Direct-to-Consumer Genetic Testing : The FDA's Dual Role as Safety and Health Information Regulator

The proliferation of direct-to-consumer (DTC) genetic testing poses new regulatory challenges as genetic testing and information, once within the exclusive domain of medical institutions, has migrated into the private commercial sector. The FDA’s traditional “protective” medical device model threatens to stifle the burgeoning industry supporting personalized medicine, and itis increasingly at odds with a patient-driven participatory health movement grounded in patient autonomy and empowerment. While the pull towards a more consumer-oriented “libertarian” or deregulatory model is strong, if taken to an extreme it would transform hitherto medical relationships into purely commercial transactions with potentially adverse health and safety consequences for patients. The FDA is on the cusp of articulating a new flexible regulatoryparadigm that maintains the FDA’s oversight role in ensuring the accuracy of “diagnostic” genetic testing and interpretation of results, while at the same time lowering regulatory barriers to market entry of “informational” genetic testing and enabling consumers to order suchtesting on their own initiative. At this critical juncture for regulatory design and oversight, it is important to consider not only the FDA’s role in promoting health and safety but also its complementary role in innovation policy, in particular in creating and overseeing incentives forthe production and use of medical information. The FDA is well poised to play a small (albeit significant) part in the wider effort to gather and disseminate data in the health sector; its emergent hybrid regulatory model has potential implications for ensuring the creation of underlying evidence and substantiation of “big data” medical claims