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

Publication Title

JAMA Internal Medicine

Authors

Patricia J. Zettler, Georgia State University College of LawFollow
Jacob S. Sherkow, Stanford University
Henry T. Greely, Stanford University

Document Type

Article

Publication Date

4-2014

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.

Comments

External Links

SSRN

Recommended Citation

Patricia J. Zettler, Jacob S. Sherkow, & Henry T. Greely, 23andMe, the Food and Drug Administration, and the Future of Genetic Testing, 174 JAMA Internal Med. 493 (2014).

Institutional Repository Citation

Patricia J. Zettler, Jacob S. Sherkow & Henry T. Greely, 23andMe, the Food and Drug Administration, and the Future of Genetic Testing, Faculty Publications By Year 2030 (2014)
https://readingroom.law.gsu.edu/faculty_pub/2030

Volume

174

Issue

4

First Page

493

Last Page

494