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POLITICO PRO -Q&A: FDA Principal Deputy Commissioner Amy Abernethy

POLITICO PRO -Q&A: FDA Principal Deputy Commissioner Amy Abernethy

FDA this week announced a project with health tech company Aetion to track and analyze Covid-19 treatments and diagnostics in a bid to better understand what works — and what doesn’t.


The new partnership with Aetion — where former Commissioner Scott Gottlieb sits on the board — is part of an “all hands on deck” approach to answering urgent coronavirus questions, FDA Principal Deputy Commissioner Amy Abernethy told POLITICO. Besides better understanding the virus itself, FDA is hoping to learn more about doctors’ approach to drugs like hydroxychloroquine that are being used off-label for coronavirus, and whether that is helping or hurting patients.

This transcript has been edited for length and clarity.


What is the breadth of this project? What is the list of drugs and treatments that you are focusing on, to start?

One of the first tasks is to develop a list of objectives, in terms of what are the kinds of questions we’re going to work on answering together under this collaborative agreement. So, it’s best if I give you a look into what kinds of questions might come up.


One example is the natural history of Covid-19. Another is: What are the treatments that doctors are giving for Covid-19 in the outpatient setting as well as the inpatient setting? And then with respect to those treatments: How are patients faring? Both from the perspective of effectiveness of the treatment and potential to treat Covid-19, but also in terms of potential consequences or safety events in receiving the medicine.


The other kinds of questions that are potentially up for exploration are issues such as: What can we understand about what diagnostic tests are being used and issues around diagnostics in the future?


What kind of data can Aetion provide that the National Evaluation System for health Technology, NEST, and the safety database Sentinel don’t provide?

FDA has a number of mechanisms already with respect to real-world data. We have the NEST program, the BEST [Biologics Effectiveness and Safety] program, which is a CBER program, and then the Sentinel program in CDER. And those programs do not go away, we continue to rely on them, for epidemiologic surveillance and safety surveillance.


Importantly in the context of Covid-19, what we’re seeing is the need for an all-hands-on-deck type of real-world evidence and real-world data strategy. We’re just trying to figure out what that strategy looks like. There are so many questions to answer, so much work to be done.


Could this Aetion data — or real-world data in general — be used in reviews to approve or authorize any drugs to treat Covid-19?

It’s a very good question. Right now, we’re really focusing on understanding what can be done with real-world data for Covid-19, how we can rely on it for operational tasks, how we can rely on it for research tasks, how can we do this work quickly and efficiently at scale.


That is going to inform lots of things that the FDA is going to need to think about. At the moment, I really can’t contemplate the direction it would go in terms of questions around approvals or our current authorizations.


So the questions aren’t settled yet, this is the beginning of the partnership. But for you, what are some of the biggest questions or priorities?

For me, it’s really important we understand the natural history of Covid-19. That’s important because this is a disease that is unfolding in front of our eyes. And natural history has a lot of importance for everything from drugs that get developed to how patients are going to fare across time and what their downstream consequences could be.


Another thing that is huge is this issue that doctors are prescribing many different treatments and it is hard to even get our heads around how to prioritize which ones should even be prescribed at the expense of other potential treatments. The more that we can begin to understand the patterns of what doctors are prescribing — and see whether or not there are approaches that would help us understand which treatments potentially have benefits or risks — I think is very important.


Covid-19 is changing the character of many of the drugs we’re prescribing across health. Being able to better understand treatment patterns, and how that influences things like drug shortages and additional demands for certain medicines, I think is another area that is high on my mind.


It sounds like you see this real-world data collection answering some blind spots on repurposed drugs that might not otherwise be tracked the way that medicines in drug trials are?

Yeah, I think that ultimately as we try to make sense of Covid-19, we have to figure out what we can learn from what doctors are doing in practice. Whether it is a potentially repurposed drug or a drug that otherwise hit our blind spot because it is not being understood in formalized clinical trials, [we will be] bringing that together with clinical trials that are currently happening, and learning from the real world to tell us what clinical trials are needed in the future.


There is this opportunity to learn from what is currently a blind spot and there is also an opportunity for that to show us a direction of where we might want to go in the future.


How does this fit into the larger context of FDA?

Within in the context of this very important accelerator, run by Reagan-Udall Foundation and Friends of Cancer Research, we’re really partnering through that program to understand what is possible across the entire landscape of real-world data providers and analytic teams that spans from the real-world tech industry to academia to government, through to health systems.


We have a lot of work to do to make sense of what is possible and what we can confidently use real-world evidence for. We have a lot to figure out in terms of how we do the analyses, full stop. And we’ve got a lot of work to do to understand which partners can best help drive forward which tasks. I see this Aetion arrangement as one of the first important steps.…