Coronavirus Q&A: Venable's FDA Co-Chair

By Emily Field
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Law360 (September 14, 2020, 6:49 PM EDT) -- In this edition of Coronavirus Q&A, Law360 talks with Claudia Lewis, co-chair of the FDA practice at Venable LLP, about working with the agency during the pandemic, helping companies that manufacture personal protective equipment and a new type of relationship with clients and colleagues that has emerged from working remotely.

Claudia Lewis

Lewis is based in Washington, D.C., and has been with the firm since 2005. Her practice focuses the on regulation of foods, supplements, medical devices and over-the-counter drugs by the U.S. Food and Drug Administration and other federal agencies.

This interview has been edited for length and clarity.

How has the pandemic affected your practice and how you work?

Obviously I'm working from home like everyone else. COVID, because I'm a food and drug attorney, has been interesting. I always did medical device work, which would include the masks, the gowns, the ventilators and the like that everyone's been seeking for health care professionals and personal use alike. Those products are always regulated by the FDA, and some devices, depending on what they are, with higher scrutiny. Hand sanitizers, all of those things, have become critical to our health and safety. The first 45 to 60 days of COVID was just a whirlwind of requests about, "How can I source masks, how can I get through FDA's review, what are the rules and regulations?"

FDA has been amazing in coming up with emergency use authorization policies and regulations. At the beginning, FDA was very, very adjustable, but unfortunately as the industry adjusted, we found that not all masks were equal, not all sources were reliable. The FDA had to adjust its flexibility to make sure that they had solid sources of masks that were not going to receive FDA overview, and instead that you have this general emergency use and if you met certain criteria then you could proceed to import or distribute your products without full FDA clearance or approval.

There was a little bit of a learning curve as clients were learning to step up to the plate to meet demands of both the health care space and consumers. FDA was issuing EUAs and updated policies every day, so it was just making sure that claims and sources of PPE that were OK on Thursday were still OK on Monday.

I remember there was a lot of confusion as to what masks were appropriate, and at the very beginning if they were appropriate at all.

My team didn't have to address that issue. Most of our clients were trying to provide PPE to health care professionals, and I don't think they had a question as to whether it would be appropriate to wear a mask.

We had lots of questions about hand sanitizers and gowns. At the beginning, the FDA had two or three pages of what they considered reliable sources for PPE. As some of the counterfeit products [emerged] and we were discovering was that some of the documentation we were receiving was not legitimate. We had to really scrutinize the information we were receiving from sources. The FDA noticed that as well. The 10 pages or 20 pages of reliable resources over one weekend was shrunken down to two pages. It's since expanded, but it just shows you have fluid and how quickly the industry was reacting, how flexible the agency was trying to be to address the issues but also making sure that they were keeping an eye on safety and efficacy. Once it was discovered that not all sources were equal, or that the FDA needed to look a little more closely at some requirement areas, they took a step back and did it. I feel like even though COVID has been a whirlwind, the first 45 and 60 days was just a tremendous learning experience, and it was tremendous to see the FDA issuing rules in a matter of days and it would normally take them months.

What questions are you currently fielding from clients?

In connection with COVID, a lot of clients have switched to being a PPE resource, both to distributing it and sourcing it for general purposes and creating their own lines of PPE. And so now the clients are asking me, "I'm assuming these emergency use authorizations are not going to stay in place forever," or "I'm in this for the long haul, I would like to take steps to get the full 510k or some other FDA oversight." We're sort of switching to making this more long term instead of meeting societal needs in the short term. So there's a lot of questions about importing — "How do I get those products in?" I've gotten a lot of questions about how to price these products in terms of making sure that you're not gauging. The Federal Trade Commission has some regulations and the states have regulations, so we've had to do a state-by-state survey to make sure the pricing is not overinflated. Really scrutinizing the testing and understanding what testing is going to be considered appropriate and not appropriate is something that we've worked with consultants on.

The other thing we've been working on that I think is interesting — most of us are used to seeing disposable, nonreusable masks. Some of our clients have come up with reusable masks that have special technology for comfort and other types of things. Those types of masks have required a little more interaction with the FDA. We've been dealing with the agency on a much more day-to-day basis on that.

Obviously in the beginning, people didn't think kids were impacted. Now that kids are going back to school and kids are being impacted, we've dealt with a lot of kids' issues in terms of what materials are OK for kids, how long should the kids wear the masks. It's just been a broad range of issues and things that we've had to think about and talk to the FDA about or talk to the Consumer Product Safety Commission about, and everybody has all these questions about things like that.

Yes, the kids going back to school issue just feels impossible to me.

I have four kids, one who is in college and one who is in the Army, and I have a senior and I have a second grader, so all the issues you see on the news, [I'm dealing with them]. There's distance learning. If I had to do distance learning with my second grader — she's in school today, she goes to a very small school — I wouldn't be able to do it. There's just no way to home-school and work.

I don't know how parents are doing it, to be honest.

It's one of those things that no one's really talking about, but at Venable we had to put together a parent support group to talk about how we can support one another while home-schooling is in effect. If someone said you had to home-school your daughter and work for the next 45 or 60 days, you wouldn't like it, but you could get through it. But having to do it for the whole year? Or even until December — who would start?

