Episode 2: Interview with Dr. Janet Woodcock, Principal Deputy Commissioner of the FDA

For the second episode of the Patient Safety Podcast, host Jim Fries, CEO of Rx-360, speaks to Dr. Janet Woodcock, Principal Deputy Commissioner of the Food and Drug Administration.

Throughout the course of their conversation, Fries and Woodcock cover a litany of topics, but, and perhaps most importantly, Fries takes the time to dig into Woodcock’s experience in the FDA and how it has shaped her understanding of the pharmaceutical ecosystem. Listen in as Woodcock details how Patient Safety and Supply Chain Security has evolved over the past two decades.

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

Thank you to our guest Dr. Janet Woodcock: https://www.fda.gov/about-fda/fda-organization/janet-woodcock


Read the Interview:

Jim: Hi everybody. And welcome to episode two of Rx-360 patient safety podcast. It’s really exciting for me today to, to not only take the second step in our podcast series, but really welcome somebody that I have been incredibly honored to follow throughout my career. Our guest today is Dr. Janet Woodcock.

Dr. Woodcock, Janet, has been the acting commissioner of the FDA now for the, for the last year, tomorrow’s actually the one-year anniversary. And her career with the FDA really started way back in 1986 and, and has really taken her through a pathway of leadership. If the FDA where she’s worked hand in hand with not only drug approvals, but really looking at.

Safety of medicine, safety of pharmaceuticals and with Rx-360 that’s part of our mission. So I thought it would be really great for not only our membership, but the industry as a whole, to be part of a conversation today that I’m going to have with Janet in regards to what patient safety supply chain security in the pharmaceutical industry, how it’s really evolved in the last, I’m going to say 13 or 14 years.

So with that, Janet, welcome to the podcast. 

Janet: Thank you. Great to be here. 

Jim: Thanks. Well, listen to kick us off. You know, really I’ve always looked at, I’ve been at Rx-360 now as their CEO for four years. And one of the things that has. Hit me on a daily basis is how this world of pharmaceutical quality and, and really supply chain security evolves on a daily basis.

How have you seen it evolve? Like what’s changed. How has it evolved for you as you’ve seen it grow from the regulatory?

Janet: Well, you know, I think from when I started, as you said long ago, when I first took over Cedar in 94, I don’t think anyone even thought about this at all. It was not on people’s minds and, over the years, you know, with introductions in times of counterfeit, slipping into the supply with shortages.

And so for every, year there’ll be more and more attention. And then of course, on the distribution chain and integrity, we had the QSA pass that we have been implementing on, on distribution and a track and trace. And then on the supply chain with COVID. Coming in the last two years of the pandemic, it’s been front and center for many people, including, the us government, Jim it’s much more engaged now.

So I think, it really has, moved from, an issue that many people really didn’t think about at all to, to a really important issue going forward. And I think there’ll be more and more attention on it. 

Jim: I agree. And I know one of the things that I’ve seen evolve is when you really look at even some of the things that we’re doing at Rx-360 with our working groups and that type of thing, we might’ve started, you know, 13 years ago with just like the supply chain security steering committee and looked at supply chain as a, as kind of a singular event.

But now we talk about security from a data integrity standpoint, a material quality standpoint. There’s so many things, even when you get into counterfeiting and diversion, It seems every year. One of the comments somebody had made to me recently was “we have to do our best as an industry to stay one step ahead of the bad guys, because the bad guys are working doubly hard.”

Janet: That’s right. Well, the criminals are always trying to stay one step ahead in any, any kind of, criminal scheme. And this is, among them, you know, these are valued and expensive, sometimes products, valuable products and, you know, there’s a criminal opportunity there. So, we all have to be even more vigilant.

And with the supply chains being so long and so varied, there’s so many opportunities, as you said for incursions and so forth. 

Jim: Yeah. One of the things that I’ve noticed in the, again in the four years that I’ve been here at Rx-360 in my time in the industry is. You know, you had mentioned in your kind of opening answer there, in our dialogue about how maybe 13 years ago, people weren’t even thinking about, you know, the supply chain security piece, when it came to pharmaceutical products.

The other thing that I’ve noticed is recently, and I’d love your opinion on this or your thought process. There’s the quality aspect of pharmaceutical manufacturing, and then there’s this supply chain security aspect. And for a long time, or at least in my four years – Four years ago, I actually saw them where they were separated almost in silos, but I’m starting to see more and more of an alignment between those two areas.

And I’m wondering if you’re seeing the same thing. 

Janet: I am. Always part of quality maturity has been having that kind of control over your supply chains, over, you know, verification, like you said, data validity and so forth. They’ve always been part of quality and more and more, we understand they’re part of a risk management and maintaining your supply chain.

 So I think ever since the heparin episode happened, people. Begin thinking of these things, you know, it was a quality issue. It was a supply chain security issue. It was many different things, but, basically it showed some of the vulnerabilities and how companies and patients can really be harmed when there are these intrusions.

