During the report out and follow-up discussion at last week’s FDA Drug Supply Chain Security Act (DSCSA) Pilots Workgroup (see “The 2016 FDA Pilots Workshop”) I heard an example of the industry throwing interoperability under the bus. That is, setting us all up for major complications down the road that could easily be avoided if the leaders would just address interoperability right today. One of the long-time leaders of the use of serialization and traceability in the U.S. pharma industry spoke up in front of the entire assembly and said that there existed a general “agreement” within the industry that “not everyone will use EPCIS”. That is, not everyone will use GS1’s Electronic Product Code Information Services (EPCIS) standard for meeting the DSCSA, and consequently, the FDA and the industry will need to allow other formats of the data in 2023. I just about fell out of my chair.
If I understood her correctly, she was likely referring to smaller companies (primarily dispensers) who will prefer not to spend any money on meeting the DSCSA if they can get away with that, despite the fact that drug manufacturers and wholesale distributors will have spent hundreds of millions of dollars preparing for the same regulation. Interestingly, the U.S. DSCSA does require the FDA to investigate the economic impact of the regulation on small enterprises (25 employees or less) and make adjustments to their requirements as warranted [see Sections 582(g)(2)(B) Compliance—Alternative Methods and 582(g)(3)(A) Assessment].
That’s fair, but in my view, no one should go in to that assessment making statements excusing these companies from making use of a simple data formatting standard. Did anyone excuse small entities from using the current CMS claims form for submission of Medicare claims? Why would they? Is a different format cheaper? No, it’s just different, and different would be very costly to everyone else because those companies would need to accommodate multiple formats. That kills interoperability.
Don’t worry, once we know what the EDDS data exchange architecture is there will be multiple vendors who target small dispensers with very low cost solutions, and unless you give them an opening to use something else, those solutions will use the GS1 EPCIS event structure to format the data they exchange. In fact, those solutions are already being offered. Stop throwing interoperability under the bus! Hold onto the GS1 EPCIS interface standard as tightly as you can and everyone will benefit—including those small enterprises.
I suspect what she meant was, small entities will not invest in the kind of large data repositories that larger companies have already invested in. Those large data repositories are complex and expensive, and unfortunately, they are too often referred to as “an EPCIS”. As a result, the term “EPCIS” has mistakenly become synonymous with “big”, “complex”, and “expensive”. Stop that. GS1’s EPCIS standard is an “interface standard” that defines how data would be formatted as it is being exchanged between systems. Small companies that need simple functionality and that only need to communicate with larger entities will only need simple solutions, but no one should expect those simple solutions to communicate in anything other than GS1 EPCIS standard formatted messages.
This new data will need to be formatted one way or another. Implementation of one format will be just as costly as implementation of another format. Let’s make sure everyone implementing only does it using the GS1 EPCIS interface standard way. And everyone will, unless you offer them an alternative way. Disagree? Leave a comment.