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Full Text of this Amendment

SA 1013. Mr. VITTER submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:

At the appropriate place, insert the following:
SEC. __. OFFICE OF GENERIC DRUGS.
(a) Findings.--Congress makes the following findings:
(1) More than $100,000,000,000 in blockbuster brand pharmaceutical products will lose patent protection between April 2007 and 2010. As a result, more applications for generic versions of these products will be filed with the Office of Generic Drugs of the Food and Drug Administration.
(2) The staff of the Office of Generic Drugs is backlogged. Approximately 800 generic drug applications are pending review as of April 2007.
(3) The workload of the Office of Generic Drugs has increased by 36 percent since 2004, yet the Office has the same budget and the same number of staff.
(4) The workload of the Office of Generic Drugs also has increased due to the filing of citizen petitions by brand companies designed to delay generic drug approvals.
(5) A modest investment in the Office of Generic Drugs, such as $15,000,000, would help to make more affordable medicines available in a timely manner to consumers and public and private health care purchasers, who would save billions of dollars.
(6) Those savings also would enable the Federal Government to reach more Americans through important health care initiatives, such as Medicare, Medicaid, and programs to improve children's health care, assist the chronically ill, and fight HIV/AIDS.
(b) Authorization of Appropriations.--Notwithstanding section 736(b) of the Federal Food, Drug, and Cosmetic Act (as amended by section 103(b) of this Act), the Secretary of Health and Human Services shall allocate $20,000,000 of the user fees generated by section 736(a) of the Federal Food, Drug, and Cosmetic Act (as amended by section 103(a) of this Act), for each fiscal year beginning with fiscal year 2009 and ending with fiscal year 2012, to the Office of Generic Drugs of the Food
and Drug Administration, for the sole purpose of reviewing and approving abbreviated new drug applications.


(As printed in the Congressional Record for the Senate on May 2, 2007.)