HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Sunday, March 23, 2014

Guest Blogger Professor Jonathan Kahn: Regulating Direct-to-Consumer Genomics

KahnConsumer genomics company 23andME wants you to be able to Google your genome to find out all sorts of things, ranging from your ancestry to your ear wax type to your risk of contracting diabetes. Spit into a tube, send it in along with a payment of $99 and before you know it you can log onto their web site to get a personalized readout of key aspects of your genetic makeup. It is all big data so it is perhaps not surprising to find that its CEO, Anne Wojcicki, is the wife of Google founder Sergei Brin who has invested heavily in the company. 23andME had been riding fairly high as a standout in the field of direct-to-consumer genomics until last November when it received what amounted to a cease-and-desist letter from the FDA, ordering 23andMe to “discontinue marketing” its Personal Genome Service until such time as it can provide evidence to substantiate its broad marketing claims. In a nutshell, the FDA was concerned that 23andME was providing medically actionable information through a product that had not been “analytically or clinically validated.” 

Responses have been varied with many applauding the FDA’s intervention into this relatively unregulated field while others decry the action as premature and unwarranted. I would like to address some of the criticisms of the FDA’s actions here. The concerns are various but tend to cluster around three themes.

  First, the FDA clampdown is premature because the mere provision of genetic information by 23andME has not been shown to have resulted in any harm; Second, the order interferes with democratization of healthcare facilitated by the widespread distribution of this information; and Third, as a regulation of information, the FDA action may implicate First Amendment concerns of freedom of “Commercial Speech." As to the first concern, this is a curious sort of inversion of the precautionary principle which essentially shifts the burden of proof to those proposing new technologies to show they are safe if a credible concern over safety has been raised. Here, critics of the FDA action are essentially saying federal regulators should not intervene until they can clearly establish that a harm has occurred. Certainly, we would not want the FDA to take this approach to a new drug, I do not see why they should take this approach to information that could lead to such health actions as taking, or refraining from taking a drug. Second, there is a difference between empowering a citizen and empowering a consumer. This is about putting conditions on a corporation’s ability to sell a product that may have direct consequences for people’s health. Regulating the provision of this information does not impede the “democratization” of health care any more than requiring accurate labeling on drugs. Providing actionable health related information that is neither analytically nor clinically validated does not empower anyone other than the company that is making a profit off of the transaction. Finally, invoking First Amendment concerns about commercial speech are perhaps most troubling here. This places the critique of the FDA’s action in the context of a much broader move to restrict regulatory oversight of the provision of a wide array of health-related information from nutritional to drug labeling in the name of protecting the free flow of consumer information. But the creeping expansion of commercial free speech doctrine threatens to undermine all reasonable regulation of consumer information. Do we really want actionable health information to be regulated only to the extent that it constitutes outright fraud?  Going down this road promises to do for public health reform what Citizens United has done for electoral reform.

-Guest Blogger Professor Jonathan Kahn

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