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)
Do you have negative results from your research you’d like to share?
Related eJournals
-
Stanford Law School, Public Law & Legal Theory Research Paper Series
Stanford Law School, Public Law & Legal Theory Research Paper Series
Subscribe to this free journal for more curated articles on this topic
FOLLOWERS4,623PAPERS788This Journal is curated by:Barbara H. Fried at Stanford Law School -
Intellectual Property: Other eJournal
Intellectual Property: Other eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS963PAPERS5,064This Journal is curated by:Robert P. Merges at University of California, Berkeley - School of Law -
Public Health Law & Policy eJournal
Public Health Law & Policy eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS828PAPERS8,983This Journal is curated by:Scott Burris at Center for Public Health Law Research, Temple University - James E. Beasley School of Law -
Telecommunications & Regulated Industries eJournal
Telecommunications & Regulated Industries eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS712PAPERS5,090This Journal is curated by:John Shepard Wiley Jr. at Independent -
Ethics eJournal
Subscribe to this free journal for more curated articles on this topic
FOLLOWERS649PAPERS9,293 -
Sustainable Technology eJournal
Sustainable Technology eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS604PAPERS9,907 -
Consumer Law eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS389PAPERS9,600This Journal is curated by:Jeff Sovern at University of Maryland Francis King Carey School of Law -
Risk, Regulation, & Policy eJournal
Risk, Regulation, & Policy eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS362PAPERS5,778This Journal is curated by:Adam M. Finkel at University of Michigan School of Public Health, Alberto Alemanno at HEC Paris -
Biology & Law eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS319PAPERS3,115 -
Biology & Anthropology eJournal
Biology & Anthropology eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS317PAPERS2,805 -
Medical Anthropology eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS276PAPERS5,950 -
Innovation Law & Policy eJournal
Innovation Law & Policy eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS260PAPERS29,444 -
Genetics eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS141PAPERS6,506 -
Data Science, Data Analytics & Informatics eJournal
Data Science, Data Analytics & Informatics eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS110PAPERS4,236 -
Developmental Psychology eJournal
Developmental Psychology eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS63PAPERS5,960 -
Medical Genetics & Genomics eJournal
Medical Genetics & Genomics eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS51PAPERS2,773 -
Pharmaceutical Business & Regulatory Environment eJournal
Pharmaceutical Business & Regulatory Environment eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS30PAPERS1,348 -
Pharmacy eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS21PAPERS308 -
Anthropology of Science & Technology Studies eJournal
Anthropology of Science & Technology Studies eJournal
Subscribe to this fee journal for more curated articles on this topic
FOLLOWERS16PAPERS3,559