Research

Research

A Cross-Reference of PGx Drug-Gene Association Listings in FDA’s Table of Pharmacogenetic Associations and CPIC Clinical Guidelines

Conducted Quarterly by

Background

By uncovering new insights about how individual patient genetic variation can affect responses to various drugs, researchers in the field of pharmacogenomics (PGx) are establishing a foundation for genetically guided personalized medicine. While many drug-gene interactions have been studied, experts from different institutions sometimes have differing perspectives regarding the evidence of the validity of certain drug-gene interactions, and regarding how they should affect clinical decision-making.

Recognizing that conflicting information about drug-gene interactions may be confusing to health care leaders who want to use certain PGx tests to help guide treatment decisions as part of a fast-evolving personalized medicine approach, PMC published a peer-reviewed article on March 1, 2022, to flag and explore inconsistencies in the drug-gene associations listed in the U.S. Food and Drug Administration's Table of Pharmacogenetic Associations and widely consulted clinical guidelines published by the Clinical Pharmacogenetics Implementation Consortium (CPIC). The article also explored the perspectives of the Pharmacogenomics Knowledge Base (PharmGKB), which curates knowledge about the impact of genetic variation on drug responses for use by researchers and clinicians.

To help show how FDA and CPIC's perspectives on the field are evolving, Dave Kisor, Pharm.D., at Manchester University (dfkisor@manchester.edu) in Fort Wayne, Indiana, leads a team of Master of Science in Pharmacogenomics students through the following quarterly comparative analysis of FDA and CPIC's resources. By centralizing information about changes in drug-gene association information published by leading sources, this resource is designed to help researchers, genetic test developers, and health care decision-makers keep up with the latest thinking in the field.

Results: January 4, 2023

According to the most recent cross-reference analysis, 207 drugs are listed with PGx information in FDA's table, CPIC's guidelines, or both. The results show that FDA's table and CPIC's guidelines overlap through the inclusion of 48 drugs listed by both sources. It is important to note, however, that FDA and CPIC often list differing gene associations and/or dosing implications in connection with those 48 drugs.

Below, you will find an online list of the drugs included in FDA's table, CPIC's guidelines, and both; a Venn diagram showing the numbers of drugs included in FDA's table, CPIC's guidelines, and both; a downloadable Excel document analyzing the information provided for each of the 48 drugs listed by both sources; and lists of changes made to the drug-gene associations listed in the two sources since the publication of PMC's original comparative analysis on March 1, 2022.