Episode 4: Interview with Leigh Verbois, Director of the Office of Drug Security, Integrity and Response for the FDA

Host Jim Fries speaks to Leigh Verbois, the Director of the Office of Drug Security, Integrity, and Response for the FDA, in the fourth episode of The Patient Safety Podcast. The episode covers Verbois’ time developing the APEC toolkit designed to assist pharmaceutical companies in rooting out bad actors in the supply chain. Listen in on the conversation between Fries and Verbois on how collaboration, communication, and innovation are the keys to improving supply chain security.

Thank you to Rx-360: https://rx-360.org/ 

Thank you to our guest Leigh Verbois: https://www.linkedin.com/in/leigh-verbois-8b12316/

 

Read the Interview:

Jim (00:32):

Hi, this is Jim Fries again, and welcome to episode four of the patient safety podcast sponsored by Rx-360. I’m super excited today because today’s topic really is something that’s near and dear to my heart. It’s, it’s a, it’s a kind of a piece of the pharmaceutical supply chain security puzzle that I learned early on in my, uh, my tenure with Rx-360 and, and our guest today is what I would refer to as probably the preeminent expert in the, uh, um, the APEC toolkit. So, uh, so what I’d like to do is, introduce Leigh Verbois from the FDA. Leigh, why don’t you go ahead and introduce yourself, and then we’ll just kind of dive into the conversation?

Leigh (01:11):

Jim, thank you. My name is Leigh Verbois like you said, and I’m the director of the office of drug security, integrity and response, and Cedar’s office of compliance at the food and drug administration. And as you said, this is near and dear to my heart too.

Jim (01:25):

Great. Great. Yeah, I think, uh, what I’ve seen is, so, you know, I, I’ve been here at Rx-360 now for over four years. And when I first started, this was one of the first act I I’ll use the, I’ll probably use the word 50 times during this podcast, but it was one of the tools that was given to me to really kind of self-educate. And one of the things that always impressed me was how user friendly it was, how, how transferable it was. So even though it was set up, maybe around one region, it really is a worldwide toolkit that anybody can use and, and the reach of it has been outstanding. Can you kinda walk us through, or talk to us a little bit Leigh about the history of it?

Leigh (02:09):

Yeah. So while we call it the APEC toolkit, we actually worked really hard to make sure we were bringing others to the table. So the Asia Pacific Economic Cooperation really was the impetus for the development of this toolkit. But as we were developing it, we realized that supply chain integrity is not just about the APEC region. Supply chain integrity is a worldwide concern. So as we were bringing this to the table at APEC in the life science innovation forum in the regulatory harmonization steering committee, we realized this wasn’t about the life science innovation forum in the regulatory harmonization steering committee. It was about the world and we needed organizations around the world to be on point and to be committed, to making sure we were making the right decisions and that we would bring others to the table. So when we were developing the toolkit, we had others at the table.

Leigh (03:05):

We had regions that were not part of APEC working with us and regulators that were not part of APEC working with us. We had non-government organizations working with us, and we had academia working with us to help put this toolkit together. It was really important to make sure that we were multifaceted in the development of the toolkit, because it really brought a diversity of expression and a diversity of experience to ensure that that toolkit could be used by many, many organizations that we’re really grappling with supply chain, integrity issues around the world, because we know that supply chain integrity really is important to everybody.

Jim (03:46):

It is. And, and I’m really super happy that you use that word integrity, because I, I think when we talk about the supply chain, I think by nature, a lot of people always just say, supply chain security or, or pharmaceutical supply chain security. I even make that, that, that kind of verbiage sometimes, but it really is integrity. And that’s what, you know, at Rx-360 is, you know, that’s, our mission is based around supply chain integrity. So, thank you for using that word. It makes me feel good. Um, when you look at the toolkit and the evolution of it from how you just walked us through how it started in the history, what makes it important today? Why is it still applicable? Why, why does it still work today and what have, what have you and, and, and your team done to make it applicable for today?

