FDA Reconsiders Changes to Generic Drug Warning Labels

pills2The Food and Drug Administration (FDA) has been considering making changes to its labeling rules with regard to generic drugs.  The changes could provide generic drug users with more protection.

Currently, those that have been injured by a brand-name drug can win compensation from the manufacturer if it can be shown that the drug was unreasonably dangerous or that the warning label did not disclose the risks properly.  Those injured by a generic medicine?  Not so much.  Those injured by a generic medicine can’t hold the manufacturer liable as long as the drug maker used the same active ingredients and displayed the same warnings as the brand-name drug.  Crazy, huh?

All of that could be changed by a new rule that the FDA expects to formally propose in September.  The new rule would “revise and clarify procedures for changes to the labeling” of approved drugs.  This will include both brand names and generics.  This change would either enable or require (not yet clear based on the information provided by the FDA) drug makers to announce possible changes to their warnings while the FDA is considering the warning.

Currently, though generic drug makers are required to advise the FDA of any new evidence that might demand a change, they aren’t allowed to make the change.  They are required to wait until the FDA formally decides that the warning label from the drug, as well as the brand name drug, must be changed.  Under the new rule, there would be parity between brand-name and generic drug makers, and generic drug makers would be able to make unilateral changes to their warning labels.

It’s beyond me why this was not always the case – but let’s give credit where credit is due.  At least the change is expected to be made.