TortsProf Blog

Editor: Christopher J. Robinette
Southwestern Law School

Thursday, January 19, 2006

FDA Rulemaking

The Products Liability Prof blog has noted the new FDA rulemaking reiterating/declaring the agency's current view that state law labeling claims are generally preempted.  A couple of document pointers may be helpful:

The relevant part of the rule starts on page 38 of this document [PDF]. 

Or, if you'd rather just see the most relevant 9 pages instead of all 100, I've excerpted them in this document [also PDF, but only 1.9 MB instead of 9.7].

ATLA's press release on the topic is available here.

[Disclosure: In practice I did pharmaceutical tort defense and continue as a consultant in ongoing litigation.]

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What, if any, retroactive effect will the preemptive provisions of the new FDA rule have?

Posted by: DW | Jan 19, 2006 8:46:28 AM

ATLA link is munged.

Posted by: Ted | Jan 19, 2006 5:03:29 PM

Ted: Thanks for the catch; fixed it.

DW: Interesting question. I'll do a post with my initial thoughts about it.

Posted by: Bill Childs | Jan 21, 2006 9:40:25 AM

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