• COVID has magnified many of the concerning issues the FDA already faced regarding drug quality and shortages.
  • Any situation or event similar to the COVID pandemic can stress the drug supply chain and lead to shortages.
  • A list of current drug shortages can be found on the FDA website.

Video Transcript

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JOHN WHYTE: You're watching Coronavirus in Context. I'm Dr. John Whyte, Chief Medical Officer at WebMD. Today we're going to talk about drug quality. And I asked two of my former colleagues, Dr. Mike Kopcha, he is the Director of the Office of Pharmaceutical Quality, and Dr. Adam Fisher is the Associate Director of Communications at the Office of Pharmaceutical Quality at the FDA. Gentlemen, thanks for joining me.

ADAM FISHER: Thanks for having me, John.

MICHAEL KOPCHA: Hey.

JOHN WHYTE: Mike, let's start with you. How is COVID-19 impacting your day to day work at FDA?

MICHAEL KOPCHA: Well, John, as you can imagine, there's been an increase in the volume of work related to COVID while we're still trying to do our day to day jobs. Um, so obviously that creates, um, uh, a lot more workload or an increase in the workload for us.

Um, [INAUDIBLE] itself has some key issues that the agency is tackling that we need to continue to-- to work on, um, as we deal with the COVID issue as well. Things around over-the-counter drugs with the recent approval of the, um, program itself, making safe hand sanitizers, as you can imagine, testing non-COVID drug applications on top of the work that we've already got, and then managing drug shortages.

And we have to deal with the inspections being on hold and what ways to deal with that. So as you can imagine, COVID has magnified, um, many of the issues we've already been concerned about related to drug quality itself.

So things such as supply chain visibility, redundancy, manufacturing capacity, shortages, and being able to expand access while maintaining quality. However, the silver lining that's come out of all of this, um, is now that we can come together, both the industry and the FDA, to focus on solutions to these kinds of problems.

JOHN WHYTE: Yeah. Well, as-- as you know, the Office of Pharmaceutical Quality is essentially still a relatively new office that was created in the last few years. What does the word quality mean when it comes to pharmaceuticals?

MICHAEL KOPCHA: Well, quality in general, uh, for any product of any kind is that it needs to meet the expectations of the ultimate user. In our case, the ultimate user-- user is the patient itself. So with drugs, it's no different. You know, we-- we need to meet that expectation.

And patients expect safe and effective drugs with every dose that they take. So to do this, drug manufacturers must meet quality standards that exist that ensure every dose of a drug on the market is safe and effective and free of contamination and defects. So quality is what gives patients the confidence in their next dose of that medicine.

JOHN WHYTE: OK. Well, let's get practical and drill that down. And-- and Adam, I'll ask you. What do patients and consumers know about the quality of their drugs?

ADAM FISHER: John, that's a really great question. Because it wasn't too long ago that we really didn't know the answer to it. But we were fortunate to be able to do a survey, uh, with WebMD, and particularly WebMD.com.

We were capable of finding 3,500 different patients and consumers that went onto the website, and we were able to ask them about their perceptions of pharmaceutical quality. Now, overall, the findings were pretty positive.

So over 70% of patients and consumers rated the quality of their prescription drugs as being very good or excellent. But beyond that, there were some problems, right? And one of the problems was that although prescription drug quality was generally rated high, patients and consumers tended to rate the quality of brand name drugs as higher than the quality of generic drugs.

And not only that, but they were also less likely to believe that international drug manufacturers held to the same strict standards as required by the FDA as manufacturers within our country.

JOHN WHYTE: OK. Do you think there's the perception that cheaper, which generic drugs are usually cheaper, does that mean inferior to some people? Is that why you think they're seeing generic drugs as of lesser quality?

ADAM FISHER: Well, we certainly didn't probe that as a reason, but it is a possibility, John. And the thing that I'll say from the FDA perspective, we don't care whether the drug is generic or a brand name, made in the US or made elsewhere around the world. We have the same expectations for quality no matter what.

