FDA Pushes Back the Date for Issuing Generic Drug Labeling Rule to April 2017

Jordan Lipp, Esq. | Partner, Davis Graham & Stubb

On Thursday, the FDA again pushed back the date it expected to issue its final rule on generic drug labeling.  The final rule is now expected in April 2017.  The highly controversial proposed rule, as discussed in more depth in earlier posts, would permit generic drug manufacturers to unilaterally change their labels under the changes-being-effected (“CBE”) process.  Besides likely creating a bureaucratic headache and allowing generic and brand-name labels to differ (potentially in violation of the Hatch-Waxman Act), the proposed rule would also threaten to undermine the generic drug preemption decisions by the U.S. Supreme Court.  The proposed rule has generated significant political heat for these reasons, and the date for the final rule has already been pushed back several times.  Although the FDA did not state a reason for pushing back the announcement of its final rule again, the new date of April 2017 is, of course, after the next election.  Whether the final rule will ever be issued, and what it may look like, are open questions.  In any event, the wait continues.