FDA provides update on efforts to modernize generics labeling

The US Food and Drug Administration has said it is withdrawing a proposed rule which would have allowed generic drugmakers to independently update and distribute new safety information in drug labels.

The proposed Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, which the FDA put forward in November 2013, would have given manufacturers of generics similar powers to branded drugmakers, in that they would not have required prior approval from the agency.

FDA Commissioner Scott Gottlieb said: “We heard from manufacturers that they believed this change would have imposed on them significant new burdens and liabilities.”