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

Abstract

Pharmacogenomics, the study and development of compounds according to how an individual’s genes affects the body’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.