The regulation of pharmacogenomics-based drugs and policy making.

In addition to potential future clinical benefits such as reducing adverse drug reactions and optimizing therapeutic efficacy, pharmacogenomic applications promise numerous benefits for the pharmaceutical and biotechnology industries, including decreasing the size and expense of clinical trials and streamlining the drug development process. The application of pharmacogenomics and related technological advances to drug development has prompted various regulatory agencies such as the United States Food and Drug Administration to issue guidance documents and other advisory statements. This article delineates the impact of pharmacogenomic-guided drug development on the regulatory process in the United States including relevant highlights of industry guidance documents and policy statements. Hypothetical vignettes are used to illustrate a number of issues that are challenging to policy makers and the potential impact of pharmacogenomic based drug research and development on the regulatory environment.