The FDA hosted representatives of the healthcare industry for the Summer DSCSA meeting on August 23rd. 2017.  This article is RXTransparent’s summary of the meeting and represents  our opinion and our opinion only.  As with previous RXTransparent publications, this summary is presented from our customer’s perspective, Healthcare Providers and Dispensers.  A cross section of drug manufacturers, distributors, logistics companies, dispensers, and solutions attended.   The participants in the meeting are collaborating with FDA and provide input into developing the shield that protects patients from counterfeit and suspect drugs in the U.S. and ensuring that U.S. drug supply is one of the safest in the world.

As of this date, we are about half way through the final implementation of the 2013 DSCSA, and are on our way to a fully interoperable environment in 2023.  DSCSA in healthcare does get more difficult as time goes on, as we move beyond the upcoming bar-coding changes and on to serialization of product and data.

This meeting operated differently as compared to previous industry and government collaborations.  Instead of a lecture followed by a Q&A type of meeting, the FDA facilitated a workshop in which the various stakeholders were able to discuss, interact, and collaborate around big DSCSA topics including:

  • What supply chain security should look like in 2023 and the future benefits
  • Enhanced drug distribution security needs

Overall this meeting’s agenda was focused on bringing together the industry partners and we discussed where we are going and outline a high-level plan as to how we will get there together.  DSCSA has created an unusual environment in which natural competitors are working together for the greater good.   Some of the ideas about future benefits beyond DSCSA (e.g. shortage mitigation, recall process facilitation, and 340B automation) are feasible, once system interoperability is achieved.  If you have been following RXTransparent’ s future plans, you have already seen the possibilities of serialized DSCSA supply chain data.    From a security perspective, the entire industry agrees that the drug supply chain needs to be secure: between and amongst internal and external trading partners.  Based on these high-level goals in 2023, we are now focusing on how we will get there.

Looking forward, the remainder of the discussions and collaborations between industry and government will focus on specific standards that need to be defined to get to full interoperability in 2023.  Areas that need to be addressed include:

  • Aggregation
  • Inference
  • Grandfathering
  • Electronic Interoperability
  • Trading partner certification
  • Security

Each of these topics will require more discussion, testing and comprehensive collaboration from the industry and regulators to balance the interpretation of the DSCSA and trade-off between efficiency, scalability, and approaches.

We will be updating this blog with links to the material that was presented in the meeting as soon as it is available and we are preparing our feedback and commentary for the public docket.   The FDA will be hosting additional DSCSA Meetings on December 5th and 6th as well as February 28th, which provides a timeline relating to selecting standards and approaches in the months to come.  The team at RXTransparent is proud to be actively participating in the process of helping to shape the DSCSA in the future.  If any of our customers or prospective customers would like to discuss, I would be more than happy to share what we are hearing.   Look for our feedback and official comments on the DSCSA public docket.

Dwight deVera

CEO RXTransparent

ddevera@rxtransparent.com