COVID has been very interesting from the FDA issues, FTC issues and personal issues. Obviously with a pandemic like this, there's some people who really believe that natural ingredients or some kind of respirator is better, and they might not have any science about it, but they're true believers. You might have seen that the FDA sent out a rash of warning letters in connection with colloidal silver. It's so funny how things come back full circle. When I started practicing back in 1990, everyone had these questions about whether colloidal silver could classify as a dietary ingredient or not. There has always been a segment of the industry that really believes in colloidal silver and that it is antibacterial and has cleansing capabilities. I remember that FDA had questions about its safety. It's just full circle, 25 years later, Oh, people are back to colloidal silver, which I hadn't heard about in such a long time. It didn't surprise me that the agency would have questions.

But I think that the FDA and the FTC are rather skeptical about products that claim to be able to have an impact on COVID because there's so little science. They're still trying to figure out how to treat it, so how could you know whether — and I'm just making this up — some solution could have an impact on it or not. The agency is very much about safety data, so it's not hard to believe that it would have a strong view about claims in connection with COVID. It's not surprising that in a pandemic, people would have opinions about what might be helpful.

The FTC always does its job when people are making claims, and the public is going to rely on it. They'll send out letters to say, We saw advertising for a filter or some home concoction that you would make and drink. The FTC says that unless you have substantiation and underlying data to support it, we have questions about whether these claims are potentially false and misleading.

What is the legal fallout and potential consequences from the FDA's warning letters over COVID claims?

I think that in the era of COVID, if you are making COVID claims, I think there's always a high risk of regulatory scrutiny, whether it be the FDA, the FTC or the states. We're all hoping for something that will help protect us or eliminate COVID, so I think everyone is maybe more prone to believing things than normal. You always have a chance of sort of trying to convince the agencies, one or the other or both, that you do have the data, and you may be able to continue to make the claims. But more likely, if you're saying it addresses COVID, you're talking about a drug or a medical device that probably needs to go through proper FDA review. So even if you have some data, it probably doesn't mean you get to make the claim, it just means that you have a path forward to getting some type of clearance through the FDA process.

Usually when you get a warning letter, you might have a back-and-forth with the agency to come to some sort of compliance conclusion with the agency and move on. I think that in the past if you made a misstep again the agency would try to engage again. But what we're seeing in the era of COVID is that FDA is seizing products and taking enforcement action faster than it might otherwise.

Are you concerned that because the FDA is focused so much on COVID, there might be other areas that have less priority?

We still have clients who are looking at new dietary ingredients, or working on medical device submissions to the agency, or cosmetic work. There are lots of different areas FDA has jurisdiction over that we're still addressing. The FDA has been fairly responsive, but sometimes they'll say, Hey, I need to talk to XYZ about this, but I know they're on a COVID committee, there might be a little delay in connection. Obviously with COVID the agency is not out there doing inspections and things like that, so some things might have been put on hold and there might be a little delay with the agency, but I have been very surprised by how responsive and comprehensively attentive the agency has been. Clients are still receiving updates about their 510k submissions, FDA is still having meetings on novel food ingredients and things like that, so things are still moving along.

One of my clients early on in COVID received a warning letter. We hadn't heard from the agency and the agency sent a letter that they had a couple questions. We got on the phone to talk about it and it had nothing to do with COVID. Work is being done across all areas, even in light of COVID.

That's reassuring to hear.

Yes, and one thing that we haven't talked about, in the beginning of COVID, everyone was worried about the food supply and how long [the coronavirus] would stay on surfaces, and both FDA and FTC feel very confident that we don't have to worry about COVID in connection with the food supply. I just find it amazing in this time of crisis how nimble the agency is, when outside of the pandemic, sometimes it is not that nimble.

More broadly speaking, how is the pandemic going to affect the practice of law?

Normally, instead of having calls we would huddle in a conference room, I might fly to LA to talk to them about something and bring the client in. So now all of this is taking place over Zoom and it's just a really concerted effort to making sure that we're putting in place best practices to make sure everyone, lawyers and staff, still feel connected and still making sure we're providing A+ service for our clients. People talk about hoteling — whether your office is going to be just your office or would it be shared with other people. We talk about whether you need to be stationed someplace specific anymore. Now everything is virtual — if you want to go to Maine for a month, is that really going to make a difference? So I just think there's a lot of flexibility in terms of what's happening personally, but it's a challenge in the practice staying connected with clients when you can't really travel to them anymore, and staying connected with your clients who really help you provide quality lawyering to your clients as well. We're all sort of working through that — we all thought this was going to be short-term, and as the days and weeks turn into a year next March, what adjustments are we really going to have to make?

Have you had any funny Zoom moments?

There's been lots of funny Zoom moments. Before my daughter realized that the camera was on, she would come in and ask me a question, like can she have a piece of chocolate? Yesterday I was on a call with the CEO of one of the largest companies in the world, and my dog was just in the background looking out the window.

People forget that we can see them. I know this is cliche, but literally people will have on a nice shirt and then get up and clearly have on college shorts that have seen better days. No one really says anything about it, but I guess it really does happen that someone will put something nice on the top and do whatever on the bottom.

The one thing is that it lends itself to a degree of intimacy, right? If you and I were on a phone call while I was sitting in my dining room, you wouldn't have a clue what my dining room looked like. Now you are seeing parts of peoples' lives as people are working from home in different areas. You can see pieces of sports memorabilia, and it's like, I didn't realize you were a big Red Sox fan. It's giving you a lot more insight into your partners and your clients, and it's giving them greater insight into you.

--Editing by Alanna Weissman.

Check out Law360's other installments of Coronavirus Q&A.

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