23andMe, the Food and Drug Administration, and the Future of Genetic Testing

Zettler, Patricia J.; Sherkow, Jacob S.; Greely, Henry T.

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23andMe, the Food and Drug Administration, and the Future of Genetic Testing

174 JAMA Internal Medicine E1-E2 (2014)

Stanford Public Law Working Paper No. 2402877

2 Pages Posted: 1 Mar 2014

See all articles by Patricia J. Zettler

Patricia J. Zettler

Ohio State University (OSU) - Michael E. Moritz College of Law

University of Illinois College of Law; Carle Illinois College of Medicine; University of Illinois at Urbana-Champaign - Carl R. Woese Institute for Genomic Biology; Center for Advanced Studies in Biomedical Innovation Law

Henry T. Greely

Stanford Law School

Date Written: February 17, 2014

Abstract

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 (Hank) 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