FDA Petitioned to Change Regulations for Generic Drug Makers

The consumer advocacy group, Public Citizen, is urging the FDA to revise regulations that prevent generic drug makers from changing warning labels about potential health risks associated with their drugs.

Under current regulations, brand name drug manufacturers are able to make changes to their drugs’ warning labels without approval from the FDA. But, generic drug makers are not allowed to update their drug labels, as they are supposed to match the brand name drugs.

This prevents generic drug makers from notifying and warning consumers about serious side effects and risks, according to Public Citizen. The group filed a petition with the FDA on Aug. 30, arguing that this type of change could help consumers learn about potential risks associated with the drugs.

As of now, generic drug makers are arguing that they cannot be held accountable for withholding information from consumers.

This petition could affect generic drug makers such as Teva Pharmaceuticals, maker of metoclopramide, generic Reglan®.