Genetic Testing and Government Regulation: The Growing Significance of Pharmacogenomics

Abstract

Genetic testing, currently a diagnostic tool used by only a small fraction of the population, promises to become a routine and critical part of medical care and drug prescription in the near future. This change will come chiefly through improvements in pharmacogenomics, the use of genetic testing to tailor medical care to an individual's unique genetic makeup. Current regulation of genetic testing is inadequate to meet the challenges of this new regime. Federal regulatory agencies, and in particular the FDA, are currently unprepared for the dramatic increase in scope and complexity of both the prescription drug market and the genetic testing market that is likely to result from the rise of pharmacogenomics. Although government advisory committees and legal scholars have long called for reform of genetic testing regulation, they have focused excessively on the moral dilemmas raised by predictive genetic testing at the expense of the increasingly significant area of pharmacogenomic research. This article provides a brief description of genetic testing, pharmacogenomics, and the current regulatory system, and highlights several areas where change is long overdue.