Generic drug labeling: Recent developments since Pliva, Inc. v. Mensing

Abstract

The Hatch-Waxman Amendments to the Food, Drug, & Cosmetic Act requires generic drug manufacturers to match their labeling to the bioequivalent brand-name drug. The decision in PLIVA, Inc. v. Mensing reinforced the liability implications when there is a lack of safety information on brand-name drugs by holding the brand-name drug manufacturer liable for failing to fully inform consumers of the relevant safety risks associated with a particular drug. Following this decision, the Consolidated Appropriations Act of 2021 introduced a new process for generic drug manufacturers to update their safety information independent of its bioequivalent brand-name drug.