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.