Regulatory agency consideration of pharmacogenomics.
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.
Pendergast
Mary K
MK
Pendergast Consulting, Washington, DC 20016, USA. marykpendergast@aol.com
D002986:Clinical Trials as Topic; D017277:Drug Approval; D004345:Drug Industry; D026724:Ethical Review; D028744:Ethics Committees, Research; D036281:Genetic Research; D005820:Genetic Testing; D033161:Government Regulation; D006801:Humans; D004364:Pharmaceutical Preparations; D010597:Pharmacogenetics; D010601:Pharmacology, Clinical; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations