Document Type

Article

Publication Title

DePaul Law Review

Abstract

A brave new world of genetic testing and personalized medicine—one in which vast amounts of patient genetic raw data can be readily produced and analyzed in light of rapid technological advances in whole genome sequencing and large-scale research and testing of the effects of genetics on human health—is upon us. 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 it is 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 regulatory paradigm 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 such testing 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 for the production and use of medical information. Part I presents the saga of 23andMe to illustrate the shifting regulatory regime for DTC genetic testing over the past decade. 23andMe burst onto the scene in 2007 when it began marketing its flagship Personal Genome Service. At that time, 23andMe operated largely outside the purview of the FDA, against an ambiguous and uncertain regulatory landscape. This continued until 2013, when the FDA demanded 23andMe (and other DTC testing companies) cease marketing their products—the apogee of the FDA’s precautionary paternalistic regulatory response. This moment took on added salience in contrast with the company’s successful launch of DTC genetic testing with approval by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom in 2014. The FDA seemed to signal a shift in its regulatory approach with its approval of 23andMe’s DTC carrier screening test for Bloom Syndrome in February 2015. In the years since, the signal has intensified, with the FDA approving ten genetic health risk tests (including Alzheimer’s risk, Parkinson’s disease, and hereditary thrombophilia) in April 2017, the first genetic cancer health risk test (for selected variants on BRCA1/BRCA2) in March 2018, and pharmacogenetic tests for variants associated with metabolism of some therapeutic drugs in October 2018. Part II generalizes from this case study to characterize the FDA’s emerging regulatory model as a hybrid, combining elements from the traditional “protective” medical device model and its contrasting consumer-based “libertarian” model. What is perhaps most surprising, given the Trump Administration’s overall deregulatory thrust and the conservative and libertarian attacks on the regulation of information-based technologies, is that the FDA continues to assert the need for oversight, albeit pursuant to a new and evolving regulatory model. Part III focuses on the dual roles of the FDA as safety regulator and as health information regulator by highlighting the less well-recognized (albeit traditional) role of the FDA in medical information production and then considering new challenges posed by DTC genetic testing. 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.

First Page

343

Volume

68

Publication Date

2019

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