FDA Announces a Return to In-Person Meetings for All PDUFA, BsUFA, and OMUFA Meeting Types

FDA, like much of the rest of the world, has been adjusting to the rapid changes in our world these last few years.  For nearly three years following the declaration of the COVID-19 health emergency, there were no in-person meetings held.  Then, in early 2023, CDER and CBER started a slow phase-in of in-person meetings in a hybrid format, with some attendees present only virtually.  The hybrid format was necessary due to limitations in the number of attendees who could be accommodated in-person in the handful of newly revamped meeting rooms.  At first, this option was only available for Type A meetings, Biosimilar Product Development (BPD) Type 1 sessions, and Type X meetings.  In June 2023, the list expanded to include Type B End-of-Phase 2 meetings (which we blogged about here).

And there we stayed for 6 more months, until now.  On Monday, December 18, FDA announced its most recent update for in-person meetings, and it is one we have been eagerly awaiting.  The Agency has completed upgrades to its conference rooms with new technology to enable participation by virtual attendees.  CDER and CBER will expand in-person face-to-face formal meetings to all PDUFA, BsUFA, and OMUFA meeting types.

This will apply to all meeting requests received on January 22, 2024, or later.  Meetings will still be hybrid, with core attendees, those with a primary speaking role, attending in-person, and others joining virtually.  Even after the implementation of this update, there is no guarantee of an in-person meeting; the review division will make the final determination on the format.

Still, we are very glad to see this update.  At this point we all have extensive experience with conversations over Zoom or Teams and the like and have experienced both the convenience and limitations as compared to an in-person conversation.  Most FDA meetings are strictly limited to one hour, and minutes lost to technical issues in virtual meetings are keenly felt by sponsors.  More significantly, virtual meetings seem to result in more limited engagement by FDA staff, and the important ability to “read the room” is significantly impaired. An hour can go by noticeably faster with all of these challenges, and it is crucial to make the most of these limited engagements.

As reported in this recent Pink Sheet article, FDA staff recently noted that a substantial majority of meeting requests for eligible in-person meeting types have not been requested as such.  Here at HPM, we were surprised to hear this, as we find that for most FDA meetings, in-person meetings are preferable, if at all possible.  Simply put, it is hard to overstate the value of an in-person conversation; the in-person meetings we have attended with FDA since the reopening have allowed for collaborative dialogue that is not fully replicated even via Zoom.  An in-person meeting may not be the best choice for all sponsors for all meetings.  However, it is a welcome sight to see that there is now a possibility of one for all PDUFA, BsUFA, and OMUFA meeting types.

As we have blogged about before, “face-to-face” can now mean either in-person face-to-face or virtual face-to-face.  This has been memorialized in draft guidance and is not changed by the recent announcement.  Therefore, sponsors must be specific when requesting in-person meetings and specify whether an in-person or virtual face-to-face meeting is requested.

We hope to see you soon at White Oak!