Lawmakers overwhelmingly approve animal drug user fee act

By Agri-Pulse staff

© Copyright Agri-Pulse Communications, Inc.



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WASHINGTON, June 4, 2013 - The Animal Drug User Fee Amendments (ADUFA), H.R. 1407, passed the House of Representatives last night with an overwhelming vote of 390-12. The current law, which authorizes the user fees, expires at the end of fiscal 2013.

The measure authorizes the Food and Drug Administration (FDA) to collect fees for certain animal drug applications. A companion version of the legislation, sponsored by Sen. Tom Harkin, D-Iowa, passed the Senate by unanimous consent on May 8.

NCBA President Scott George said passage of ADUFA is important because new animal health technologies allow cattle producers and veterinarians to prevent, control and treat diseases to maintain a healthy herd.

“Raising healthy cattle is of utmost importance to cattlemen and women, and it is important for producers and the veterinarians they work with to have the ability to best manage herd health and produce safe, nutritious beef,” said George. "The reauthorization of ADUFA will provide resources for the FDA to conduct timely and thorough reviews of new animal drugs for safety and effectiveness."

George added that with a "clean" bill free of amendments, the fees paid by animal health companies to fund FDA reviews and evaluations will be utilized to support and facilitate the new animal drug approval process.

"Cattle producers know that keeping our animals healthy is critical to the viability of our operations and our industry," said George. "We sincerely thank the Senate and House leadership for working together to pass this legislation and for realizing the importance of passing a clean bill without unnecessary language or amendments."

At times, it appeared the bill would not be so “clean.” During a House Energy and Commerce Committee hearing in April, a few Democrats said they hoped ADUFA would be a vehicle for anti-antibiotic legislation. Rep. Harold Waxman, D-Calif., made clear his intention to attach his Delivering Antibiotic Transparency in Animals (DATA) Act to the bill. He introduced the legislation in October, but it failed to reach the House floor.

“We're simply asking the industry to tell us more about how these drugs are used,” he said. “Now is the time for the next step for moving the DATA Act. I understand argument for keeping ADUFA free of controversy, but we need to address this soon.”

Under FDA revenue recommendations, the animal drugs industry would pay about $23.6 million in fiscal 2014 and $21.5 million in each of the subsequent four years. In addition, the generic animal drugs industry would pay roughly $7.3 million in fiscal 2014 and $30 million annually through 2018.

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