Coronavirus in Context: FDA Action on Dangerous COVID-19 Products

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You're watching "Coronavirus in Context." I'm Dr. John Whyte, chief medical officer at WebMD. I'm joined today by Dr. Janet Woodcock. She's the director of the Center for Drug Evaluation and Research at the US Food and Drug Administration. Dr. Woodcock, thanks for joining me. Great being here.

Now, I saw you recently joined Twitter, and I want to get it right. It's @DrWoodcock [? atFDA. ?] Um, I was always trying to get you to join Twitter. Now, one of the first tweets you did was about hand sanitizer, which certainly has been in the news, and a lot of folks don't know that FDA regulates over-the-counter drugs, which hand sanitizer is. But you, um, had some cautionary words about making your own hand sanitizer. Can-- can you talk a little bit about that?

Well, one of the things we've seen over the past few months is, uh, calls to Poison Control spiking. Um, and we have seen that, um, with children, uh, getting access to hand sanitizer and drinking it or other-- ingesting it in some way and getting poisoned. Um, it can be-- ethanol-based hand sanitizers can be extremely dangerous to young children and toddlers.

Mm-hm.

And we've also seen people try to make home hand sanitizer with what we would consider toxic ingredients and actually cause harm. So--

Burns is common with that?

Yes. Yes. So people don't know what should be in there, and they put things together, and they can harm themselves or their children. And so that's really not a good idea at home. Most-- most homes in the United States have good access to soap and water, and good old soap and water is really the best hand sanitizer you can use in wa-- hand washing.

Mm.

So what we have done, though, for the health care professionals and for others who must be out and about and who need hand sanitizers, they don't have access to washing their hands all the time, is we put out a large series of guidances. And these guidances have, number one, published the recipe for how to make a hand sanitizer--

OK.

--that's ethanol-based.

Mm-hm.

And then how groups such as distilleries or breweries or others could contribute, uh, ethanol or make hand sanitizer themselves.

Mm-hm.

And what is done for those hand sanitizers is extremely bitter compounds are added to them. And that will make a child, if they taste it, spit it out immediately. And that makes it much safer, uh, for-- for everyone that there isn't that risk of ingestion. So we've had hundreds of, um, uh, distilleries and other-- uh, other types of industries, um, sign up and register as drug manufacturers. And we assume many of them are making hand sanitizers, and we hope that the shortage will be mitigated.

Now, Dr. Woodcock, it's hard to go through one's Twitter feed or Facebook feed without seeing, uh, a lot of ads and claims for COVID-19 cures, uh, supplements one can take to prevent it.

Mm-hm.

What is FDA doing, and how concerned are you about these fraudulent claims about either protecting, um, or preventing and even treating coronavirus?

We are trying to go after some of the most egregious ones because, um, certainly, for example, we don't have-- want people to go out and think they're being protected, right? And they're going to mingle with others because they have this wonderful protective, uh, pill or supplement or whatever. Um, and of course, they aren't protected at all, most likely. So we try to go after those.

We also go after, um, things that might be toxic, uh, because, obviously, if people are sick with COVID-19, they don't need toxic-- don't need to ingest toxic substances in an effort to, uh, improve their health. We can't get to everything, unfortunately, because, as you said, there's just this complete proliferation of different claims claiming all sorts of things. But we try to take a risk-based approach and go after the worst of them, the ones that might have adverse health consequences.

Yeah. Now, it-- I'm sure it's all hands on deck at FDA, and clearly, there's been a lot of activity on COVID-19, but there is a lot of other drugs in development that are awaiting approval. And-- and we're starting to hear some chatter that people are concerned that there may be missed PDUFA dates, the-- the goal date for which drugs are approved, particularly in the infectious disease group because there's just so much going on.

Um, what are your thoughts in-- in terms of, um, you know, the ability to manage COVID-19 and just to continue to do the day-to-day work that FDA was doing pre-COVID-19? It-- it's a lot. Is-- is there a concern about missing goal dates?

Well, uh, there is a concern. Uh, o-- obviously, in some areas such as oncology, they're plowing right ahead and continue to, um, approve oncology drugs. The neurologists are continuing to work on serious, uh, neurodegenerative diseases.

Mm-hm.

We have many other applications that we can keep working on.

OK.

As you know, we are well-equipped to telework and work at home.

Mm-hm.

And many people tell me they're more productive.

Mm-hm.

[CHUCKLES]

JANET WOODCOCK: On the other hand, um, we have a huge volume of additional work. So we have all these IND programs now--

Mm-hm.

--uh, that we're working on. You know, there's probably going to be 100, perhaps, agents over time in development. And we have to oversee that development, give advice--

Sure.

