WASHINGTON – The Food and Drug Administration is seeking a rule change to allow generic drugmakers to quickly update their warning labels with new safety information for doctors and patients.
Current regulations require generic drugs to bear the same labels as their branded counterparts. That policy has left generic companies with little control over their drug labels, and also shielded them from legal liability in court.
In 2011, the Supreme Court ruled that generic drugmakers cannot be sued for failing to warn consumers about possible side effects of their products if they use the exact same warnings as the original medicines.
Under today’s proposal, generic drugmakers would have the same power as brand-name drug makers to update their drugs with new information.
Regulators will take comments on the proposal for 60 days.