THE EMERGENCE OF PERSONALIZED MEDICINE: POLICY IMPLICATIONS FOR REGULATORY OVERSIGHT, PRODUCT LABELING, AND DIRECT TO CONSUMER ADVERTISING

Abstract

Personalized medicine is a scientific approach that leverages knowledge gained from an individual's or group of individual's genetic profile to select combinations of treatments and preventative measures that are likely to provide patients improved health outcomes. At present applications of personalized medicine are limited but growing rapidly, and many predict that personalized medicine has the potential to substantially transform modern medical practice. Despite its potential, its use to date remains sporadic due to a variety of scientific, medical, and regulatory challenges. This analysis reviews these challenges and examines alternative public policy approaches to accelerating the development and adoption of personalized medicine in clinical practice, including the clarification of US Food and Drug Administration's (FDA's) regulatory authority regarding genetic testing and drug labeling, and the role of direct to consumer advertising in public education.