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Friday, November 21, 2008 9:48:22 PM
"...a third piece of legislation might be the key to unleashing a new wave of drugs designed for subgroups of the population based on genetics. Senators Obama (D; IL, USA) and Burr (R; NC, USA) introduced the Genomics and Personalized Medicine Act of 2007 (S 976).[30] It emphasizes the need for standardized terminology, systematic data storage and collection, and habitual use of data throughout clinical trials and in the doctors office. The bill recognizes the need for a central harmonized biobanking initiative through which institutes and industry can more efficiently access and analyze large amounts of genetic information. In addition, Obama proposes funding for training in applied genomics and economic incentives for development of pharmacogenomic diagnostics, making provisions for US$150 million to sponsor research on genomics, and a 100% tax credit for the development of companion diagnostic tests that would expectantly decrease the incidence of unpredictable drug reactions.[31–33] The most promising picture for the next generation of drug development is an FDA that integrates parts from each of these bills, although the Obama legislation is critical in order to modernize drug safety. No clinical trial can predict each and every potential adverse reaction, but pharmacogenomic data can help us learn when and how to prescribe our drugs if scrutinized in the way that other clinical-trial data are."
subtract from >>>Personalized Medicine. 2008;5(2):133-139. ©2008 Future Medicine Ltd.
http://www.medscape.com/viewarticle/573754
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