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.]