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 >

FDA Should Come Clean on the 2010 ADUFA Data

Last Friday, the U.S. Food and Drug Administration (FDA) posted data on antimicrobial drug sales collected under the Animal Drug User Fee Act (ADUFA). ADUFA requires drug companies to report information on sales of antimicrobial drugs intended for use in animals, including food animals. These data provide the most reliable information we have on the use of antimicrobials in animal agriculture.  CLF’s Ralph Loglisci and David Love, PhD, used 2009 ADUFA data to calculate the quantity of antimicrobial drugs used in food animal production in that year as a percentage of the total amount of antimicrobial drugs used in the U.S. over the same period—the number, they determined, was almost 80 percent!

The data that FDA posted on its website (October 28) was a PDF that contained sales data for 2010.  These data showed a significant increase in antimicrobial drug sales—almost 7 percent.  But a funny thing must have happened over the weekend.  Read More >

Drug amounts for food animals now reported by FDA: Thanks, it’s about time!

19240The Food and Drug Administration (FDA) published a report last Thursday (Dec 9, 2010) that 13.1 million kilograms of antimicrobial drugs were sold or distributed for use in food-producing animals in 2009 in the United States (pdf). Why is this important? It represents the first time the FDA has reported the quantity of antimicrobial drugs that are available for use in the production of swine, dairy cow, cattle, and poultry in the US.

The recent FDA value also settles a longstanding dispute between the Union of Concerned Scientists (UCS) and an industry lobbyist group, the Animal Health Institute (AHI). UCS estimated that in 1998, 13.4 million kilograms of antimicrobials were used in food animal production, while for the same year AHI reported that just 8.1 million kilograms were used (Mellon et al. 2001).  The new FDA report shows that UCS was much close to the actual amount than AHI. Read More >