Direct-to-consumer genetics, 23andMe and the FDA

Whenever pgEd is out talking with students, we often spend some time talking about how it is becoming increasingly inexpensive to learn about one’s own DNA.  Students are very quick to grasp the implications of easy access to genetic information, and we typically have spirited conversations about ethics, medicine, health, family and always..”hmm, do I want to have that information?”.

23andMe is a company that sells genome analysis kits online for $99 dollars US and has over 100,000 customers.  23andMe and related companies have sparked an extensive amount of conversation about how much information people want and need about their DNA and the role of doctors and genetics counselors to guide people through their genomes.  For years, questions have persisted about what sort of oversight, if any, was needed.  In late November, the Food and Drug Administration (FDA) told 23andMe to stop selling their product.

Many excellent writers, scientists, bioethicists and lawyers have weighed in on this question: Should the FDA regulate direct-to-consumer genetic testing? Where is the line between a recreational product and a medical device?

The piece by Jennifer Wagner and John Conley at Genomics Law Report (GLR), The sky is falling on personal genomics! Oh, nevermind. It’s just a cease and desist letter from the FDA to 23andMe, is a balanced,  comprehensive overview of the issues.  Genomics Law Report is an excellent resource to keep up with the intersection of biology and law, and in addition to the biology classroom, we believe GLR would be a great resource in a history, government, law or civics classroom.

In addition, science writer David Dobbs has collected many articles and commentaries, I got your 23andMe – FDA food fight  links right here. It looks like he is regularly updating his list, so it is a good spot to check in on as this story develops.