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Barton: Congress Must Move Quickly to Reauthorize Animal Drug User Fee Act

July 9, 2008

WASHINGTON – U.S. Rep. Joe Barton, R-Texas, ranking member of the House Energy and Commerce Committee, issued the following statement today as part of an Health Subcommittee markup of the Animal Drug User Fee Act, Animal Generic Drug User Fee Act and Michelle’s Law:

“Mr. Chairman, thank you for holding this markup on the Animal Drug User Fee Act, Animal Generic Drug User Fee Act  and Michelle’s Law.

“Development of animal drugs takes years and costs millions of dollars. The animal drug user fee program has been a good success. Since the law was first passed in 2003, we have seen numerous new animal drugs come to the market and review times have decreased by almost 40 percent from 295 days in FY2004 to 180 days in FY2008.

“I am pleased to support the reauthorization of the ADUFA program. The bill will provide for $98 million in user fees from FY2009 to FY2013. In addition to increased funding, the bill also creates efficiencies within the review process and provides financial stability for the program.

“I would like to stress the importance of timing in this reauthorization. This program expires at the end of the fiscal year. If it is not reauthorized then the FDA will lose its authority to collect user fees and will have to lay off employees whose jobs are dependent on these fees. If Congress fails to act by the end of this month then the FDA may be forced to issue Reduction in Force notices to employees. That is not a good thing and hopefully we can prevent that by moving quickly today and hopefully next week at full committee.

“In addition to the ADUFA proposal, we’re also consider a plan to improve the approval process of generic drugs. The Animal Generic Drug User Fee Act, or AG-DUFA, will allow the FDA to collect user fees to decrease approval times for these drugs, thereby lowering costs. Under this bill, we can hopefully speed up the approval process from the current 700 days to around 270 days by the end of the authorization period.

“Finally, we will also consider H.R. 2851, Michelle’s Law. Many full-time college students continue their health care coverage under their parent’s policies. This bill seeks to help college students who lose their full-time status due to a serious illness. Students will be able to continue their coverage for a period of one year in this situation. I’m very supportive of this legislation since I have a step-daughter who is a freshman at the University of Texas and is covered through her mother’s plan and her father’s plan. So I have a personal interest in this bill.

“Thank you, Mr. Chairman. I look forward to a successful markup and yield back.”

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