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SYMPOSIUM: PROGRESS IN PHARMACOGENETICS AND ITS PROMISE FOR MEDICINE

Regulatory Agency Consideration of Pharmacogenomics

Pendergast Consulting, Washington, DC 20016

To whom requests for reprints should be addressed at ¹ Pendergast Consulting, 4328 Yuma Street, NW, Washington, DC 20016. E-mail: marykpendergast{at}aol.com

Abstract

This article discusses the current ambiguous state of federal regulatory agency control over pharmacogenomic testing, a subset of genetic testing that combines information about genetic variability with pharmacology in order to improve drug recommendations. An analysis of the common three terms used to evaluate regulation of pharmacogenomic testing: research validity, clinical validity, and clinical utility, followed by a case study involving U. S. Food and Drug Administration (FDA) regulation of laboratory developed tests, illustrates the present gap in pharmacogenomic oversight. The existing agency overlap in regulating pharmacogenomic testing leads to unclear or even contradictory authoritative advice.

Key Words: pharmacogenomics • federal regulation • Food and Drug Administration