Jenner & Block

“Drug Safety Labeling: Generic Versus Branded,” Pharmaceutical Compliance Monitor

In this article, Jenner & Block Partner Louis E. Fogel and Associate Peter H. Hanna explore the implications of the different safety labeling requirements for generic and branded drugs.  The authors explain that while a branded drug  manufacturer is responsible for the accuracy and adequacy of its drug label, under federal law, a generic drug company has an ongoing duty of “sameness” and ensure that its warning label is identical to brand-name reference listed drug label.  The authors also examine litigation by consumers who have attempted to sue both generic and branded drug manufacturers for failure-to-warn and inadequate labeling claims.