Highlights from the first 2025 DSCSA Town Hall

On March 28, 2025, the Partnership for DSCSA Governance (PDG), in collaboration with the FDA, hosted the first of three town halls focused on the Drug Supply Chain Security Act (DSCSA) implementation. Eric Marshall, PDG’s Executive Director, opened the session, emphasizing industry readiness as the May 27, 2025, exemption deadline for manufacturers approaches.

Key Points:

• Purpose: The town hall addressed progress in meeting DSCSA’s enhanced traceability requirements, with today’s focus on manufacturers. Future sessions will cover wholesalers and dispensers.

  
  

• Survey Insights: PDG’s survey revealed 85% of manufacturers provide serialized data for 95–100% of products, up from May 2024, while 75% of wholesalers receive data for over 80% of purchases, a leap from 8% last year. However, data quality emerged as a persistent hurdle. Manufacturers reported steady efforts to assess outbound data accuracy, with wholesalers noting a significant uptick. 93% now actively evaluate inbound data quality, up from last year. Challenges include incomplete or inaccurate serialized data, with exceptions like missing fields or delayed transmissions still prevalent.

• FDA Remarks: Dr. Leigh Verbois praised the stabilization period’s success, noting exemptions (e.g., manufacturers until May 27, 2025) have bolstered progress without disrupting supply. She emphasized that data quality imperfections are expected, advocating for robust, risk-based processes to manage errors rather than aiming for perfection.

• Industry Voices: Trade associations like AAM, Pharma, and HDA reported near-complete data connections but stressed ongoing data quality issues. AAM’s Brian Rezach noted members’ “build is complete,” yet data refinement will extend beyond May due to discrepancies reported by downstream partners. HDA’s Kala Shankle highlighted that while accurate data exchange has risen, 9% of product still risks disruption due to upstream inaccuracies. Public comments echoed this: Novartis’ Dave Mason cited a lack of data expertise downstream, hindering remediation, while Genentech’s Vid Rajaram detailed rapid resolutions for minor data issues (1–3 days) versus weeks for quality-related fixes, underscoring the need for workarounds.

• Takeaways: Phased exemptions are effective, and connections are nearly complete, but data quality remains a focal point. Collaboration is vital to address inaccuracies, exceptions, and niche challenges (e.g., 340B, returns). While progress is strong, refining data systems and processes will continue beyond 2025, with optimism tempered by the need for sustained effort.

The session highlighted significant strides toward DSCSA compliance, with data quality as a critical area for improvement. Recordings and summaries will be available on PDG’s website. Register for the upcoming meetings.