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Public Statements

Performance Goals for the Prescription Drug User Fee Amendments of 2007

Floor Speech

Location: Washington, DC



Mr. Kennedy. Mr. President, on September 20, 2007, the Senate passed H.R. 3580, the Food and Drug Administration Amendments Act of 2007. Title I of this bill is the reauthorization of the FDA's prescription drug user fee program, and includes the initial authorization for a voluntary user fee program for advisory reviews of direct-to-consumer television advertising.

Performance goals, existing outside of the statute, accompany the reauthorization of the drug user fee program and the authorization of the advisory review user fee program. These goals represent a realistic projection of what the Food and Drug Administration's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research can accomplish with industry cooperation. The Secretary of Health and Human Services forwarded these goals to the chairmen of the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate, in a document with two sections entitled ``PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES'' and ``PERFORMANCE GOALS AND PROCEDURES FOR ADVISORY REVIEW OF DIRECT-TO-CONSUMER TELEVISION ADVERTISING.'' According to Section 101(c) of H.R. 3580, ``the fees authorized by the amendments made in this title will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals . . .in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.''

Today I am submitting for the Record this document, which was forwarded to the Committee on Health, Education, Labor and Pensions on September 27, 2007, as well as the letter from Secretary Leavitt that accompanied the transmittal of this document.

The agency-industry agreement on prescription drug user fees includes, for each of the 5 fiscal years of the reauthorization, an additional $29,290,000 and 82 full time employees for the postmarket drug safety activities described in the document. These funds are augmented in Title I of H.R. 3580 by an additional $225 million for postmarket drug safety, $25 million for fiscal year 2008, $35 million for fiscal year 2009, $45 million for fiscal year 2009, $55 million for fiscal year 2010, and $65 million for fiscal year 2011. The FDA will use this $225 million to implement the postmarket drug safety programs and authorities set out in Title IX of H.R. 3580.

I ask unanimous consent this material be printed in the Record.


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