On February 20, 2020, the Food and Drug Administration (FDA) introduced a new web-based resource describing pharmacogenetic associations for which data support therapeutic management recommendations. This resource is a product of a collaboration between the FDA’s Center for Devices and Radiological Health and Center for Drug Evaluation and Research and is intended to provide the Agency’s view of the state of the current science in pharmacogenetics. The Table of Pharmacogenetic Associations resource can be accessed at https://go.usa.gov/xdPht.

Pharmacogenetic tests, along with other information about patients and their disease or condition, can play an important role in drug therapy. When a health care provider is considering prescribing a drug, knowledge of a patient's genotype may be used to aid in determining a therapeutic strategy, determining an appropriate dosage, or assessing the likelihood of benefit or toxicity.

The new web-based resource includes a table of some of the gene-drug interactions that the FDA has evaluated and believes there is sufficient scientific evidence to support the described associations between certain genetic variants, or genetic variant-inferred phenotypes, and altered drug metabolism, and in certain cases, differential therapeutic effects, including differences in risks of adverse events.

This version of the table is limited to pharmacogenetic associations that are related to drug metabolizing enzyme gene variants, drug transporter gene variants, and gene variants that have been related to a predisposition for certain adverse events. FDA recognizes that various other pharmacogenetic associations exist that are not listed in this resource.

The Agency feels it is important to provide clinicians, patients, and test developers with information now and anticipates updating this web-based resource periodically as the evidence evolves.

The FDA has opened a public docket for stakeholders—including scientific and medical communities, patients, providers, and industry—to offer specific comments on pharmacogenetic associations that the Agency should or should not include in this table, along with the rationale and underlying evidence that supports the pharmacogenetic association.

The Table for Pharmacogenetic Associations public docket, Docket No. FDA-2020-N-0839-0001, is available at https://go.usa.gov/xdEqc. These data will be evaluated as the Agency considers updates to the table.

The Agency feels it is important to provide clinicians, patients, and test developers with information now and anticipates updating this web-based resource periodically as the evidence evolves.