FDA Reopens Debate Over Contentious Generic Drug Labeling Rule

FDA plans to reopen the comment period for its controversial proposed rule requiring that generic drug makers modify their labels independently of their brand-name counterparts and will do a new economic analysis, the agency reveals in its fiscal 2016 budget justification material. A former FDA official said the move is a clear signal the agency may “re-propose” the rule, which has come under intense fire from the generic drug industry since it was proposed in 2013. The agency also plans...