domingo, 21 de diciembre de 2014

Guidance for pharmacogenomic biomarker testing in labels of FDA-approved drugs : Genetics in Medicine : Nature Publishing Group

Guidance for pharmacogenomic biomarker testing in labels of FDA-approved drugs : Genetics in Medicine : Nature Publishing Group



Guidance for pharmacogenomic biomarker testing in labels of FDA-approved drugs

Genetics in Medicine
 
(2014)
 
doi:10.1038/gim.2014.181
Received
 
Accepted
 
Published online 

Abstract

Purpose:

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%).

Conclusion:

Inclusion of biomarkers in drug labels does not always correspond to required or recommended genetic testing, especially outside oncology.
Genet Med advance online publication 18 December 2014
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Keywords:

 
biomarkers; Food and Drug Administration; genetic testing; personalized medicine; pharmacogenetics

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Author information

Affiliations

  1. Centre d’Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique des Hôpitaux de Paris, Paris, France

    • Alexandre Vivot,
      •  
    • Isabelle Boutron,
      •  
    • Philippe Ravaud &
      •  
    • Raphaël Porcher

  2. METHODS Team, Unit 1153, INSERM, Paris, France

    • Alexandre Vivot,
      •  
    • Isabelle Boutron,
      •  
    • Philippe Ravaud &
      •  
    • Raphaël Porcher

  3. Faculté de Médecine, University of Paris Descartes, Sorbonne Paris Cité, Paris, France

    • Isabelle Boutron,
      •  
    • Philippe Ravaud &
      •  
    • Raphaël Porcher

  4. Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York, USA

    • Philippe Ravaud

Corresponding author

Correspondence to: 

Supplementary information

Word documents


  1. Supplementary Tables (76 KB)


  2. Supplementary Materials and Methods (33 KB)

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