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U.S. Department of Health and Human Services

For Industry

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Questions and Answers: Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals in 2011

FDA’s annual report on antimicrobial sales and distribution in food-producing animals provides the agency and the American public with data that are important for tracking antimicrobial use trends and examining how such trends relate to antimicrobial resistance. Because more use of antimicrobials is generally associated with greater levels of resistance, these data help supplement FDA’s ongoing activities in minimizing antimicrobial resistance. The report also reinforces the agency’s guidance on the judicious use of certain antimicrobials in food-producing animals.

Why does FDA collect this information?

Under the 2008 amendment to the Animal Drug User Fee Act (ADUFA), Congress requires antimicrobial drug sponsors to annually report the amount of antimicrobial active ingredient in the drugs they sold or distributed for use in food-producing animals.

ADUFA Section 105 only requires animal drug sponsors to describe each of their approved drug products and to list the target animal and production class specified on the approved labels of the products. Animal drug sponsors do not have to break down the data into total sales for each food-animal species. Information for each calendar year must be submitted to the FDA by March 31st of the following year.

ADUFA also requires that FDA provide publicly the summaries of this sales and distribution information.

What is ADUFA?

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

Section 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 is exploring ways to enhance future summary reports, and in July 2012 published an Advance Notice of Proposed Rulemaking (ANPRM) to solicit comments from the public on a number of issues regarding the collection of antimicrobial drug sales/distribution data, including how FDA can best compile and present the annual summary information while still protecting confidential business information as directed by statute. The comment period closed November 26, 2012. Based on the input received, FDA is currently in the process of revising the format of its annual summary in an effort to enhance the report’s clarity and level of detail. FDA intends to utilize the updated format when it summarizes the data reported for 2012, and also plans to re-analyze prior year reports to conform with the new format.

Why did FDA seek comment on possible enhancements to the existing requirements related to collecting antimicrobial drug sales/distribution data?

FDA believes having additional information would lead to a better understanding of the extent to which medically important antimicrobial drugs are used in food-producing animals and will support the agency’s antimicrobial resistance strategy announced on April 11, 2012. FDA’s current thinking and strategy to protect public health and promote the judicious use of medically important antibiotics in food-producing animals is outlined at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm299802.htm. Under this strategy, certain antibiotics would only be used to address diseases in animals under the supervision of a veterinarian.

In addition, having improved data would also support the agency’s ongoing efforts to better correlate resistance data collected under the National Antimicrobial Resistance Monitoring System (NARMS) with drug exposure, thereby providing improved information for science-based decision making in the approval and monitoring of safe and effective antimicrobial drugs.

FDA solicited public comment on:

  • Whether FDA should amend its regulations to require additional sales and distribution information. Specifically, for drug products that are approved and labeled for more than one food-producing animal species, how sponsors can practically and accurately provide separate sales and distribution information for each species on the label.
  • How FDA can best compile and present the annual summary information, while still protecting confidential business information as directed by statute.
  • Alternative methods available to FDA within its existing authority for obtaining additional data and information about the extent of antimicrobial drug use in food-producing animals. This would help FDA analyze factors related to the development and spread of antimicrobial resistance in connection with the use of medically important antibiotics in food-producing animals.

How will FDA use these data and how do they relate to Guidance #209, “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals”?

Section 105 sales and distribution data are relevant to FDA’s ongoing analysis of antimicrobial resistance and the use of antimicrobials in food-producing animals. The Judicious Use Guidance, which is primarily based on a review of key scientific reports on the use of antimicrobial drugs in animal agriculture, outlines strategies for assuring that antimicrobial drugs that are medically important for humans are used judiciously in food-producing animals in order to help minimize antimicrobial resistance development.

Why is it necessary to track this type of information?

Antimicrobial drug data collection helps FDA evaluate antimicrobial resistance trends. The data also help the agency in its analyses of other issues that may arise relating to the safety and effectiveness of antimicrobial drugs approved for use in food-producing animals.

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 Section 105 sales and distribution data in association with known resistance patterns. It is not unexpected to see transient increases or decreases in sales of certain drugs in a given year due to various factors (e.g., occurrence of disease outbreaks, fluctuations in animal populations). Therefore, given that only three years of sales data have been compiled so far, it is difficult at this time to draw conclusions about whether any changes in sales data represent meaningful trends in overall volume of sales or the resulting effect on antimicrobial resistance.

Where can I find Section 105 reports for previous years?

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

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

The Section 105 summary report is not directly comparable to other previously reported estimates of antimicrobial drug sales or distribution. The Section 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 Section 105 summary report.

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

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

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

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

It is very difficult to compare the animal and human reports in any meaningful way. Before making comparisons between human and animal sales and distribution data, there are a number of differences in the circumstances of use of antibacterial drugs in human and veterinary medicine that must be carefully considered, including:

  • The number of humans in the population compared to the number of animals in each of the many veterinary populations (veterinary data provided to FDA are not broken down by species)
  • Differences in physical characteristics of humans compared to various animal species (e.g., weight)
  • Antibacterial drug use in humans can be for the treatment or prevention of an infection, whereas animal use may include treatment, control, prevention, and growth promotion. The available animal data are not reported to the FDA by indication and so do not allow us to distinguish between or among these different types of uses. For example, the majority of antimicrobial drugs used in animal feed are approved for both therapeutic and production purposes. Therefore, the indication cannot be determined based on the route of administration (i.e., medicated feed).
  • Milligram dosages for different antibacterial drugs differ (e.g., the usual adult human dosage for amoxicillin is different from the usual adult dosage for doxycycline). Total weights across different antibacterial drug classes (and even, to a lesser extent, within classes) are therefore difficult to interpret.
  • Duration and dosage of antibacterial drug administration may also vary by indication and, in general, between the various animal species and humans.

It is, therefore, difficult to draw definite conclusions from any direct comparisons between the quantity of antibacterial drugs sold for use in humans and the quantity sold for use in animals.

It is also important to note that for human antibacterial 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.