23AndMe, the First Amendment, and Sorrell v. IMS Health

December 9th, 2013

David Rivkin and Andrew Grossman write in USA Today an opinion piece arguing that the FDA’s decision to clamp down on the 23AndMe home DNA test suppresses speech.

The agency worries that individuals, with information about their genetics, could make the wrong choices. As an example, the agency suggests a customer informed of a heightened risk for breast or ovarian cancer might undergo unnecessary prophylactic surgery or chemotherapy. But this could not happen without first consulting a doctor and undergoing diagnostic tests.

Yet the FDA maintains that 23andMe has to keep that knowledge away from its customers. Forget about the FDA’s medical “device” claims, its stance puts the agency in direct conflict with our free speech rights. Shuttering a service such as 23andMe is no different from censoring home medical references or any of myriad websites that link symptoms with medical conditions.

In fact, the Supreme Court has long rejected the premise that government may “substitute its judgment as to how best to speak for that of speakers and listeners.” While the FDA may prefer that scientific research be limited to professionals and then filtered through a physician or FDA-approved service for the rest of us, the First Amendment prevents it from suppressing speech.

What’s troubling is that the FDA knows this. Two years ago, the Supreme Courtstruck down on First Amendment grounds a state law that blocked pharmacists from disclosing information about doctors and their prescribing habits to pharmaceutical manufacturers, who would use it for research and marketing. As the court observed, the free flow of information has “great relevance in the fields of medicine and public health, where information can save lives.”

That connection is far more direct here. The knowledge that a person is at heightened risk for a particular disorder could prompt lifestyle changes to reduce the risk or encourage early detection and treatment.

This is an interesting application of Sorrell. Certainly if the Court found unconstitutional the law preventing big pharmaceuticals from sharing patient information, then the First Amendment interest in learning about your own genetic code would much stronger.