Prescription Drugs

FDA to Allow Updates for Generic Drug Warnings

Bad regulations prevent manufacturers from updating labels about new risks


The Food and Drug Administration announced plans Wednesday to give generic drug manufacturers permission to change safety labels on drugs when new information about potential risks is discovered.

This comes after years of petitioning from consumer watchdog groups such as Public Citizen, which issued a report last week calling on the FDA to make it easier for generic drugmakers to update safety labeling.

Long after a drug is put on the market, pharmaceutical companies often become aware of new risks associated with the drug. Under current rules, brand-name drugmakers can change their labels without FDA approval, while generic drug makers are restricted from updating safety labels to reflect new information unless it meets certain criteria.