Direct-to-Consumer Genetic Testing: Let the Debate Begin

The FDA’s recent warning letter to 23andMe, the maker of mail-order genetic tests, highlights the challenging legal and ethical issues posed by direct-to-consumer genetic testing. 

In addition to discussing the specifics of the FDA’s recent action, we also discussed First Amendment issues related to FDA regulation of DTC genetic testing, and explore consent and privacy topics.

Specific questions that were debated and discussed include:

• Should direct-to-consumer genetic testing be regulated as the practice of medicine?
• Should DTC genetic tests be regulated as a medical device?
• Are there adequate privacy protections for DTC genetic test information?
• What perspectives do consumers have on these issues?
• What positions do professional organizations take on the issue?

Panelists for the event included Drinker Biddle lawyers Kenneth Wilbur and Fatema Zanzi. Our discussion was moderated by Robyn Shapiro.