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FOR IMMEDIATE RELEASE |
Media Inquiries: 301-827-6242 |
We would like to commend today’s House passage of H.R. 1260, “The Animal Drug User Fee Act of 2003” to authorize the Food and Drug Administration (FDA) to collect user fees in order to speed FDA review and approval of safe and effective animal drugs. In particular, we would like to thank the bill’s sponsors including Representatives Fred Upton and Diane Degette as well as Energy and Commerce Committee Chairman W.J. “Billy” Tauzin and Ranking Member Dingell who worked together on a bipartisan basis with other Members to move this legislation forward. Thanks to their leadership and the broad bipartisan action of the House of Representatives, the FDA is an important step closer to improving the review of new animal drugs. These improvements would help speed up the availability of safe and effective new animal medications, which is good news not only for our pets and farm animals, but also consumers.
ADUFA is patterned on the Prescription Drug User Fee Act of 1992, a highly successful law that has enabled the agency to reduce by half its review times for drugs and biological products. Last year, Congress also passed the Medical Device User Fee and Modernization Act, which authorizes collection of user fees for FDA's evaluation of new medical devices. ADUFA would authorize FDA to collect $5 million in animal drug user fees from product manufacturers in the current fiscal year, which started on October 1, 2003. Earlier this year, the Senate passed a virtually identical bill, S. 313 sponsored by Senators Ensign and Harkin along with HELP Committee Chairman Judd Gregg and Ranking Member Kennedy. We look forward to working with Congress to move this legislation forward to enactment.
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