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

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., which cited the forthcoming rule in pleading with the Alabama Supreme Court to revoke its decision holding Pfizer’s Wyeth subsidiary liable...