Monday, August 7, 2023

"Saying The Quiet Things Out Loud" Episode 1: A New Approach, In More Ways Than One Full Transcript


Listen to the "Saying the Quiet Things Out Loud" Podcast:" Episode 1


Hi everyone, this is Scott Pugh, principal of Jennason, LLC. I'm excited today to welcome everybody to the first official installment of the “Saying the Quiet Things Out Loud” podcast.

I'm calling this a podcast, but I will say upfront that what I hope to do through this audio approach is really a continuation of what I've done for many years through my writings and other posts on my blog at and other channels such as LinkedIn, which is to focus on the pharmaceutical serialization space, but more importantly, use this as a platform to bring attention to specific topics and areas that I feel are not really getting enough attention, yet are often things that can lead to challenges, risks, issues that companies might encounter as we're all marching towards compliance, whether it be with DSCSA or other regulations.

So, I look forward to using this platform to further discussions and conversations in those areas. I hope this is a much more interactive way to connect with people in the industry. I certainly encourage everyone to provide feedback and comments. Again, my goal at the end of the day is to make sure that everybody is being educated with good information. I think it's something that's long been a challenge in this space. A lot of times what you might gather from conferences, from marketing materials and other advertisements, can paint quite a different picture than if you're actually in the depths of going through these implementations, understanding the systems and the processes and just the general capabilities that are being put in place.

I'm going to try to keep these segments rather short just so everyone doesn't need to set aside thirty minutes or an hour to listen to an episode. Hopefully we'll try to keep them more towards five or ten minutes or so. And again, each one will really focus on a specific issue.

Today in particular, I want to focus on the topic that's at the top of most people's minds, which are these recent letters that have come out from a variety of groups addressed to the FDA in regards to the upcoming November DSCSA deadline.

We've had at least three of these letters in the past few weeks. We had a letter from the HDA. We had a letter from the NABP and then we had a letter from a group of House Representatives. Again, all of these letters addressed to the FDA, and all of them, I would say, basically had the common theme of asking the FDA for more time to ensure that the industry would be ready to meet the requirements that are set to go into effect this November.

What I really want to focus on today, though, is not to dive into each of these letters and dissect the finer points of what they were proposing and highlighting some of the challenges that the industry has faced up to this point. But I really want to use these letters as the backdrop or foundation for what I think should be the critical questions that we as an industry should be asking at this stage of our DSCSA and serialization compliance journey. Because I think, right off the top, the fact that there's significant efforts and proposals being pushed towards the FDA that all revolve around asking for more time, I think nobody's going to disagree with that, right? I think anybody who's in this space is very aware that the industry has a long way to go before we could say that the full industry is truly ready to comply with DSCSA.

And I think it is important to highlight that the responsibility (of being ready) across the industry really is spread across all segments. There are many manufacturers that are not ready. There are many wholesale distributors that are not ready. There are many dispensers that are not ready. And the nature of DSCSA being a regulation that sits over a supply chain inherently requires that all segments and all entities within those segments are ready to comply, right? You have one link in the chain, so to speak, that's not ready, and it basically breaks down for everybody else in that chain.

So, I think that is an important thing to highlight. And I say that somewhat specifically because having read primarily the HDA letter, sometimes you read the HDA letter and you might come away thinking, man, this seems like it's all manufacturers' fault, right? Seems like wholesale distributors are ready to go, but manufacturers have really been dragging their feet. And again, there are plenty of manufacturers that are not ready. But at the same time, there are just as many, if not more distributors and dispensers, that are also not ready. So, this is equally shared across all the segments.

My main focus as I read all of these letters was really on what I didn't see. What I didn't see in terms of the questions being raised or the proposals being put forward. Because in my position, I think the thing that we all should be pushing for is if we're going to go to the FDA and collectively say, “hey, the industry needs more time”, which again, I don't think anybody's going to disagree with, then what are we to do with that additional time that's given to us?

And I think this is where I really start to differ a bit from what we see generally having been put forward in the letters thus far. Because in my opinion, the answer to that question is we shouldn't be asking for more time to simply do the same thing we've been doing for the past 10 years at this point.

The way I like to describe it is if I were to have the opportunity to basically sit and down with a blank piece of paper in front of me and be tasked with designing the most efficient, most cost-effective way to facilitate interoperability between supply chain entities, in this case to support product traceability, I'm confident, I'm extremely confident that myself and most people especially those who have been involved in this space, but I think even people who have been outside the space, but at least understand supply chains, I don't think anybody would draw a picture that anywhere resembles what we've, as an industry, have tried to put in place today.

These efforts, especially over the past, let's call it, a year, 18 months, maybe two years, where many in the industry have been going off to establish all of these connections between all of their trading partners. There is no possible way that is the best way for us to go about this. I recognize on one hand, as an industry, we have to leverage the capabilities and the systems that are available to us. And for that reason, we maybe didn't have many other choices or options, but to go down this path of establishing point-to-point connections to each other. But I think if we've reached this kind of stage that we're at now, which is where we are all desperately looking to have the FDA take action to essentially provide us with more time, then the first question we should all be asking is, are we even going about this the right way? Are we even on the right path?

That's really what I'm going to be interested to watch and look for as these discussions progress forward. And it could be discussions that come about because of the letters that have been authored or undoubtedly, there's going to be additional letters coming from other organizations and other key members within the supply chain. What I'm going to be looking for is, as part of those future proposals, does it not just ask for more time, but does it recommend an approach that says as a first thing we should do once you give us more time is we should all take a step back and just determine and evaluate have we really been going about this the right way.

