Evans, Barbara J.2006-12-072006-12-072006Evans, BJ, What Will It Take To Reap the Clinical Benefits of Pharmacogenomics? Food & Law Journal, 61(4):753-794 2006https://hdl.handle.net/1805/657Posted with permission from FDLI <http://www.fdli.org>; Food and Drug Law Journal <http://www.fdli.org/pubs/Journal%20Online/>Genetically targeted drug and biologic therapies promise a new era of personalized medicine, but there has been frustration with how slowly these therapies are moving from concept to actual clinical application. Various legal and regulatory barriers threaten to delay translation of basic discoveries into approved products and to slow the clinical uptake of new therapeutic products as they become available. There is a pressing need to reach consensus on what these barriers are, so that they can be addressed in a timely and effective manner. This paper explores what some of the key barriers may be. It examines: (1) legal, regulatory, and commercial barriers to “successive improvement” of existing drugs through improved targeting strategies; (2) barriers to cooperative, multi-party development of targeted therapies; (3) methodological problems in assessing the incremental health and economic benefits of an improved targeting strategy; (4) limitations of traditional product labeling as a medium for communicating timely, clear information about drug targeting to clinicians and the need to create new mechanisms within the medical profession to manage and communicate this information; and (5) difficulty defining the appropriate line between regulation of medical products and regulation of medical practice, in the case of targeted therapies.542461 bytesapplication/pdfen-USPharmacogenomicsEthicsPublic PolicyGeneticsPharmacogeneticsDrug TherapyDrug ApprovalProduct LabelingGenetic Predisposition to DiseasePolicy MakingArticleBiohazards of Genetic Research 15.7Genetic Screening 15.3DNA Research 15.1Diseases, Genetic 15.1Drugs and Drug Industry 9.7Ethical Guidelines 6Health Care for Particular Diseases or Groups, General 9.5.1Human Genome Mapping 15.10