Coronavirus Q&A: Arnold & Porter's Chair Of Health, Life Sci

By Jeff Overley
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Law360 (May 14, 2020, 2:03 PM EDT) -- In this installment of Coronavirus Q&A, one of Arnold & Porter's top health and life sciences lawyers discusses how the pandemic could profoundly reshape patient experiences across the American health care system and spark a sweeping reappraisal of the global supply chain for medical products.

Daniel A. Kracov

Daniel A. Kracov, a partner in Washington, D.C., co-chairs the health care and life sciences regulatory practice at Arnold & Porter. He shared his perspective as part of a series of interviews Law360 is conducting with law firm practice leaders about legal, regulatory and business fallout from COVID-19.

This interview has been edited for length and clarity.

How has your practice's work been affected by the crisis?

Obviously it's not our druthers to be dealing with a pandemic, but it turns out that we're well-positioned to help clients. Folks in our practice have been working on pandemic-related issues since the early 2000s.

Concern about an influenza pandemic emerging in this way has been around for a long time. There's been lots of thinking and efforts around pandemic planning and stockpiling over the last couple decades. We were very involved originally in the PREP [Public Readiness and Emergency Preparedness] Act [of 2005]. We're very familiar with these issues and kind of hit the ground running.

From a work perspective but also psychologically, it's been very good for folks in our group to feel like we're actually contributing to these efforts. We've been working with companies on COVID-19 vaccines, a lot of diagnostics and drugs that were never really used at all — or were approved for totally unrelated things — and might have usefulness here. We've worked on a 3D-printing open-source effort for ventilators. The variety of issues has been pretty extraordinary.

How have the operations of your clients changed because of the pandemic?

That's the other side of the coin we've been dealing with — helping clients transition to a remote environment and still do business. Part of that is clinical trials — [clients are asking], 'How do we conduct virtual monitoring with clinical trials? Can we figure out a way to ship the drug to the patient's home? Can we send a nurse to the patient's home? How do we deal with COVID-19 issues in our informed consent forms?'

And also, look, these are businesses that are trying to continue to carry out their commercial activities, so they want to be able to detail doctors and do speaker programs and do it virtually. It's an interesting [challenge], because the current rules around speaker programs or participating in medical meetings as a [drug or device] manufacturer were not written for doing it over Zoom. So we've been spending quite a bit of time advising clients on how you do that in a compliant way.

To what extent was remote detailing happening before the pandemic? How effective has it been during the crisis?

I certainly think some companies had previously dipped their toes into remote programs, particularly remote speaker programs. Obviously this has changed the game — I never have seen companies do remote detailing the way they're trying to do it now.

In terms of the success, it's mixed. It depends on what the doctors are doing. Obviously if they're busy with COVID-19 patients, it's a whole different ballgame from those who largely do nonessential medical services — they might have more time on their hands, and this might be a good time to learn about products that companies present on.

I know you've followed the trend of making health care more consumer-friendly. What have you been watching in that regard during the pandemic?

[One thing] is the government has relaxed a lot of the rules around when telemedicine can occur and how you get paid for it. It's going to be hard to reel some of that back in. After all of this is over, it's going to be hard to tell patients, 'Sorry, we're going to take that back.' Just as a matter of patient demand, it's going to be a fact of life.

Now, that doesn't change everything — you can't do cancer treatment via telemedicine. But there's a lot of disease states where telemedicine makes a lot of sense. And you're starting to see some companies — essentially telepharmacy companies — that are marketing themselves for specific disease states. And I think that's going to accelerate.

I know you also follow digital health products. Have any of those gotten a boost during the pandemic?

There have been some companies proposing to use, for example, artificial intelligence to sort through lung scans of COVID-19 patients — there's potential predictive value. There is also a big push to aggregate data from all of these uses of different drug products that are being deployed and develop a large body of real world evidence that might help [the U.S. Food and Drug Administration] make some decisions about how these products can and should be used for COVID-19.

Once you see the numbers, you may be able to see which treatment paradigms are associated with better outcomes. That might give you some insights on what we should be emphasizing. People are desperate for guidelines.