If you don’t have a tight grip on your suppliers, basically.

Jim: Yeah, but , I think that patient safety aspect is something that a lot of us, you know, live and die with every day. We want to make sure that the end-user is taken care of. one of the things that I always talk to a lot of different people about Janet is this whole idea of, of supply chain security, you know, pharmaceutical quality in the areas that.

Best practices, what have we learned? And then also just because this is the way that I’m wired, I always want to make sure again, we’re staying one step ahead of the bad guys is what worries us? What do we have to have our radar up about? So I’d love to get your feedback a little bit, or your thought process on, on what have we learned?

I mean, we talked about at the beginning, you’d kind of talked about the evolution, but is there one, one thing that you can point to, or maybe a couple of things. Hey, this is something that we’re doing today that we weren’t doing before. This is something we’ve learned. 

Janet: Well, you know, on the security issue, I think we have really learned about the industry and the agency, you know, know your suppliers.

It is no longer. In, in quality, as well as security, you know, we’ve seen these problems that have really hurt, companies and then denied patients access to products because they were failures, based on, supplies that were substandard, for example, or lack of supplies. We have seen much more now problems with,

through this pandemic, people understand where that, those key intermediates, for example, and where they come from and who is making them and so forth and having redundancy of your supply, all those things are critically important. And if there isn’t a control over those and understanding, it provides an opportunity, like you said, for the bad guys, because you know, we’ve seen shortages in a lot of areas.

And during the pandemic and particularly in a number of PPE and some of the other areas on there, those are devices, but what we’ve seen is a massive infiltration of counterfeits. Okay. We’ve been able to interdict a lot of them at the border, but probably not all of them and these gaps in the supply chain and lack of control provide opportunities for

criminal elements to intrude themselves. And I think we’ve learned a lot more about this over the last say decade and tremendous amount during the pandemic. 

Jim: Yeah. One of the things I was recently talking to some Rx-360 members about that goes right along with what you were just saying was when you look at.

 Best practices in the world of supply chain security and quality. We’ve learned a lot during the pandemic because we’ve, as an industry have had to pivot to do things a little bit differently. 

Janet: Right. 

Jim: And, and what it’s done is it’s created this level of being hyper-focused and what I’m sharing with a lot of people now is as we begin to come out of the pandemic.

Let’s not forget about being hyper-focused, let’s take what we’ve learned. Let’s not go back. Let’s take some of those learnings and continue to drive those thought processes and those best practices. You know, one of the things that at Rx-360, we’ve done a lot of work on is this whole idea of remote auditing too, to maintain quality.

And, and I think that that’s something that’s not going to go away after the pandemic and the industry is getting really good at it, which is, which is really fun to see.. 

Janet: Right. Yeah, we are too. All right. Right now with this current variant spiking throughout the country, our inspectors now are again on pause for going mission critical for surveillance inspections, for example, but we have to verify certain things.

There are things that are mission critical. We have to do pre-approval inspections and we are doing a lot of remote assessments of different kinds. And finding them, you know, relatively satisfactory in many settings. So I think that type of you know, audit having good data integrity, and then being able to audit data rather than, you know, just get some certificate of analysis or, you know, some kind of hand-waving assurance from one of your suppliers I think is going to be very powerful.

So yeah, we consider probably some of these remote assessments to be best practice when they are suitable and we will be continuing. 

Jim: Yep. So when you think about, again, our theme here today is talking about supply chain security and quality in the, in the pharmaceutical theater. What worries you when you, when you sit back and you say, okay, we’re tackling all of this stuff today, but we all kind of put our futuristic hat on too.

And what worries you? What’s on your radar down the road?

Janet: Well, as you probably know, we’ve pushed very hard on advanced manufacturing and trying to shorten the supply chains, trying to have better redundancy. I worry this pandemic showed us some things that maybe we, as a species don’t want to acknowledge.

We’re very vulnerable. Okay? We could have another pandemic and have China shut down. Right. And we came somewhat close to that. You know, that would be horrendous problem for a pharmaceutical manufacturing and pharmaceutical availability. We are with these long supply chains and not enough redundancy and supply.

We’re really, all of us are vulnerable all around the world toward, for natural disasters, for fires, for earthquakes, for pandemics to cut off a supply. And if, if we haven’t assured redundancy, then you know that that might be it. So. I think that’s what worries me the most is we don’t have the capacity right now to pivot for these essential medicines. 

Jim: And I think that’s one of the things that we’ve learned. I think that’s a great point. It’s one of the things I think we’ve learned during our hyper-focus here during the pandemic, because you know, you never want to look at what’s gone on with the pandemic as something positive, but you know, maybe some of these things that were positive that came out of it was our revelation of certain gaps that may be, we have kind of like when you go back to the heparin adulteration, you know, 14 years ago, It, it allowed us to recognize gaps and we’re taking a negative and maybe turning it into a positive.

