Pathway spokesman Robert Blodgett said the company believes that "FDA clearance is not necessary to sell the Pathway Genomics Insight Saliva Collection Kit in retail" and hadn’t submitted the test for approval.
When Pathway announced this morning that they had reached a distribution deal to sell their unapproved medical device at Walgreens, I knew it was a disaster in the making. I commented to a co-worker that they would be eating their words by the end of the week. I figured I had until the end of the day to write a blog saying as much.
It turns out that I was overly optimistic. FDA has already launched an investigation. Later the same day. Alberto Gutierrez even went on the record saying as much.
There was a time when you could skirt the law and maybe reap the benefits in the time it took FDA to warn you to stop. That was never a great plan, but you can stick a fork in it now.
You might think that a lot of people would pay good money to receive your unproven diagnostic information. FDA is still the law of the land and there's nothing you can to do get on their bad side faster than to announce you're disregarding their authority.