This Article is one of the first to analyze the effect of the 23andMe Warning Letter on the industry, to focus on the bifurcation of genetic interpretation and information as an independent medical device, and to analyze future regulatory approaches available to FDA. Part II of this Article offers an overview of public access to genetic information: the significance of genetic information, the transition from discrete genetic testing to large-scale genetic testing and genomic sequencing, and the movement of genetic interpretation from the clinic to DTC. This Part will also discuss government scrutiny of the DTC genetic-testing industry. Part III of this Article will conduct a deeper examination of the agencies poised to regulate DTC genetic testing. This Part analyzes FDA’s Untitled and Warning Letters and highlights four major insights for the industry going forward. But, although FDA is best-positioned to regulate the industry, it is not the only agency with the power to engage. Several other federal agencies—such as the U.S. Federal Trade Commission (FTC) and the U.S. Centers for Medicare and Medicaid Services (CMS)—can also influence access to, and the validity and utility of, DTC genetic testing. Finally, the Supreme Court’s recent decision in Myriad, invalidating patents on human genetic material, eliminates a potential barrier to DTC genetic testing and suggests a way in which the U.S. Patent and Trademark Office (PTO) can help ensure continued access to certain types of genetic interpretation. Part III will clarify the ways these agencies can support access to valid and useful genetic information and will highlight their limitations in this rapidly evolving field. State law provides an additional layer enhancing federal protections. Part IV considers the particular challenges associated with regulating bifurcated genetic data and interpretation entities. Entities that merely provide genetic data are likely to remain unregulated both because they do not satisfy FDA’s definition of a medical device and because FDA officials have explicitly disclaimed interest in their regulation. Entities that interpret genetic data and provide associated medical information, even without access to the underlying biological sample, give rise to a different analysis. Here, comparisons to FDA regulatory approaches taken with WebMD and mobile medical devices will likely fall short, whereas the approach taken with regulating software might be helpful—but even then, regulation of DTC interpretation services will face serious First Amendment scrutiny. Part V offers a risk-based stratification approach to regulate largescale genetic and genomic information as a medical device—treating interpretation of large-scale genetic data and genomic sequences as a compilation of smaller products as opposed to a single device. This would allow FDA to continue its regulatory focus on genetic interpretation that carries the greatest possible risk to the consumer (such as analyzing genes associated with diagnosing a predisposition to breast cancer for which individuals could seek out risky medical interventions such as mastectomy) without allocating time and energy to genetic interpretation that carries little to no risk (such as analyzing genes associated with earwax type). FDA has made clear that it will treat DTC genetic tests, including individual components used to produce patient-specific information, as medical devices falling under its regulations—and that labeling these devices as for educational or research use only while marketing them for health-related indications or knowingly selling them to companies will not shield the manufacturer from enforcement. Also, although FDA might consider some genetic tests as falling into lowerrisk regulatory categories, a manufacturer’s decision not to validate or substantiate individual tests might result in an entire genetic or genomic interpretation device being classified in a higher-risk regulatory category, thereby requiring full FDA premarket approval. However, as companies continue to bifurcate into entities that produce data- or information-only products, including entities that provide Internet-based, open-source genetic and genomic interpretation, FDA will face increasing difficulty enforcing its medical device regulations as typically done. If FDA and the DTC industry approach large-scale genetic and genomic interpretation as a compilation of discrete genetic tests, they can address the riskiest aspects of the product without allowing the evolving field to overwhelm current quality assurances and without limiting consumer access to accurate and valid genetic information.
Kayte Spector-Bagdady and Elizabeth R. Pike,
Consuming Genomics: Regulating Direct-to-Consumer Genetic and Genomic Information,
92 Neb. L. Rev.
Available at: http://digitalcommons.unl.edu/nlr/vol92/iss4/2