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Thursday, February 21, 2008

Updated: After Riegel

The Drug & Device Law Blog has a looking-forward post about what happens post-Riegel -- and, by implication, what happens after the rest of the preemption trilogy if, as seems at least possible, much state tort litigation related to FDA-approved drugs is preempted.

The question, as they accurately note, comes down to whether the mostly-regulatory, mostly-not-litigation approach to pharma safety can work. (Or at least whether it can work as well as the litigation-intensive system existing now.) I expect many (including me) would feel much more comfortable about a broad preemption in a world where the FDA didn't confuse factories with similar names and the like. Indeed, that's an example the D&D folks mention as "not cutting it." But that's not the world we have. Perhaps in light of the new world of preemption, FDA funding will get increased and expectations raised. We'll see.

If it does turn out to be a catastrophe, of course, Congress has the power to explicitly reject preemption, express, implied, and otherwise.

The post is worth a read. I think they've accurately captured what their clients need now to do in order to show that preemption is not a mistake.

Update: Eric Turkewitz discusses the post and links to more.


(As usual, I have done consulting to pharma clients. I realize that it's actually been a while since I've had any of that work, but I still note it in case it's of interest.)

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"Perhaps in light of the new world of preemption, FDA funding will get increased and expectations raised. We'll see."

Ain't gonna happen. Unless there is a Dem Prez and Congress, the GOP will make sure the FDA is NEVER funded to an extent that it actually can get anything done.

The FDA still handwrites out reports.

Posted by: mike | Feb 21, 2008 10:03:43 AM

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