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ENZI URGES SENATE TO ACT SWIFTLY ON CRITICAL ANIMAL DRUG LEGISLATION


Washington, D.C. – U.S. Senator Mike Enzi (R-WY), Ranking Member of theSenate Health, Education, Labor and Pensions (HELP) Committee, today urged theSenate to approve legislation that would prevent expiration of the Animal Drug User FeeAct (ADUFA), which provides the Food and Drug Administration (FDA) with theresources to evaluate and approve new drugs for animals in a timely and effectivemanner. The bill also would create a new user fee program for generic animal drugs. “Pet owners, farmers, ranchers, and veterinarians rely on FDA’s ability toevaluate and approve life-saving drugs for animals,” Enzi said. “If Congress does notreauthorize ADUFA soon, we will be forcing FDA to lay off valuable employees. Wecannot afford to lose their talent and expertise.” “ADUFA has been a success, and we should build on that success by creating asimilar user fee program for generic animal drugs. If we do not provide FDA with theresources it needs to approve generic drugs, we will not be able to tap into their costsavingbenefits.” The House of Representatives approved the “Animal Drug User Fee Amendmentsof 2008,” H.R. 6432, earlier today. That bill reauthorizes the Animal Drug User Fee Act(ADUFA) and creates a new Animal Generic Drug User Fee Act. It also includes abipartisan provision to expand and streamline the reporting of antibiotics in animals, andtwo technical corrections to the FDA reform bill, PL 110-85, which Congress enacted lastyear. “I am disappointed that this bill contains just two of several technical changesneeded to properly implement the FDA reforms we enacted last year,” Enzi said. “Thefull package of technical corrections is critical to ensure that key safety andaccountability provisions in the bill work as Congress intended.” “However, there is much to like in this bill, and we cannot afford to hold ADUFAhostage to unrelated provisions like technical corrections to another bill. I support thislegislation and I strongly urge the Senate to act on final passage this week.” ####