Leigh (04:33):

Yeah, so the supply, there’s a couple of different things. The supply chain sec, um, security toolkit contains, recommended best practices and tools to prevent, detect, and respond to substandard and falsified medical products before they reach consumers and to efficiently respond if they do. So, we’re really making sure that parties that need information, have that information at their fingertips. As you mentioned, it’s one of those easy to use tools. And you said, we’re gonna use that word a lot during this podcast. We are. It’s tools. It’s about having those tools in your tool belt. We wanna make sure that someone can, um, access the toolkit and understand what information is in there. So we really, um, made sure that as we were putting the, um, the tools together, that we were efficiently, um, putting pieces together so that they were easily accessible. I think the way we do it now is we have a steering committee that works to ensure that it’s a living document that we’re not just putting, we didn’t just put something together that is going to sit, um, on a website and is not going to be changed.

Leigh (05:45):

So it’s really important to understand that there’s going to be evolution associated with that document and that it’s going to be something that is going to really address the situation as we’re addressing it. Now that’s important because we’re, you know, really addressing the changing life cycle of products. We’re changing the, we’re looking at the, the difference that we may be seeing, um, during the pandemic. And we’re looking at how we might need to address, um, specific aspects of the actual toolkit. So our organizational unit is really looking at how we are, um, needing to update specific pieces of the toolkit, including the postmarketing surveillance aspects, the internet pharmacy aspects. And we’re working really closely with leaders within the steering committee to update those specific pieces. Um, while I can’t really, um, speak to what we’re changing within the toolkit, I can’t give you a pre, uh, a prequel of a preview, I should say, of what we’re changing in that toolkit. We are changing it, um, and, and addressing some of the aspects that we saw associated with. COVID great. And I, what we wanna be able to do is to give individuals that are using it the best information they possibly can have to address the pandemic. Um, and that’s really important now, um, to make sure that we have, we can really provide information that’s the most up to date.

Jim (07:18):

Yeah and I, I, I think that’s really interesting that you said that because I think when you look at the toolkit evolution and really our industry as a whole, I just gave a talk last week about kind of where supply chain integrity is, um, during the, the pandemic post, the pandemic. And I used the word hyper focused, and I, I, you know, I talked about the industry being, uh, this, this short term hyper focused, which actually developed a lot of incredible best practices that were able to put in place, right. I want to go backwards. There was a lot of great learnings during that time period that we need to kind of, you know, really capitalize on at this point. But when you look at kind of the world that you live in Leigh, when you look at the pandemic and you look at supply chain integrity, what do you think is a change? What, what are some of those, those evolving things that happened that you think might have been good for the industry during that time period?

Leigh (08:14):

Yeah. I think that the pandemic has really underscored the complexity of supply chains and the impact of supply chain integrity on patient safety. Uh, this can be highlighted both from product availability perspectives, as well as that patient safety perspective. And as you said, there’s a lot of lessons to be learned. We really wanna make sure that we’re, we’re taking that information and we’re integrating that back into our best practices. Um, since the pandemic we have, um, seen the market flooded with products that we’re falsely claiming to prevent, um, prevent treat, or cure COVID and bad actors have taken advantage of unsuspecting consumers. And we as, um, we as FDA really have heightened our awareness of this and are really creating systems to make sure that we’re addressing this. There has been one specific example that I have worked on to a, um, to really mitigate this, and that is rated hand sanitizers.

Leigh (09:18):

So at the beginning of the pandemic, uh, there was a tremendous surge in demand, and we all know that when there’s a tremendous surge in demand, that’s when bad actors step in. So there was a tremendous surge in demand for hand sanitizers. Um, and the challenge that FDA dealt with at that, before that specific, tremendous surge in demand is that OTC, um, the law for OTC, uh, products is that we are not, um, required, or we do not have the authority to specifically require an inspection for OTC facilities, um, in, in advance of, um, in advance of shipping those products into the United States, or even for a domestic facility to begin introduction into interstate commerce. So we discovered that products were in the marketplace that were adulterated with methanol and methanol is really toxic at very, very low levels. So what we needed to do was really activate quickly.

