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 article explores some of the obstacles to pharmacogenomic advancement including industry reluctance to pursue research because of potentially prohibitive costs associated with developing products and legal liability concerns. The implications pharmacogenomics has for drug research and development as well as various areas of law will be discussed in light of current FDA regulation and guidance and the Orphan Drug Act. 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.
Valerie Gutmann Koch,
Incentivizing the Utilization of Pharmacogenomics in Drug Development,
J. Health Care L. & Pol'y
Available at: http://scholarship.kentlaw.iit.edu/fac_schol/317