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Will FDA Crash Pathway's Walgreens Spit Party?


By Turna Ray

There is a difference, as far as the US Food and Drug Administration is concerned, between offering direct-to-consumer genotyping services through the virtual world of the internet and marketing them at brick-and-mortar retail stores.

Direct-to-consumer genomics firm Pathway Genomics announced this week it will begin marketing its genome-scanning service at around 6,000 Walgreens stores nationwide, except for in New York where health regulators exercise more stringent oversight over genomic firms than other states do.

But the company's plans don't square with the FDA, which believes that moving DTC tests onto pharmacy shelves violates regulatory guidelines.

"Pathway Genomics has moved outside of the currently sanctioned boundaries for lab-developed tests by marketing a product in a retail store that asks consumers to collect the sample," Erica Jefferson from FDA's Office of Public Affairs told Pharmacogenomics Reporter this week. "FDA has concerns because the test is being marketed as a tool to make determinations about medical treatments, and yet they have never been reviewed by FDA to determine if the tests are accurate."

Pathway's Insight Saliva Collection Kits will be available at Walgreens stores, priced between $20 and $30. Consumers purchasing the kits will then have to mail their sample to Pathway and then visit the company's website to purchase different genome scan packages at varying price points, ranging from $79 for a report on pharmacogenomic response to nine drugs, to as much as $249 for a report containing gene mutations related to drug response, pre-pregnancy planning, and disease predisposition.

Pathway Genomics, like many other DTC genomics firms, believes that its direct-to-consumer marketing strategy is democratizing access to genetic information. In response to initial reports that the FDA is investigating its marketing claims, the company said it believes it is playing by the rules since Pathway's clinical laboratory is cleared under the Centers for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments.

FDA has not formally taken any regulatory action against online DTC genomics firms, such as 23andMe, Navigenics, or Decode, but has said it is watching the nascent industry with interest. In response to Pathway's decision to go from the internet to retail stories, however, the agency seems to be ending its quiet vigilance and taking action.

Although FDA has exercised "enforcement discretion" over the majority of laboratory-developed tests, leaving most CLIA-approved labs to fall under CMS' purview, the FDA has always asserted that it has the power to regulate all LDTs if it sees a risk-based need.

"It is important … to recognize that FDA has regulatory authority over all lab-developed tests, but historically the agency has not exercised this authority," Jefferson said. "As new technologies become available and are marketed directly to consumers FDA will consider all regulatory options."

Additionally, Jefferson noted that the agency "has been reviewing the online marketing practices of companies with products available online and has reached out requesting that the companies speak to the agency about the claims being made."

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.

For example, the New York Department of Health issued warning letters to 23 DTC genomics in 2008 indicating that these firms would require a laboratory license to operate in the state and that consumers would need go through a physician to order the tests.

Not only that, but New York residents aren't even allowed to provide a spit sample in the state — whether they are using online DTC services or buying a kit at Walgreens. 23andMe, which doesn't have a lab license to operate in New York, has worked around this by providing a disclaimer on its web site informing New York residents ordering saliva kits online to spit outside NY state boundaries (PGx Reporter 03/18/09).

Navigenics, another firm warned by New York health regulators, decided this year to not market its consumer genetic testing services directly to customers in the state, but go through physicians' orders instead (PGx Reporter 01/20/10).

For its online service, Pathway offers disclaimers about the medical use of its services that are very similar to competing firms. "Pathway Genomics and the services do not provide medical advice or diagnosis or treatment recommendations for diseases or other health conditions," the company's Terms of Service informs customers. "The services provided by Pathway Genomics are solely for research and educational purposes and uses."

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While Pathway holds the distinction of being the first firm to offer genetic testing on such a broad scale to consumers, others have tried the storefront genetic testing route but on a smaller scale. In late 2007, Sorensen Genomics began selling its Indentigene DNA Paternity Test Kit in Rite Aid stores in California, Washington, and Oregon.

