FDA Puts the Brakes on Pathway-Walgreens Pairing; What’s Next for DTC?

Well that was quick. On Tuesday, Pathway Genomics and Walgreens announced a partnership to sell a saliva collection kit for Pathway Genomics’ direct-to-consumer (DTC) genetic tests in Walgreens’ thousands of drugstores nationwide. Less than forty-eight hours later, after the FDA repeatedly voiced its concerns about the arrangement, Walgreens has hit the brakes.

According to an MSNBC story, the FDA sent a letter to Pathway “asking the test maker to show it has regulatory approval, or prove why [the test] should be sold without the agency’s blessing.” In response, Walgreens is “elect[ing] not to move forward with offering the Pathway product to our customers until we have further clarity on this matter.”

Back to the Drawing Board. Despite its obvious significance, it is hard to be surprised by this latest development. When the Director of the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) tells The Washington Post that you would be selling an “illegally marketed device” if you proceed as intended, you should know the letter is already in the mail and retreat to the drawing board as quickly as possible.

The real question is what happens next. For years the FDA has been watching the development of the DTC genetic testing industry from the sidelines. No longer. But what we don’t know is just how extensive a regulatory push the FDA is planning to make.

According to MSNBC, the FDA letter, which was signed by the Deputy Director of OIVD, considers Pathway’s “Genetic Health Report…to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act.”

Section 201(h)(2) of the Federal Food, Drug, and Cosmetic Act (FFDCA) defines “device” as:

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is…intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals

That definition covers a lot of ground, but what it almost certainly does not cover is a saliva collection kit on its own (without more, that’s just a means of collecting and storing saliva), which is all that Pathway Genomics was actually planning to place on Walgreens’ shelves. Although I have not seen the full text of the FDA’s letter the excerpted sections strongly suggest that the FDA is focusing its regulatory attention on Pathway’s actual genetic test and its subsequent interpretation of the test results, and not on the fact that Pathway was opening up a new distribution channel for those tests. [See subsequent GLR post for analysis of additional comments from the FDA. The FDA has also made its letter to Pathway Genomics public.]

Industry-Wide Regulation? If that is in fact the case, it’s difficult to see other DTC genetic testing companies escaping increased regulatory scrutiny. As we’ve written several times previously, apart from the matter of visibility, Pathway’s tests appear to be highly similar, both in terms of what they test and how they present the results, to the tests offered by other DTC genetic testing companies. It would come as no surprise to find out that the FDA has sent similar letters to other DTC genetic testing companies, or will in the coming days and weeks. [Update: The New York Times reports that this is exactly what has been happening.] In fact, the only outcome that would surprise me here is if the FDA focused its regulatory attention exclusively on Pathway, while ignoring its competitors.

It should be added that, at least for the moment, all the FDA has done is backed up several public comments that suggest it believes Pathway is on the wrong side of the law with a formal letter requesting more information from the company. That letter also leaves a window, however small, for Pathway to “prove why [the test] should be sold without the agency’s blessing.” Pathway, for its part, continues to claim that it can sell its products without FDA approval because they are “not intended for use in diagnosis, treatment or for the mitigation or cure of a disease,” and therefore fall outside of the FFDCA’s definition of a device.

Will the FDA buy that argument? If it does not, and the agency decides to regulate DTC genetic tests, what will those regulations look like? Will it require Pathway – and other DTC genetic test providers – to pull tests from shelves and websites until they can be reviewed and approved by the FDA, or will there be some manner of regulatory transition period designed to minimize disruption to an industry that is still in its early stages?

A Challenge for the FDA. Despite the flurry of activity over the past few days, the FDA’s regulatory policy with respect to DTC genetic testing leaves us with far more questions than answers.

It has long seemed inevitable that the FDA would regulate DTC genetic tests in some fashion. Indeed, as Turna Ray reported today in Pharmacogenomics Reporter, many of Pathway’s peers have indicated that they would welcome federal regulation:

23andMe, Navigenics, and Decode have all indicated they would welcome more federal guidance for the DTC genomics industry. Particularly after New York and California decided to regulate certain firms two years ago, industry leaders from DTC genomics firms noted that they prefer to have more overarching and definitive guidance from federal health regulators than have to deal with authorities on a state-by-state basis.

The fact that the FDA is finally tackling the regulation of DTC genetic tests is not a problem per se for the industry. But it could quickly become one. To avoid this, what is needed from the FDA is a clear set of guidelines, provided in a timely fashion, that address the agency’s concerns without unduly burdening an industry that is still trying to establish itself. That’s quite a challenge for an agency not always known for its promptness or clarity. DTC companies, customers and commentators will all be anxiously watching to see if the FDA is up to the task.