title: Guidance for pharmacogenomic biomarker testing in labels of FDA-approved drugs.
abstract: OBJECTIVE
  The aim of this study was to compare guidance for genetic testing in US Food and Drug Administration (FDA)-approved drug labels in oncology to those of drugs for other therapeutic areas.
  
  
  METHODS
  We reviewed labels of all the FDA-approved drugs with labels containing pharmacogenomic information. We assessed whether genetic testing was required or recommended before prescription and, if not, the reason for pharmacogenomic labeling.
  
  
  RESULTS
  We included 140 drugs corresponding to 158 drug-biomarker pairs. Overall, 46 (29%) of 158 pairs stated a requirement or recommendation for genetic biomarker testing in the label. This proportion was higher in oncology than in other areas (62 vs. 12%; P < 0.001). For the 112 drug-biomarker pairs (including 20 in oncology) without recommendation or requirement for genetic testing, the main reasons for pharmacogenomic labeling were change in pharmacologic end points (32%) and higher risk of toxicity (30%). For 11 (10%) pairs (including 1 in oncology), a genetic biomarker was mentioned only to inform that it was not relevant. In oncology, the main reasons for pharmacogenomic labeling were higher risk of toxicity (55%) and definition of the mechanism of action (25%).
  
  
  CONCLUSIONS
  Inclusion of biomarkers in drug labels does not always correspond to required or recommended genetic testing, especially outside oncology.Genet Med 17 9, 733-738.
authors.affiliation: Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique des Hôpitaux de Paris, Paris, France.|METHODS Team, Unit 1153, INSERM, Paris, France.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Vivot
authors.affiliation: Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique des Hôpitaux de Paris, Paris, France.|METHODS Team, Unit 1153, INSERM, Paris, France.|Faculté de Médecine, University of Paris Descartes, Sorbonne Paris Cité, Paris, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Boutron
authors.affiliation: Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique des Hôpitaux de Paris, Paris, France.|METHODS Team, Unit 1153, INSERM, Paris, France.|Faculté de Médecine, University of Paris Descartes, Sorbonne Paris Cité, Paris, France.|Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York, USA.
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
authors.affiliation: Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique des Hôpitaux de Paris, Paris, France.|METHODS Team, Unit 1153, INSERM, Paris, France.|Faculté de Médecine, University of Paris Descartes, Sorbonne Paris Cité, Paris, France.
authors.forename: Raphaël
authors.initials: R
authors.lastname: Porcher
mesh_terms: D054316:Biomarkers, Pharmacological / Q000032:analysis*; D017277:Drug Approval; D004348:Drug Labeling / Q000592:standards*; D005819:Genetic Markers; D005820:Genetic Testing; D006801:Humans; D010597:Pharmacogenetics / Q000379:methods* / Q000592:standards / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D054316:Biomarkers, Pharmacological; D005819:Genetic Markers