NCC Provides Comments to FDA about Animal Drug User Fee Act Reauthorization
December 18, 2012
“The National Chicken Council (NCC) supports a science-based, statistically-validated and technically-sound approach to antibiotic usage and data collection,” said NCC Vice President of Scientific and Regulatory Affairs, Ashley Peterson, Ph.D., in remarks delivered today at a Food and Drug Administration (FDA) public meeting about the reauthorization of the Animal Drug User Fee Act (ADUFA).
ADUFA gives FDA the authority to collect user fees from the animal health industry and has enabled FDA to speed up the application review process for pioneer and generic new animal drugs without compromising the quality of the agency’s review. This program expires on September 30, 2013.
NCC supports a clean reauthorization of the user fee bill.
Peterson in her comments noted that NCC and other livestock and poultry trade associations continue to work with FDA’s Center for Veterinary Medicine (CVM) on how to capture representative usage information as demonstrated in the comments NCC submitted to the recent ANPR titled: Antimicrobial Animal Drug Sales and Distribution Reporting. “We believe that CVM should continue to address this issue through the regulatory process so that all stakeholders are provided with the same opportunities to deliver constructive input,” Peterson said.
Additionally, NCC believes a common misconception is that the amount of antimicrobials used in livestock is directly correlated to antibiotic resistance patterns observed in human medicine. Peterson added, “As illustrated by the lack of effect on resistance in human Camplylobacter cases observed after the withdrawal of enrofloxacin from the poultry industry and Denmark’s similar experience, a direct correlation is difficult to demonstrate.”
Peterson also noted that there are a variety of issues and complications with collecting data at feed mills or requiring species-specific sales and distribution data from drug sponsors themselves. “ We hope to continue to work with CVM to determine what the questions are that we are trying to answer and secondly to develop a logical and sound approach to answering them,” she said.
“NCC supports continued scientific research in this important topic area as protecting food safety and promoting public health is the chicken industry’s number one priority,” Peterson concluded.
Peterson’s comments echoed those delivered by the National Cattlemen’s Beef Association, National Pork Producers Council, Animal Health Institute and the American Veterinary Medical Association, among others.