Interoperably Exchanging Information with FDA: Agency Holds First DSCSA Public Workshop

By Jessica A. Ritsick & William T. Koustas –

On May 8th and 9th, FDA got the ball rolling on the implementation of Title II of the Drug Quality & Security Act (“DQSA”), the Drug Supply Chain Security Act (“DSCSA”), by hosting a public workshop for interested parties.  The workshop was just that – a workshop – bringing together different members of the supply chain to collaborate on the potential challenges of exchanging Transaction Information/Transaction History/Transaction Statement (“TI/TH/TS” or “the three Ts”).  Supply chain members must start passing TI/TH/TS on January 1, 2015, and the DSCSA requires FDA to issue guidance on this no later than November 27, 2014, giving supply chain participants approximately six weeks to comply with whatever standards may be set forth in the guidance.  The purpose of this workshop was to get supply chain participants talking with each other, as well as with FDA, about which mechanisms would be best and most feasible to implement by the January 1, 2015, deadline.  The workshop participants were also asked to think about future interoperability, as the goal of the DSCSA is to move to a fully electronic interoperable system in 10 years.  FDA seemed very interested in getting all participants talking to each other:  every attendee was assigned to a table, and that table included various members from different areas of the supply chain.  Discussion was not just encouraged, but necessary.

The meeting agenda and discussion topics (here and here) facilitated discussion of potential gaps in the DSCSA, such as definitions and requirements that required clarity, as well as the challenges of complying with the three Ts by January 1, 2015.  At the end of the first day of the workshop, each table provided a summary of what it considered to be the most feasible “tools” for exchanging the three Ts in an interoperable fashion by January 1, 2015.  Surprisingly, all tables’ preferences and suggestions were strikingly similar, and there were many areas of consensus throughout the room.  The overall consensus was that, by January 1, 2015, the most logical means to transmit TI/TH/TS would be the same means frequently used now to transmit certain transaction information:  paper packing slips and Electronic Data Interchange ("EDI"), including Advance Ship Notices ("ASN").  Web portals were also seen as a viable option for January 1, 2015, compliance.  Looking 10 years down the road, the ultimate goal would be to transition all parties to one electronic system, such as Electronic Product Code Information Services ("EPCIS").  Unsurprisingly, participants requested that FDA produce its TI/TH/TS guidance document sooner rather than later.  FDA seemed to hear the suggestions loud and clear. 

Without an issued guidance, however, what are supply chain members to do in the meantime?  Perhaps the most important thing to do is to try to understand the DSCSA, and how different sectors of the supply chain are expected to interact, or “interoperate,” with each other.  Several resources are available, including some from FDA, as well as a fairly comprehensive DSCSA implementation timeline recently released by The Pew Charitable Trusts.  This timeline illustrates the requirements for each supply chain member, as well as how that supply chain member must interact with others in the supply chain.  As the FDA workshop made clear, the better the supply chain members understand their own responsibilities and challenges, as well as the responsibilities and challenges faced by the parties they work with in the supply chain, the better and more interoperable this new system could be.