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Full Text of this Amendment

SA 1016. Mr. SPECTER 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 in the bill, insert the following:
SEC. __. NATIONAL CENTERS FOR PHARMACEUTICAL INNOVATION.
Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end the following:
``Subchapter __--Establishment of the National Centers for Pharmaceutical Innovation


``SEC. __1. ESTABLISHMENT OF THE CENTERS.
``(a) In General.--The Commissioner of Food and Drugs, in consultation with the Secretary, shall establish through competitive selection not more than 5 university-based National Centers for Pharmaceutical Innovation (referred to in this subchapter as the `Centers').
``(b) Purpose of Centers.--The purpose of the Centers is to advance the Food and Drug Administration's Critical Path Initiative, as well as subsequent efforts, to modernize medical pharmaceutical product development by--
``(1) designing methodologies to dramatically increase the speed at which new drugs enter the market while significantly reducing the cost of such process;
``(2) developing new technological tools to speed the creation of safer, more effective drugs targeted at individuals;
``(3) assisting the Food and Drug Administration with drug therapy-monitoring programs to look for adverse consequences utilizing medicines;
``(4) expanding the quality and number of professionals trained in translational medicine, translational therapeutics, and the manufacture of pharmaceutical and biotechnology products; and
``(5) introducing new technologies to improve the manufacture of pharmaceutical and biotechnology products.
``SEC. __2. CRITERIA FOR SELECTION.
``The Commissioner of Food and Drugs, in consultation with the Secretary, shall select the Centers from among qualified university or university consortium applicants on the basis of key factors in pharmaceutical product development, safety, and manufacturing technology, including--
``(1) whether the applicant has established graduate training programs that integrate the elements of translational therapeutics, including basic and clinical pharmacology, pharmaceutical science, including pharmacokinetic modeling, analytical technologies, genomics and proteomics, pharmacoepidemiology, informatics, and statistics;
``(2) demonstration of extensive experience in the development and evaluation of medicines through drug approval to the post-marketing process;
``(3) scientific programs in translational therapeutics and pharmaceutical science designed to hasten the personalization of medicine;
``(4) proficiencies in pharmaceutical and biotechnology science and engineering, including therapy development and manufacturing; and
``(5) other factors that the Commissioner of Food and Drugs determines appropriate.
``SEC. __3. AUTHORIZATION OF APPROPRIATIONS.
``There are authorized to be appropriated to carry out this subchapter such sums as may be necessary for each of the fiscal years 2008 through 2013.''.


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