By Kirell Lakhman
Two days after announcing it would carry Pathway Genomics' DTC genetic tests in most of its 7,500 stores nationwide, Walgreens buckled under FDA pressure and called off the deal, at least for now.
With FDA on Pathway's heels, Walgreens said "we've elected not to move forward with offering the Pathway product to our customers until we have further clarity on this matter," the pharmacy giant said in a statement, referring to discussions presumably underway between Pathway and FDA.
The statement also comes one day after Walgreens argued that FDA clearance is not required to sell the kit in its stores, which already hawks pregnancy tests, paternity tests, and drug tests, all of them kits.
This morning Dan Vorhaus at Genomic Law Report, saying that it's "hard to be surprised by this latest development," quips that "[w]hen the director of OIVD tells The Washington Post that you would be selling an 'illegally marketed device' if you proceed as intended, you should know the letter is already in the mail and retreat to the drawing board as quickly as possible."
According to that Post article, Alberto Gutierrez, referring to Pathway's test, said "[w]e think this would be an illegally marketed device if they proceed. They are making medical claims. We don't know whether the test works and whether patients are taking actions that could put them in jeopardy based on the test."
FDA's swift response to the Walgreens deal could have to do with the fact that the DTC tests are being sold at a brick-and-mortar pharmacy rather than online, as Sample sister pub Pharmacogenomics Reporter writes.
Or it could be a sign that FDA has regained its mojo. According to Ira Loss, a senior health policy analyst at Washington Analysis, the agency “has been rejuvenated by new leadership and this is in many ways a direct challenge to that leadership.”
Mya Thomae, writing in MyRAQA, put it best: "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."