We just read on 360 this morning that the FDA has again postponed its schedule for finalizing the generic drug labeling changes (the so-called “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” rule) it proposed two years ago in order to overturn Supreme Court precedent recognizing preemption in generic drug product liability litigation.  The new date is apparently July, 2016.  We looked briefly on the FDA’s website, but couldn’t find anything about this, but given the interest, it seemed important enough to pass along.

This is starting to look like the FDA is playing out the string.  With this date, there doesn’t seem any way that the rule becomes effective during this administration, given the time that expected legal challenges would take.

  • Anonymous

    The July 2016 date is included in the entry for this rulemaking in the recently released Fall 2015 regulatory agenda for HHS/FDA, which can be found on the OIRA website: http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201510&RIN=0910-AG94.

    Dates included in the regulatory agenda are routinely missed and then extended in the next update to the regulatory agenda.

  • Thank you to anonymous for the additional information.