July 26, 2012
The Food and Drug Administration today announced an Advance Notice of Proposed Rulemaking (ANPRM) to solicit comments from the public on possible enhancements to the existing requirements related to the collection of antimicrobial drug sales/distribution data as well as input on alternative methods for monitoring antimicrobial use in food-producing animals. Such information is important for supporting FDA’s strategy for promoting the judicious use of medically important antibiotics in food-producing animals.
Section 105 of the Animal Drug User Fee Amendments (ADUFA) of 2008 established requirements regarding the collection and reporting of certain data regarding the sales/distribution of approved antimicrobial new animal drugs intended for use in food-producing animals. However, additional information beyond that directed by ADUFA 105 may be needed.
The FDA believes having additional information that provides a better understanding of the extent of use of medically important antimicrobial drugs in food-producing animals will support the implementation of the agency’s strategy announced April 11, 2012. Under this strategy,once implemented, certain antibiotics would only be used to address diseases in animals under the supervision of a veterinarian.
In addition, having improved data would also support the agency’s ongoing efforts to better correlate resistance data collected under the National Antimicrobial Resistance Monitoring System (NARMS) with drug exposure, thereby providing improved information for science-based decision making in the approval and monitoring of safe and effective antimicrobial drugs.
Through this ANPRM, FDA is soliciting public comment on:
- Whether FDA should amend its regulations to require the submission of additional sales and distribution information. Specifically, for drug products that are approved and labeled for more than one food-producing animal species, how sponsors can both practically and accurately provide separate sales and distribution information for each species on the label.
- How FDA can best compile and present the annual summary information, while still protecting confidential business information as directed by statute.
- Alternative methods available to FDA within its existing authority for obtaining additional data and information about the extent of antimicrobial drug use in food-producing animals to further support the analysis of factors related to the development and spread of antimicrobial resistance in connection with the use of medically important antibiotics in food-producing animals.
The agency invites comments on all aspects of ADUFA 105, available online at: http://www.gpo.gov/fdsys/pkg/FR-2012-07-27/pdf/2012-18366.pdf. This information may be used to help draft a proposed rule in the near future.