“While AFIA welcomes the proposed changes that would reduce duplicative reporting requirements, AFIA strongly contests the wisdom and FDA’s legal authority to require new animal drug sponsors to report species-specific estimates of product sales,” the comments state.
“This is a crystal clear example of FDA ignoring congressional intent,” said Richard Sellers, AFIA senior vice-president of legislative and regulatory affairs. “We are not debating the overall goal—to monitor the use of antibiotics within agriculture—we are debating FDA’s legal authority to require new animal drug sponsors to report species-specific distribution estimates. The sponsors do not have that data, and the proposed requirement to ‘estimate’ it from data extrapolation of expected use is a poor use of the available information.”
The proposed rule would require new animal drug sponsors to submit estimates of antimicrobial ingredient sales by species. The estimates would then be submitted as part of the annual distribution reports required by the Animal Drug User Fee Amendments of 2008.
“However, Congress has not provided FDA the authority to require reporting of these estimates,” the comments remind.
“New animal drug sponsors do not maintain sales distribution records by species. Many of these products are sold as premixes to distributors and licensed feed mills, and at this point, the new animal drug sponsors are no longer responsible for what species of animals actually receive the products,” said Sellers.
“Bad data should not be preferred over a lack of data,” the comments state. “Without actual data, an estimate is nothing more than a guess.”
“The President’s National Action Plan for Combating Antibiotic Resistance requires FDA and USDA to cooperate and develop a plan to collect more detailed farm-level data on usage through the National Animal Health Monitoring System,” said Sellers. “This will be much more useful information than what is being suggested in this proposed rulemaking.”
AFIA supports sections within the proposed rule that would allow animal drug sponsors an option to exclude annual antimicrobial distribution data from the annual drug experience reports as it would eliminate unnecessary, duplicative reporting requirements for sponsors. The organization also lends support to FDA’s proposal that would allow sponsors to report antimicrobial sales by unit versus the volume of active ingredients as it would simplify the distribution reporting process and minimize the tedious recordkeeping burden tedious recordkeeping burden.
AFIA is working with the Animal Agriculture Coalition, a group of 45 food, feed and fiber groups dedicated to working with Congress and federal agencies for mutual benefit. This group has met with FDA on several occasions to discuss animal drug use data collection and to reach a reasonable consensus on what data are available that will assist in determining use by animal producers.