These are hectic days for the field of direct-to-consumer (DTC) genetic testing. Every week, and sometimes every day, seems to bring a new development. Two weeks ago it was pharmacy giants Walgreens and CVS unveiling agreements with Pathway Genomics to offer Pathway’s genetic testing kits in drugstores nationwide, to which the FDA responded first by declaring such a strategy illegal and, shortly thereafter, launching an investigation. Last week, on the same day that the University of California, Berkeley announced it would be offering genetic tests to all incoming freshmen, a House of Representatives committee announced it was launching its own investigation into three prominent DTC genetic testing companies.
These developments reflect an uncertainty about the regulatory status of DTC genetic testing that is dramatic, although it is not new. In the summer of 2008, public health officials in New York and California sent warning letters to a number of DTC companies, including 23andMe and Navigenics (both targets of the current Congressional investigation). These state regulatory activities prompted concern that other states might follow suit, potentially subjecting DTC companies to the nightmare scenario of inconsistent state-by-state regulation. Nearly two years later, those particular concerns appear to be unfounded.
There is a two-part question that we are frequently asked these days: “When is Bilski going to be decided and what’s the decision going to be?”
The first part of that question is easy to answer. Bilski will be decided soon. Need something more specific? Bilski will be decided sometime between today and the end of June or beginning of July, when the Supreme Court’s current term ends.
The second part of the question involves predicting the future. We’re happy to take a shot at that, but only after a few caveats. First, these predictions are for entertainment purposes only. Betting on Supreme Court decisions is illegal in most states and several foreign countries, so don’t. Second, pay no attention to alleged inside information about what the Court is going to do or when it’s going to do it. There are no credible Supreme Court leaks—the Court is tighter than Putin’s old KGB (or his new FSB). Third, remember that it takes the votes of four justices for the Court to take a case. So we can presume that at least four justices wanted to say something about Bilski. But we don’t yet know what that might be. With those disclaimers, let’s proceed to the prognostication.
With so many developments at the intersection of genomics and the law, there are often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here is a recap of what I was Tweeting recently @genomicslawyer:
- For my $ @matthewherper has the best take on Venter’s Mycoplasma mycoides: “Don’t Freak Out” http://bit.ly/acTfVI
- Where to next for personal genomics? http://bit.ly/9bAEG3 Comprehensive, incisive post from @dgmacarthur
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The United States House of Representatives Committee on Energy and Commerce today launched an investigation into direct-to-consumer (DTC) genetic testing, sending letters to three prominent DTC companies: 23andMe, Pathway Genomics and Navigenics. Here is the announcement from the Committee:
Today Chairman Henry A. Waxman, Ranking Member Joe Barton, Subcommittee Chairman Bart Stupak, and Subcommittee Ranking Member Michael C. Burgess sent letters to 23andMe, Inc., Navigenics, and Pathway Genomics Corporation in light of recent reports that at least one of the companies is seeking to sell personal genetic testing kits in retail locations, despite concern from the scientific community regarding the accuracy of test results.
The Committee is requesting information from the companies on several aspects of the tests: How the companies analyze test results to determine consumers’ risk for any conditions, diseases, drug responses, and adverse reactions; the ability of the companies’ genetic testing products to accurately identify any genetic risks; and the companies’ policies for the collection, storage, and processing of individual genetic samples collected from consumers.
Two months ago, the Myriad gene patent litigation generated a slew of national and international coverage. We said, “Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims.” “Is the DNA patent dead?” asked CNN. Wired (apparently answering CNN) declared the “End of Gene Patents Will Help Patients, Force Companies to Change.” Everyone, it seemed, either had an opinion on what the Myriad decision meant for the future of biotechnology or was looking for somebody who did.
It’s not surprising that the Myriad litigation has dominated the headlines. The ACLU’s challenge to Myriad Genetics was a first-of-its-kind frontal attack on gene patents. But with Myriad now on appeal to the Federal Circuit, and a final resolution to that particular piece of litigation likely several years away, a variety of other legal developments are slowly but surely reshaping the biotechnology patent landscape. In the next few years, while frontal attacks such as Myriad are likely to occupy the press and policymakers, those interested in forecasting the future of biotechnology patents will be paying equally close attention to the various collateral attacks on gene, protein, association, diagnostic, and other biotechnology patents and claims.
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.”
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.
Yesterday, direct-to-consumer (DTC) genetic test provider Pathway Genomics and drugstore giant Walgreens announced a partnership that will place Pathway’s tests on the shelves of thousands of Walgreens stores across the country. Earlier coverage from the GLR reviewed the announcement in detail, and examined whether the Pathway/Walgreens partnership might prove to be the catalyst for increased FDA regulation of DTC genetic tests.
Introducing the FDA to Pathway, but not to genetic testing. Continuing national media coverage has focused on comments from the FDA that the agency was unaware of Pathway’s genetic test and that it has opened an investigation into its legality. Yesterday, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) Director Alberto Gutierrez told The Washington Post that he thought Pathway’s genetic test “would be an illegally marketed device” if the company proceeded with the announced Walgreens partnership. Gutierrez was also widely quoted as saying that the FDA was not aware of the test previously and that the agency was “in the process of investigating the test.”
The direct-to-consumer (DTC) genetic testing marketplace is on the move again. Just last week, in Mapping the Personal Genomics Landscape, I wrote that “predicting precisely which consumer services will be offered and how, if at all, they will be regulated, is impossible. All we know is that personal genomics consumers ten years from now are certain to have many, many more options than they do today.”
Turns out we only needed to wait a week – not a decade – for the landscape to shift again. Earlier today, DTC provider Pathway Genomics announced that it was partnering with drugstore giant Walgreens to offer its genetic testing service through most of that chain’s 7,500 stores.
Is Walgreens the Tipping Point for Personal Genomics Regulation? At first blush, this might appear to be nothing more than a creative product partnership between a fledgling personal genomics company and a giant drugstore chain. As it turns out, there are early indications that the Pathway/Walgreens partnership could turn out to be a tipping point in the regulation of personal genomics.