There are many terms specifically defined within the Drug Supply Chain Security Act (DSCSA) text (see “Don’t Skip The DQSA Definition of Terms Section”). One of the words you should expect to be defined there is “interoperability”, because it plays such a big role in the system(s) that must be used by everyone in the supply chain after November 27, 2023. That is, the “…interoperable, electronic tracing of product at the package level…” that is at the core of the Enhanced Drug Distribution Security (EDDS) phase that is defined in Section 582(g). But surprisingly, the term is not defined in the text.
In fact, it appears to be left up to the FDA to define. Section 582(a)(2)(A) of the DSCSA instructs the FDA to publish draft guidance “…that establishes standards for the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format…”. And they fulfilled that mandate with the publication of the original data exchange guidance back in 2014 (see “FDA Publishes Draft Guidance For DSCSA Data Exchange”).
And now the FDA is required to work with stakeholders to determine the attributes necessary to support the EDDS, and by doing so, they must finalize that draft guidance from 2014 by updating it before May 27, 2021. That’s a calculated date based on when they are likely to conduct one of the five DSCSA public meetings the FDA is required to hold (for more details on my calculations, see “Interoperability And The DSCSA”).
During the recent FDA DSCSA public meeting (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals”), Dr. Ilisa Bernstein asked an interesting question. Dr. Bernstein, Pharm.D., J.D., is Deputy Director of FDA’s Center for Drug Evaluation and Research’s Office of Compliance, the group that hosted the meeting. During the afternoon session she asked rhetorically, “Does the definition of ‘interoperability’ change in 2023?”
The FDA’s current working definition of ‘interoperability’ for data exchange under the DSCSA is explicitly defined in that draft guidance published back in November 2014. It says:
“For the purposes of this guidance and establishing initial standards for the exchange of tracing information, FDA believes that ‘interoperability’ encompasses the ability to exchange product tracing information accurately, efficiently, and consistently among trading partners. In order for any system, process, or practice to be interoperable, the subsequent purchaser must be able to successfully capture and maintain the product tracing information, regardless of whether the information is provided in a paper or electronic format.”
And then it says:
“FDA may revisit this application of ‘interoperability’ as processes and capabilities that promote more standardization become available and as electronic systems evolve and are more widely accessible.”
Thus her question at the recent public meeting is especially pertinent.
I remember being disappointed with the FDA’s 2014 definition of “interoperability”. There was no mention of standard interfaces and processes, which I think will be essential, but maybe I’m being too specific. So when I heard Dr. Bernstein ask if the definition might need to be changed for the EDDS, I was glad. I suppose it made sense for the definition to be more broad in 2014 than in 2023.
So what should the new definition be? Here is one look at the interoperability concept in healthcare, though not related to the DSCSA: “The four definitions of interoperability” by Colin Rhodes.
It is in the best interest of the industry that the FDA get this right. I suggest you help them by sending them your ideas about it in response to one of their dockets. Here are the DSCSA dockets that are currently open according to www.Regulations.gov:
- Pilot Project Program Under the Drug Supply Chain Security Act; Request for Comments
- Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability
- Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act; Public Meetings; Request for Comments
- Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of Comment Period; Request for Information
- Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for Industry
The concept of interoperability touches all of these so I really don’t think it matters which one you use. Your comments will be received by the same team.