Janet: Right.

Right. And so if we can learn from this and improve I think it will be very, very important. And, you know, the U S government is focused on this, as I said, the Biden administration, because they realize in many manufacturing sectors, the U S is dependent on other, other regions. And pharmaceuticals is one of them.

We worked on the a hundred day report presented you know, our findings. We previously did that shortage report. And as you said, these things are all related. I think one of the things I worry about is when we do shortages, it does introduce the gray market. And it provides, we get desperate hospitals and desperate providers and they’ll buy basically anything that’s labeled, you know.

Jim: And desperate patients, right?

Janet: And patients that’s right. And with the internet, people can slip in. And you know, we’ve seen that counterfeits improper products haven’t been stored correctly, you know, that were perhaps remanded or rejected or whatever, and then, or simply fakes. And so the shortages create situations where particularly of essential medicines, where desperate people in healthcare and the patients are looking anywhere to find these medications and they may get something that is totally invalid. 

Jim: And I think along those lines, when we look at, at incidences like that, one of the things that really encourages me about the pharmaceutical industry as a whole is you look at all these different pharmaceutical companies around the world and, and you can, you can classify it as big pharma, however you want to classify it.

But a lot of these pharmaceutical companies, no matter what their size is, As compared to like four and five years ago, they’re really growing what I would call their supply chain security departments within their organization. And, and to me, that is so encouraging when you see companies that are literally saying, you know what, we’re going to put infrastructure around this issue. 

And, and to me, you know, listen, I’m a patient, just like anybody else, right. Is that makes me feel real good. Is that, is that there are people that are working at the company level to ensure that protection and that patient safety. 

Janet: I agree.

I agree. And this is all the pandemic I think has highlighted all this. For people and for companies.

Jim: I agree. Janet quick question for you, you know, and, and, and thank you so much, by the way, for your time today for, for the back and forth, I value your opinion. One of the things that I always think about is.

Listen, at Rx-360 we represent the industry as a nonprofit. We really try to work towards our mission every day. And that’s one of the things that encourages me about the consortium is I see that from our members. But one of the things that we’re always focused on is what we can do better. And, you know, I’ll have round table discussions with people and, hey, what can we do better as a group? 

 In your mind, what, what can the pharmaceutical industry start thinking about or doing better when it comes to not only material quality, but also the supply chain security. 

Janet: Yes. Well, as you said, I think the companies and the resources are really beefing up in the area of their security and their quality of their supply chain and monitoring that, doing the risk management plans and so forth so that they understand, I think my own belief is there are several things.

Can be done. Additionally, one of them may seem out of scope, but I think it’s very important in that is, as I said, advanced manufacturing, because to have more redundancy, to have maybe smaller plants or whatever, but that can produce a lot because they’re using more advanced techniques, cut out several steps in the supply chain. I think to add redundancy can really help. 

So that’s one thing.

Another thing of course is I think Rx-360 is really important. I think, gathering together industry and working collectively on solutions. And best practices for some of these problems, because many of the problems still remain is really important for the industry to do.

And so I’m really glad Rx-360 is out there working on this every day. 

Jim: Thank you. That makes me feel good. One of the things along those lines, just to kind of piggyback off of what you said, one of the things that excites me a lot, when I, when I talk to our members is just that idea of, of you, you talked about redundancy and stuff like that is I actually do a lot of our, our members that our suppliers I’m actually seeing a pretty aggressive transition.

How to do things better and more efficiently, which I think will help in, in kind of that initiative endeavor, getting us to where we need to be.

Janet: No, I agree. 

I agree. And that’s another piece of it. You know, that sort of what you might call it’s a part of quality maturity, okay. Is to really have a handle on these things and do them as effectively and efficiently as possible.

And You know, part of quality maturity is understanding the supply chain and managing it really well. 

Jim: Great. Well, listen, Janet, I wanted to thank you for your time today. Is there any kind of parting comment or anything you’d like to share from whether it’s something that you’re working on on the FDA side, or just something about our topic in general, feel free to fire away with anything that’s on your mind that maybe we didn’t cover.

Janet: Well, I think the pandemic has really shown everyone how important pharmaceuticals are. It was something people took for granted that there would always be supply, okay. That their supply would always be valid that they didn’t have to worry about, about problems with you know, fraud or contamination, and so forth.

 So I think there really is an increased focus. I believe we do have the tools to continue to improve and, and and, and keep the quality of pharmaceutical supply at that level we all need. And so I think that is one of the positive things we can take out of the pandemic that we’re all going forward with a much greater appreciation of how important this is. Everything. 

Jim: Janet, thank you very, very much for your time today. I could not be more humbled and honored and I look forward to talking to you again at a future conference when we’re all not remote anymore or anything like that. And we will make sure that we touch base. But again, on behalf of all of Rx-360, on behalf of the industry, thank you very much for your time today.

Janet: Sure, it was great! You take care. Thank you.