Law360 (July 24, 2020, 8:18 PM EDT) -- In this edition of Coronavirus Q&A, the U.S. Food and Drug Administration's former chief counsel, who now leads Sidley Austin's FDA group, discusses the agency's pandemic-era performance, looming court clashes over legal immunity for COVID-19 products, and why the crisis could be an inflection point for the FDA approval process.
Wood shared the perspective as part of a series of interviews Law360 is conducting with prominent lawyers regarding the legal, regulatory and business challenges of the coronavirus crisis, which has officially infected more than 4 million Americans.
This interview has been edited for length and clarity.
You recently served as the FDA's chief counsel. What are you hearing from former colleagues about how the agency is holding up?
FDA has always had a very strong sense of mission, and of course it has a very old and established public health culture. And I think there is a sense of an enormous esprit de corps and rising to the occasion, to respond as quickly as possible to the changing needs and emergency nature of the pandemic.
So people are very focused, is my sense, and really feel honored to be in public service and helping to work on all aspects of providing amelioration for patients. But it's certainly an incredibly busy and challenging time.
And so, in this challenging time, where has the FDA done well, and where has it struggled?
The agency has done an incredible job of getting out an avalanche of immediately-in-effect guidance documents dealing with really nuanced questions across a number of very important topics that industry was really looking for guidance on with respect to emergency use applications and all manner of medical countermeasures.
And there's been an enormous effect of having publicly available, outward-facing questions and answers, and having regulator teleconferences to take questions, and having people available around the clock to help process emergency applications. There's been a real effort and many successes in terms of getting out that information as quickly as possible to respond to COVID.
In terms of challenges, as COVID has properly taken up resources and attention, we are hearing concerns that people who have therapies in the pipeline feel like they're getting less attention and fewer meetings. And so there's increasing concern about making sure that the agency has the resources it needs and is able to move that non-COVID freight, particularly with respect to really important products.
So has this affected products across the board, or only certain categories of products?
I think it's across the board. There are limits [on FDA resources], of course, but we certainly have heard criticism from people who felt like they weren't getting the attention and meetings that they deserved. We've perceived a crescendo of that and an increase in that.
We spoke in early 2019, right after the government shutdown, and you expressed concern about it harming the FDA's ability to attract talent. How might the pandemic affect recruitment?
It's a really interesting question, and my sense is that if there is a silver lining to this, it is that this pandemic has shone more of light on the importance of agencies like the FDA that serve a critical public health function.
And so the core things that drive people into a career at FDA — like wanting to be part of a public health solution — are really magnified in a pandemic. And so my hope certainly is that it will put a focus on more people wanting to go into public service.
What COVID-19 issues are you working on most for clients right now?
It has evolved over time to follow the life cycle of the pandemic. In the very early days, we were getting a number of questions about personal protective equipment, particularly from market entrants who hadn't been regulated by FDA. Also questions about diagnostics, about potential therapies and questions about potential liability limitations in the Public Readiness and Emergency Preparedness Act.
The Trump administration issued an emergency declaration under the PREP Act granting immunity for certain entities and products involved in the pandemic response. Is there anything significant that wasn't immunized by that declaration?
It was an incredibly important move when the U.S. Department of Health and Human Services came out with its statements about PREP Act immunity fairly early on. The intent of that is to give a very significant protection to covered countermeasures. I think you'll see courts, when lawsuits are brought, have to interpret the boundaries of that and any lingering questions, because the PREP Act has not been interpreted very much historically.
But the information we've seen from HHS, including their guidance document on their interpretation of it, indicates that they intended to cast a fairly broad net in terms of protections for covered countermeasures. There were some questions early on, for example, where a product might be used both for COVID-related and non-COVID-related [care], about whether you would have to prove that it was actually used for COVID if the requirements were already met. And I think the agency has given assurance that the intention is to cover both. That it really is meant to [immunize] covered countermeasures that can be used for COVID, because of course products are interchangeable.
You've worked on the use of real-world data to get medical products on the market faster. What do you think of how the FDA has used that data in its pandemic response?
This is another example of perhaps a silver lining with COVID — that it could serve as a catalyst for projects that the agency has been working very hard on and have now become even more significant and important.
In the context of COVID, we've seen a number of announcements from the agency and [FDA Principal Deputy Commissioner] Amy Abernethy focusing on the agency, as she has put it, going outside of its comfort zone in how it potentially leverages this information. And so we're watching COVID become sort of a microcosm for spurring best practices and the way the agency perhaps increases its comfort level.
If the FDA ultimately decides that real-world data improved the coronavirus response, do you expect it will be more open to factoring that data into approvals in other areas?
There's certainly that possibility. Sometimes you need a signal event to show you the potential uses. This may be a place where the overwhelming need for moving forward causes the agency to redouble its efforts in how it gets comfortable using [the data]. And then, will it in future cases use it only in the most pressing public health needs? Or will it get comfortable using it more broadly? I think it's an open question.
Have you seen any notable impact of the pandemic that hasn't received as much attention as it deserves?
There hasn't perhaps been as much focus as there might be on the great charitable and humanitarian efforts we're seeing. We've seen an enormous groundswell of interest among clients that are not in the life sciences space, but that wanted to focus their efforts and resources on entering that space and being part of the solution, for example, getting PPE out to their local communities. They were worried about their local hospitals. We've seen a lot of that.
And we've certainly seen examples of companies in the fashion industry. They have seamstresses who are not doing alterations now spending their free time making masks and wanting to do it in a way that's appropriate in light of FDA's guidance.
I think there's also just been an enhanced humanity. As all of us are working from home and dealing with each others' lives in ways that we perhaps don't normally do in professional settings. I think we're seeing a little bit of deepening of friendships and that sort of thing. If there's anything that we can all take out of this that's for the good, I'm hoping that's a piece of it.
--Editing by Alanna Weissman.
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