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

https://www.fda.gov/news-events/press-announcements/fda-announces-collaborative-review-scientific-evidence-support-associations-between-genetic?utm_campaign=022020_FDA%20on%20Review%20of%20Scientific%20Evidence%20for%20Pharmacogenetic%20Tests&utm_medium=email&utm_source=Eloqua

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

The following statement is attributed to Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health and Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Pharmacogenetic testing is a type of genetic test that in some instances can predict how a person will respond to specific medications. Thus, this type of testing offers promise for informing the selection or dosing of some medications for certain individuals. When there is sufficient scientific evidence demonstrating a relationship between how a person’s genes may impact their metabolism of a drug or how they may respond to the drug, this information can be useful for health care providers. However, for many medications, there is not sufficient scientific evidence to support using pharmacogenetic test results to inform prescribing decisions. In a 2018 safety communication, we warned the public about the FDA’s concerns with firms offering genetic tests making claims about how to use the genetic test results to manage medication treatment that are not supported by recommendations in the FDA-approved drug labeling or other scientific evidence. Clinicians order tests to ...

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