ISPOR: Amy Abernethy Talks About the FDA During the Pandemic and the Agency's Independence

Below is a brief Q&A of the interview with Abernethy. It has been edited for clarity and length.

Q: The use of telehealth and remote patient monitoring exploded during COVID-19, but so did concerns about cybersecurity and patient privacy. Given your technology background, what concerns do you have going forward, and how do the issues that have come up during COVID-19 fit into FDA guidance?

A: Like social determinants of health and health disparities, the issues of cybersecurity and patient privacy were something that became really evident, came into focus in the context of COVID-19. In fact, my family is in North Carolina right now trying to figure out how to get gas in the car because of the recent ransomware attack on the pipeline. Importantly, I think what we've seen in the context of COVID, is we can't just keep saying cybersecurity is something for the tech folks to take care of, really, cyber security is all of our concern.

We have a responsibility to make sure our computers are up to date and that we've developed smart practices among all of the team members within the organizations where we work so we're training our staff, we're developing protocols for acute events, we're updating software and updating patches in a routine way. We don't just see this as an annoyance. Doing the phishing test, so to speak, but rather a critical set of capabilities to keep us all safe in a landscape where cybersecurity is a real thing.

I think that's similar for protecting a personal patient's health information and privacy. This is all of our responsibility. We have to do the basics. For example, we need to re-identify datasets, and we need to make a commitment not to try and re-identify patients. We need to get smarter, we need to learn to leverage privacy sparing innovations like tokenization or synthetic datasets. We also need to stimulate the development of new innovations that advance privacy so that we can continue to do the good work we're seeing in real world data, real world evidence and HERO. Practically speaking, less cybersecurity and patient privacy is part of our national conversation and our national understanding from us as a society about what we must do to protect ourselves and protect our futures.

Q: Where did FDA use data effectively during COVID-19? What are the lessons that the agency can learn from going forward?

A: When I was in the FDA, I was both principal deputy commissioner and the acting chief information officer. It was really interesting to see the landscape unfold before my eyes. I remember that as we set out the technology modernization action plan in September of 2019, what I was thinking about at the time, was vaping and vaping-related lung impact. We quickly rounded the corner into 2020 and the COVID-19 pandemic came.

Suddenly, the preparations that we were putting in place in the end of 2019 took incredible new meanings. What we saw was data starting to be put to use a ton of different ways. Some of that was observational and descriptive, like supply chains. Some of that was really using data to drive algorithms that helped FDA do its work, such as algorithms that allowed FDA inspectors to decide which factories and manufacturing plants to inspect and when it was safe to do those inspections. Some of it was using data now in new ways to inform both our understanding of the pandemic and also our understanding of medical products in near real time, whether that was diagnostics for COVID or vaccines.

One of the things I learned and I think all of FDA learned during this period of time, is we have many different types of data sets that can be brought to bear. However, we need to learn quickly how to work with these new datasets and how to have credible results that we can trust. That actually was an important aspect of what FDA did as a part of COVID. I think what happened really across all of the research, data, government spaces, through public private partnerships, and other mechanisms, FDA developed new ways of thinking about data sets. I think we saw that really across the entire landscape of people coming to work with data in service of COVID-19.

Q: Would you share some thoughts on the FDA’s independence. It was challenged several times when you were there. Do you think there are enough safeguards of the agency’s independence in place? And do you think the agency’s reputation was harmed during the previous administration?

A: FDA is a science-based public health agency. FDA regulates somewhere between 20% and 25% of the world's economy and has as a direct responsibility to protect and promote public health. There's over 18,000 people that work at FDA and one of the things I learned while I was there is there is an incredible career staff at FDA. These are dedicated scientists, many of whom have been there for a long time. They're dedicated individuals who understand medicine, who understand food, who understand the different products that FDA regulates. What I saw at FDA, is that even in complex environments, where in the world outside of FDA was sort of arguing in different ways, FDA is career staff was able to focus and really focus on doing the right thing, performing thoughtful regulatory review, making hard and judicious decisions, communicating with the public, revising decisions when needed.

I personally believe we need to have societal safeguards to make sure that an agency like the FDA is able to do its work and focus on the science. It is a science based agency. Therefore, I really believe we need to continue to advance our societal discussion of they understand the importance of FDA is responsibility of following the science and making thoughtful decisions. And we also need to continue important communication with the public about what this looks like for the future.

Q: Did Stephen Hahn consult with you during those episodes? Any thoughts on what could be done to ensure the agency’s independence?

A: So I was both Principal Deputy Commissioner and acting CIO during this incredibly important time of the pandemic. I've really focused on making sure that the career staff and I were able to focus on the science-based public health responsibility of the agency. I personally also focused on making sure that we can bring data and technology to bear both now, in the context of the pandemic, but also in the future to make sure the agency could continue to do its work. I'm really positive that how we got there as it relates to leveraging data and technology and focusing on getting the right work done. And really their work across the agency.

Q: Would you share some thoughts on the length of time it is taking the Biden administration to nominate an FDA commissioner. Does it reflect indecision or perhaps a struggle over the future of the agency?

A: You know, after January 20, I heard really some interesting things from the Biden, Harris administration. I heard an incredible confidence in the senior career leadership of the agency on how to run an agency in a way that keeps your eye on the ball of a science based public health mission and an incredible confidence in the agency leadership to keep doing what needs to be done. With respect to the nomination, I anticipate that the Biden Harris administration is going to nominate somebody when the time is right.

I've come out quite publicly saying I really have confidence in Janet Woodcock and I continue to do so. She's been at the agency for over 35 years and really understands what it means to be at a science based public health agency and to advance regulatory work across time in contemporary and new ways. I think the other thing that she's done since January 20, which is very remarkable, is she's gone from leaving a specific center, to leading an entire agency with her eye on how to you help the whole agency move forward, representing all of the different products of agency regulates. I think that she has shown that there's no question that she is able to keep pushing that forward as a senior leader of the agency.