Regulatory approval for genetic tests.
The week of May 10th was not a good one for Pathway Genomics. That’s when the FDA sent a letter saying it was looking into Pathway’s genetic test offering. And it’s not the only interested party.
According to Genome Web, the House Energy and Commerce Committee wants more information about Pathway’s test, and about similar tests from other companies, 23andMe and Navigenics. Key questions are how the test is analyzed and how accurate those analyses are. The firms are being asked to come up with proof that they have regulatory approval or convince regulators that they don’t need it.
The accuracy of the analysis may go directly to the interpretation of the tests. While it might be possible to send the same sample to all three of these companies, all of which may get similar results, it’s the interpretations that can be wildly different. Responses are required by May 25, 2010. Hold on!
Read our previous blog about this issue.
The danger of marketing without FDA approval
The strange story of drug store–based genetic tests.
It was a quick trip on and off the shelves at several thousand Walgreens drug stores for Pathway Genomics direct-to-consumer genetic testing kit. Less than 48 hours after announcing the availability of the test kits, Walgreens pulled back due to an intervention by the Food and Drug Administration saying that the test was without regulatory approval, telling Genetic Pathways that it would be an “illegally marketed device.” In Act II of this genetic drama, CVS also pulled out of marketing the same product a few days ago.
For my money, I can’t believe they went to market without considering the FDA’s reaction. Naivety? Cockiness? When you work in a regulated environment, particularly one in which the regulations are under development and fluid, assume nothing. I have clients that have worked with the FDA, not around them, even thought their product did not require FDA approval. They obtained the guidance they needed to move forward and both parties were better off for the interaction.
Imagine all that must have been involved in doing two deals of this magnitude. But, according to the FDA, “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.”
Duh!
Read another blog entry about this issue.