And another thing that I would emphasize here is that we at the FDA, as you're aware, John, we at the FDA are patients too, right? We don't have a special FDA stash of medicine that we get to tap into. We buy and use the same products as everybody else. So when we make decisions in the name of the patient and the consumer, we are considering ourselves in that as well.

JOHN WHYTE: And you mentioned the perception of drugs made internationally. So I want to ask Mike, how can a consumer figure out where their drug is made? It-- it is a complicated issue than looking at the box or the label. How can you ever actually figure it out?

MICHAEL KOPCHA: Well, that's one of the issues that-- that we face is that you can't. You can't make that distinction. But generally, um, you know, speaking about the quality of drugs, um, regardless of where they're made, um, it goes through a rigorous review process by-- by us as well as the, um, you know, other parts of the FDA as well.

But from a quality standpoint, the, um, quality has to meet the same standards regardless of where the drug is manufactured. So it's to our standards regardless of whether it's manufactured here in the US or abroad.

So when it meets those standards, that's what we're interested in and that's how we actually then, uh, you know, move at least from the quality standpoint to-- to approve that drug or to be part of the approval of that drug.

JOHN WHYTE: I mean, most listeners aren't going to be able to figure out what those standards are. So what are some of those quality problems that your office sees in the creation manufacturing of these drugs?

MICHAEL KOPCHA: Well, the tools that we use, generally we test products on the market as well in our laboratories to confirm that they meet quality standards. Because when they go through the approval process, there's quality standards they need to meet.

So what we do is that every so often we will go out, purchase these products on ourself, you know, whether we go to pharmacies or we go onto the internet, and then we test them within our own labs. And, um, you know, we check to make sure that they still meet those quality standards.

And for the most part, they do. Um, if there is a problem with it, we will send it over to our Office of Compliance and they will take whatever appropriate action they need to take, um, because the drug is not living up to its standards.

Um, but we do conduct, uh, as well, surveillance programs that we do, which help identify possible problems. So manufacturers can address them before they cause potential harms to patients. So we get involved in, uh, in engaging with companies that we know may be struggling or may have issues, and we'll address those issues or we'll work with them to address those issues to make sure that the supply or the continuity of the supply is indeed there.

If there are reports of defects or recalls, we monitor the manufacturers to ensure that they fix those problems in a timely manner. So while none of these tools are sufficient on their own, but when we use them collectively, then they give us high conf-- confidence the quality of the drug up there in the US marketplace.

JOHN WHYTE: Are we see more recalls in the last few months?

MICHAEL KOPCHA: In, uh, I don't know if it's-- it's-- not in the last few months. We're still doing our surveillance work. We're still doing our monitoring to keep track of that. But I, you know, offhand from what I can remember, I don't-- I don't know if there's been an uptick in the quality issues or the compliance issues, um, over the last few months.

JOHN WHYTE: How are you doing inspections? You can't do them virtually, can you?

MICHAEL KOPCHA: Right, no. Not at this point. So what we're doing is there are a couple of mechanisms or a couple of tools, uh, that we're actually able to use in order to do those inspections. One of the tools we'll do is that we will, um, request from a company all of their documentation that we would typically see when we go in and do a physical inspection.

And they would send us that information and we'd do what's called the desk review. Um, we also, uh, rely on what's called mutual reliance. And mutual reliance is a, um, program that was set up with the FDA and certain, um, qualified, uh, groups within other, uh, health agencies that we can trust and utilize their inspections to help inform our inspections.

Um, so we're able to use that in lieu of going there and doing the inspection ourselves. We rely on, you know, through a mutual agreement, hence the name mutual reliance, on what a, um, a competent health authority has done, and then we make our assessments based on their review of that particular manufacturing site.

JOHN WHYTE: Yeah. I mean, both of you have mentioned drug shortages. I want to ask Adam about drug shortages. Is COVID-19 exacerbating the supply chain, resulting in more shortages?

ADAM FISHER: Well John, I think it's clear that something like this, um, does stress the supply chain for sure. But FDA has a drug shortages web page that I would encourage anyone to look into if you're interested in knowing any of the most up to date shortages that we're aware of.

