FDA takes action to speed safety information updates on generic drugs

A proposed US Food and Drug Administration rule would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drugmakers to use the same process as brand drug manufacturers to update safety information in the product labeling.

Under the proposal, released on Friday (November 8), generic drug manufacturers would be able to independently update product labeling (also called prescribing information or package inserts) with newly-acquired safety information before the FDA’s review of the change, in the same way brand-name pharma companies do today. Generic manufacturers would also be required to inform the brand name manufacturer about the change.

The FDA would then evaluate whether the proposed change is justified and make an approval decision on the generic drug labeling change and the corresponding brand drug labeling change at the same time, so that brand and generic drug products would ultimately have the same FDA-approved prescribing information.