In this insightful interview, Josh Eaton, Senior Director for Scientific and Regulatory Affairs at the Parental Drug Association (PDA), discusses the vital role of the organization in ensuring drug safety and availability. He shares his expertise on the challenges faced by the pharmaceutical industry during the pandemic regarding drug shortages and supply chain disruptions and PDA's mission to bridge the gap between drug manufacturers and global regulatory agencies, in light of the challenges posed by the pandemic.
The conversation also addressed the recent updates to PDA’s Technical Report TR68, which now reflects lessons learned from the pandemic. While the original report addressed manufacturers' accountability for shortages, the revision incorporates newer technologies and regulatory trends to provide a more holistic approach to risk management.
Listen to the interview or read the transcript to discover how PDA is adapting to evolving regulatory landscapes and fostering collaboration across the globe to enhance drug manufacturing processes.
In addition, the referenced technical report TR68 is available for free to the industry to ensure dissemination of these tools for companies to assess and respond to potential shortages effectively and ensure that critical medications reach patients without interruption.
The link to download the TR is: https://www.pda.org/bookstore/product-detail/7852-technical-report-no-68
Chris Hayden:
Well, welcome everyone. Thank you for tuning in today. My name is Chris Hayden, I am with Fierce Pharma. And today I'm joined by Josh Eaton, Senior Director for Scientific and Regulatory Affairs at Parental Drug Association. Josh, I'd like to just take a quick minute and let you introduce yourself.
Josh Eaton:
Sure. Thanks very much for having me today, Chris. It's a pleasure to be here. As you mentioned, my name's Josh Eaton and I work at the Parental Drug Association, also just known as PDA. What PDA does is acts as kind of a conduit between drug manufacturers and suppliers and the regulatory agencies worldwide. We are a global organization of over 10,000 members. We have chapters all over the globe from Japan to Australia to Germany to Brazil, plus many here in the US and Canada. We've been around for 78 years, and our whole mission is just to make sure that drugs are made safely. They are made in the first place so that there are no shortages like we're going to be discussing today, and also that they get to the patient and abide with all the regulatory expectations that go along with them.
Chris Hayden:
Great, thank you. Well, let's jump into these questions here. I hate to bring us back to the pandemic, but I think that's where we should start and just kind of talk about some of the challenges that were faced globally as far as getting access to these drugs, supply chain, and all those kinds of challenges that we all dealt with during the pandemic. I'd like to ask you specifically what specific challenges were faced during the pandemic and how did this influence or change the industry and the regulations?
Josh Eaton:
Yeah, sure. As everybody is very painfully aware, shortages were definitely a major issue during the pandemic. And part of that was not just the supply of materials because there were no workers to make the drugs or the raw materials to ship to the manufacturers themselves, there was also an issue of what to do when the shortages happened in terms of who to notify, what information they needed, what the timing was on when the triggers pulled to say, I'm going to have a shortage, that sort of thing. And then there was another issue of when's the right amount of attention being placed on the right types of manufactured pharmaceuticals, how critical were they to the patients, that sort of thing. And it wasn't really clear. One of the main outcomes that we can see from this is that now in the EU, they've implemented a system wherein the EMA can now be tasked with coordinating shortage events within the EU and not leaving it just up to the member nations.
Because, like I just said, sometimes the communication isn't there. One country might be manufacturing something for another country and they don't know where to go from the recognition there's going to be a shortage to how to get themselves out of it and come out on the other side. And then worldwide, which is a very good thing and another topic that PDA is very involved in, is the regulators are moving toward more acceptance of platform technologies. And what this does is concept of baseline of where the manufacturers can start and where the regulators are comfortable with either changes or add-ons to existing technologies and processes that hopefully would accelerate acceptance of those changes or acceptance of applications for new drugs. And all of these things together hopefully will make these events... It certainly won't avoid them in the future, but hopefully make them much less painful.
Chris Hayden:
I mean, hopefully we don't have to go through all that again. Fingers crossed.
Josh Eaton:
Fingers crossed.
Chris Hayden:
It brings me to our next question, a little more specific to your work at PDA, but did the pandemic influence the need to revise PDA TR68?
