US - The American animal feed industry has hit out at plans by the Food and Drug Administration to require new animal drug sponsors to submit estimates of antimicrobial ingredient sales by species.
Earlier this year the FDA put forward plans that it said would improve understanding of how antimicrobials are sold or distributed for use in major food-producing animals and help the FDA further target its efforts to ensure judicious use of medically important antimicrobials.
The FDA rule calls for animal drug sponsors of all antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales by major food-producing species - cattle, swine, chickens and turkeys.
The proposed rule also includes a provision to improve the timeliness of the report by requiring the FDA to publish its annual summary report of antimicrobial sales and distribution information.
However, the American Feed Industry Association said the proposed rule is “a giant overstep of the legal boundaries established by Congress in the Animal Drug User Fee Act”.
In its comments on the new rule the association said: “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 AFIA said that it is a clear example of FDA ignoring congressional intent.
The association added that new animal drug sponsors do not maintain sales distribution records by species.
It said that many of the 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.
“Bad data should not be preferred over a lack of data,” the AFIA said in its comments.
“Without actual data, an estimate is nothing more than a guess.”