More on Pathway and Walgreens: The Price of Visibility and Adding the FTC to the Regulatory Mix
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.”
To clarify, while this may well be the first that the FDA – or at least OIVD – has heard of Pathway Genomics and its specific DTC genetic tests, the agency is clearly familiar with DTC genetic testing and its associated policy issues and regulatory uncertainty. DTC genetic testing has been on the FDA’s radar screen for years, including as part of the ongoing discussion concerning the regulation of laboratory developed tests (LDTs). The FDA also participated in the development of the 2008 SACGHS report on the oversight of genetic testing (pdf), and FDA officials have appeared at consumer genetics conferences (pdf) to discuss the agency’s possible regulatory strategy.
It’s clear that DTC genetic tests as a category are not new to the FDA, and there is also nothing to suggest that the specific tests Pathway offers are substantively new. Although not identical to tests offered by other DTC companies, they appear to offer the same categories of information (carrier status, disease risk, drug response, etc.) and report on substantially overlapping lists of specific traits. They are also performed in a CLIA laboratory, as is true of other DTC genetic tests.
The only element of Pathway’s DTC genetic tests that appears to be new is the visibility that Pathway has achieved by partnering with Walgreens (visibility which will only increase if, as The Los Angeles Times reports, Pathway’s tests will also be available in CVS stores beginning in August). For Pathway, the primary goal of this increased visibility is likely an expanded customer base. But by turning a Walgreens-sized spotlight on itself, Pathway has also caught the eye of regulators. The FDA has responded by publicly commenting on the investigation and possible regulation of a specific DTC genetic testing company, and that is new.
All of this leaves us with a question: if the FDA investigates and ultimately decides to regulate Pathway Genomics, will the rest of the DTC genetic testing industry soon receive similar scrutiny?
Another Regulatory Route? Earlier this morning, an FDA spokeswoman told Reuters that “if a company is making claims about a product that hasn’t been reviewed or validated by FDA, we want to make sure the information to consumers is accurate and the test will do what it says it will do.”
When it comes to medical drugs and devices, the FDA plays an important role in ensuring that consumers receive accurate information. However, as we discussed yesterday, DTC genetic testing companies, including Pathway, do not necessarily agree that they are selling medical devices subject to FDA regulation. According to Reuters:
‘FDA clearance is not necessary to sell the Pathway Genomics Insight Saliva Collection Kit in retail,’ [Pathway Genomics] said.
It said the tests are not intended for use in diagnosis, treatment or for the mitigation or cure of a disease – qualities that would make it an in vitro medical device, which the FDA does regulate.
‘It does provide information that allows a person to learn about their health to make healthier lifestyle choices,’ the company said.
Without rehashing the is-this-a-medical-device-or-not debate, it should be pointed out that there is another regulatory agency that focuses specifically on consumer goods and services, including those that have nothing to do with health or medicine, that has previously taken an interest in DTC genetic testing: the Federal Trade Commission (FTC).
In 2006, well before Pathway Genomics, 23andMe and other companies offering genome-wide DTC genetic testing arrived on the marketplace, the FTC published guidance entitled At-Home Genetic Tests: A Healthy Dose of Skepticism May Be the Best Prescription. Prepared in conjunction with the FDA and the CDC, the FTC’s guidance reviews the state of DTC genetics, including a number of its limitations (circa 2006), and advises consumers to talk to their doctor before ordering, taking or making decisions based on a DTC genetic test. It also reminds consumers of the FTC’s mission: “to work[] for the consumer to prevent fraudulent, deceptive, and unfair business practices in the marketplace and to provide information to help consumers spot, stop, and avoid them.”
Let me be crystal clear: the FTC guidance was published in 2006, and does not criticize, or even discuss, any specific DTC genetic test. Indeed, most if not all of today’s most popular DTC tests were not on the market in 2006. Furthermore, this should not be read as an indication that any of the current tests, including those offered by Pathway Genomics, are themselves false or misleading.
As the Pathway/Walgreens announcement has made the rounds, many of the concerns voiced by commentators and regulators - as was the case in previous debates over the merits of DTC genetic testing - have centered on a fear that consumers may be confused or misled by the tests, or unable to interpret their results. The National Society of Genetic Counselors, for example, issued a statement yesterday (pdf) warning that “receiving genetic information directly from a manufacturer or supplier and without input from a qualified health care provider increases the chance for misunderstanding or misinterpretation of results.” If the fundamental concern here relates not to the information content of the tests themselves, but how the tests are marketed to and understood by consumers, perhaps the FTC stands as an alternative, and likely less burdensome, regulatory avenue.
