For Industry

11/12/97 Letter: Goals Pertaining to the Reauthorization of the Prescription Drug User Fee Act

NOV 1 2 1997

The Honorable James M. Jeffords
Committee on Labor and Human Resources
United States Senate
Washington, DC 20510

Dear Mr. Chairman:

As you are aware, the Prescription Drug User Fee Act of 1992 (PDUFA) expired at the end of Fiscal Year 1997. Under PDUFA, the additional revenues generated from fees paid by the pharmaceutical and biological prescription drug industries have been used to expedite the prescription drug review and approval process, in accordance with performance goals that were developed by the Food and Drug Administration (FDA) in consultation with the industries. To date, FDA has met or exceeded the review performance goals agreed to in 1992, and is reviewing over 90 percent of priority drug applications in 6 months and standard drug applications in 12 months.

FDA has worked with representatives of the pharmaceutical and biological prescription drug industries, and the staff of your Committee, to develop a reauthorization proposal for PDUFA that would build upon and enhance the success of the original program. Title 1, Subtitle A of the Food and Drug Administration Modernization Act of 1997, S.830, as passed by the House and Senate on November 9, 1997, reflects the fee mechanisms developed in these discussions. The performance goals referenced in Section 101(4) 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 the additional resources identified in the bill.

This letter and the enclosed goals document pertain only to Title 1, Subtitle A (Fees Relating to Drugs) of S. 830, the Food and Drug Administration Modernization Act of 1997.

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.


Donna E. Shalala



FDA Modernization Act of 1997

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