Earlier today I examined the FDA’s emerging regulatory “policy” with respect to direct-to-consumer (DTC) genetic tests. The thrust of the FDA’s comments to date appear to focus on Pathway’s proposed partnership with Walgreens, specifically the fact that Pathway’s tests would be available in a “drugstore,” as the impetus for the FDA’s prompt and public regulatory response.
I questioned whether the apparent distinction driving the FDA’s policy—focusing on the point of sale—is an appropriate one. I also asked if that is, in fact, to be the applicable distinction, where you draw the line?
The fact that Walgreens is referred to as a “drugstore” is not much help, particularly when you consider that the number of products sold by Walgreens and similar chains that are not regulated by the FDA—everything from sandals and sunglasses to batteries and beach balls—dwarfs the number of products that are regulated. So what is it, exactly, about the Pathway/Walgreens partnership that prompted the FDA to act so quickly and publicly? Would the FDA’s response have been different if Pathway had partnered with Wal-Mart? With Amazon.com? And if we get all the way to Amazon.com, how different is this from what Pathway was already doing: selling its test directly to consumers through a publicly accessible website? (emphasis added)
As it turns out, 23andMe’s own DTC genetic tests are available through Amazon.com.
Andrew Pollack of The New York Times reports that, in an interview, OIVD Director Alberto Gutierrez indicated that the saliva collection kit Pathway had planned to sell through Walgreens may be a clearer case of a DTC genetic test subject to FDA oversight. According to Director Gutierrez, “Once you take a collection device and you are marketing through a drugstore, it is very easy for me to say whether something would fall under our policy.”