I just arrived home from a vacation in Aruba so I missed out on the winter weather many of you experienced last week. Here are a few pictures to help warm you up!
While I was in Aruba I spent some time thinking about interoperability as it applies to the provisions of the U.S. Drug Supply Chain Security Act (DSCSA). The text of the law uses the term “interoperable” multiple times with regard to the exchange of data between trading partners, but interestingly, it does not define the term. That leaves the definition of the term up to the FDA.
Before we look at the FDA’s definition of “interoperable”, let’s review the sequence of events outlined in the DSCSA for establishing standards for the interoperable exchange of transaction data.
|1||11-27-2013||President Obama signed the DSCSA into law|
|2||11-26-2014||As required, the FDA published draft guidance on the initial standards for the interoperable exchange of transaction data for use in meeting the 2015 data exchange requirements (see “FDA Publishes Draft Guidance For DSCSA Data Exchange“)|
|3||Between 11-27-2014 and about 5-27-2021||FDA must hold a public meeting to collect input on the system attributes necessary to support the “Enhanced Drug Distribution Security” (EDDS) system that will go into effect on 11-27-2023, including the standards necessary for adoption in order to support the secure, interoperable electronic data exchange among sectors within the pharmaceutical distribution supply chain (this meeting is in addition to other topical public meetings required by the DSCSA)|
|4||18 months after #3 above but no later than 11-27-2022||FDA must publish final guidance on the standards for the interoperable exchange of transaction data that the industry must begin doing on, or before, 11-27-2023, the “Enhanced Drug Distribution Security” phase of the DSCSA. This is the mandated finalization of the draft guidance that the FDA published last November–#2 above|
Here is a timeline for these events:
On the timeline, I have only indicated the latest date that the FDA could publish the final guidance on interoperable data exchange (#4 in the table). It could be published earlier, depending on when the FDA holds the public meeting (#3 in the table). By law, it cannot be published sooner than 18 months after that public meeting is held, and the guidance cannot become effective until at least 12 months after it is published. My prediction is that the FDA will wait until about as late as possible to hold that meeting so they have time to collect as much other information as possible. If I am right, that meeting would then be held sometime in the first half of 2021—about six years from now. Between now and then, the FDA has at least four other DSCSA topical public meetings they will need to hold.
That is how long the FDA has to figure out a final definition of “interoperable” when it comes to transaction data exchange. In the interim, they published a definition of sorts in their initial draft guidance on data exchange (#2 in the table). In it, they said:
“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. 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.”
I think this definition is suitable for the current phase of implementation (for another definition, see Wikipedia “Interoperability”). However, in the Enhanced Drug Distribution Security (EDDS) phase that starts in November of 2023, all data exchanged between trading partners will likely need to be in a single, highly standardized electronic format to ensure efficiencies and therefore lower costs. This will probably require a narrower definition of “interoperability” and so the FDA rightly indicated that they may revisit this definition in their final guidance.
This need for efficiency could lead to the specification of a single existing standard, such as GS1’s Electronic Product Code Information Services (EPCIS), for EDDS data exchange. I think that would only happen if the industry continues its preference for EPCIS and no viable alternative crops up in the meantime. As the timeline above shows, there are quite a few years between now and the time the FDA will need to settle on their final data exchange guidance. I’m sure the industry will have a lot to say about their data exchange and other preferences in the various public meetings and dockets that will occur between now and then. And I am confident that the FDA will strongly consider the preferences of the industry—especially if the industry ends up speaking with a single “voice”—but in the end, the FDA will have the final say about what is interoperable and what is not.
I’ve written about interoperability in the past. Click here to see a list of essays that touch on interoperability as a concept.