The Human Genome Project has fueled rapid progress in pharmacogenomics over the past decade. Genetic variability of drug response was suspected in the mid-twentieth century, but scientists only now are gaining the ability to explain this variability and harness it to improve health outcomes. These advances are forcing health care professionals and regulators to reevaluate the duties they owe to the people they serve and protect. Patients with identical symptoms may have genetic differences that carry important implications for the best choice of therapy and for the physician's standard of care. Clinical trial subjects who seem comparable under traditional trial selection criteria like age, gender, or severity of underlying disease may not be comparable at all when genetic differences are taken into account. Studies that gloss over these differences may mislead the public about the safety and effectiveness of the drugs they consume, yet regulators routinely rely on such studies when approving new drugs. Additional steps are needed to protect the public. The very notion of “the public” is evolving as pharmacogenomics divides the population into multiple subgroups. Regulators who once needed only to protect a single, homogeneous “public” now face a situation where their decisions visit disparate impacts on various subgroups within the broader public they are seeking to protect. This shift in perspective already is reshaping the legal and commercial environment for medical products and health care.

This chapter explores trends that are emerging as law adapts to the era of personalized genomic medicine. The focus is on how the broad contours of regulations affecting drugs and medical devices are changing and how these changes may affect clinicians, patients, medical researchers, and people who participate in biomedical research. Important reforms already are in progress, and more can be expected in coming years. One concrete example is the Food and Drug Administration Amendments Act of 2007 (FDAAA), which instituted a major program to modernize medical product regulation by the U.S. Food and Drug Administration (FDA). Related reforms are on the drawing board or already are being implemented in various nations around the world.