Since the completion of the human genome project, individuals have clamored for ways to test for their genetic predisposition to future disease, and the market has responded with direct-to-consumer (DTC) genetic health risk tests. Those tests, however, have not been without controversy. In November 2013, the FDA sent a warning letter to one of the leading companies in the DTC genetic testing market, 23andMe Inc., ordering it to stop marketing a saliva collection kit and personal genome service without FDA approval. The FDA's concern stemmed from a lack of consumer clarity that the tests were not intended to diagnose diseases but to simply report on whether an individual is a "carrier" for genes that impact the risk of developing a given condition. A few years later, several plaintiffs brought suit against 23andMe Inc., alleging that the company falsely advertised its products as a way to potentially mitigate the risk of disease. Since then, additional companies have offered DTC genetic health risk tests with varying marketing claims, sparking debate about the required regulatory approval and the appropriate advertising for these products.
Recently, the FDA announced that it will allow DTC genetic health risk tests from 23andMe Inc. for 10 specific diseases and conditions, including Parkinson's disease, late-onset Alzheimer's disease, and celiac disease. These tests are intended to help inform consumers about changes in behavior and lifestyle that could help reduce the identified risk. However, the FDA cautioned in its authorization that these tests cannot "determine a person's overall risk of developing a disease or condition" but simply provide information on an individual's genetic risk.
The FDA granted authorization for 23andMe Inc.'s tests through its de novo premarket review pathway. This pathway is designed to provide a regulatory mode of review for "low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device." Additional 23andMe Inc. genetic health risk tests will be exempt from the FDA's premarket review, and other manufacturers may likewise be exempt after submitting a one-time premarket notification for approval. However, the FDA made clear that diagnosis tests used "as the sole basis for major treatment decisions" will not be eligible for marketing authorization and exemption.
The FDA's grant of marketing authorization to 23andMe Inc. suggests that the agency will likely be more willing to grant approval for similar tests in the future. A greater proliferation of DTC genetic health risk tests also brings the heightened risk of litigation that companies may face from consumers. If you are representing a healthcare company that is currently or may begin manufacturing DTC genetic health risk tests, then there are several points to keep in mind.
- Avoid false advertising claims! You should counsel companies to be clear and deliberate in their marketing strategies. These tests are not meant to diagnose diseases nor are they meant to take the place of a physician. Clarity in the marketing of these tests will be crucially important in avoiding consumer claims.
- The FDA has created a pathway to expedite the approval of DTC genetic health risk tests. Even though companies in the past have marketed DTC tests without seeking premarket review by the FDA, there is no need to risk receiving warning letters. It's become a lot easier to follow the rules!