FDA moves for generic companies to change labels

FDA issued a proposed rule on Friday that would allow generic drug manufacturers to change the label of a generic independent of the reference brand drug -- potentially opening the door for generics companies to be held liable for failure to provide adequate warnings. Under current federal regulations, only the branded manufacturer can change a drug's label, which they can immediately distribute without FDA review of the changes.

In June, the Supreme Court once again ruled that a generic drug manufacturer was not liable for injuries to a patient because the manufacturer could not update the generic's label (see BioCentury Extra, June 24). ...