News Tip: FDA Overreached in Ordering 23andMe to Stop Selling DNA Tests

Law professor Nita Farahany says action may derail 23andMe from democratizing science

The FDA has issued a cease and desist letter to 23andMe and ordered the firm to stop selling its DNA tests. Duke University professor Nita Farahany argues that the FDA has overreached.Nita FarahanyProfessor of law and philosophy; professor of genome sciences and policy, Duke UniversityFarahany@duke.eduhttp://law.duke.edu/fac/farahany/Farahany specializes in law, bioethics and the biosciences, particularly genetics and neuroscience.Quote:"23andMe has empowered individuals to learn their own genetic information and predispositions, and the FDA is seeking to make it more difficult, and more costly to do so. While 23andMe is helping to democratize science, the FDA's heavy-handed approach may derail them from doing so.""A 23andMe report gives you probabilistic information about your genetic predispositions. It does not offer, nor does it purport to offer, a medical diagnosis of any condition. Just because information can help in the diagnosis of a medical condition does not mean that it should be considered a 'medical device' subject to FDA jurisdiction.""Although some people might make health decisions partly based on their 23andMe report, they make health decisions based on their fitness trackers, too. Is the FDA going to issue Fitbit and Nike cease and desist letters, too?"                                 _        _        _        _Duke experts on a variety of other topics can be found at http://newsoffice.duke.edu/resources-media/faculty-experts.