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.

FDA’s 2012 summary report incorporates a new, more detailed format. In revising the report’s format, FDA took into account feedback received from the public on how to provide more meaningful information about antimicrobials sold or distributed for use in food-producing animals. FDA’s annual summary reports now 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. FDA also has revised reports from all previous years (2009-2011) to include this additional information.


Why does the FDA collect this information?
How do the sales and distribution data in this report translate to actual use?
What additional information is the FDA now including in the annual summary report?
What are the benefits of the new report format?
Where can I find the FDA’s annual summary reports from previous years?
Why have there been changes in the sales data previously presented in the 2009- 2011 summary reports?
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?
How do the data collected for animal use compare to the amount of antimicrobial drugs used in humans?
Does a summary report exist for antimicrobial sales and distribution for human drugs?


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. Information for each calendar year must be submitted to FDA by March 31st of the following year.

ADUFA 105 also requires that FDA provide summaries of this sales and distribution information, by antimicrobial class for classes with three or more distinct sponsors, while protecting both national security and confidential business 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, the sales and distribution data that FDA currently collects are not broken out by species, although many of these products are approved for use in multiple species. Additionally, drug products entering the market may not necessarily be distributed all the way to the farm; veterinarians and animal producers may purchase drugs in anticipation of using them but never actually administer them to animals.

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What additional information is the FDA now including in the annual summary report?

The new report format contains additional 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.

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What are the benefits of the new report format?

The new format used in the 2012 report, and in the updated 2009-2011 reports, increases transparency about the extent to which antimicrobials are sold or distributed for use in animal agriculture. The enhanced annual summary reports will also provide more detailed information to the public on changes in antimicrobial sales over time as GFI #213 is implemented.

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

The FDA has updated the annual summary reports from all previous years (2009–2011) to provide the public with more detailed information about antimicrobial sales and distribution. Changes were made to these reports to reflect the additional data tables, and to add any late data submissions, to correct erroneous submissions submitted to the agency after publication, and, for the 2009 report, to revise some numbers due to process improvements. These reports and additional information on ADUFA can be found at: http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042896.htm.

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Why have there been changes in the sales data previously presented in the 2009- 2011 summary reports?

Significant improvements occurred after FDA published the summary report for the 2009 data. For example, sponsors submitted data more uniformly; an FDA database was developed to store and more effectively process and summarize the data; the agency increased the number of personnel dedicated to the program; and additional quality measures were put in place. These measures resulted in some changes to the 2009 sales and distribution data. In addition, some minor changes in sales numbers for the 2009, 2010, and 2011 summary reports occurred as a result of revised sales data for a few applications that were submitted by drug sponsors after the reports had already published.

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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 section 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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How do the data collected for animal use compare to the amount of antimicrobial drugs used in humans?

Before comparing human and animal sales and distribution data, there are several differences in the circumstances of use of antimicrobial drugs in human and veterinary medicine that must be carefully considered, including:

  • Sizes of human and animal populations
  • Physical characteristics (e.g., weight and physiology)
  • Intended indications/uses
  • Duration of treatment and dosage

It is also important to note that for human antimicrobial drugs, these sales data represent the volume of product being sold to the various outlets from the manufacturer, not the volume of product being sold by the outlets to patients. Therefore, these sales data do not provide a direct estimate of human use. Similarly, the animal data represent a summary of the volume of product sold or distributed (through various outlets) by the manufacturer, and not the volume of product purchased by the end user for administration to animals.

Finally, the antimicrobial drug class known as ionophores, which are not used in human medicine and are not associated with antimicrobial resistance issues, contributes significantly to the total of antibiotics sold or distributed for use in food animals.

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Does a summary report exist for antimicrobial sales and distribution for human drugs?

Yes. Please see: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm261160.htm.

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Page Last Updated: 10/02/2014
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