174 JAMA Internal Medicine E1-E2 (2014)
2 Pages Posted: 1 Mar 2014
Date Written: February 17, 2014
On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.
Keywords: 23andMe, genes, genetics, genetic testing, DTC, FDA, biotech, sequencing, DNA, health, law, science
JEL Classification: K00, K13, K19, K2, K23, K32, K42, I11, I18, L5, L51
Suggested Citation: Suggested Citation
Zettler, Patricia J. and Sherkow, Jacob S. and Greely, Henry T., 23andMe, the Food and Drug Administration, and the Future of Genetic Testing (February 17, 2014). 174 JAMA Internal Medicine E1-E2 (2014); Stanford Public Law Working Paper No. 2402877. Available at SSRN: https://ssrn.com/abstract=2402877