title: Clinical and regulatory considerations in pharmacogenetic testing.
abstract: OBJECTIVE
  Both regulatory science and clinical practice rely on best available scientific data to guide decision-making. However, changes in clinical practice may be driven by numerous other factors such as cost. In this review, we reexamine noteworthy examples where pharmacogenetic testing information was added to drug labeling to explore how the available evidence, potential public health impact, and predictive utility of each pharmacogenetic biomarker impacts clinical uptake.
  
  
  CONCLUSIONS
  Advances in the field of pharmacogenetics have led to new discoveries about the genetic basis for variability in drug response. The Food and Drug Administration recognizes the value of pharmacogenetic testing strategies and has been proactive about incorporating pharmacogenetic information into the labeling of both new drugs and drugs already on the market. Although some examples have readily translated to routine clinical practice, clinical uptake of genetic testing for many drugs has been limited.
  
  
  CONCLUSIONS
  Both regulatory science and clinical practice rely on data-driven approaches to guide decision making; however, additional factors are also important in clinical practice that do not impact regulatory decision making, and these considerations may result in heterogeneity in clinical uptake of pharmacogenetic testing.
authors.affiliation: Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD. robert.schuck@fda.hhs.gov.
authors.forename: Robert N
authors.initials: RN
authors.lastname: Schuck
authors.affiliation: Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Marek
authors.affiliation: Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
authors.forename: Hobart
authors.initials: H
authors.lastname: Rogers
authors.affiliation: Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
authors.forename: Michael
authors.initials: M
authors.lastname: Pacanowski
mesh_terms: D000066491:Clinical Decision-Making; D005820:Genetic Testing / Q000331:legislation & jurisprudence / Q000639:trends; D006801:Humans; D010597:Pharmacogenetics / Q000331:legislation & jurisprudence* / Q000639:trends; D000071185:Pharmacogenomic Testing / Q000331:legislation & jurisprudence* / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence* / Q000639:trends
keywords: drug labeling; genetic testing; pharmacogenetics