“if a company is making claims about a product that hasn’t been reviewed or validated by FDA, we want to make sure the information to consumers is accurate and the test will do what it says it will do.”
I think I saw this spokeswoman the other night doing stand-up at the Funny Bone.
Alberto Gutierrez and the FDA just make up the rules as they go along, and decide what to prioritize as a function of what they read in the morning papers.
They are total idiots over there. I’m sure their first contact with Pathway was a quote in the papers slamming them as “illegal”. Oh really? Illegal?
But when you dig in, the FDA has never said what *is* and *isn’t* illegal in this area. They are literally making up that rule right now! And of course it is credulously reported as “didn’t get FDA approval” when the FDA has ceded ground to CLIA for any test which runs through a clinical lab.
Remember, the first tier scientists are the ones publishing papers and founding companies. The second and third stringers are at the FDA, and don’t keep up on the literature or the industry. They are just gray bureaucrats who professionally advance by destroying companies (and jobs, and industries) in fits of pique. Think Eliot Spitzer during his crusading days, before he became Client #9.
Here’s how it works: a reporter’s choice of words on CNN means the FDA guy gets annoyed, and poof, there goes your company’s revenue stream for at least six months as the cease & desist nastygram comes out of nowhere. Good luck getting back on track — they send their cease & desists at the drop of a hat, and then make you wait 90 days for each “review” of the documents. They always want additional information. That means another 90 days while they sit on their hind legs.
I mean, try finding out what the FDA actually thinks about personal genome sequencing, which is barreling down upon us. Are they going to do marker-by-marker regulation? Are they really going to ban an individual’s access to their own genome? Because that is what the jihad against “direct to consumer” really means.
Think about it: who “peer reviews” the FDA’s material? Are they required to pass tests of competency to retain their status as regulators? Do they face any penalties for making erroneous or misleading statements to the media? Is their standard protocol to communicate with a company by the medium of ABC News? Do they pay back the financial damages and delays they inflict out of their own ignorance and arrogance?
These questions answer themselves.
While the NIH is pushing forward sequencing, the FDA is just holding it back, just like they’ve held back the drug industry. When 30% of prescriptions are for ‘off-label’ uses of drugs, the cat is out of the bag — doctors only actually use the FDA to evaluate basic safety and toxicity, which has a $1-10M price tag, rather than *efficacy* as well, which is more in the $100M to $1B range. In other words, a doctor’s choice of whether to prescribe a drug off-label is a function of the peer reviewed literature and their own expert judgment rather than the received wisdom of some remote despot whose transitory attention has been drawn to the area by a feature on the six o’clock news. Fancy that.
Jihad against DTC?
Seems a little premature, and overstated, especially given the distinct lack of regulation on DTC genetics to date. Lots of valid points in there Anne but….
Hey Dave, just trying to balance the ledger.
No one ever turns a microscope on the FDA and their decision making process. They’re portrayed as this neutral arbiter of quality. Anyone who’s tangled with them (or worked for them) will laugh at that.
Regarding the jihad against DTC, you can’t have missed the last 3 or 4 years of swelling attacks by gatekeepers. Stones through windows is how it begins, and then the govt. takes action. How dare people look at their own sequence information without registering a billing event for a physician, a genetic counselor, and the FDA (through the new 2.3% levy on all medical devices).
Look, we’re all very sophisticated when it comes to analyzing conflicts of interest in other context. Basic public choice econ tells you that regulators respond to incentives too. The FDA is not incentivized to improve people’s health, it’s incentivized to avoid any kind of negative press coverage of the FDA. Those are two VERY different things and have lead to our insanely risk averse medical system, the equivalent of grounding every plane for fear of imaginary volcanic ash.
The machinery of Washington is absolutely byzantine and every single regulator has a finger to the political winds when he chooses which company to smash. Always remember that these are *not* disinterested regulators but political actors.
Jihad against DTC?
Seems a little premature, and overstated, especially given the distinct lack of regulation on DTC genetics to date. Lots of valid points in there Anne but….
Jihad against DTC?
Seems a little premature, and overstated, especially given the distinct lack of regulation on DTC genetics to date. Lots of valid points in there Anne but….
Jihad against DTC?
Seems a little premature, and overstated, especially given the distinct lack of regulation on DTC genetics to date. Lots of valid points in there Anne but….