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


New York 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





Download This Paper

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
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/
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)
Feedback to SSRN


Paper statistics
Abstract Views: 327
Downloads: 77
Download Rank: 188,465

© 2014 Social Science Electronic Publishing, Inc. All Rights Reserved.  FAQ   Terms of Use   Privacy Policy   Copyright   Contact Us
This page was processed by apollo6 in 0.297 seconds