Of Drugstores and Devices: Parsing the FDA’s Evolving DTC “Policy”
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.”
Having never publicly announced any regulatory guidance with respect to DTC genetic tests, it’s somewhat unclear what “policy” Director Gutierrez is referring to. However, if the relevant distinction between Pathway and other DTC genetic testing providers is the act of placing saliva collection kits on a drugstore shelf, it is not a distinction I find particularly persuasive—or clear—because it distinguishes tests on the basis of location (where the tests are marketed for sale) rather than substance (how the tests are described to consumers, which genetic variants are tested or how those variants are interpreted).
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?
Pollack and The Times report that, in addition to the letter it sent to Pathway, the FDA has sent similar letters “to a number of companies selling genetic tests directly to consumers, asking them to explain their tests and their business models,” although Director Gutierrez “would not identify the companies or say whether any action had been taken.” Case-by-case responses to company announcements that begin with statements to reporters do not provide current or prospective DTC companies with much guidance, so hopefully the FDA is in the process of formalizing an industry-wide policy that will provide clear(er) direction for what DTC genetic companies seeking to develop their businesses can and cannot do without the agency’s approval. Barring a successful legal challenge, the FDA’s regulatory policy, whatever it turns out to be, is what the DTC genetic testing industry will be forced to come to terms with. For that to happen, however, the industry must first understand what that policy is.
Maybe I’m crazy, but a regulatory policy that distinguishes between tests on the basis of where they are marketed for sale makes some sense to me. DTC genetic tests that are truly sold directly to the consumer (e.g. 23andMe) have to be more or less sought out. This implies that the seeker has some rudimentary understanding of genetic testing and its limitations. In contrast, tests marketed via 3rd parties such as Walgreens or Amazon.com are much more likely to be purchased on impulse by uninformed consumers. Someone running into a “drugstore” to buy hair dye and leaving with a genetic test kit is the kind of scenario that probably makes the regulators at the FDA cringe. If this is the case, I hope that the FDA clearly articulates its stance and that its final policy includes safe-harbor provisions that protect true DTC genetic tests from being treated as Class I medical devices.
Matthew: I don’t think you’re crazy, but I still don’t find the distinction persuasive. 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.
But that doesn’t mean that the FDA will agree. Regardless, you’re correct to note that whatever the FDA does decide it must do so in a way that is clearly articulated to the DTC industry, including prospective DTC companies. Assuming that part of the FDA’s policy involves a determination that DTC genetic tests are medical devices, it will be interesting to see how the FDA ultimately classifies them.
I agree with Matthew’s assessment that consumer genetic tests could become compulsive buys if marketed over the counter. Not that I see anything wrong with that: Condoms were sold behind the counter for decades on the fear they would become compulsive buys, as well as for other, similarly puritanical reasons. And in some states birth control was even illegal until 1972.
A concern with distinguishing online from in-store shopping should be that it can close off access to the tests to people with no or limited internet access [http://www.slate.com/id/2210835/], and to those who use the Internet but are leery of making online purchases.
Kirell: those are good points – particularly the access issue. With respect to impulse buys, is it not possible to make impulse buys online as well as in the store? I’m thinking in particular of Amazon’s recommendation engine (“Customers who bought X also bought…”), which has successfully tempted me into online impulse buys in the past.
Dan: No doubt. But I think DTC tests could become a greater impulse buy if they’re sold in a store. I think I’ve been guilty of impulse buying at Wal-Mart once or twice, but I know I’m not as impulsive in its online store.
First of all there are many good points in this article as well as the comments, but I do feel that you should not be able to just walk into any drugstore and but these products. I think that stores such as Wal-Mart or Wallgreens, or whoever would want to sell these products should have a permit to have a sell these products.