FDA Intervention Shelves Plan for Drugstore Genome Tests
Earlier this week, Pathway Genomics was poised to begin selling its Insight genetic test kit at 6,000 Walgreens pharmacies nationwide, but then the Food and Drug Administration put its foot down. On May 10, just after Walgreens and Pathway made their announcement to the press, FDA sent a letter to the testing company asking if it had sought agency approval for the device, and if not, why company officials think it does not need that approval. Walgreens has since postponed plans to sell the tests.
According to FDA, Pathway Genomics is in fact selling what appears to be a medical device under section 201(h) of the Federal Food Drug and Cosmetic Act, which defines a medical device as an instrument that is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.” As the Washington Post reported, the tests would scan consumers’ genes “for a propensity for Alzheimer’s disease, breast cancer, diabetes and other ailments.” Up until this point the FDA has exercised its enforcement discretion to refrain from regulating direct-to-consumer genetic tests as medical devices.
Other companies offering these types of tests by mail have maintained that the products they sell are for informational purposes only. Despite repeated calls for FDA to set rules for genetic tests during the Bush administration, the lack of federal attention came into sharp focus in 2008, when California and New York sent “cease and desist” letters to several companies offering direct-to-consumer tests through the mail, including 23andMe and Navigenics. Along with a few others, these companies won approval from the state of California by demonstrating that they used up-to-date genetic research to back up their claims, had physicians and genetic counselors on staff to help customers, and contracted their genetic sequencing out to labs that were state-licensed and certified according to federal standards under the Clinical Laboratory Improvement Act, known as CLIA. Navigenics successfully applied for approval under New York’s licensing board and now markets mostly to physicians, but 23andMe and Pathway are not approved and their test cannot be ordered in New York. In fact, Walgreens did not plan to sell the Pathway test kit in any of its New York stores.
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