More Data, Better Data: How FDA Could Improve the Animal Drug User Fee Act

Also contributing to this post is Tyler Smith, Senior Research & Policy Assistant in the Farming for the Future program.

The U.S. Food and Drug Administration (FDA) held a public meeting (video on YouTube) this past Monday at its Rockville campus to discuss reauthorization of the Animal Drug User Fee Act (ADUFA).  The current version of ADUFA includes an important provision that requires drug sponsors to report sales of antimicrobial drugs intended for use in food animals to FDA.  The agency compiles these sales data and releases a limited summary to the public each year. The 2009 summary report of ADUFA data allowed CLF researchers to calculate the quantity of antimicrobial drugs sold domestically for use in food animals as a percentage of the total quantity of antimicrobial drugs distributed in the U.S.  While useful, these public summaries of ADUFA data are very short, comprising just a few pages that provide the quantities of certain antimicrobial drug classes sold in the previous calendar year (see the reports for 2009 and 2010).  The summaries do not currently provide many data that non-governmental public health scientists, state and local public health officials, and veterinarians need to better understand patterns in antimicrobial use and resistance. Read More >