Orphan Drug Incentives in the Pharmacogenomic Context: Policy Responses in the US and Canada

Shannon Gibson & Barbara von Tigerstrom, “Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada” (2015) Journal of Law and the Biosciences, 1-29 doi:10.1093/jlb/lsv013

29 Pages Posted: 23 Apr 2015

See all articles by Shannon Gibson

Shannon Gibson

University of Toronto Faculty of Law

Barbara von Tigerstrom

University of Saskatchewan - College of Law

Date Written: April 19, 2015

Abstract

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.

Keywords: pharmaceutical policy, pharmacogenomics, orphan drug policy, rare diseases, Food and Drug Administration

Suggested Citation

Gibson, Shannon and von Tigerstrom, Barbara, Orphan Drug Incentives in the Pharmacogenomic Context: Policy Responses in the US and Canada (April 19, 2015). Shannon Gibson & Barbara von Tigerstrom, “Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada” (2015) Journal of Law and the Biosciences, 1-29 doi:10.1093/jlb/lsv013, Available at SSRN: https://ssrn.com/abstract=2597185

Shannon Gibson (Contact Author)

University of Toronto Faculty of Law ( email )

105 St George Street
Toronto, Ontario M5S 3G8
Canada

HOME PAGE: http://www.linkedin.com/in/shannongibson

Barbara Von Tigerstrom

University of Saskatchewan - College of Law ( email )

Saskatoon, Saskatchewan
Canada

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