FDA Rule for Generic Drug Labels Would Alter Scope for Tort Liability

Courts have relied on the differences in the regulations of the Food and Drug Administration (FDA) governing the labeling of brand-name and generic prescription drugs to justify the differences in the courts’ application of preemption and, in a few jurisdictions, the merits of the controversial innovator liability doctrine in duty-to-warn cases. Now, in response, the FDA has proposed a rule amending its regulations governing generic drug labeling that, if approved and implemented, would significantly alter the scope of potential tort liability of brand-name and generic drug manufacturers. The proposed FDA rule would also dramatically change the drug-labeling process and the duties and responsibilities of generic drug manufacturers.

Current FDA Regulatory Requirements for Labeling

Before a brand-name drug manufacturer places a new drug on the market, it is required to submit a new drug application (NDA) to the FDA which includes, among other things, a proposed label. If the NDA is approved, the brand-name drug manufacturer has the exclusive right to sell the “reference listed drug” (RLD) for a period of time. Once that time expires, other manufacturers may enter the market.