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Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada

Advances in pharmacogenomic research and increasing industry interest in personalized medicine have important implications for the way that orphan drug policies are interpreted and applied. Concerns have been raised about the potential impact of pharmacogenomics and new genomic technologies on our u...

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Detalles Bibliográficos
Autores principales: Gibson, Shannon, von Tigerstrom, Barbara
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5034370/
https://www.ncbi.nlm.nih.gov/pubmed/27774196
http://dx.doi.org/10.1093/jlb/lsv013
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author Gibson, Shannon
von Tigerstrom, Barbara
author_facet Gibson, Shannon
von Tigerstrom, Barbara
author_sort Gibson, Shannon
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description Advances in pharmacogenomic research and increasing industry interest in personalized medicine have important implications for the way that orphan drug policies are interpreted and applied. Concerns have been raised about the potential impact of pharmacogenomics and new genomic technologies on our understanding of how disease categories are delineated, and subsequently, how the concept of rare disease should be defined for the purposes of orphan drug policies. This article considers whether orphan drug legislation can be drafted in a way that will maximize benefits and minimize concerns relating to the impact of pharmacogenomics on orphan drug research and development. After reviewing the issues that may arise at the intersection of orphan drug policies and pharmacogenomics, this article will discuss the potential impact of pharmacogenomics at two critical points: orphan designation and approval of the drug product. At each of these points, the relevant aspects of current US orphan drug legislation are examined, focusing on the extent to which recent amendments may address concerns that have been raised previously. This analysis will then provide the foundation for a critical review and recommendations regarding the proposed new Canadian orphan drug framework.
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spelling pubmed-50343702016-10-21 Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada Gibson, Shannon von Tigerstrom, Barbara J Law Biosci Original Article Advances in pharmacogenomic research and increasing industry interest in personalized medicine have important implications for the way that orphan drug policies are interpreted and applied. Concerns have been raised about the potential impact of pharmacogenomics and new genomic technologies on our understanding of how disease categories are delineated, and subsequently, how the concept of rare disease should be defined for the purposes of orphan drug policies. This article considers whether orphan drug legislation can be drafted in a way that will maximize benefits and minimize concerns relating to the impact of pharmacogenomics on orphan drug research and development. After reviewing the issues that may arise at the intersection of orphan drug policies and pharmacogenomics, this article will discuss the potential impact of pharmacogenomics at two critical points: orphan designation and approval of the drug product. At each of these points, the relevant aspects of current US orphan drug legislation are examined, focusing on the extent to which recent amendments may address concerns that have been raised previously. This analysis will then provide the foundation for a critical review and recommendations regarding the proposed new Canadian orphan drug framework. Oxford University Press 2015-04-19 /pmc/articles/PMC5034370/ /pubmed/27774196 http://dx.doi.org/10.1093/jlb/lsv013 Text en © The Author 2015. Published by Oxford University Press on behalf of Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Original Article
Gibson, Shannon
von Tigerstrom, Barbara
Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada
title Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada
title_full Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada
title_fullStr Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada
title_full_unstemmed Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada
title_short Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada
title_sort orphan drug incentives in the pharmacogenomic context: policy responses in the us and canada
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5034370/
https://www.ncbi.nlm.nih.gov/pubmed/27774196
http://dx.doi.org/10.1093/jlb/lsv013
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