New Public Citizen report highlights need to allow generic drugmakers to update labeling as they learn of new risks

Many potential hazards are not discovered until years after drugs have been on the market, a new Public Citizen report released this week finds, yet generic drug manufacturers can do little to warn doctors and patients about newly discovered information, putting patients at risk.

Safety issues often arise years after the generic version of a drug has entered the market – sometimes more than a decade later. At least 53 drugs approved by the Food and Drug Administration more than 10 years ago have required new black-box warnings over the past five years, the new Public Citizen report shows.

Over the past 30 years, sales of generic drugs have skyrocketed, and generics now constitute the majority of all prescriptions filled. Despite considerable changes in the market, FDA regulation of generic labeling has remained substantially unchanged.