Closer Scrutiny Ahead for DTC Genetic Testing Claims

The FDA’s public meeting on the future of clinical direct-to-consumer (DTC) genetic testing (which we have covered herehere and here) is continuing to draw significant attention from the media and other commentators. Most of the coverage, especially over the past 7-10 days, has added little that is new in the way of either reporting or analysis. One exception, however, comes from Robert VerBruggen of National Review in his column on “The FDA’s Genetic Paternalism.”

What’s new and interesting here is not the substance of VerBruggen’s analysis. Whether or not you agree with Verbruggen’s particular formulation, the “paternalism” critique of proposed FDA regulation of DTC genetic testing is not new. What caught our eye is a comment from deCODE genetics’ CEO Kári Stefánsson. When questioned by VerBruggen about his company’s marketing of its DTC genetic test offering, deCODEme (see screenshot) – which includes statements such as “your genes are a road-map to better health” – here is how Stefánsson responded:

“I think that is both cheesy and somewhat incorrect. I don’t know who came up with that, but whoever it is, is going to be duly punished,” [Stefánsson] said. “I think it’s safe to say we’ll probably be removing that statement and putting up something that at least sounds better.”

After its well-publicized 2009 bankruptcy, deCODE emerged in 2010 as a privately-held company and so it is unlikely the public will know whether Stefánsson follows through with his promise to “duly punish” the source of the “road-map” statement. On the other hand, whether and how deCODE follows through with Stefánsson’s not-quite-a-promise to change deCODEme’s marketing and claims is something that will happen in full view of the public.

Why does DTC marketing matter? One of the major challenges for DTC genetic testing companies, since the industry’s inception, has been the ongoing attempt to tightrope the distinction between offering genetic tests and services that appeal to consumers (and, by extension, investors) without overly alarming state and federal regulators. The reasons for this delicate balancing act seem clear. On the one hand, a genetic test that provides a “road-map to better health” is much more likely to induce a consumer to pay several hundred dollars or more out of her own pocket than the same test promoted solely as a mere informational or educational tool. On the other hand, genetic tests intended to affect a consumer’s health or well-being, and marketed accordingly, are certain to draw far closer scrutiny from the FDA and other regulators.

We examined this issue nearly 18 months ago in “The Open Secret of DTC Medical Genetic Testing.” In many important respects the analysis has changed little since then. While the composition of the industry has changed somewhat, many of the companies still providing true DTC genetic testing products continue to attempt the seemingly impossible task of enticing consumers to purchase genetic tests by highlighting their potential clinical significance while using fine print to argue that their products’ intended uses are informational and educational.

Take, for example, leading DTC genetic testing company 23andMe. The company currently offers a single product featuring both health and ancestry components. Their “health” product page (see screenshot) offers consumers a chance to use DNA to “help you plan for the important things in life,”  “take charge of your health and wellness today” and “make better health decisions by learning your genetic risks.”

As was the case 18 months ago, however, the company’s Terms of Service continue to strike a somewhat different tune:

23andMe Services are for research, informational, and educational use only. We do not provide medical advice. The Genetic Information provided by 23andMe is for research, informational, and educational use only….23andMe does not recommend or endorse any specific course of action, resources, tests, physician or other health care providers, drugs, biologics, medical devices or other products, procedures, opinions, or other information that may be mentioned on our website. As explained on our website, 23andMe believes that (a) genetics is only part of the picture of any individual’s state of being, (b) the state of the understanding of Genetic Information is rapidly evolving and at any given time we only comprehend part of the picture of the role of genetics, and (c) only a trained physician or other health care provider can assess your current state of health or disease, taking into account many factors, including in some cases your genetics as well as your current symptoms, if any. Reliance on any information provided by 23andMe, 23andMe employees, others appearing on our website at the invitation of 23andMe, or other visitors to our website is solely at your own risk. (emphasis in original)

Most consumers, and probably the FDA as well, would be excused for taking away two fairly different messages from 23andMe’s product marketing and claims and its underlying Terms of Service.

The FDA and Intended Use. The FDA, for its part, has maintained that its regulatory interest lies with clinical DTC genetic tests (pdf), and has previously indicated and recently confirmed that the basis for determining whether a genetic test is clinical, and thus subject to FDA oversight, is the test’s “intended use” (and not its actual or potential clinical significance).

This is consistent with §201(h) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which defines a medical device subject to the FDA’s authority as one “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease…” It would also appear to logically require an FDA policy whereby DTC genetic tests clearly limited to research, educational or informational intended uses would not be subject to FDA regulation.

The claims of DTC genetic testing companies have been scrutinized before, especially last summer during the events leading up to and following the Congressional hearing and GAO report. As the FDA and other federal (e.g., FTC) and state regulators continue to ponder what’s next for these companies, it’s a safe bet that DTC marketing and product claims will come under closer scrutiny still, not just to ensure their accuracy but also to determine which products are subject to FDA regulation (and to what degree).

When it comes to DTC genetic testing, nothing is certain. Still, we think it likely that one consequence of closer regulatory oversight will be that DTC companies are forced to choose, and to much more clearly convey to their potential customers, whether they are offering a clinical service (e.g., one designed to provide clinically useful information or to otherwise affect the individual’s health or well-being) or merely an informational service (e.g., one designed to provide access to personalized genetic information, possibly in conjunction with certain interpretive tools). The former is certain to be far more tightly regulated than the latter, at least at the outset.

Again, as we wrote several times following this month’s DTC meeting, such an outcome is highly unlikely to result in meaningful limitations on the ability of motivated consumers to access their own raw genetic or genomic data. It is likely, however, to result in a greater degree of clarity and consistency with respect to the marketing and product claims of DTC genetic testing products and services (although exactly how and by whom this will be enforced remains unclear at this time). In the long run, that development should benefit DTC companies, consumers and the industry as a whole.

Filed under: Direct-to-Consumer Services, FDA LDT Regulation, Featured Content, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Industry News, Legal & Regulatory, Pending Regulation
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