annual summary report to include these species estimates.


Why does the FDA collect this information?
How do the sales and distribution data in this report translate to actual use?
What information does the FDA now include in the annual summary report?
Where can I find the FDA’s annual summary reports from previous 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?
In the past, there has been speculation that as much as 80 percent of antibiotics sold in the United States are used in food-producing animals. Can you confirm this?
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 2016 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?


Why does the FDA collect this information?

Under ADUFA 105, Congress requires animal drug sponsors (i.e., drug manufacturers) to annually report to FDA on the amount of antimicrobial active ingredient in the drug products they sell or distribute for use in food-producing animals.

ADUFA 105 only requires sponsors to list the target animals and production classes specified on the approved labels of the products. It does not require animal drug sponsors to break out the total sales or distribution data by individual food-animal 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.

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How 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.

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

The report format contains information, including data tables on the importance of each drug class in human medicine, provides aggregate data on the approved routes of administration for these drug products, whether they 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 latest annual summary report, which covers the period of calendar year 2016, includes for the first time sales and distribution information broken down by major food-producing species (cattle, swine, chickens, and turkeys).

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Where can I find the FDA’s annual summary reports from previous years?

These reports and additional information on ADUFA can be found at: http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042896.htm.

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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.

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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.

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In the past, there has been speculation that as much as 80 percent of antibiotics sold in the United States are used in food-producing animals. Can you confirm this?

While FDA collects data on antimicrobial quantities sold or distributed for use in food-producing animals, we currently do not have data on the actual amount of antimicrobial drugs used in animals in the U.S. or the amount used for specific purposes . FDA and USDA are currently working on strategies for collecting on-farm data on antimicrobial use.

The 80% figure cited in several media reports and in the November 2017 WHO announcement is likely derived from a previous FDA report regarding drug sales, not drug use. Further the 80% is likely referring to a comparison of FDA animal sales data and Information Management Services (IMS) Health human sales data. The FDA cautions that it is difficult to draw definite conclusions from any direct comparisons between the quantity of antimicrobial drugs sold for use in humans and the quantity sold for use in animals using these data because of a variety of complicating factors, such as:

  • The number of humans in the U.S. population (approx. 320 million) compared to the much larger number of animals in each of the many animal species (e.g., approx. 9 billion chickens slaughtered annually).
  • The differences in physical characteristics of humans compared to various animal species (e.g., physiology and weight– average adult human, 182 lbs. vs average adult cattle live weight, 1,363 lbs.).
  • Duration and dosage of antibacterial drug administration may also vary by indication and, in general, between the various animal species and humans due to differences in physiology.
  • As noted above, the available animal sales and distribution data are not reported to the FDA by each use indication and, thus, do not allow the FDA to distinguish between or among the different types of uses. The data, therefore, do not allow a direct comparison of the amounts of antimicrobials sold for certain human uses with those sold for certain animal uses.

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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 132 actively marketed, medically important antimicrobial products approved for use in food-producing animals in 2016, there are only 13 actively marketed drug products approved for both food-producing animals and companion animals. With the exception of one tetracycline medicated feed product, the other 12 products are approved for use in dogs, cats, and/or horses (in addition to food-producing animals), and collectively represented 148,025 kg of active ingredient domestic sales in 2016. There was a total of 8,361,740 kg of active ingredient domestic sales reported in 2016 for the medically important antimicrobial products. The one tetracycline medicated feed product is 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. Use of this product in psittacines is infrequent compared to use in the food-producing animal species. The use of these thirteen drug products in companion animals likely has little to no effect on trends in the overall reported sales of antimicrobial drugs.

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How much of the recent domestic sales as reported in the 2016 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? (See Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals)

Individuals exploring this question should be aware that, in accordance with the law, the antimicrobial drug sales and distribution data provided to FDA and summarized in the Summary Report are only for FDA-approved, FDA-labeled products. Sponsors of FDA-approved antimicrobial products for food producing animals sometimes sell some of their products to drug distribution firms who, in turn, sell them to customers in the United States. There is the possibility that some of these distributors or customers might export some amount of these products without the sponsors’ knowledge. If the sponsor has no knowledge of such exportations, the sponsor would report them as part of the domestic sales and distribution. However, the FDA does not believe that such unknown exportation happens to any significant extent, if at all. Many other countries have their own approval process for animal drugs, so these countries would not likely be importing and using the FDA-approved, FDA-labeled products, but rather animal drug products that are approved and specifically labeled for use in their own country. Further, the trends in increased sales and distribution apply to a wide variety of different products representing most antimicrobial drug classes and dosage forms. Increasing exportations involving so many different animal drug products is considered as unlikely.

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Page Last Updated: 12/07/2017
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