Last month, Clarkston serialization experts Michael Marrone and Dave Treadaway attended an open discussion between the Food and Drug Administration (FDA) and representatives from across the U.S. pharmaceutical supply chain. Below, we outline their key takeaways from the June 2024 PDG-FDA DSCSA Meeting and our recommendations for U.S. pharmaceutical supply chain stress testing ahead of the final DSCSA ruling. 

Preparing for the Final DSCSA Ruling 

The June meeting was ostensibly open to the public, but the interest and attendance were weighted toward established pharmaceutical manufacturers, third-party logistics (3PL) providers, distributors, and – now, noticeably, – national-level dispensers and practitioners and their representative trade groups.  These “last mile” supply chain participants are especially likely to go through a period of disruption in their normal business disruptions in the next one to two years as the final Drug Supply Chain Security Act (DSCSA) roll-out milestones are formally enacted. 

The nominal purpose of the two-day conference was to take a readiness pulse of the full U.S. pharmaceutical supply chain as it passes the halfway mark in a “stabilization period” announced by the FDA in November 2023. By November 2024, the FDA’s stated expectation is that all participants in the U.S. pharma supply chain will be fully capable of being compliant with the requirement that they can transact salable-item serialization data with downstream partners.   

However, the discussion frequently returned to issues still unresolved at the earlier nodes in the U.S. distribution network. As have been the themes around compliance with DSCSA in rooms like this one since the first “public” sessions in 2013-14, this session was no different:  

• There’s an abundance of good faith intent expressed and ongoing action taken in the interest of everyone being full and willing partners with the FDA in strengthening the integrity and safety of the U.S. supply chain, using the objectives of the Act as guideposts. 
• Despite 10+ years’ experience in developing and implementing standards to ease the electronic interoperability of serialized data (e.g., EPCIS for message coding; GS1 for packaging and labeling master data and operational business “vocabulary;” rationalized inter-partner serialized transactions driven by validated SOPs and Computer Systems Production Qualification methodologies, etc.), the greatest risk to an efficient flow of product through the supply chain remains data issues causing product stoppages, quarantines, and false-positive triggers for suspect product. 
• The most critical success factors in reducing that risk of impact to the national supply of critical medicines that are technically packed and labeled in compliance with the Act are: 
  • Clear and tested lines of communication between trading partners, beyond data exchange for serialized products 
  • Defined and tested processes between partners for rapid (ideally less than 2 business days) resolution of data- and process-based exceptions that result in product stoppages 
  • As much as possible – given their role in oversight and enforcement of DSCSA – the FDA should provide guidance on how participants can develop internal risk-weighted decision-making when product stoppages of any length and any product volume are under consideration 

A Need for U.S. Pharmaceutical Supply Chain Stress Testing 

Taking the above observations into account, and leveraging our years of implementing serialization systems, optimized serialized processes, and providing organizations with traceability program teams, Clarkston expects that the U.S. pharmaceutical supply chain will continue to be beset by: 

1. Complications arising from data exchange 
2. A lack of maturity around resolution practices needed for disruptions in an otherwise optimal commercial distribution product flows between partners 
3. Further needed guidance from the FDA on what constitutes reasonable and actionable decision-making all the way down to the inbound and outbound product lanes in facilities across the US. 

We recommend a comprehensive “stress-testing” of the serialized supply chain using scripted scenarios between all partners – both upstream and downstream – in participants’ networks to provide assurance (or a lack thereof) of the level of readiness for compliance with DSCSA. Professional services practices are uniquely positioned and capable of providing such auditing and scorecarding to aid these serialization and traceability efforts.  

Closing Thoughts: June 2024 PDG-FDA DSCSA Meeting Takeaways

After attending the public meeting, we remain inspired. We believe that the collaborative spirit consistently shown by all in attendance for the 12 hours of discussion will continue to produce improvements in the sustainability and integrity of the U.S. pharmaceutical supply chain envisioned by the DSCSA. If your team is looking for further guidance in this space, our serialization teams can help. Reach out to us today.