The new reporting requirement would have drug sponsors include an estimate, by species, of antimicrobial ingredient sales when the products were to be used in “food-producing” animals, stated FDA information.
“The additional data would improve understanding about how antimicrobials are sold or distributed for use in major food-producing species and help the FDA further target its efforts to ensure judicious use of medically important antimicrobials,” said the agency. It added that more information regarding farm-level practices also will have to be gathered.
AFIA recently filed comments with the FDA protesting the potential inclusion of species-specific estimate reporting in the Animal Drug User Feed Amendments of 2008 (ADUFA). AFIA is an organization comprised of more than 575 domestic and international companies and represents the feed industry, stated group information.
Questions remain regarding why the FDA wants to collect the information, and what it plans to do with any data collected, said Richard Seller, AFIA senior vice president of legislative and regulatory affairs.
“AFIA has many questions surrounding FDA’s reasoning,” he told FeedNavigator. “Why do they want them? What will they do with them? Congress did not give them the authority; therefore we believe FDA does not need these numbers.”
Gathering useful drug data
The new information to be included in the report would be challenging to document as several antimicrobials are sold as premixes and go to distributors and licensed feed mills, wrote John Dillard, associate with AFIA’s legal counsel Olsson Frank Weeda Terman Matz. The drug sponsors have little control over the product at that stage and would not have the ability to say which animal received it.
Because drug sponsors do not have these records, their best estimate would be a guess at the information, said the lawyer.
“FDA has not demonstrated how gathering a series of ‘guesses’ regarding antimicrobial use will support its monitoring efforts under programs, such as the National Antimicrobial Resistance Monitoring System (NARMS),” he wrote. “Scientific decisions should not be based on wholly inadequate and unreliable data.”
Farm-level information that is set to be gathered though the National Animal Health Monitoring System (NAHMS) would be a better way to determine possible links between use of antimicrobials and the growth of resistant bacteria, as it would look at how products are being used by livestock producers and veterinarians, he added.
AFIA worked with the FDA to establish some alternatives through the NAHMS, but those pathways appear to be being ignored, added Seller.
Challenges to the proposal
The response to the proposed rule changes argued that the FDA overstepped their bounds in requesting species-specific reporting, wrote Dillard.
“FDA proposes requiring new animal drug sponsors to submit estimates of antimicrobial ingredient sales by species,” AFIA’s lawyer said. “These estimates would be submitted as part of the annual distribution reports required by § 105 of the Animal Drug User Feed Amendments of 2008 (ADUFA). However, Congress has not provided FDA the authority to require reporting of these estimates.”
Drug sponsors are already required to release certain information as part of distribution reports, he said. They have to produce an annual report detailing the amount of the “each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals.” Drug sponsors also have to document the amount of the active ingredients “by container size, strength and dosage form; by quantitates distributed domestically and quantities exported; and by dosage form, including, for each such dosage form, a listing of the target animals, indications and production classes that are specified on the approval label of the product.”
With these requirements currently in place, Congress has outlined what the FDA can require drug manufacturers or sponsors to report, the lawyer said, and the current proposals go beyond these boundaries.
“AFIA is, appropriately, perplexed at FDA’s inclusion of such a provision in the proposed rule when it is not supported by any modicum of congressional intent,” he said.
Areas of agreement
However, there are elements in the proposed rules at that organization supports, Dillard wrote.
AFIA supported an option changing how amount of antimicrobials sold is reported as the change simplifies the process, he said. The update would have amounts listed in units instead of volume of active ingredients.
The organization also is in favor of proposed alterations that would give sponsors the ability to not include distribution data in their annual drug experience reports, he said. The change eliminates duplication in the reporting process.