Leigh (10:26):

We needed to understand supply chains really fast. We needed to test products that were coming into our country test products that were in domestic distribution and understand what the impact on supply chains were overall. And FDA activated really fast to do a number of different things. We worked closely with customs and border patrol. We tested shipments that were at our borders and domestic supply chains. We confirmed that there were low levels of ethanol, which really pointed to economically motivated adult alteration. And I know a number of people that are listening to this have worked in this space before. Um, and we worked with manufacturers and distributors to effectuate recalls and recommend recalls. So we really needed to make sure that consumers understood the impact of this adulter duration on the products that they had in their hands or in their medicine cabinet. So it was really important for us to, um, do the enforcement action, but then follow up with that communication piece.

Leigh (11:36):

So a lot of these aspects are essentially described within the APEC toolkit. If you have, if you have a concern, if you have a regulatory concern, how do you then effectuate that for supply chains overall? And I think that there’s this like companion piece in ensuring that you’ve got the testing, the, um, the removal from the supply chain, and then that companion piece in terms of the communication piece to protect public health, because that’s what this is all about. And what we saw was this overwhelming number of products that were in the marketplace. Um, we’ve effectuated over 150 recalls. There are. Um, and as of now, there are approximately 300 entries on a, on a list that’s on FDA’s website to communicate with consumers so that they do not use these products. And that’s really important in terms of that long term U use of a communication tool to ensure that patients aren’t utilizing a product that is inherently risky for them to use.

Jim (12:43):

So I’m gonna make two comments in regards to that. One is I as a consumer. I mean, I work in the industry, but as a consumer boy, that makes me feel really good that those identifications were made and, and, and kind of those hurdles were being crossed to kind of fix some of those challenges. The other comment I wanted to make was not only the pandemic brought about that realization from the FDA standpoint, and you guys took action. I’ve seen the same thing in our industry as a whole, the organizations that are members of Rx-360, really, I think again, in the spirit of being hyper-focused during the pandemic, maybe some things that weren’t realized before were realized during the pandemic. And I’ve seen a tremendous upgrade in identification of challenges, getting over hurdles and really tackling some of these, uh, these challenges in a, in a consortium mentality. So it’s, it’s not only neat to see everybody at the FDA doing things like that, but our industry as a whole it’s, it’s been incredibly encouraging and validating for me.

Leigh (13:49):

Yeah. And I would say, you know, this, this highlights that understanding of good manufacturing practices, products, sales, and distribution, that pro that post marketing surveillance and detection technology, and that intermingling of understanding of all of those pieces together, right. And the conversations that are really necessary between industry and among partners to really make sure that you understand the interactions of all those pieces.

Jim (14:18):

Yep. So to kind of circle back what we started with, which was the APEC toolkit, um, I know you talked to us a little bit about the history you talked to us about, you know, um, um, the evolution of it and, and, and how it integrated with some thoughts around the pandemic and that type of thing, but in general, what’s next for the, the, the APEC toolkit to me, that’s, that’s where my brain is wired right now is what what’s next? What, what do I get to learn next?

Leigh (14:43):

Yeah. So I alluded to some of the things that are next. We are working on some of those changes for the APEC toolkit as a supply, uh, supply chain steering committee. And some of those changes will be coming in, um, the internet sales, uh, piece, as well as the postmarketing surveillance piece. We’re really excited to work with some of our partners, including the United States Pharmacopia and the Alliance for safe online pharmacies. This is really critical to ensure that we are providing the most up to date information associated with these specific tools. So we’re working closely with partners around the world to make sure that we’re updating these specific tools within the toolkit. We’ll also as the host for APEC 2020, the United States will be convening meetings in the United States in 2020, 2023. I’m sorry. And we’re really looking forward to ensuring that, um, we’re highlighting the role that supply chain integrity is playing, um, in 2023. So we’ll be working closely to make sure that we’re highlighting what supply chain integrity means and using the toolkit as a tool to do that. So we will be, um, planning some events around the toolkit and making sure that we highlight what that means. Um, and we haven’t got the specific dates for that, but we’ll be working to make sure that that happens.

Jim (16:11):

Yeah. I’m looking to, I’m looking forward to being involved in that. I think that’s gonna be great. Not only to host it here, but to be part of the next steps. I think that’s exciting.

Leigh (16:21):

Yep.

