Comments on: Breaking: FDA Moves to Broadly Regulate LDTs

By: Hank Greely

Hank Greely — Fri, 25 Jun 2010 22:48:54 +0000

Another interesting analysis, Dan. I would just add one point about possible reasons for changes in FDA position. This is no longer the Bush Administration FDA, which, among other things (including some strong apparent political interference on decisions around reproduction), was fairly allergic to regulation. The Obama FDA may be marking a return to older FDA impulses and not a brand new turn of its own.

By: Kathleen J.

Kathleen J. — Fri, 18 Jun 2010 12:42:53 +0000

All of this discussion is such an abstraction. Dan it is SO important for you to point out that a 510k (let alone PMA) requirement will impose up front costs in the MILLIONS for labs to just keep doing what they’ve already done! In tight times this will push lab after lab into the red — and for what? We all must have missed the slew of statistical papers showing that LDTs were more expensive, less safe, or in any way worse than test kits.

Forget about the burgeoning genomics startup industry. What investor in their right minds would put money to work in an area where companies are randomly blown up by the FDA?

This is all just so sad. They will pay in November I can tell you that. We are clinical laboratory scientists and we VOTE.

By: Anna Faris

Anna Faris — Thu, 17 Jun 2010 03:09:09 +0000

Gavin Williams from Genentech and the FDA…a match made in heaven.

Big business using big government to regulate startups out of existence, by eliminating regulatory choice and raising the barriers such that only companies with billion dollar market caps can compete.

It’s a page out of pharma’s book…no pharma startup can become the next Roche. They can’t go 10 years without revenue, 10 years before their first New Drug Application (NDA) gets through. Instead they get it perhaps to the IND stage and then sell out.

That’s the model Genentech would prefer as well. Who are these nouveau riche startups intruding on our turf?

Helps the FDA out as well of course as it’s a great excuse for them to get more power and more budget.

All in the name of protecting “patient safety”…

By: Gavin Willliams

Gavin Willliams — Thu, 17 Jun 2010 02:42:44 +0000

I called it! :)

[e.g. my comment in your post a few days ago http://bit.ly/dCwiyt

Thanks Dan – your analysis is always appreciated.

Gavin

By: Steven Murphy MD

Steven Murphy MD — Wed, 16 Jun 2010 22:21:14 +0000

Dan,
In retrospect, this certainly seemed like the bigger intention from the get go. DTCG is small fry compared to this whole industry. That being said, with BRCA and other patents likely to go soon and whole genome coming cheaply, there is a need to figure out what the hell is going on in the LDT space. More labs will likely enter the clinically relevant space and someone has to get rid of hucksters. Hence Generation Health et.al.

My guess, DTCG served as the poster boy for regulating LDT. While everyone reveled, I felt this trainwreck coming and hope it doesn’t crush many good labs, like Genomas and others with paperwork and costs.