The First Amendment may not protect someone yelling “Fire!” in a crowded theater, but should shield 23andMe and other direct-to-consumer (DTC) genetic testing companies from “overcautious” FDA regulation, two longtime supporters of test providers argue, reopening the debate over agency dealings with the company.
Robert C. Green, Ph.D., and Nita A. Farahany, Ph.D., J.D., urged FDA to avoid restricting consumer genomic testing “unless faced with empirical evidence of harm.” They cited two cases where courts used free-speech protection to overturn a law curbing the use of doctors’ prescription records, and a doctor’s conviction for promoting off-label drug use.
“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,” Drs. Green and Farahany concluded.
The co-authors’ arguments, published in Nature, come about two months after FDA ordered 23andMe to stop selling its Saliva Collection Kit and Personal Genome Service (PGS), and obtain agency approval to market the $99 “spit kit.” The company still provides consumers ancestry-related information and raw genetic data without interpretation, uses its database of genetic and phenotypic data in research, and maintains educational efforts.
While FDA considers the PGS a medical device requiring agency approval, the test is designed to provide interpretations about common genetic variants that 23andMe says are meant to provide users with deeper insights into their ancestry and inherited traits, not a diagnosis.
That lack of diagnostic analysis was faulted last month in an adverse-event report filed with FDA by an unidentified user who criticized the PGS for lack of information about a colorectal cancer mutation that led the person to undergo a colonoscopy and barium enema. 23andMe won’t comment on the case, in which the mutation turned up in raw data but not a genetic report. The variant either hasn’t been curated by 23andMe, or may not meet its criteria for inclusion in reports, such as 98%+ reliability and availability of published research.
Dr. Green is associate director for research at Partners HealthCare Center for Personalized Genetic Medicine, and an associate professor at Brigham and Women’s Hospital and Harvard Medical School. Dr. Farahany is a professor at Duke University School of Law and Duke Institute for Genome Sciences and Policy.
Drs. Green and Farahany cited several studies concluding that DTC testing results had not plunged large percentages of customers into despair or panicked them to visit their doctors.
In the Scripps Genomic Health Initiative (SGHI) launched in 2009, 2,037 participants showed no significant differences in anxiety, diet, or exercise at a mean 5.6 months after testing with Navigenics’ Health Compass. The Impact of Personal Genomics (PGen) Study, co-led by Dr. Green, yielded preliminary data on 1,800 23andMe and Pathway Genomics customers surveyed in 2012–13. That data suggested customers never showed heightened anxiety or distress over the following year. And an earlier Johns Hopkins survey showed just over one-quarter of more than 1,000 DTC testing customers shared results with physicians a few months after receiving them.