JANET WOODCOCK: --to the companies and so forth. Then we have the gigantic issues with drug shortages that we're trying to manage, and we're working with FEMA and others. Uh, if the outbreak does die down, at least for the time being, we'll be somewhat relieved, but we still have the issues of drug shortages and planning, forward planning for if-- if the outbreak becomes severe again, what are we going to do for the drug supply?

Mm-hm.

And then, all the social distancing has required us to issue numerous guidances on things like how to deal with your clinical trial--

Right. Mm-hm.

--when people can't come for visits.

Mm-hm.

So drug development has slowed down, and we're going to be dealing with a lot of missing data and interrupted clinical trials over the next year or so.

OK.

So there is a lot of extra work. We can't, uh, really necessarily bring on a whole lot of additional staff to deal with this right now. And so, I would think, in some areas, there may be slow-downs. And of course, we can't do inspections right now--

[INAUDIBLE].

And so, eventually, that may lead to some problems.

Mm-hm. What's morale at the FDA? Um, as we know, folks often like to criticize regulatory agencies. You all have a lot going on. How-- how are people feeling?

Well, I think, uh, it's varied. I think most people are-- are chin-up. Of course, many people have to be home with their-- [INAUDIBLE] small children all day-- [CHUCKLES] and-- and do their work.

Yes.

And that is very challenging, as-- as many people know. But the public health mission has never been more clear than right now. And our central role in this means that the work is extremely meaningful that we do every day.

Yeah.

And I think there is real, uh, public health spirit, as you know, at the agency. And it is times like this when people really step up and-- and really do their part. So--

You've been at the helm for, uh, quite some time and involved in a lot of epidemics. You were involved in approval for HIV drugs. I remember talking about that. Um, are there-- are there comparisons to-- to how we were in HIV a-- as we are today in-- in COVID-19?

Well, I think, at the beginning of the HIV epidemic, the agency was coming off of the-- um, still coming off the 62 amendments in the establishment efficacy standard. And so it was kind of, uh, pretty rigid. Like, we have to have these two trials and we have to do everything this way.

And I think the activists taught the agency a lot with their voices about, we have to look at the situation and there's not just one way to approach it. Here, the situation is just so urgent. I mean, it's so much-- so, so urgent, and, uh, the agency has a lot more tools at its disposal. And the science, of course, has advanced much faster. So we have this deluge of, um, approved and investigational--

Right.

--agents that people want to study.

Yeah.

So it's--

[INAUDIBLE]

The pace is much faster.

Sure. Now, uh, vaccines are primarily regulated in another group, but you know all things FDA. Well, what are your thoughts when you hear, um, there might be a vaccine in 12 to 18 months, knowing the time course that, typically, it takes, sometimes a decade, um, to get a vaccine right?

Yes. Well, that's true with many things, therapeutics as well. Let's say we can only hope. All right? There is more experience with the coronaviruses because of SARS. There is-- so people have a head start on understanding, I think, some of the biology.

There are multiple groups in the game here because this is such a giant problem, and, um, it will be a giant market and, um, unlike many, uh, infectious diseases, uh, where there might be vaccine resistance, um, by the populous and so forth and so on. Here, a successful vaccine will be, uh, mightily embraced, and probably, you know, we'll-- [? you'll ?] not be able to produce enough. So, as a result, there are many-- going to be many entrants in this game.

Mm-hm.

And vaccines are being developed all over the world. And so we have a higher probability of success by starting a whole lot of programs right away.

But even in a 12 to 18-month, that's-- would you say that's an optimistic time frame?

Well, part of-- um, part of this is, uh-- is how-- picking an area where there is an outbreak, uh, and you can get a lot of events quickly.

Mm-hm.

If you're going to take a disease that doesn't-- isn't occur very much and you try to develop a vaccine against it, then you have trouble demons-- you know, it takes a long time, a long duration of trial because you don't get a lot of infections. But here, in-- if you can test a vaccine in an area where the, um, virus is spreading rapidly or saying health care professionals, first responders, people are going to get exposed--

Yeah.

--you have a better chance of a rapid-- rapidly getting an answer.

Now, Dr. Fauci's an avid walker. He talks about walking, you know, around Bethesda. You're an avid Gardener.

[CHUCKLING]

Have you had time to do any gardening?

Yes, I must. Uh--

OK.

You know, you're just sitting in front of your computer screen and your phone all day, and talking to disembodied voices and faces all day is really not good for the spirit. So I try to spend some time outside every day, and we're having a lovely spring in-- um, in this area, in the DC area. It's cool and kind of rainy, which doesn't sound that great, but think about an English summer or something like that. It's like that. It's very green. It's very beautiful.

Well, good. Well, Dr. Woodcock, I want to thank you for taking time today.

Thank you. It was great talking to you.

And thank you for watching "Coronavirus in Context." I'm Dr. John Whyte.