More on Pathway and Walgreens: The Price of Visibility and Adding the FTC to the Regulatory Mix
Yesterday, direct-to-consumer (DTC) genetic test provider Pathway Genomics and drugstore giant Walgreens announced a partnership that will place Pathway’s tests on the shelves of thousands of Walgreens stores across the country. Earlier coverage from the GLR reviewed the announcement in detail, and examined whether the Pathway/Walgreens partnership might prove to be the catalyst for increased FDA regulation of DTC genetic tests.
Introducing the FDA to Pathway, but not to genetic testing. Continuing national media coverage has focused on comments from the FDA that the agency was unaware of Pathway’s genetic test and that it has opened an investigation into its legality. Yesterday, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Director Alberto Gutierrez told The Washington Post that he thought Pathway’s genetic test “would be an illegally marketed device” if the company proceeded with the announced Walgreens partnership. Gutierrez was also widely quoted as saying that the FDA was not aware of the test previously and that the agency was “in the process of investigating the test.”
Personal Genomics Follows Pathway to Corner Drugstore; Is Regulation Next?
The direct-to-consumer (DTC) genetic testing marketplace is on the move again. Just last week, in Mapping the Personal Genomics Landscape, I wrote that “predicting precisely which consumer services will be offered and how, if at all, they will be regulated, is impossible. All we know is that personal genomics consumers ten years from now are certain to have many, many more options than they do today.”
Turns out we only needed to wait a week – not a decade – for the landscape to shift again. Earlier today, DTC provider Pathway Genomics announced that it was partnering with drugstore giant Walgreens to offer its genetic testing service through most of that chain’s 7,500 stores.
Is Walgreens the Tipping Point for Personal Genomics Regulation? At first blush, this might appear to be nothing more than a creative product partnership between a fledgling personal genomics company and a giant drugstore chain. As it turns out, there are early indications that the Pathway/Walgreens partnership could turn out to be a tipping point in the regulation of personal genomics.
