DNA Spit Kits Off Walgreens’ Shelves? Try Amazon.com
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.
If it’s not eligible for Amazon Prime, then forget it.
I don’t think I would define the relationship between 23andMe and Amazon.com as a “partnership”. The 23andMe kit is not being sold by Amazon, but through Amazon. That is a significant distinction. Virtually anyone can sell anything on Amazon. Including, but not limited to, Uranium ore (http://amzn.to/d6xrVS).
Dave: good point, and I have updated the post accordingly.
@Dave and Dan
“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…..”
Now it has…..
-Steve
@Dan,
The guidance is simple. If you sell this other than to that select sect of early adopters online and without coming to get our permission, we will investigate you.
They all should have gone to the FDA in the first place if you ask me.
-Steve
I was not aware of this, and it is worrisome even though the kit is sold through, and not by, Amazon.com. The main problem is that Amazon.com tries to cross-sell items via its ability to show you what similar customers bought or viewed. Furthermore, it doesn’t help that the product is in the “Health & Personal Care” department. In my mind, the more distribution channels a product is offered through the less it seems like a laboratory developed test (LDT) and the more it appears to be a diagnostic test kit.
” 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?”
Yes, exactly. The emperor has no clothes. The FDA decides what to do based on what it sees in the morning papers. They sat on this for years and only decide to move when someone gets a little too entrepreneurial. How dare someone do something without paying off the FDA bureaucrat?
Also remember, they have a big incentive now to class EVERYTHING as medical devices because device manufacturers have to fork over 2.3% of rev to the FDA (massive new tax included with the health care bill).
The same pecuniary motivations led to that $175M fine of Genzyme. Where did that come from? Weren’t they already losing market share and hurting? Why did the FDA pile on? Again, because they saw the opportunity to grab some of your $$$ and mug for the cameras. Sigh…this country is well on its way to DMV style healthcare.
This is your govt at work:
http://www.youtube.com/watch?v=_ES0Q8emDsg
DMV care is already here Anna. It happens every day at Partners or local mega group.
Medicare and insurers all but guarantee that with 30 day delays on payments and screwed up Alice in Wonderland type laws/contracts.
Welcome to the valley of the real.
And what about Navigenics’ strategy of partnering with health care institutions and physician groups to get their test offered in clinics and doctor’s offices? That clearly extends their reach well beyond any “select sect of early adopters online.”
Dan,
I’m very much enjoying your commentaries on this subject. Thank you.
Totally agree with Steve. They should have gone to FDA first.I have clients with LDTs who have worked successfully with FDA, not around them, even when it wasn’t “necessary.”