Premium
Bridging the Consumer‐Medical Divide: How to Regulate Direct‐to‐Consumer Genetic Testing
Author(s) -
Edwards Kyle T.,
Huang Caroline J.
Publication year - 2014
Publication title -
hastings center report
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.515
H-Index - 63
eISSN - 1552-146X
pISSN - 0093-0334
DOI - 10.1002/hast.310
Subject(s) - food and drug administration , liberian dollar , agency (philosophy) , genetic testing , government (linguistics) , government regulation , consumer safety , direct to consumer advertising , business , marketing , trustworthiness , consumer education , consumer advocacy , advertising , public relations , internet privacy , political science , medicine , law , sociology , computer science , finance , pharmacology , social science , linguistics , risk analysis (engineering) , philosophy , medical prescription , china
Abstract While 23andMe aspires to be “the world's trusted source of personal genetic information,” the U.S. Food and Drug Administration (FDA) believes that the company's advertising practices have been anything but trustworthy. Last November, a harshly worded FDA “warning letter” demanded that the direct‐to‐consumer genetic testing company immediately discontinue marketing its unapproved “medical device.” The tussle between 23andMe and the FDA has attracted more attention than a typical disagreement between a company and a government agency. Larry Downes and Paul Nunes identify 23andMe as a “Big Bang Disruption”: an invention that revolutionizes the existing market, foiling both industry incumbents and unprepared regulators. The outcome of the FDA's current review to hold the answer to the million‐dollar question: how will DTC genetic testing be regulated in the future? Ideally, the FDA's regulations should not pose undue burdens on consumers seeking personal genetic information but, rather, help consumers make a transition out of the consumer setting and into the medical setting .