Jim (16:22):

Um, just to kind of, you know, wrap up here from a, from a general overview, it’s something that I’m always interested in, how people think about things. And we talked about the appreciation I had for you using the word integrity and supply chain integrity and that type of thing. But when you look at supply chain integrity specific to pharma Leigh, how, what do you think the next few years are gonna look like? I, I, I know that we move at warp speed. Think whatever was going on last week is different this week, and it’s gonna be different next week. But I think we all kind of sit back sometimes and say, Hey, what is it gonna be like in two or three years? And, and what do we need to be prepared for as an industry when it comes to supply chain integrity? What are your thoughts on that? And, you know, what, what, uh, what type of, uh, ideas can you leave us with that we can mull around?

Leigh (17:13):

Yeah, I think, you know, I, I, I always like to start these questions off with, we recognize that medicine approved in the United States is recognized as the gold standard, that our approval system is recognized as the gold standard and the products distributed in the United States is the gold standard. Um, we wanna make sure that we’re holding that standard upright. And continuing to, to hold that standard up. Um, I think we still wanna emphasize the need for good quality management systems and the need for emphasizing where corporate policies, quality procedures, employee training, and thoughtful selections of suppliers and distributors can assist firms and implementing effective product integrity management for all products. For all pharmaceuticals. We’ve seen this throughout the pandemic. We’ve seen this through for all products. And I think the hand sanitizer example is the perfect example where manufacturers and distributors bore responsibility for understanding quality associated with products as pharmaceuticals are being developed and being distributed over the next three years.

Leigh (18:36):

I think that there needs to be a continued emphasis on the development of good quality management systems, as firms are continuing to move their development systems and their processes to different locations. As we see this happening, we wanna make sure that they’re continuing that emphasis. I know that there’s a, there’s a lot of different, um, a new processes that are being developed, but this piece cannot be left by the wayside.

Jim (19:04):

You’re right.

Leigh (19:05):

Um, and I think that one other thing is, um, the pandemic has underscored that importance of partnerships in all of this. And so as we continue to think about what we need to do, as you’re moving through the development of new processes, the pro the development of partnerships to ensure that you have your processes in place is really, really valuable. So we really wanna make sure that we’re continuing our commitment to building coalitions and ensuring that we can continue to deepen our commitment to coalitions, because we don’t believe we can do this alone.

Jim (19:49):

Yeah. I agree with you. And as you know, that’s one of the things that Rx-360 also tries to do, but one of the things that’s always amazed me and just really it’s because of, of getting to know you, is that, that value, I think if maybe sometimes, and I might be steep speaking out of turn here, Leigh, but I think sometimes people don’t think of the FDA in your department or any department as, as being open to coalitions or partnerships as, as you described, but, but it’s really part of how you’re successful. So, I really, really am appreciative of that. And I’ve seen it firsthand at work. So, you know, on behalf of at least myself, but everybody at Rx-360, thank you for that. And, we appreciate your hard work.

Leigh (20:30):

Thank you so much.

Jim (20:32):

Is there anything you’d like to leave our audience with any, any final thoughts or anything like that?

Leigh (20:37):

Yeah, you know, I think in, in final thoughts, we’re working to ensure that tools are available to prevent and detect substandard and falsified medical products before they reach consumers and provide tools to efficiently and effectively respond to substandard and falsified medical products. That’s the goal of the APEC toolkit. And we will be continuing as we update the toolkit to make sure we have those tools available to everyone around the world.

Jim (21:03):

Great. And I’m gonna encourage anybody listening today. If you’re interested in any information about the APEC toolkit, feel free to reach out to us here at Rx-360. We can get you a copy of it. We can, uh, get you in connection with the right people and that type of thing, but it’s something that we live by, and it’s something that we’re always excited about and always willing to help out with. So with that Leigh, I’m gonna, I’m gonna thank you for your time. This was, uh, incredibly, uh, motivational for me. It’s always exciting to see what the FDA is working on. And, this APEC toolkit is something that I think will continue to evolve. And on behalf of the industry, I’m still excited about it. And thank you very much. So thank you to everybody for listening today. And we look forward to, uh, to our next episode and stay tuned. So thank you very much.

Leigh (21:47):

Thank you.