The market for DTC genetic tests has boomed as consumers become more educated and proactive about their own health. Tests range from standard ancestry/paternity/ethnicity and disease risk tests to more lifestyle oriented tests. One even makes personalized wine recommendations based on genetic makeup. However, gaps in the regulation of these tests exist, and some are going to market without any independent analysis.
Three federal agencies have a hand in regulating DTC genetic tests. The Food and Drug Administration (FDA) regulates the safety and efficacy of genetic tests, the Center for Medicare and Medicaid Services (CMS) controls clinical laboratories and testing processes, and the Federal Trade Commission (FTC) oversees false and misleading advertising. The FDA has the broadest authority to regulate DTC genetic tests and warns that some tests mislead and harm patients with erroneous or incomplete results. Recently, the FDA announced it would defer the decision to regulate the test to Congress and to President Trump.
Proponents praise the industry for empowering consumers and increasing access in this new age of personalized medicine. Critics argue DTC genetic tests are misleading and do not meaningfully improve health. Further, critics are skeptical of genetic companies that sell depersonalized consumer data to pharmaceutical companies.
In this fragmented regulatory landscape, it is important for consumers to know the potential risks associated with DTC genetic tests.
Justin T. Berger is a Partner at Cotchett, Pitre & McCarthy, LLP, where he handles high-profile cases of corporate fraud, including representing whistleblowers in qui tam actions under the federal and California False Claims Acts ...