It’s been a pleasure to return to the PDA/FDA’s 2024 Joint Regulatory Conference.  This is the first FDA co-sponsored conference that I’ve attended since my retirement from the Agency in 2023, and it has a bit of a high-school-reunion atmosphere for me.  I’m grateful for the friendships with my FDA colleagues that have extended beyond my exit from the FDA, and it speaks to the professionalism of this hardworking Agency.

I offer here a short synopsis of the updates and/or interesting points that were takeaways for me on Day 1 of the conference.

CDER’s Director, Patrizia Cavazzoni, provided opening remarks and offered these eye-opening nuggets for audience digestion:

  • Significant problems in data integrity (DI) continue to develop with one in five Warning Letters referring to DI in 2023.
  • Roughly half of the BLA submissions in 2023 resulted in Complete Response Letters from the FDA mainly due to facility issues found during inspection.
  • She offered a best practice recommendation to “get away from paper” in response to an audience question on how to best resolve DI issues.

ORA’s newly minted Associate Commissioner for Regulatory Affairs (ACRA), Michael Rogers, provided engaging opening remarks (with no slides!):

  • He introduced the soon-to-be-reorganized Office of Regulatory Affairs (ORA) as the Office of Inspection and Investigations (OII), effective October 1, 2024.  It’s a major reorganization that will move investigational compliance into the FDA Centers and thereby significantly reduce the overall headcount in the new OII office.  (See here for the new organizational chart for the OII.)
  • He acknowledged the need to support field inspectorates to mitigate attrition with recruitment, retention, and salary adjustments.
  • He highlighted a recent development program for inspectoral training at NC State University and proposed future training collaborations across universities countrywide.

CDER’s Brooke Higgins (Branch Chief, OC, CDER) gave an interesting presentation titled “De-Risking your Aseptic Process” with some comments that caught my attention:

  • She took a roll call of microbiologists in the room to demonstrate the scarcity of subject matter experts in this area as a plea for industry not to overlook this critical expertise in their facilities.  Go Brooke!
  • She pointed out smoke studies as a frequent shortfall in facility de-risking and offered specific examples (i.e., smoke too heavy or light, can’t see aseptic operation under review, no interventions simulated), including one egregious example of a firm submitting hand-drawn smoke studies as supportive data, and she recommended multiple and simultaneous camera angles as a best practice.
  • Audience questions regarding an update of the aged 2004 FDA Aseptic Processing Guidance (here) to reflect the recent EU Annex 1 revision were met with a interesting (and debatable) response that the documents are very well aligned and were deliberately aligned by design.

It was a full day of updates and networking, with a reported attendance record of around 900 people.  The day ended with a reception that included a guest-star appearance by recently retired Acting FDA Commissioner Dr. Janet Woodcock.  She was presented with a PDA award, and she offered brief comments to an appreciative audience.  I was grateful to be able to speak briefly with Dr. Woodcock to personally thank her for her thirty-eight years of public service.

If you have interest in learning more about any of these topics, Lachman Consultants is ready to help!  Please contact LCS@lachmanconsultants.com for a consultation.