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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  

Patricia J. Zettler

Georgia State University - College of Law

Jacob S. Sherkow

New York Law School; Columbia University - Department of Health Policy and Management; 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

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

Patricia Zettler

Georgia State University - College of Law ( email )

P.O. Box 4037
Atlanta, GA 30302-4037
United States

Jacob Sherkow

New York Law School ( email )

185 West Broadway
New York, NY 10013
United States
212.431.2355 (Phone)

HOME PAGE: http://www.nyls.edu/faculty/faculty-profiles/faculty_profiles/jacob-s-sherkow/

Columbia University - Department of Health Policy and Management ( email )

600 West 168th Street, 6th Floor
New York, NY 10032
United States

Center for Advanced Studies in Biomedical Innovation Law ( email )

Studiestraede 6
Studiestrade 6
Copenhagen, DK-1455
Denmark

HOME PAGE: http://jura.ku.dk/cebil/staff/

Henry (Hank) Greely (Contact Author)

Stanford Law School ( email )

559 Nathan Abbott Way
Stanford, CA 94305-8610
United States
650-723-2517 (Phone)
650-725-0253 (Fax)

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