CVM Reports on Antimicrobials Sold or Distributed for Food-Producing Animals

December 22, 2010 — 

On December 9, 2010, FDA's Center for Veterinary Medicine published its first annual report summarizing sales and distribution data of antimicrobial drugs approved for food-producing animals. The Animal Drug User Fee Amendments of 2008 (ADUFA), Section 105, requires antimicrobial drug sponsors to report 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 these summaries to the public.

FDA's current thinking regarding the use of antimicrobials in food-producing animals is outlined in the draft Guidance for Industry (#209) entitled "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals."

The collection of data on antimicrobial drugs, such as this sales and distribution information, 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.

In order to protect confidential business information as directed by Congress, sales and distribution data for antimicrobial classes with fewer than three sponsors are collectively reported in the summary for both domestic and international data.

[Editor's note: The report indicated that approximately 29 million pounds of antimicrobials were sold or distributed in the U.S. in 2009 for use in livestock. Tetracycline made up the largest volume at approximately 10.15 million pounds. It is important to understand a few key points regarding the collection and presentation of this information:

1. The volume of products reported are sales and distribution figures not usage figures. Sales data for any given year is not an accurate reflection of actual usage.
2. The volume of antimicrobial used is irrelevant when considering the implications of antimicrobial usage in livestock and the development of antimicrobial resistance in humans. The key to the development of resistance is the interaction between specific antimicrobials and the individual bacterial pathogens.
3. Almost 29% of the sales volume reported is made up of the ionophores which are not used in human medicine and therefore do not contribute to resistance concerns.
4. The sales data reported includes all dosage forms of the active ingredient (including feed grade, injectable and water soluble).
5. When considering the volume of drugs used in livestock and attempting to compare that to the volume used in human medicine, it is important to recognize the weight difference between the average livestock patient and the average human patient being treated.]

Source: FDA Press Release