Abstract

http://ssrn.com/abstract=2402877
 


 



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


Patricia J. Zettler


Stanford Law School

Jacob S. Sherkow


Stanford Law School

Henry T. Greely


Stanford Law School

February 17, 2014

174 JAMA Internal Medicine E1-E2 (2014)
Stanford Public Law Working Paper No. 2402877

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.

Number of Pages in PDF File: 2

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

Accepted Paper Series


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Date posted: March 1, 2014  

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: http://ssrn.com/abstract=2402877

Contact Information

Patricia J. Zettler
Stanford Law School ( email )
Jacob S. Sherkow
Stanford Law School ( email )
559 Nathan Abbott Way
Stanford, CA 94305-8610
United States
Henry (Hank) T. 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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