Statement of Congressman John D. Dingell, Chairman
Committee on Energy and Commerce

SUBCOMMITTEE ON HEALTH HEARING ENTITLED, "COMMITTEE PRINTS OF ADMINISTRATION LEGISLATIVE PROPOSALS ON THE ANIMAL DRUG USER FEE ACT AMENDMENTS OF 2008 AND THE ANIMAL GENERIC DRUG USER FEE ACT OF 2008"

June 5, 2008

Mr. Chairman, thank you for beginning the consideration of two legislative proposals recently sent up by the Administration, and for your leadership on these important public health matters. Today’s hearing is the first step in crafting legislation that will provide the necessary resources for the Food and Drug Administration (FDA) to safely and efficiently review animal drug applications.

The Animal Drug User Fee Act (ADUFA) expires on October 1, 2008, less than four months from now. It is the responsibility of this Committee and the Congress to ensure that this program is reauthorized in a timely manner to avoid any personnel disruptions at the FDA. Hardworking, skilled employees at FDA are depending on us to do our job, so they can continue to do their job.

An important component of the Administration’s proposals focuses on the need for greater resources at FDA. We have heard from a wide range of stakeholders on this point and I agree. This legislation must provide FDA with the necessary user fee structure to provide resources for the timely and thorough review of new animal drug applications. Equally important, we must ensure that Congress appropriates the requisite funds that have been authorized for FDA.

As we begin this process of reauthorizing ADUFA and considering the proposed legislation to establish an animal generic drug user fee, we must diligently work towards strengthening the safety and effectiveness of the Nation’s supply of animal drugs. I thank the Chairman for holding this hearing on the proposals before us today and I look forward to the testimony of the witnesses.