Phillips Kathryn A, Van Bebber Stephanie L
University of California, San Francisco, CA 94143, USA.
Med Care Res Rev. 2006 Jun;63(3):301-26. doi: 10.1177/1077558706287020.
Pharmacogenomics (PGx), the use of genetic information to individualize drug therapy, is an immediate and important application of the Human Genome Project. The advent of PGx presents challenges to the U.S. Food and Drug Administration (FDA) in pursuing its mandate of protecting public health and safety. The authors conducted a review of academic, industry, and government literature using a technology diffusion framework to identify issues faced by the FDA relevant to the application of PGx. Two hundred and ten articles were reviewed. Key issues were categorized as rationale and structure for PGx regulation, regulation of PGx-based testing technologies, regulation of applications in clinical settings, regulation of data, and regulation of product life cycles. This review identifies issues faced by the FDA with respect to PGx, which the FDA is addressing through several initiatives. It also illustrates the complex issues involved in developing, implementing, and adopting new technologies.
药物基因组学（PGx），即利用遗传信息实现药物治疗个体化，是人类基因组计划的一项直接且重要的应用。PGx的出现给美国食品药品监督管理局（FDA）履行其保护公众健康与安全的职责带来了挑战。作者运用技术扩散框架对学术、行业和政府文献进行了综述，以确定FDA在PGx应用方面面临的问题。共审查了210篇文章。关键问题被归类为PGx监管的基本原理和结构、基于PGx的检测技术的监管、临床环境中应用的监管、数据监管以及产品生命周期监管。本综述确定了FDA在PGx方面面临的问题，FDA正在通过多项举措来解决这些问题。它还阐明了在开发、实施和采用新技术过程中涉及的复杂问题。
