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Schrader, Mullin Introduce Bipartisan Reauthorization of Animal Drug User Fee Act

Congressman Kurt Schrader (D-OR-05) and Congressman Markwayne Mullin (R-OK-02) and introduced H.R. 5554 to reauthorize the Food and Drug Administration’s (FDA) Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA). ADUFA and AGDUFA would continue agreements between the FDA and the animal drug industry to pay user fees that help speed the approval of new drugs for farmers, ranchers, families, and veterinarians so they can keep their animals and pets safe and healthy.
 
“As a veterinarian in rural Oregon, I understand firsthand the importance of ADUFA and AGDUFA,” said Rep. Schrader. “They allow veterinarians, companion animal owners, and livestock owners to have the same streamlined process our human counterparts have for their pharmaceuticals and biologics. This means better, cutting-edge care when our animals need it the most. They also recognize the smaller market share veterinary pharmaceuticals have and allow for a unique and safe way to innovate in the marketplace for our four footed friends. Our reauthorization bills will continue to allow and encourage innovation across the industry, benefiting owners, veterinarians, and, of course, the animals themselves.”
 
“After the last ADUFA reauthorization, drug approval times reduced drastically and farmers, ranchers, and veterinarians had access to cheaper, safer medicines for their animals,” said Rep. Mullin. “Our rural and farming communities rely on these medicines to keep their animals—and our country’s food supply—healthy. I am proud to sponsor this year’s reauthorization of ADUFA and AGDUFA and look forward to approving this valuable program for another five years.” 
 
ADUFA and AGDUFA give the FDA authority to collect user fees from sponsors for the review of animal drug applications. ADUFA was first authorized in 2003, giving the FDA authority for the first time to collect user fees for the review of animal drugs similar to fee programs for human drugs and medical devices. AGDUFA, authorized in 2008, gave the FDA the same authority but for generic drug applications. The current reauthorization of both ADUFA and AGDUFA expires on September 30, 2018.