Genetic Testing and Government Regulation: The Growing Significance of Pharmacogenomics

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Genetic Testing and Government Regulation: The Growing Significance of Pharmacogenomics

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Lumelsky, Anna E. en_US
dc.date.accessioned 2012-06-07T20:14:45Z
dc.date.issued 2003 en_US
dc.identifier.citation Genetic Testing and Government Regulation: The Growing Significance of Pharmacogenomics (2003 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852131
dc.description.abstract Genetic testing, currently a diagnostic tool used by only a small fraction of the population, promises to become a routine and critical part of medical care and drug prescription in the near future. This change will come chiefly through improvements in pharmacogenomics, the use of genetic testing to tailor medical care to an individual's unique genetic makeup. Current regulation of genetic testing is inadequate to meet the challenges of this new regime. Federal regulatory agencies, and in particular the FDA, are currently unprepared for the dramatic increase in scope and complexity of both the prescription drug market and the genetic testing market that is likely to result from the rise of pharmacogenomics. Although government advisory committees and legal scholars have long called for reform of genetic testing regulation, they have focused excessively on the moral dilemmas raised by predictive genetic testing at the expense of the increasingly significant area of pharmacogenomic research. This article provides a brief description of genetic testing, pharmacogenomics, and the current regulatory system, and highlights several areas where change is long overdue. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject genetic testing en
dc.subject pharmacogenomics en
dc.subject pharmacogenetics en
dc.title Genetic Testing and Government Regulation: The Growing Significance of Pharmacogenomics en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-07T20:14:45Z

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