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Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013

Floor Speech

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Date:
Location: Washington, DC

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Mr. PALLONE. Mr. Speaker, I rise in strong support of S. 622, the Animal Drug and Animal Generic Drug User Fee Reauthorization Act.

Congress enacted the Animal Drug User Fee Act (ADUFA) in 2003 to help improve the FDA review of new animal drugs, and subsequently enacted the Animal Generic Drug User Fee Act (AGDUFA) to improve the review of abbreviated new animal drug applications, or generic versions of animal drugs. These programs have been extremely effective, and have helped expedite the approval process, reduce application backlogs, and improve communications with drug sponsors.

Without congressional action, the current agreements will expire at the end of this fiscal year, which would have a serious and harmful impact on the ability of the FDA's Center for Veterinary Medicine to review new and generic drug applications in a timely manner. S. 622 will extend FDA's authority to collect user fees from manufacturers for five years.

I urge my colleagues to vote in favor of S. 622, so that progress is not impeded and the Food and Drug Administration can continue to review new and generic animal drug applications in a timely manner. Industry, farmers, ranchers, and pet owners are counting on an uninterrupted supply of animal drugs.

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