By Riëtte van Laack –
The Animal Drug User Fee Amendments of 2008 (“ADUFA”) directs FDA to prepare and publish annual summaries of antimicrobial animal drugs sold or distributed for use in food-producing animals. The data are derived from information submitted by sponsors of antimicrobial new animal drugs who each year must submit to FDA a report regarding, among other things, their distribution data for antimicrobial animal drugs distributed domestically and exported for use in food-producing animals.
A 2011 GAO report suggests that this information is insufficient to support a meaningful analysis of the possible relationship between antimicrobial resistance and the use of medically important antibiotics in food-producing animals, however.
On July 27, 2012, FDA published an Advance Notice of Proposed Rulemaking requesting comments as to how the Agency might be able to obtain more detailed information about the use of antimicrobial animal drugs when the drugs are used in numerous species, including non-food producing animals. Specifically, the Agency invites comments on:
- Whether and how it should amend its regulations to obtain additional accurate sales and distribution information for each food producing species on the label;
- How it can best compile and present the annual summary information, while still protecting confidential business information as directed by the law; and
- Options, within FDA’s authority, for obtaining additional data and information about the extent of antimicrobial drug use in food-producing animals to further support the analysis of the relationship between antimicrobial resistance and the use of medically important antibiotics in food-producing animals.
Comments are due September 25, 2012.