The US Food and Drug Administration (FDA) announced its intent to issue a rule by September 2013 to allow generic drug manufacturers to change their products’ labeling. The proposed rulemaking comes in the wake of the Supreme Court’s decision in June in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), holding that state-law design defect claims against generic drug manufacturers that turn on the adequacy of a drug’s label are preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).
Although the precise contours of the proposed rule remain to be seen, a brief summary states that it will “clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA’s review of such a change” and that such a rule “would create parity” between brand-name and generic manufacturers.
The proposed rule could have a number of important implications. Most obvious, the rule could limit the scope of generic manufacturers’ preemption defenses. Doing so may also have implications for branded companies. With preemption of generic claims on the rise, plaintiffs have sought with limited success to hold innovator companies liable for injuries allegedly caused by taking the corresponding generic drug. If generic companies once again may generally be held liable for product liability claims, it may further dampen that effort by the plaintiffs’ bar.