It’s time to assess the progress of the industry and the FDA in their quest toward the November 27, 2023 Drug Supply Chain Security Act (DSCSA) goal known as the Enhanced Drug Distribution (EDDS) phase…otherwise known as just ‘2023’ (see “EDDS: The New Data Exchange Requirements”). Let’s step back and look at where we have come and where we need to go.
Here is a high-level view of the full 10-year schedule with today indicated (click on the image to enlarge it). As you can see, we’ve already made it through the big 2015 and 2018 deadlines—both delayed from the original dates of 2014 and 2017 respectively. We are right at the beginning of the six month DSCSA pilot window, which officially begins in August (see “FDA Announces Start Of DSCSA Voluntary Piloting Program”). We are four months away from the wholesale distributor saleable returns verification and prohibition of engaging in transactions with non-exempt/non-grandfathered product that doesn’t have a DSCSA product identifier (the serialized 2D barcode) on it. And we are just shy of 1 ½ years from a similar deadline for dispensers.
I will remind you that I am the one who went out on a limb and predicted that the FDA would delay the wholesaler’s requirement (see “Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?”). I took some heat for that from a few vendors. I should have said that no one should use my prediction as the excuse to stop working on meeting that deadline, despite my correct prediction that they were about to delay the manufacturer’s requirement a few weeks before the actually did. I’m probably wrong this time. My case was a lot stronger back then compared to now.
Back then, the FDA announced their enforcement discretion (the delay) at the end of June, 2017. Here we are in late July and they haven’t given any hint that a delay is under consideration. So maybe it’s not. It’s probably not. We should all just focus on preparing to meet those requirements. But there were reasons why the industry would have been harmed if FDA had withheld their announcement until the last minute back in 2017 (as explained here), and those reasons don’t really exist this time. So, in theory, IF the FDA is thinking about enforcement discretion, they could hold out until the last minute before they announce it—maximizing urgency on the work needed—and then they could announce a shorter delay than one year. IF they were to do it at all. They probably aren’t.
When I look at where we’ve come, and where we need to go, it seems like the path ahead looks foggy compared with the way the prior deadlines looked as we approached them. There were some questions about what we were trying to accomplish and how to do it back then, but going forward, I’d say it is currently unknowable what we are supposed to do and how we are supposed to do it. It’s not just me. No one knows it. Not even the FDA knows it. That’s the point of the milestones in the upper right corner of my timeline, labeled “Future FDA Deadlines”. These are deadlines that the DSCSA defines for the FDA to accomplish so that the industry will know exactly what it needs to do to prepare for the November 27, 2023 final deadline. What are in those Future FDA Deadlines?
Here is an updated reproduction of the FDA’s original plan for DSCSA implementation. It is a list of the deadlines for the work that the FDA is required to do. It’s “their part” of the DSCSA implementation. Now that we are a little past the middle of the 10 year sequence of deadlines we can see how they have done so far. I’ve added a line to show “Today”. The past is to the left of that line and the future is to the right. I’ve also added red bar extensions to the FDA’s original blue and green bars to indicate where the FDA took longer than Congress gave them to complete their tasks.
As you can see, they’re not doing very well. The purpose of those green bars is to show where the industry would be able to take advantage of the delivery of the guidance documents that the FDA was to deliver at the end of the blue bars. So wherever you see a red bar, it means that the industry was hampered in achieving their own milestones because they did not have the full benefit of the FDA’s completed work. That’s partly why they delayed the manufacturer’s 2017 deadline. Maybe it doesn’t matter to the 2019 or 2020 deadlines.
Considering the FDA’s performance with their past deadlines, how do you think they are going to do on their next deadlines? You can see that there are some more green bars coming up, where companies will need to implement the guidance and requirements that the FDA publishes between now and then. Not much time available for slippage there.
Obviously they are going to make their deadline to establish at least one pilot. That’s good. And they will probably establish another series of public meeting in 2020 to discuss the implications of the results of all those pilots. That’s an easy one to meet.
I hope they have a plan for working on those other milestones, and a plan to get the funding necessary to accomplish them on time. The future will remain foggy until they do, and then there won’t be much time left for the industry to get it done.