Similarities and Differences between US and Japan as to Pharmacogenomic Biomarker Information in Drug Labels

Abstract

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.

Pharmacogenetics and Cardiovascular Disease—Implications for Personalized Medicine

“…Pharmacogenetic information has been added to the labeling for many drugs marketed in Japan. In fact, the majority of drugs with FDAapproved pharmacogenetic labeling also contain pharmacogenetic information in their PMDA-approved package insert (Otsubo et al, 2012). However, in fewer instances is this information included in the warning or contraindication section of label.…”

Personalized medicine: is it a pharmacogenetic mirage?

“…The approach of these three major authorities frequently varies. They differ not only in terms of the details or the emphasis to be included for some drugs but also whether to include any pharmacogenetic information at all with regard to others [13, 14]. Whereas these differences may be partly related to inter‐ethnic differences in relevance of the available pharmacogenetic data, they also indicate differences in the assessment of the quality of these association data.…”

Systems-Based Approach to Drug Response

“…The inclusion of clear and comprehensive drug labeling that provides information about genetic tests that are relevant to the safety or efficacy of use is critical to enhancing patient care [8]. The information of drug label differs among countries [9]. For UGT1A1, the adjustment decision making (how best to use the genetic information for prescribing a drug) dosage was not included in the label for irinotecan in Japan.…”