23andMe and First Amendment

23andMe is a personal genetics company that has been providing customers with information about ancestry and inherited traits based on their DNA samples since 2006. They discontinued part of the their service as of November 22, 2013 after receiving a warning letter for the US Food and Drug Administration. In this letter [1], FDA stated that Personal Genome Service they offer is considered a device, and they feel concerned that the use of 23andMe analysis results may put the customers at risk. FDA ordered 23andMe to “discontinue marketing the PGS” and inform FDA of their action plan. Two weeks after receiving the warning letter, 23andMe released a statement [2] on their website announcing that they will not provide health related results to their new customers who purchased their kits on or after the date they received the FDA warning letter.

There are a few interesting aspects of this situation that could be addressed in a court case. The first is considering if the data 23andMe collected is protected under the First Amendment. The second is investigating the FDA’s attempts to regulate indirect information. And third is the question of whether there is compelling data to support the FDA’s claim that people “may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment.” [1]

In relation to the First Amendment question, Sorrell v. IMS Health (2011) [4] has several similarities to the 23andMe situation. Sorrell ruled that after data had been legally collected by a private entity (prescriptive data collected by Pharmacies in the Sorrell case) the data was then protected speech under the First Amendment. Therefore the private entity had the right to communicate that data to its customers unless the Government was able to prove that it had compelling interest to stop that communication. It is important to point out that the burden is on the Government to prove that there is a compelling reason for the private entities right to free speech to be restricted. The similarities are striking between the Sorrell case and 23andMe’s situation. 23andMe legally collects and analyzes genetic data. Once the data is compiled it should be considered speech and protected by the First Amendment.

In relation to the FDA’s attempts to regulate indirect information, the court case United States v. Caronia (2012) [4] recently ruled on a related situation. They found that a pharmaceutical salesman was allowed to discuss off-label uses of drugs he was selling with potential clients, which was against FDA regulations at the time, because his speech about the alternate uses of the drugs was protected by the First Amendment. The court found that the communication of this medical information that was not directly approved by the FDA was still protected speech. We can apply the same logic to the medical information being provided by 23andMe to its customers.

Based on first amendment, government may only regulate speech “when it has a compelling reason and does so in a content-neutral way.” In the case of 23andMe, Green and Farahany [5] argue that “the FDA’s precautionary approach may pose a greater threat to consumer health than the harms that it seeks to prevent.”  After reviewing several surveys done on people who received similar health related data, they found that only an insignificant fraction of the participants engaged in potentially dangerous behaviors such as consuming prescription drugs without medical consultation after receiving this information. Also, they did not find any remarkable increase in participants’ level of distress or anxiety. These findings suggest that FDA does not have sufficient data to support its claim about the potential risk of patients misusing their health data.

[1] http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm

[2] http://mediacenter.23andme.com/press-releases/23andme-inc-provides-update-on-fda-regulatory-review/

[3] http://www.supremecourt.gov/opinions/10pdf/10-779.pdf

[4] http://www.reedsmith.com/files/uploads/DrugDeviceLawBlog/Caronia.pdf

[5] http://www.nature.com/news/regulation-the-fda-is-overcautious-on-consumer-genomics-1.14527