Heidi Alexander: “I ask unanimous consent to have printed in the Record a copy of the commitment letters from the Secretary of Health and…”

“I ask unanimous consent to have printed in the Record a copy of the commitment 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 regarding reauthorization of the Biosimilar User Fee Act, Generic Drug User Fee Act, Prescription Drug User Fee Act, and Medical Device User Fee Amendments. There being no objection, the material was ordered to be printed in the Record, as follows: Department of Health & Human Services, Washington, DC, January 4, 2017. Hon. Lamar Alexander, Chairman, Committee on Health, Education, Labor and Pensions, U.S. Senate, Washington, DC. Dear Mr. Chairman: The Generic Drug User Fee Amendments of 2012 (GDUFA) enacted as title III of the Food and Drug Administration Safety and Innovation Act [Pub. L. 112-144], expires at the end of Fiscal Year 2017. With this letter the Administration is providing our recommendations for the reauthorization of GDUFA for the Fiscal Years 2018-2022 (GDUFA II). Under GDUFA, the revenues generated from fees paid by the generic pharmaceutical industry have been used to expedite the process for the review of generic drugs and to support and augment regulatory science and drug development.…”