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.
I don’t know how long Amazon, one of the world’s largest retailers, online or otherwise, has been offering 23andMe’s test. But 23andMe’s Amazon availability certainly was not widely publicized in the way that Walgreens and Pathway Genomics announced their plan to stock Pathway’s tests on Walgreens’ shelves. So, is that the fundamental difference here? That Pathway partnered with a commercial retailer and turned it into a PR event, while 23andMe did not? Or is it that the FDA simply is unprepared to take its regulatory approach to DTC genetic testing beyond the corner drugstore?
This morning, in response to a comment, I elaborated on why I continue to find the distinction between online and drugstore availability of DTC genetic tests unpersuasive:
DTC companies that sell their tests online have all been exploring ways to identify and market themselves to potential customers. 23andMe, for example, has used blimps, product giveaways, corporate partnerships and widely publicized spit parties. Not to mention the fact that Time Magazine declared 23andMe’s “Retail DNA Test” the invention of the year for 2008.
I’m not sure it’s accurate to say that purchasers of a DTC genetic test that is sold online have necessarily sought out those products any more than an individual who sees one while walking down Aisle 8 at the local Walgreens. That may be true in some instances but, at the end of the day, all of these companies are in the business of widely promoting their products and attracting new customers.
With 23andMe branching out from its own modestly visible website to Amazon’s online bazaar, the distinction the FDA appears to have focused on is even less supportable. There’s still only one conclusion here: the FDA, which jump-started the regulatory discussion surrounding DTC genetic tests via comments to The Washington Post, needs to deliver much clearer guidance to the DTC industry, including prospective DTC companies, customers and investors.