Monday night the House passed, 390-12, a bill to reauthorize for five years the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA). The House took up the measure (S. 622) approved by unanimous consent in the Senate May 8.
First enacted in 2003, ADUFA and AGDUFA allow the U.S. Food and Drug Administration to collect fees from animal health companies for the review and approval of animal health products, including ones for farm animals and pets. The fees supplement the agency’s annual congressionally-approved appropriations and have enabled FDA to dramatically reduce its review time for new animal drugs, bringing medications to market more quickly while maintaining high standards for safety and effectiveness.
The legislation was approved without amendments. Opponents of modern livestock production had threatened to offer provisions to restrict from use in food-animal production certain antibiotics and to require reporting of on-farm uses of animal health products. [FDA already collects antibiotics sales data, which a number of groups have misused in efforts to blame animal agriculture for the rise of antibiotic-resistant illnesses in people, the National Pork Producers Council said in a statement.
“We want to commend the leadership on both sides of the aisle in the Senate and House for approving this important legislation,” said NPPC president Randy Spronk, a pork producer from Edgerton, Minn. “The laws will help ensure that pork producers have access to products that keep our pigs healthy and our products safe and wholesome.”
“NPPC thanks Sens. [Tom] Harkin and [Lamar] Alexander and Reps. [John] Shimkus, [Fred] Upton, [Joe] Pitts and [Cory] Gardner for making sure this was a ‘clean’ bill,” Spronk said. “They understood that limiting our ability to keep our animals healthy and burdening producers with paperwork wasn’t going to help us produce safe food or add to the knowledge base about the important issue of antibiotic resistance.”