May 2, 2007, 12:00 am ET - Amendment SA 985 proposed by Senator Brown for Senator Brownback.
May 3, 2007, 12:00 am ET - Considered by Senate.
May 7, 2007, 12:00 am ET - Considered by Senate.
May 8, 2007, 12:00 am ET - Considered by Senate.
May 8, 2007, 12:00 am ET - Amendment SA 985 as modified agreed to in Senate by Unanimous Consent.
Full Text of this Amendment
At the appropriate place, insert the following:
SEC. __. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL DISEASES.
Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the end the following:
``SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL DISEASES.
``(a) Definitions.--In this section:
``(1) AIDS.--The term `AIDS' means the acquired immune deficiency syndrome.
``(2) AIDS DRUG.--The term `AIDS drug' means a drug indicated for treating HIV.
``(3) HIV.--The term `HIV' means the human immunodeficiency virus, the pathogen that causes AIDS.
``(4) NEGLECTED OR TROPICAL DISEASE.--The term `neglected or tropical disease' means--
``(A) HIV, malaria, tuberculosis, and related diseases; or
``(B) any other infectious disease that disproportionately affects poor and marginalized populations, including those diseases targeted by the Special Programme for Research and Training in Tropical Diseases cosponsored by the United Nations Development Program, UNICEF, the World Bank, and the World Health Organization.
``(5) PRIORITY REVIEW.--The term `priority review', with respect to a new drug application described in paragraph (6), means review and action by the Secretary on such application not later than 180 days after receipt by the Secretary of such application, pursuant to the Manual of Policies and Procedures of the Food and Drug Administration.
``(6) PRIORITY REVIEW VOUCHER.--The term `priority review voucher' means a voucher issued by the Secretary to the sponsor of a tropical disease product that entitles such sponsor, or a person described under subsection (b)(2), to priority review of a new drug application submitted under section 505(b)(1) after the date of approval of the tropical disease product.
``(7) TROPICAL DISEASE PRODUCT.--The term `tropical disease product' means a product that--
``(A) is a new drug, antibiotic drug, biological product, vaccine, device, diagnostic, or other tool for treatment of a neglected or tropical disease; and
``(B) is approved by the Secretary for use in the treatment of a neglected or tropical disease.
``(b) Priority Review Voucher.--
``(1) IN GENERAL.--The Secretary shall award a priority review voucher to the sponsor of a tropical disease product upon approval by the Secretary of such tropical disease product.
``(2) TRANSFERABILITY.--The sponsor of a tropical disease product that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher to a sponsor of a new drug for which an application under section 505(b)(1) will be submitted after the date of the approval of the tropical disease product.
``(3) LIMITATION.--A sponsor of a tropical disease product may not receive a priority review voucher under this section if the tropical disease product was approved by the Secretary prior to the date of enactment of this section.
``(c) Priority Review User Fee.--
``(1) IN GENERAL.--The Secretary shall establish a user fee program under which a sponsor of a drug that is the subject of a priority review voucher shall pay to the Secretary a fee determined under paragraph (2). Such fee shall be in addition to any fee required to be submitted by the sponsor under chapter VII.
``(2) FEE AMOUNT.--The amount of the priority review user fee shall be determined each fiscal year by the Secretary and based on the anticipated costs to the Secretary of implementing this section.
``(3) ANNUAL FEE SETTING.--The Secretary shall establish, before the beginning of each fiscal year beginning after September 30, 2007, for that fiscal year, the amount of the priority review user fee.
``(A) IN GENERAL.--The fee required by this subsection shall be due upon the filing of the new drug application under section 505(b)(1) for which the voucher is used.
``(B) COMPLETE APPLICATION.--An application described under subparagraph (A) for which the sponsor requests the use of a priority review voucher shall be considered incomplete if the fee required by this subsection is not included in such application.''.
(As printed in the Congressional Record for the Senate on May 1, 2007.)