What pandemic-related changes in your clients' operations could be long-lasting?

Really looking at the current supply chain for medical products — it is 100% clear that that is going to be a focus going forward.

The globalization of the pharmaceutical and medical device business has brought a lot of good things, but it's also created some vulnerabilities in a situation like this. It's not only regulatory — it's also geopolitics and trade and other factors. And in the [Coronavirus Aid, Relief and Economic Security] Act, there is a mandate for the National Academies of Sciences, Engineering and Medicine to do a big report on exactly that.

I think the industry has done a really good job compared to what was anticipated in this type of situation — there was a lot of concern. There have been some very difficult situations in terms of the availability of products, most notably personal protective equipment. But in terms of drug products, it could have been a lot worse.

Every single company that is global in nature in the field is going to have to conduct a risk assessment of their supply chain in light of what's going on here. And there's also going to be an emphasis on using technologies that allow better, more efficient and more robust [drug] manufacturing. FDA has been very focused on continuous manufacturing — they got quite a bit of funding in the last budget to focus on that. I suspect we'll be working on supply chain issues for a long time to come.

The White House says this supports its goal of bringing more manufacturing back to the U.S. And some Democrats want more government control of the supply chain. To what extent could either of those come to fruition?

I certainly don't see anything like a nationalization of the supply chain, sort of Defense Production Act-style, at all. But there will be pressure to ensure that there is redundancy in supply chains and that there is planning that can allow rapid adjustments of supply chains. And there will be cases in which companies may need to move some production back to the U.S.

It's been a big change in production over the last 20, 30 years. There's nothing wrong with producing in India and China. Putting aside the trade politics and so forth, it's good for consumers in the U.S., it's good for patients, etc.

But a lot more thought is going to have to be put into, how do we ensure that we get the benefits of globalization but also mitigate the risks of globalization? And this pandemic has made that much more real.

What's a notable impact of the pandemic that hasn't received as much attention as it deserves?

We talked about the consumerization of medical products, and [part of that is] the diagnostic area has become so critical. One of the impacts of this whole COVID-19 pandemic has been people really realizing the importance of our diagnostic technology and diagnostic infrastructure in this country.

We have amazing technology and commercial infrastructure in this area — companies with incredible diagnostic technologies and manufacturing and lab capabilities. We went into this with a policy focus on diagnostics that had been out there for a couple of years, but I think that's going to intensify over the next couple years in terms of, how do we not only make sure this doesn't happen again, but also are we regulating diagnostics the way we should be regulating them? 

Pharmacies are touting plans to widely offer COVID-19 tests at brick-and-mortar stores — the sort of wide access they have long been eyeing for routine blood tests. Could the crisis finally make that access a permanent fixture at pharmacies?

I think it will to a degree. As you said, it's something that's been [talked about] for a long time, and I think consistent with our discussion about telemedicine, people are very much like, 'Why can't I get the test?' Politicians listen to that type of thing. I think we'll be hearing more of that from a policy perspective in the coming years.

There are good reasons not to blow open the gates and allow everyone to be tested for whatever they want, because they're going to make mistakes as a result in terms of their treatment. So we need to have a learned intermediary guiding people through what these results mean. A lot of the barriers are at the state level, and there's going to be a lot of debate across the country about, do we need to re-look at how patients access testing?

Does it feel like an upshot of this pandemic could be more convenience generally in health care, be it telehealth office visits or more diagnostic testing at local pharmacies?

It's much broader than this pandemic disease. There are technologies now, like liquid biopsy technologies, and you could easily see a scenario where maybe 10 years from now everyone gets a periodic liquid biopsy to see if they have any circulating cancer cells in their body. It raises a lot of issues.

Remember when the Apple Watch came out, and they could track whether you had [atrial fibrillation], and the cardiologists went crazy because they were concerned that people would come running in demanding to be treated? So what happens if people get a periodic biopsy? There are lots of interesting questions because the technology is just getting so powerful, and it's hard to keep it out of people's hands.

--Editing by Kelly Duncan.

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

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