FDA Criteria for Consideration of Potential Candidates for Drug Relabeling with Pharmacogenomic Information

The FDA considers both unwanted harmful effects and lack of efficacy to be adverse events*. When considering candidates for pharmacogenomic relabeling, the FDA evaluates the severity of the adverse reaction, the degree to which genetics predicts the reaction, and the total number of individuals likely to be affected. These factors are important in assessing the potential public health impact of a recommendation to consider genetics when using the drug.

There are three entry points where initial information with the potential to trigger a drug label update with pharmacogenomic information can be introduced:

• A sponsor, who can be a pharmaceutical company or an individual, submits data and requests a label update.
• Academia brings experience and/or recent developments to the attention of the FDA.
• FDA trend-watching based on literature that shows an association between a particular biomarker and drug pair that can potentially inform drug prescription or dosing.

Seeking Input on PGx Drug Relabeling Opportunities

The PharmGKB also collects recommendations of potential candidates for PGx drug relabeling.

Please send suggestions using our contact form or email feedback@pharmgkb.org directly, including the reason for relabeling and supporting evidence (e.g., PubMed IDs of relevant publications). The PharmGKB will evaluate suggestions and communicate them to the FDA.