I ask unanimous consent to have printed in the Record a copy of the transmittal and commitment letters from the Secretary of Health and Human Services to the chair and ranking member of the Committee on Health, Education, Labor, and Pensions of the Senate and the chair and ranking member of the Committee on Energy and Commerce of the House of Representatives regarding reauthorization of the Prescription Drug User Fee Act, Medical Device User Fee Amendments, Generic Drug User Fee Amendments, and Biosimilar User Fee Act. There being no objection, the material was ordered to be printed in the Record, as follows: The Secretary of Health and Human Services, Washington, DC, January 12, 2022. Hon. Patty Murray, Chair, Committee on Health, Education, Labor and Pensions, U.S. Senate, Washington, DC. Dear Chair Murray: The Prescription Drug User Fee Act [PDUFA] as reauthorized by the Food and Drug Administration Reauthorization Act [FDARA P.L. 115-52], expires at the end of Fiscal Year 2022. With this letter the Administration is providing our recommendations for the reauthorization of PDUFA for the Fiscal Years 2023-2027 [PDUFA VII]. Under PDUFA, the revenues generated from fees paid by the pharmaceutical industry have been used to expedite the process for the review of new prescription drugs and to support and augment regulatory science and drug development.…
On the recordSeptember 28, 2022
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