Comments on: FDA Puts the Brakes on Pathway-Walgreens Pairing; What’s Next for DTC?

By: Melanie Duquette

Melanie Duquette — Fri, 21 May 2010 13:37:43 +0000

Hey Steve-
Just so you know, that wasn’t the Oragene kits as you mentioned above. Pathway has their own device.

By: Steven Murphy MD

Steven Murphy MD — Thu, 13 May 2010 19:22:38 +0000

Not preserve saliva, to preserve DNA. But agreed. Ahh it all depends on what the meaning of “is” is…..

By: Dan Vorhaus

Dan Vorhaus — Thu, 13 May 2010 15:15:48 +0000

Steve:

The saliva kit could certainly be considered a medical device, but only when considered in connection with the rest of Pathway’s testing service. Otherwise, it’s just a tool for collecting and preserving saliva, without the required diagnostic or treatment component to make it a device.

To your other point, it’s not at all surprising that the FDA decided to exercise its regulatory authority in a more direct fashion. What is surprising, however, is the manner and speed in which this has played out.

Dave: until companies have a better idea of what the approval process will look like, that’s an impossible question to answer. All serious DTC companies should have been prepared, at least to some degree, for this type of scenario. The FDA has already been talking to some of those companies, as The New York Times article notes, so that might provide a leg up. Hard to say at this point.

By: Dave

Dave — Thu, 13 May 2010 14:18:30 +0000

Good piece, thank you.

Dan, do you have any reason to believe that one or more of the DTC companies is particularly well poised or prepared to make an FDA submission?

By: Jon

Jon — Thu, 13 May 2010 14:04:23 +0000

The FDA is the worst kind of government agency: the kind that showboats for the cameras and gives copious access to all newsmedia without bothering to actually do its job and issue clear guidance. How hard is it for one of the small companies at his mercy to get an audience with Gutierrez? And how easy is it for a reporter to get quality time with the whole agency at the drop of a hat? Their incentive structure is all f’d up.

Let’s be very clear, this wasn’t “illegal” until Alberto Gutierrez decided it was time for his close up. Obviously gunning for a promotion, the FDA can move real fast when it sees an opportunity to get on TV.

By: Steven Murphy MD

Steven Murphy MD — Thu, 13 May 2010 10:26:19 +0000

Dan,
I disagree. Oragene’s stabilization chemicals could be considered a reagent.
Also, why the big surprise? I have said for over 2 years now, this is medicine.
These tests give diagnostic information. Or is having a founder mutation in BRCA1 merely an educational endeavor/”for fun”?

Thoughts?