Labeling Rule Stirs Discord

Abstract

For nearly three decades, generic drug companies have relied on safety labels from the makers of brand-name medicines to warn consumers about product risks. In fact, Food & Drug Administration regulations require that generic drugs carry the same warnings and precautions as their name-brand counterparts. Now—citing issues of balanced risks for drugmakers and transparency for doctors and patients— FDA wants to change the regulations so that generic drug manufacturers will be motivated to take greater responsibility for their products. Specifically, FDA has proposed a rule change that would allow generic drug companies to independently warn consumers when important new safety information surfaces about one of their drugs. It would remove a shield from product liability claims that currently protects generics manufacturers from personal injury lawsuits. Generic drug manufacturers are not happy with the proposal. “New labeling regulations should protect patients, facilitate care, and reduce costs,” says Ralph...