A New Era in Drug Development: Legal and Ethical Implications of Pharmacogenomics

A New Era in Drug Development: Legal and Ethical Implications of Pharmacogenomics

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A New Era in Drug Development: Legal and Ethical Implications of Pharmacogenomics

dc.contributor.advisor	Hutt, Peter Barton	en_US
dc.contributor.author	Gutmann, Valerie	en_US
dc.date.accessioned	2012-06-07T19:40:58Z
dc.date.issued	2005	en_US
dc.identifier.citation	A New Era in Drug Development: Legal and Ethical Implications of Pharmacogenomics (2005 Third Year Paper)	en
dc.identifier.uri	http://nrs.harvard.edu/urn-3:HUL.InstRepos:8848306
dc.description.abstract	Pharmacogenomics, the study and development of compounds according to how an individualâ€™s genes affects the bodyâ€™s response to drugs, holds enormous promise for increasing the safety and efficiency of drug development while decreasing adverse reactions and the trial-and-error nature of drug prescription. However, pharmacogenomics may not be the panacea for all development and prescription problems. This paper explores some of the obstacles to pharmacogenomic advancement including industry reluctance to pursue research because of potentially prohibitive costs associated with developing products. The implications pharmacogenomics has for drug research and development as well as various areas of law, such as patent law, medical liability, and insurance and discrimination law, will be discussed in light of current FDA regulation and guidance and the Orphan Drug Act. The diverse practical, economic, legal, and ethical issues associated with genetic discoveries within the current regulatory and legal regime are also considered. An ideal system will advance, rather than hinder, appropriate technological progress while protecting the rights of individuals and ensuring that they receive the best medical treatment available.	en
dc.language.iso	en_US	en
dash.license	LAA	en_US
dc.subject	Food and Drug Law	en
dc.subject	Pharmacogenomics	en
dc.title	A New Era in Drug Development: Legal and Ethical Implications of Pharmacogenomics	en
dc.type	Paper (for course/seminar/workshop)	en_US
dc.date.available	2012-06-07T19:40:58Z