1. Pink Sheet

FDA Generic Labeling Rule Could Help Pfizer In Reglan Product Liability Suit

 
• By Brenda Sandburg

Alabama Supreme Court is reconsidering its decision holding brand-name manufacturers liable for injuries caused by generics; Pfizer argues that FDA’s forthcoming proposed rule would eliminate concerns that no company could be held liable for injuries from a generic.

As September draws to a close, drug makers are watching FDA’s docket to see if the agency meets its target deadline for issuing a proposed rule to enable generic manufacturers to unilaterally change their drug labeling. While generic firms have the most at stake, the rule will also impact brand-name companies.

It is particularly important to Pfizer Inc

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