Consuming Genomics: Regulating Direct-to-Consumer Genetic and Genomic Information

Abstract

Since its advent in 2007, direct-to-consumer (DTC) genetic testing has raised increasingly complex regulatory and policy issues for the industry and regulators alike. In November 2013, FDA sent its first DTC genetic testing Warning Letter to 23andMe, one of the few remaining providers of DTC genetic data and interpretation, prompting the company to cease its health-related marketing indefinitely. Even before 23andMe stopped marketing its health-related product however, some DTC companies had begun to bifurcate into entities that offer genetic data — a file of As, Ts Cs, and Gs without any interpretation — and entities that interpret and analyze this genetic data to provide medical information — for example the consumer’s risk of developing breast cancer.

This Article analyzes the regulatory disposition of DTC genetic testing and concludes that entities that provide genetic data for research use only likely do not fit within FDA’s definition of a device and will remain unregulated. However, entities that provide genetic interpretation and corresponding information to consumers can reveal more sensitive medical information about an individual’s propensity to develop disease and pharmacogenomic information about the efficacy of particular drugs given a particular genetic makeup — placing these services within the FDA’s definition of a device. This Article therefore lays forth several important lessons for the genetic interpretation industry to date.

In addition, recently many of these interpretation services have developed as open-source, web-based platforms that analyze genetic data free of charge. This Article lays forth several major challenges to FDA regulation of such information, including serious possible First Amendment scrutiny.

In conclusion, this Article proposes that while FDA will face unique challenges engaging with the DTC genetic interpretation industry, regulating large-scale genetic and genomic interpretation similarly not as a single device, but as a compilation of genetic medical claims, would allow FDA to effectively target discrete genetic tests on the basis of risk to the consumer. By treating large-scale genetic and genomic interpretation as a compilation of discrete genetic tests, lessons learned from past FDA engagement can be applied to address the most concerning aspects of DTC genetic testing without allowing the unique characteristics of the evolving field to overwhelm the quality assurances already in place, and without prohibiting direct consumer access to valid and useful genetic information.

The findings and conclusions in this Article are those of the authors and do not necessarily represent the official position of the Presidential Commission for the Study of Bioethical Issues or the Department of Health and Human Services. Use of official trade names does not mean or imply official support or endorsement by the authors.

Keywords: Direct-to-consumer genetic testing, FDA, First Amendment, commercial speech, genetic, genomic