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U.S. Department of Health and Human Services

For Industry

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TEXT OF THE JUNE 4, 2002 LETTER TRANSMITTING THE PDUFA III PERFORMANCE GOALS AND PROCEDURES

As you are aware, the Prescription Drug User Fee Act of 1992 (PDUFA), as reauthorized by the Food and Drug Administration Modernization Act of 1997, expires at the end of Fiscal Year 2002. Under PDUFA, the additional revenues generated from fees paid by the pharmaceutical and biological prescription drug industries have been used to expedite the process for the review of prescription drugs, in accordance with performance goals that were developed by the Food and Drug Administration (FDA) in consultation with PDUFA stakeholders.

FDA has worked with various stakeholders, including representatives from consumer, patient, and health provider groups, and the pharmaceutical and biological prescription drug industries, to develop a reauthorization proposal for PDUFA that would build upon and enhance the success of the program. Title 5, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as passed by the House on May 22, 2002, and by the Senate on May 23, 2002, reflects the fee mechanisms and other improvements developed in these discussions. The performance goals referenced in Section 502 are specified in the enclosure to this letter, entitled "PDUFA Reauthorization Performance Goals and Procedures.'' I believe they represent a realistic projection of what FDA can accomplish with industry cooperation and both the additional resources identified in the bill and annual FDA appropriations that fully cover the costs of pay and inflation increases for the drug and biologics review process each year.

This letter and the enclosed goals document pertain only to Title 5, Subtitle A (Prescription Drug User Fees) of H.R. 3448, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. OMB has advised that there is no objection to the presentation of these views from the standpoint of the Administration's program. We appreciate the support of you and your staffs, the assistance of other Members of the Committee, and that of the Appropriations Committees, in the reauthorization of this vital program.

                                                                                                 Sincerely,

 

                                                                                                 Tommy Thompson

Enclosure

Identical Letters to the Chairman and Ranking Minority Members of:
Committee on Health, Education, Labor, & Pensions, United States Senate
Committee on Energy and Commerce, House of Representatives