TY - JOUR

T1 - Pharmacogenomic biomarkers in drug labels

T2 - what do they tell us?

AU - Tutton, Richard

PY - 2014/2

Y1 - 2014/2

N2 - This article investigates the number of drugs on the market with PGx biomarker data in their labels using two public sources – the FDA and the PharmKGB (Pharmacogenomics Knowledge Base). The article analyzes the FDA Table of Pharmacogenomic Biomarkers in Drug Labels to show the number of drugs with PGx biomarker information in their labels. Scrutinizing the language of labels, it also engages with whether this information is intended to direct clinicians to take particular actions or not, and whether biomarker information it is included on grounds of drug efficacy or to improve safety. The FDA table is compared to the PharmKGB Drug Labels with PGx info database to highlight how they differ in the number of drugs which they include. Analysis of the FDA and the Pharmkgb data show that in approximately 12% of drugs licensed in the period 1998-2012 had PGx biomarker information included in their labels at the time of their approval. Of that number, labels only direct clinicians to utilize PGx testing prior to prescribing treatments in only 14 cases. This clearly falls short of expectations many had in the 1990s about the transformative impact of PGx. In most cases, the inclusion of this information currently has limited or no direct clinical utility.

AB - This article investigates the number of drugs on the market with PGx biomarker data in their labels using two public sources – the FDA and the PharmKGB (Pharmacogenomics Knowledge Base). The article analyzes the FDA Table of Pharmacogenomic Biomarkers in Drug Labels to show the number of drugs with PGx biomarker information in their labels. Scrutinizing the language of labels, it also engages with whether this information is intended to direct clinicians to take particular actions or not, and whether biomarker information it is included on grounds of drug efficacy or to improve safety. The FDA table is compared to the PharmKGB Drug Labels with PGx info database to highlight how they differ in the number of drugs which they include. Analysis of the FDA and the Pharmkgb data show that in approximately 12% of drugs licensed in the period 1998-2012 had PGx biomarker information included in their labels at the time of their approval. Of that number, labels only direct clinicians to utilize PGx testing prior to prescribing treatments in only 14 cases. This clearly falls short of expectations many had in the 1990s about the transformative impact of PGx. In most cases, the inclusion of this information currently has limited or no direct clinical utility.

U2 - 10.2217/pgs.13.198

DO - 10.2217/pgs.13.198

M3 - Journal article

VL - 15

SP - 297

EP - 304

JO - Pharmacogenomics

JF - Pharmacogenomics

SN - 1462-2416

IS - 3

ER -