You know, when it comes to shortages, John, though, many of the issues that have bubbled up related to COVID-19 are issues that we've been trying to raise awareness for for a long time on the quality side.

You know, for example, this might be insight into the supply chain and things of that nature. Um, and we've come up with ways that we believe we may be able to address shortages. And there are a number of potential solutions in the FDA's drug shortages report, which is available, free public report available to anyone on the web, where they fill out some potential solutions that could address the problems related to shortages in the long term.

JOHN WHYTE: So Mike, what can patients, physicians, pharmacists do to make sure they're getting quality medicines? It's not easy.

MICHAEL KOPCHA: Well, you know, as I've mentioned, you know, the products that we approve, you know, we ensure that that quality is-- is indeed there. So as long as they're using approved drugs, you know, the quality should not be a concern.

JOHN WHYTE: What do you think the biggest misunderstanding is about quality of drugs? A-- a patient might think it's, you know, how the drug looks or tastes. You know, if it breaks, if it's a pill. Physicians might think it's-- it's more about efficacy data. But really, in your mind, um, what does quality mean when it comes to drugs?

MICHAEL KOPCHA: Whether it's free of defects, there's no contamination in the drug itself, it meets its, you know, um, label claim in terms of the strength, the potency, things along those lines. Um, so that's the, um, you know, those are the things you need to look for.

And those are some of the things, not all of the things we'd be test for, um, and we look at, when we approve-- when we review and then approve a drug application that goes through the FDA.

JOHN WHYTE: Adam, should patients be concerned about the quality of their drugs during this pandemic?

ADAM FISHER: Well John, it's our job to make sure that, uh, no one really needs to be too concerned about the quality of their medicine. And we are, as Mike mentioned, using the same tools now that we've been using. Um, maybe in a little bit of a different capacity. But for the most part, we are doing our job just as we always have.

JOHN WHYTE: What keeps you up at night, Mike?

MICHAEL KOPCHA: From a quality, uh, standpoint, the things that, um, I guess the parts that keep me up at night are just, you know, you know, trying to ensure that the, um, you know, supply chain is maintained, that we can ensure the integrity-- we can ensure the quality of the supply chain, you know, that-- that we're responsible for.

Um, you know, the best way we can do that, or one of the ways we can do that, is ensure that, you know, we educate patients and consumers, um, in terms of what to look for. Um, and, you know, the-- the better educated and informed they are about what we do and how we do it should hopefully give them confidence in terms of the drugs that they take.

JOHN WHYTE: And what's the mood of your colleagues? They're basically doing this work relating to COVID on top of their daily work. There's only so many hours in the day.

MICHAEL KOPCHA: There is a lot of work that needs to be done. But you know as well as I do, uh, John, the thing that really motivates, uh, the individuals is the mission of the FDA. And-- and that mission is really to-- to, you know, ensure that we take care of the patients.

For us at OPQ, you know, we've got our vision to make sure that there's quality drugs, uh, you know, in the marketplace. So that's what keeps them motivated. That's what drives them to continue to do that work. You know, we've got, you know, we've got a staff that's, you know, willing to put in the time and effort to be able to ensure that.

We do realize that, you know, right now, you know, the COVID situation, um, you know, we've put a lot of processes in place. We've been able to manage that work more efficiently, so that allows us then to have more time to continue to do on our day to day, uh, responsibilities as well.

ADAM FISHER: Yeah. And I-- I'd only add that we have a fairly large office at the FDA. Over 1,300 staff in OPQ. Uh, I'm sure if you asked all 1,300, you would get a quite different answer from one person to the next. But as Mike said, nearly everyone is driven by the mission.

And just anecdotally, what I've heard from, uh, the folks that I communicate with closely is that they're actually proud now that our work has gained some visibility, and that people understand why the things that we do and the things that we've been advoc-- advocating for in the past are important.

JOHN WHYTE: Well, I want to thank you both for joining me today.

MICHAEL KOPCHA: Thank you, John, for the time.

ADAM FISHER: Thank you, John, for having me.

JOHN WHYTE: And I want to thank you for watching Coronavirus in Context. I'm Dr. John Whyte.