December 9, 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FDA’s current thinking regarding the use of antimicrobials in food-producing animals is outlined in the draft Guidance for Industry (#209) entitled “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals.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.
2009 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals(PDF - 267KB) Questions and Answers: Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals
- Draft Guidance for Industry - The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals (PDF - 251KB)