23andMe and the FDA: Negotiating Conceptions of Benefit in the Direct-to-Consumer Genetic Testing Regulatory Debate
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The oversight and regulation of the direct-to-consumer (DTC) genetic testing industry has been a perennial topic of policy discussion since the emergence of the field in the early 2000s. Despite claiming authority to regulate genetic tests under the 1976 Medical Device Amendments, the U.S. Food and Drug Administration (FDA) had historically exercised enforcement discretion over the industry and not subjected the majority of genetic tests to premarket review. The DTC genetic testing industry was born into an environment of regulatory uncertainty, with stakeholders calling variously for more comprehensive federal oversight and for the minimization of regulatory burdens in order to facilitate innovation. In 2010, the FDA notified DTC genetic testing firms of its intent to regulate the genetic testing services as medical devices, enabling the agency to require premarket review to ensure the safety and effectiveness of the health-related genetic tests. Using tools drawn from discourse analysis and discourse tracing, I examined how stakeholders have framed the benefits and risks of direct-to-consumer genetic testing in justifying the need for - and proposed structure of - regulatory oversight, focusing on the interaction between the FDA and a leading DTC company, 23andMe. My analysis traced the regulatory negotiations, which culminated in a November 2013 FDA Warning Letter to 23andMe which effectively halted the firm's ability to return health-related genetic testing results to their consumers. While 23andMe have framed the benefit of their services in terms of consumer autonomy, empowerment, the potential for disease prevention, and an individual's right to access her own genetic information, many clinicians and researchers have approached the potential benefit of DTC testing with more skepticism, advocating for an evidence-based evaluation of benefits and harms. FDA's enforcement actions were ultimately constrained by their purview to address concerns about the benefit and harms of DTC genetic testing construed in a narrowly medical way, leaving questions outside of the FDA's scope to regulate - such as issues of cybersecurity, corporate transparency, and responsibility - unresolved.