Pre-Submission Facility Correspondence Session at AAM Fall Tech Strikes a Nerve

I was lucky enough to moderate the panel on the Priority and Expedited Review with panel members Scott Tomsky and Kurt Karst at the Association for Accessible Medicines (AAM) on November 8, 2017.  You all know them and it was interesting that the three of us were, without a doubt, on the same page.

What do I mean?  You would think that might come naturally as Hatch-Waxman nerds, but we do occasionally disagree or have different views on specific issues.  But today we were in lockstep!  We spoke about the Anatomy of a Priority Review and outlined the requirements under the FDA Reauthorization Act (FDARA) of 2017, priority review under GDUFA II, and expedited review under MaPP 5240.3.  Here are the major points that we can conclude from the session:

  • There is little known about what the priority and expedited review of ANDAs really means to expediting applications and how the FDA and industry will react.
  • Because the priority review program under GDUFA and FDARA are so new, we don’t have any concrete data to evaluate – this is expected at this point in time!
  • As far as expedited review goes, the term “heightened priority review” in the MaPP is still pretty much a non-quantitative term that may have different meanings to FDA vs. industry. None of the panel members could place anything concrete on what this really means.
  • The biggest bamboo under the fingernails was the discussion of the priority review program and the requirement for the submission of a Pre-Submission Facility Correspondence (PFC). Panel members agreed that, in its current form, the PFC will cause many firms to by-pass a request for priority review. This certainly could not have been the intent and (according to Scott, who was a member of the GDUFA II negotiating team), the PFC requirements were not what industry thought they agreed to during the protracted negotiations on the 8-month priority review goal date.  Scott and Kurt agreed that the PFC was thought to have been a way that the FDA could identify what facilities need inspection, so those inspections could be scheduled early in the ANDA review process.  However, as explained by the panel members, since many firms are waiting for the final bioequivalence report prior to submitting the ANDA, with that piece being dropped into the ANDA at the last minute, for firms to then have to submit the PFC 60 days before ANDA submission to qualify for priority review, this diminishes the value of the priority review.  They could submit the ANDA when the bio piece comes in and just be on a 10-month clock, vs waiting 2 months to submit, and then being on an 8 month clock.

The audience had a number of good questions and the panel suggested industry representatives to submit comments to the revised draft guidance (here) that issued November 3, 2017.   Let us know how you feel and please share your experience as GDUFA II progresses.