Lawmakers urge FDA to update drug labeling regulations

A group of U.S. lawmakers sent a letter to FDA Commissioner Margaret Hamburg on Monday urging the agency to "expedite its consideration of revisions" to FDA's labeling regulations to enable generic drug manufacturers to update labels in "appropriate circumstances." The lawmakers said the changes are "critically important" to ensure that consumers who are injured by generics "have the same legal rights as those who are injured by the brand-name versions of the same drugs." Under current federal regulations, only the branded manufacturer can change a drug's label. The lawmakers sent the letter to Hamburg after the U.S. Supreme Court once again ruled on Monday that a generic drug manufacturer was not liable for injuries to a patient because the manufacturer could not update the generic's label (see above).

In January, FDA said it was considering allowing generic drug manufacturers to change the label of approved products. The agency said it would seek public comment on any proposed regulation, but declined to provide details. ...