For those of you who have been following FDA actions against the consumer genomics company 23andMe (see my prior posts here and here), you may enjoy the commentary that Robert Green (geneticist at Harvard) and I published in Nature today.
We argue that it’s an open question whether FDA has jurisdiction over the health-related interpretations that 23andMe and other consumer genomic testing companies provide. And even if they do, that the precautionary approach the FDA adopts is unwarranted here. Early empirical data that shows little harm and significant benefits to consumers. Moreover, we believe that FDA’s regulatory approach puts it in even greater tension with the First Amendment. An excerpt from the article below:
“The FDA cannot reasonably regulate all such indirect information as medical devices. Moreover, as the court cases of Sorrell v. IMS Health (2011) and United States v. Caronia (2012) demonstrate, doing so could put FDA regulations in greater tension with the First Amendment of the US Constitution, which protects the rights of individuals to receive information, and of ‘commercial speech’1. Given this backdrop, the agency should avoid restricting consumer genomic testing unless faced with empirical evidence of harm.”
Read the rest of the commentary here.