Final Rule On Generic CBEs, EAR or a Variation Due April 2017

On August 29, 2011, Public Citizen filed a Citizen Petition calling for FDA to authorize ANDA holders to change approved generic labeling using Changes Being Effected (CBE) supplements (among other changes).  In response, on November 13, 2013, FDA issued notice of a proposed rule entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” originally set to be finalized in December 2014.  Since that time, FDA has delayed finalizing the rule three times with April 2017 being the most current target date.  Much now depends on the outcome of the 2016 elections.  The delays make since given the volume of comments received.  Notably, in November 2014 GPhA/PhRMA issued a joint counter-proposal known as Expedited Agency Review (EAR). The EAR would replace the CBE for safety related labeling changes.  Click here for a complete chronology of events, or here for help with compliance regardless of outcome.