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

The FDA report on antimicrobial sales and distribution in food producing animals provides the Agency and the American public with concrete data that are important for supporting efforts to track antimicrobial use trends and to examine how such trends relate to antimicrobial resistance. Because more use of antimicrobials is, in general, associated with greater levels of resistance, these data will supplement the FDA’s ongoing activities in antimicrobial resistance prevention. The report also reinforces the agency draft guidance on the judicious use of certain antimicrobials in food-producing animals.

What is ADUFA?

The Animal Drug User Fee Act of 2003 (ADUFA), amends the Federal Food, Drug, and Cosmetic Act (FFDCA) and authorizes FDA to collect user fees for certain animal drug applications, and for the establishments, products, and the pharmaceutical company sponsors associated with these and previously approved animal drug applications, in support of the review of animal drugs. These additional resources support FDA’s responsibilities under the FFDCA to ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals intended for food consumption.

In 2008, ADUFA was amended and extended through 2013. One part of that amendment (Section 105), requires antimicrobial drug sponsors to annually report to FDA the amount of antimicrobial active ingredient in their drugs that have been sold or distributed for use in food-producing animals. ADUFA also requires FDA to summarize the sales and distribution information received from drug sponsors each year and provide the summary report to the public.

Does ADUFA 105 require animal drug sponsors to report antimicrobial sales and distribution information by individual animal species?

No. Animal drug sponsors are required to describe their approved drug products and to include a listing of the target animals and production classes that are specified on the approved labels of the products. However, for antimicrobial drug products that are approved and labeled for more than one food-producing animal species, sponsors are not required to report sales and distribution information for each individual animal species. Only total product sales information is required.

How often and when does this information have to be reported to the FDA?

The information is collected annually by calendar year and must be submitted to the FDA by March 31st of the following year.

What is FDA’s current thinking on the use of antimicrobials in food producing animals and on appropriate antimicrobial use more generally?

FDA’s draft Guidance for Industry (#209) entitled “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals" (Judicious Use Guidance) outlines the agency’s current thinking on the topic.

How will the FDA use these data and how do they relate to draft guidance #209?

The ADUFA 105 sales and distribution data are relevant to FDA’s ongoing analysis of antimicrobial resistance and the use of antimicrobials in food-producing animals. Draft guidance #209 is primarily based on a review of key scientific reports on the use of antimicrobial drugs in animal agriculture and outlines strategies for assuring that medically important antimicrobial drugs are used judiciously in food-producing animals in order to help minimize antimicrobial resistance development. FDA is currently reviewing comments received in response to the draft guidance.

Why is it necessary to track this type of information?

The collection of data on antimicrobial drugs assists FDA’s evaluation of antimicrobial resistance trends as well as its analysis of other issues that may arise relating to the safety and effectiveness of antimicrobial drugs approved for use in food-producing animals, such as cattle, swine and poultry.

Does FDA see any trends or patterns in the sales and distribution of these types of drugs and the resulting effect on antimicrobial resistance?

FDA scientists are currently reviewing the ADUFA 105 sales and distribution data and their relationship to known resistance patterns. However, meaningful trend analyses may not be possible until several years of comparable sales and distribution data are reported.

How do the ADUFA 105 summary report data compare to the estimates of antimicrobial drug sales or distribution that have been previously reported by other organizations?

The ADUFA 105 summary report is not directly comparable to other previously reported estimates of antimicrobial drug sales or distribution. The ADUFA 105 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. Previously reported estimates included different categories of antimicrobials and used different sources of information and thus cannot be directly compared to the ADUFA 105 summary report.

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

In order to protect confidential business information, as directed by Congress, no individual sponsors are identified in the summary report. ADUFA 105 requires FDA to summarize sales and distribution data by antimicrobial class. Antimicrobial classes with fewer than three sponsors must not be independently cited in the summary report and so data from such classes are included in aggregated form in this report.

ADUFA 105 requires animal drug sponsors to report to FDA the dosage forms of their drug products. Why doesn't FDA's summary report include this information?

FDA considered breaking down the sales and distribution data to provide more detail on dosage forms in the summary reports but it became apparent that doing so was often inconsistent with the Congressional requirement to protect confidential business information.

Where can I find copies of the reports?

http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042896.htm.