I do think it's important to clarify that when I say and when I give my opinion that I don't believe the industry has gone about this the right way for many reasons, that's not the same as saying I think we should all basically start from scratch again, right? That's not me saying that people should be ripping out packaging equipment systems, other serialization systems. That's not at all what is going to feasibly or realistically or should be done in this case. I think that there has been significant learnings and maturing and evolving of systems and processes related to serialization from the packaging line level through site level. Basically, everything that we've been focusing on for the past 10 years, which is managing serialization within the four walls.

I think it's once you get outside the four walls that we've completely missed the boat. Again, going back to this approach that we've adopted of creating all these connections to our partners. There's no possible way that is the best and correct way and right way to go about this. And I think unfortunately, and sort of going back to an earlier point I made I think this is also one of the prime areas where there is a complete misperception across the industry around this notion of connecting partners and how that's actually done and the different systems and capabilities that are out there to do that.

To be very, very clear, right, regardless of what any marketing material or any presentation you might hear at a conference, we don't have today in the pharma industry, the concept or something that would represent the concept of what I consider to be a true network. And probably the better term is really a true collaboration network. We have a lot of different players that are trying to position themselves as such. But the reality is we do not have that kind of capability in its truest sense in any way, shape, or form across the industry.

That would be the first place I would be recommending an evaluation, a sort of a reflection to start, right? If we are going to be granted more time from the FDA, why don't we take a step back and really say to ourselves, look, there's got to be a better way to facilitate these exchanges of data between all these entities. Because what we have today, it's just it's not there and it's not working, right? It's not a feasible, scalable, efficient, cost-effective approach to essentially put in the foundation- which is the critical foundation to really be able to achieve true end-to-end supply chain traceability.

So again, I'm really going to be interested to look for groups that take that sort of mindset, maybe make similar proposals that as part of asking for more time, we think the first step needs to be to really do that self-reflection, that self-evaluation as an industry to determine are we even on the right path.

I don't think we can ignore the fact that there's been some pretty major pharmaceutical entities, manufacturers to be specific, that have done exactly that over the past couple of years, where they basically said, look, we've been serializing now for a long time. Let's take all of this information, all of this learning, all of this experience that we've had over that time and really make some decisions about what is going to be the best way for us to move forward.  It's been widely known, you've seen some pretty significant changes be made, some of the major manufacturers across the industry in terms of how they are approaching serialization. So, if we have the major players in the industry doing that kind of reflection and coming to the conclusion that, yeah, we needed to make some changes, why wouldn't we do that same kind of activity as an industry as a whole? It just seems like logical sense.

It would be very challenging to eventually get to a place where we've asked the FDA for more time and the end result is we continue down the same path as we have been because again, my opinion, all that's going to do is we're going to get a year or two years from now, however much additional time is granted, and we're going to basically be in the same spot as we are today. We might have more companies that are “ready”, right? They've established their connections. But that's not going to have addressed the underlying concerns and issues that are already present as people have started to create these connections, right? Which are things like the quality of data is just absolutely terrible, right? The data integrity issues across the industry are extreme, to say the least. And those types of things don't just magically go away just because everyone is now “ready”. In fact, those types of issues only get more magnified as more and more people are connected and as more and more of these data exchanges start to occur. And most importantly, more and more people actually start paying attention to that data that's being exchanged. That is by far the biggest difference of what we are just now starting to enter versus really what we've had for the past 10 years. which is we did all of the work to physically serialize the goods. We did all the work to capture that information within our four walls. But at the end of the day, because the regulations up to this point have never required us to ensure that data has to be 100% correct when I now ship product to my next supply chain partner, if there ever were issues found in the data, nine times out of ten, that product is still going out the door. Right? That product, that shipment is not going to be stopped up to this point because of a serialization data issue. Post November or whenever this final milestone of DSCSA goes into effects, again, if the industry follows the regulations and if the FDA enforces the regulations, we don't have that luxury of allowing data to be incorrect, yet still allowing that product to flow in the supply chain.

And so, it's really only going to be at that point when people actually have to start paying attention and caring about this serialization data that many, many companies are going to realize, Oh my goodness, this data by and large has been wrong for a long time. That's going to be the reality for a lot of people. And that's not a prediction of what I think is going to happen. It's because that's already happening today, right? The data exchanges you see today, being just flat out wrong, information being incorrect, whether it's master data, whether it's other associated data, things being formatted incorrectly, I mean, all of these types of things- But the end result is it can lead to a data exchange either not occurring or occurring but not being correct, which again, if we all follow the law, means that product should stop at that point. That's the big concern that I have that again has nothing to do with the readiness of people being connected, but simply paying attention, even if you're one of those companies who are already connected to your partners, really starting to pay attention to the data that you're receiving or sending, whatever it might be, depending on your function. Because that's going to be the real fundamental challenges that will lead to disruptions, which can lead to drug shortages.

And which is again, the big reason why I think the very first step we should all do as an industry if we are given more time is to really do that self-reflection and try to come up with what has to be the much better way to go about enabling interoperability across the industry.

It's a fascinating topic- obviously it's going to be a topic that's clearly something top of mind for all of us, even over the next weeks and months. I'm interested to see what kind of response comes from the FDA. Clearly there will have to be a response of some sort at some point. And so, there's not going to be any shortage of topics for us to continue to dive into. And that's really why I wanted to start this podcast, if you will, because I think it's just going to be a lot of topics that I'm going to definitely want to provide my opinions, my advice, my guidance, my recommendations out to the industry, and hopefully this more audio approach will allow me to do that in an efficient manner and really get, what I think are, some key points out there to the industry as fast as possible. So, again, I appreciate everyone for listening. I look forward to taking this ride with everyone, and we'll catch you in the next episode. Thank you.

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