In 2006, Laboratory Corporation of America announced it was planning to work with Duane Reade to place a LabCorp “patient service center” in 20 New York City Duane Read pharmacies. At the time, a LabCorp spokesperson said that the facilities would collect patient samples for nearly the full range of LabCorp diagnostics, including molecular diagnostics such as CYP450 testing. The status of this effort is currently unclear. LabCorp did not respond to an interview request by press time.

Pathway's move to retail comes during a time of rapid advancement in personalized medicine. However, most of the changes in industry and policy circles are being made cautiously with an eye toward using genomic technologies to make healthcare more efficient, reduce costs, and make drugs safer.

For example, the FDA is changing its internal processes and improving its expertise for reviewing drug/diagnostic combination products. Pharmaceutical and biotech firms are taking pains to discuss drug/diagnostic development earlier in product development with the FDA and making use of programs such as the agency's Voluntary Exploratory Data Submissions Program. Meantime, pharmacy-benefits managers such as Medco and CVS Caremark have joined with companies that can educate physicians and patients about the role genetics can play in medicine, and drive more efficiency within their systems by delivering the right drugs to the right patients.

While some industry observers and health regulators have criticized DTC genomics firms for making unvalidated medical claims and pedaling genomic disease risk based on insufficient data, the large players in the space have made moves to improve the public's perception of their services (PGx Reporter 04/15/09).

23andMe, for example, has partnered with disease research groups to highlight the benefits of consumer-driven research. And Navigenics in particular has made efforts to market to physicians and to emphasize that while patients should have access to genomic information, no medical action should be taken based on the results without consulting a physician.

"At this time, marketing genetic tests to the mass public with the promise of a longer, healthier life is not a responsible approach to improving public health," Courtney Kronenthal, director of communications for the Coriell Institute for Medical Research, told Pharmacogenomics Reporter this week.

The Coriell Personalized Medicine Collaborative was launched in December 2007 with the aim of studying the impact of genome-informed treatment on medical care. Under the project, participants can get genotyped for free by CPMC. After providing a saliva sample in person at CPMC's facility, they can choose to learn or not learn their genetic risk data for diseases approved by CPMC's Informed Cohort Oversight Board as "potentially medically actionable." The CMPC has enrolled more than 4,000 participants, and plans to ultimately enroll 100,000 people (PGx Reporter 06/17/09).

In the current environment of rapid, but cautious, progress, Pathway's move to store shelves may appear to health regulators as rash and ill-conceived from a public health standpoint, particularly since so much of the company's marketing plans are currently unknown.

For example, the level of information that the company provides consumers in the store about its service will have regulatory implications. Specifically, how much detail will the company provide about the risks and unknowns of gene risk stratification? And how prominently will the company advertise the fact that buying a $20 spit kit doesn't buy them the genetic risk assessment?

"It's great folks will have access to this information at relatively low cost and without being forced to go through the expensive (and not always easy to navigate) health system," Robert Cook-Deegan, director of the Center for Genome Ethics, Law, and Policy at Duke University's Institute for Genome Sciences and Policy, said in an e-mail to Pharmacogenomics Reporter. But Cook-Deegan said he also worries about how this information will be used, how many false-positives and false-negatives there will be, if it will cause consumers worry, and whether it will increase healthcare costs by spurring doctors to do precautionary but needless procedures based on the results of genome scans.

Pathway Genomics did not respond to specific questions about its service partnership with Walgreens. However, the company did issue a statement that it has "provided the same personal genetic report to customers for the past year, and are continuing discussion with the FDA about the regulation of personal genomic information."

Although FDA says it has been keeping tabs on medical claims made by online DTC firms all along, Pathway's move to retail has certainly made the agency more vocal about its regulatory intent.

According to FDA's Jefferson, Pathway did not discuss its plans to offer saliva collections kits at Walgreens prior to announcing the effort. "FDA has no record of [Pathway's] test being submitted to the agency for approval or clearance," she said.

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