FDA Announces Collaborative Review of Scientific Evidence to Support Associations Between Genetic Information and Specific Medications

As part of the review, it has published a table listing gene-drug interactions for which there is sufficient evidence to support associations between certain genetic variants, or genetic variant-inferred phenotypes, and altered drug metabolism /differential therapeutic effects.

SPS commentary:

The FDA notes that the table is not intended to make an assessment on the safe and effective use of, or regulatory requirements for, tests that detect variants in the referenced genes, and it is not intended to affect current regulatory requirements or policies. Although it includes specific information regarding therapeutic management for some of the listed pharmacogenetic associations, most have not been evaluated in terms of the impact of genetic testing on clinical outcomes.


US Food and Drug Administration

Resource links:

Table of Pharmacogenetic Associations