23andMe, the Food and Drug Administration, and the Future of Genetic Testing
174 JAMA Internal Medicine E1-E2 (2014)
2 Pages Posted: 1 Mar 2014
Patricia J. Zettler
Ohio State University (OSU) - Michael E. Moritz College of Law
Jacob S. Sherkow
University of Illinois College of Law; Carle Illinois College of Medicine; University of Illinois at Urbana-Champaign - European Union Center; University of Illinois at Urbana-Champaign - Carl R. Woese Institute for Genomic Biology
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
Patricia J. Zettler
Ohio State University (OSU) - Michael E. Moritz College of Law ( email )
55 West 12th Avenue
Columbus, OH 43210
United States
Jacob S. Sherkow
University of Illinois College of Law ( email )
504 E. Pennsylvania Avenue
Champaign, IL 61820
United States
Carle Illinois College of Medicine ( email )
506 S Mathews Ave
Urbana, IL 61801
United States
University of Illinois at Urbana-Champaign - European Union Center ( email )
Coble Hall
801 S Wright St
Champaign, IL 61820
University of Illinois at Urbana-Champaign - Carl R. Woese Institute for Genomic Biology ( email )
Urbana, IL
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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