Josh Eaton:
Yes and no. For the no part, as you noted it's a revision of the original document which was published way back in 2014. A drug shortage is not new for sure. What was really needed was a better way to address them and to devise plans to get out of them when they do occur, and have strategies on how to approach the whole situation in general. That didn't change. What the pandemic did influence though is how this TR was revised in terms of what specific points were addressed and how it was updated in terms of new technologies and terminologies that were coming out of the pandemic. And as well as new regulatory trends. Like I mentioned, there is some fast track options and these sorts of things that are still thankfully being held over from the pandemic, and they weren't just a flash of the pan type of thing that, well, now everything's back to normal we don't have to do this accelerated thing anymore and we can go back to the low and slow type of thing. Thankfully, those things are all still around to some extent, and this TR does incorporate those into that revision.
Chris Hayden:
Great. Now, I know to start off with we talked about a few of the specific challenges, but maybe if we can think high level or globally, what lessons were learned and how are they being implemented today?
Josh Eaton:
The lessons learned are something that I touched on briefly earlier was that communication is key. It needs to be efficient; it needs to be accurate, and it needs to go to the right place at the right time. And this is all around the risk of drug shortage in the first place and then how the company is planning on responding to those. And then going back to what the specific shortage is, where the criticality lies for the patient, where the distribution networks are going to be affected, that sort of thing. As far as the implementation, I did discuss this a little bit already. The regulations and the regulatory bodies are catching up to the reality that despite their current framework, they can be flexible and they can make changes a little bit faster than what they're normally used to and the sky will not fall. And this is great. There's still a long way to go. We have some other efforts within PDA working on regulatory convergence and trying to figure out where all these regulatory bodies can come together and agree on inspection trends or acceptance criteria or anything like that. And all of these things working together can hopefully, again, never going to get rid of shortages, they're always going to happen because of something, but at least make the impact far, far less.
Chris Hayden:
Right, exactly, exactly. Great. And then our last question, Josh, just kind of talk about that, I think it's that TR68 again, but can you talk a little bit about what some of the critical changes were for that revision?
Josh Eaton:
The original was authored back in 2014.
Chris Hayden:
Right.
Josh Eaton:
The prevailing sentiment was that drug shortages are the fault of the manufacturer. Nobody else is to blame. It was obviously something they did, something that was probably within their control, and they're on the hook for fixing it. At the time, PDA, we formed this great authoring team, which was a nice cross-industry team of regulatory experts, then they were going to address those concerns. And at the time ICH Q9, which was on quality risk management, and Q10, which was on quality systems, they were still fairly new. They'd only been out for maybe five years, so implementing those concepts was still a little bit novel. This TRA was a step in providing a practical method for using those concepts of risk management and quality systems in the space of drug manufacturing. Now, for this updated version, it is now 10 years later — there's a lot more knowledge, there's a lot more maturity in all these concepts, and a lot more, I guess, settled regulatory expectations around how companies need to approach risk management.
And then in addition to that, there's a lot of other applications from other organizations as well as PDA on application risk management and also knowledge management and how to use that effectively within any organization. Then, what the major updates now to TR68 are incorporating all those new publications which have come out within the last decade, incorporating them into the discussion of the technical report and making sure those new ideas are presented in a way that the computer can understand and use them. And then it really presents a nice holistic approach to managing drug shortages, not just on the manufacturing quality side but also the availability risks, again like I said, that may impact the patient itself. And also, they've updated the tools that are within there. There's a risk triage model, so companies can go through their process, figure out where their gaps are, hopefully address them, or at least then come up with a response plan, which is also in the TR, this nice little tool. They can fill in how they're going to react when these events occur.
These two tools together provide a really powerful resource for these organizations to make sure that they can address their drug shortages in a timely fashion, in kind of a uniform fashion. Because the hope and goal here is that many, many organizations will use the same tool, they'll all be saying the same things in the same way, that when they communicate to the regulators and with each other, across boundaries, across borders, across regulatory agencies, they all have the same information. They all understand what it means when they say it's this level of risk and this is what it means. This whole thing is really just hoping to get everybody on the same page as far as, again, communication, the terminology, and how to respond to these shortages when they do happen.
Chris Hayden:
Well, that's great. Josh, it's all I have for you today. Fairly painless. Just want to say thank you for joining us today. Again, I'm your host, Chris Hayden, and I'd like to thank Josh Eaton for joining me today. And thank you very much. Have a great day.
Josh Eaton:
Thank you, Chris. It's been a pleasure.
Chris Hayden:
Thank you, Josh.
*This transcript has been edited for clarity.