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Animal Drug User Fee Act Headed to President's Desk

Animal Drug User Fee Act Headed to President's Desk

Legislation would authorize FDA to collect fees for certain animal drug applications

The House of Representatives Monday voted 390-12 in support of the Animal Drug User Fee Act, legislation that allows the Food and Drug Administration to collect fees for certain animal drug applications.

The bill previously passed through the House Energy and Commerce Committee and the Senate in May. It now goes to the President's desk for his signature.

The National Cattlemen's Beef Association, strong supporter of the bill, says it authorizes pharmaceutical companies to pay a user fee to FDA, which is used to hire additional technical staff. By hiring additional technical staff, FDA is able to approve future animal health products without adding to taxpayer debts.

Legislation would authorize FDA to collect fees for certain animal drug applications

The future animal health technologies allow cattle producers and veterinarians increased flexibility and more choices in treating sick animals, NCBA says.

"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," says NCBA President Scott 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 adds that the bill passed without amendments, allowing all fees collected to be used to support 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."

The reauthorization of ADUFA will generate $98 million in user fees during FY09-FY13, the FDA says. The bill was first passed in 2003 and reauthorized in 2008. Without reauthorization, it would have expired this year.

TAGS: Regulatory
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