Similarities and differences between US and Japan as to pharmacogenomic biomarker information in drug labels.
Pharmacogenomics (PGx) has been utilized as a tool to improve a drug's benefit/risk ratio and the efficiency of drug developments. In order to examine what factors are involved to determine the level of contexts (contents and descriptions) of drug-PGx biomarker information, we graded sections of Japanese package inserts and US drug labels into six levels according to the importance of cautions in regards to clinical practice and compared similarities and differences of the contexts between the two countries. Out of 54 contexts identified, 33 (61%) were graded differently between Japan and the US. The different contexts were mainly related to metabolizing enzymes used in terms of safety, therapeutic areas other than oncology, outcome before 1993, Japan-based companies having marketing authorization and no PGx data on the Japanese population. We describe the potential reasons that could lead to the differences between the two countries such as genetic differences and quantitative evidence in the Japanese population, and also discuss future perspectives to improve PGx utilization in clinical practices in Japan.
Office of New Drug II, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan.
Yasuto
Y
Otsubo
Yasuko
Y
Asahina
Atsushi
A
Noguchi
Yumiko
Y
Sato
Yuki
Y
Ando
Yoshiaki
Y
Uyama
D015415:Biomarkers / Q000032:analysis; D001711:Biotransformation; D004348:Drug Labeling / Q000592:standards*; D006801:Humans; D007564:Japan; D010597:Pharmacogenetics / Q000379:methods*; D055553:Prescription Drugs / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use; D014481:United States; D014486:United States Food and Drug Administration
D015415:Biomarkers; D055553:Prescription Drugs