FDA notes plans to monitor antibiotic progress

Published on: Dec 12, 2013

Following yesterday's announcement, the Food & Drug Administration posted today information on how it intends to keep the public apprised of progress in implementing its plan on regulating antibiotics in animal feed, including:

1. FDA is making public on its website a listing of all antimicrobial products affected by the guidance (available at www.fda.gov/downloads/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/UCM378330.pdf).

2. FDA intends to publish summary information following the 3-month notification period indicated in GFI #213, to provide an indicator of the level of engagement of affected drug sponsors in the voluntary process.

3. FDA will notify the public of completed changes to affected products through publication of approval of supplemental new animal drug applications.

In addition to tracking completion of the recommended changes, FDA said it recognizes that it is important to identify ways to assess the effect of GFI #2091 and GFI #2132 over time. FDA currently collects data on the sale and distribution of antimicrobial drugs intended for use in food-producing animals, as well as data on antimicrobial resistance among foodborne pathogens as part of the National Antimicrobial Resistance Monitoring System. FDA is currently working in collaboration with other agencies, including U.S. Department of Agriculture and the Centers for Disease Control & Prevention, to explore approaches for enhancing current data collection efforts in order to measure the effectiveness of the strategy.

FDA said it anticipates seeking additional public input as it develops these enhancements.