Join FDA Commissioner Stephen M. Hahn, M.D. and Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D. for their final episode of FDA Insight as they discuss FDA’s Pandemic Recovery and Preparedness Plan, or PREPP. After this episode, the program is scheduled to go on hiatus.
FDA Insight: Episode 25 – Transcript
Dr. Anand Shah: Welcome back to another episode of FDA Insight. I'm Dr. Anand Shah, the Deputy Commissioner for Medical and Scientific Affairs here at the FDA. Thank you so much for joining us for another great episode.
This week, we'll be discussing FDA's COVID-19 pandemic recovery and preparedness plan or PREPP. Returning today is Dr. Steve Hahn, FDA's 24th Commissioner of Food and Drugs.
Dr. Hahn has been commissioner since December 17, 2019. And we're happy to have him on the show, one last time. Commissioner Hahn, welcome back to FDA Insight.
Dr. Stephen Hahn: Anand, it's great to be back on the show. Thanks for having me.
Dr. Anand Shah: Well, let's jump right in. To begin, can you tell us what is FDA's COVID-19 pandemic recovery and preparedness plan or PREPP?
Dr. Stephen Hahn: Sure, Anand. PREPP is a really important initiative that we launched in August of 2020. Now we conceived of this idea and began preparations in the spring, April, basically in May of 2020. And at the time we thought we should take a mid-action review.
That is a look at how we had performed during the pandemic so that we could identify opportunities that strengthen our ongoing COVID-19 response and build this into the agency's resilience to respond to future public health emergencies.
And as we know, FDA has played a central role in the nation's response to the COVID-19 pandemic and hopefully eventually will in the recovery. And we have a responsibility to learn from our actions, to focus on what we can and must do better in the future.
Our experience so far has taught us that transparency and continuous improvement are essential drivers of a successful response. And with that in mind, we launched PREPP in August and I'm so happy that this has now come to fruition with the report that's available for the world to see.
Dr. Anand Shah: Dr Hahn, are there specific examples in the private sector or from elsewhere in government that led you to initiate this mid-action review or hot wash?
Dr. Stephen Hahn: Yes, Anand, you're using all the right terms, mid-action review, after action review, hot wash. It's a pretty standard approach that's used, the military uses a lot. Sometimes it's used in academia and certainly I believe industries that are very committed to continuous improvement are always taking looks back.
And this is a no-blame approach to saying, "What did we do well?" during a particular episode in our time, "What can we do better?" "What can we put in place to improve both our underlying performance in normal times, but also be prepared for future emergencies."
And it really is what a learning organization does. And as you and I both know, FDA, the hallmark of us is that we are a learning organization. We have a North Star that's based on data and science. We use that data and science to make decisions that are of utmost importance to the public health of Americans.
And it really is our responsibility to take this look back. So, this is very consistent with what happens in the private sector. And I am so proud of the agency for seeing this through and, Anand, I'd be remiss if I didn't thank you personally, for really being the leader of PREPP and helping us get this to the finish line.
Dr. Anand Shah: Thanks very much Dr. Hahn. And this is very much a team play amongst all of our senior leaders here at the agency. Want to take a moment to thank to Chaitali Patel, Lowell Zeta, Tim Solberg, and John Salah, as well as all of our center directors, deputy commissioners and office directors for all of their input on this work.
Dr. Hahn, how does this important work affect the agency's ongoing response efforts? I mean, we are very much in the middle of a pandemic. Our agency continues to be nimble with respect to its regulatory actions, operations crisis communications. And so how does this work, this PREPP initiative, impact our ongoing response efforts?
Dr. Stephen Hahn: So, we've been very careful as you know, Anand, to make sure that the actual process of getting this external third-party review of our response. And I think that's important to highlight that it doesn't interfere with our ongoing response to COVID-19.
So, while this is not an exhaustive review of our response to COVID-19, it is a significant look, at what we have done. And so, as you know, we've spoken internally to internal stakeholders, leaders in the agency, center directors, and we've spoken to external stakeholders as well, and this can be built upon in the future, particularly when the pandemic's over and a much broader look is taken.
But this is a terrific first start for a mid-action review. And what it does is it allows us to make changes in real time. Now, as we'll see in this report, many of the areas, the priority areas or action areas that have been identified, are areas that this agency already knew would require additional work and additional effort, potentially even additional resources moving forward.
So some of these have been incorporated, of course, there's more to do in our ongoing response and more to learn from what we have done so far.
And then just one final point, Anand, this PREPP report is not binding on the agency. It is an important third-party assessment, but it's not exhaustive. And this really should provide some basic understanding of what external and some internal stakeholders think of our response, but we really need to think very carefully about what resources we need and also what potential statutory authority we might need as we look to how we can become more resilient and improve our responses in the future.
So, there's a lot of work ahead of us, but this is a terrific first start, and it has been fed by what we've done in response to the pandemic, but it is not binding on us. And it has not interfered with our ability to respond in real time.
Dr. Anand Shah: Commissioner Hahn, can you give us some examples of the priority areas that you mentioned or action areas identified in the report?
Dr. Stephen Hahn: Oh, yes, for sure, Anand. There are three general action areas that were identified. One is accelerating the immediate COVID-19 response. Now that's important and an example of that is how can we adjust our industry guidance to help accelerate the development of therapies?
The next is selectively sustaining and scaling innovations. So, in this area, what we want to do is build on innovations that FDA personnel have in some cases begun prior to the pandemic. But how can we build upon them and scale them to meet the incredible workload that's come our way in COVID 19.
And then the third area is enhancing future pandemic preparedness. Looking at our emergency response, how we might approach enterprise risk management. And these are actions that are more relevant to the early phases of the pandemic response, or have immediate relevance to the COVID-19 response, but a longer timeline that is multi-year to have impact.
Dr. Anand Shah: And Dr. Hahn, now that the report is publicly available, what are the agency's next steps?
Dr. Stephen Hahn: Thanks to you and your team, we've had great engagement from the senior leadership in the agency. This report will serve as a baseline report of our response to help provide further impetus and further motivation to move forward in the latter phases of our response to the COVID-19 pandemic. But also, in the future as the agency decides what it should lock in as permanent changes.
And so just a few examples to think about there, that will be considered, I think strongly by the agency, is one is how do we approach clinical trials in an era where we had very limited interaction between providers and patients because of the pandemic? How does this change how we approach clinical trials? I think that's a really important outcome from this.
The other is how do we approach inspections, given that for many of our routine inspections, we could not do face-to-face inspections, but use some of our other authorities. So how do we update our inspections in a way that allows us to respond in real time outside of a pandemic, but in a very efficient, but incredibly thorough way.
These are just two examples of things that I believe will come out of here, out of this PREPP document, and that will be used in the future to further improve the agency's response overall.
Dr. Anand Shah: Well, Commissioner Hahn, thanks for all your leadership related to the PREPP work. And finally, what's next for you after the FDA?
Dr. Stephen Hahn: Well, Anand, it has been the honor and privilege of a lifetime to serve the American people as the Commissioner of Food and Drugs. It's been an honor to serve alongside the more than 18,000 employees at the FDA who have tirelessly worked on behalf of the American public and public health.
And so, I can just say that I will look back on this year as quite the challenge, but an incredible honor and privilege. I'm going to take some time off on, Anand, and contemplate what the next steps are.
I haven't made any decisions about that. Haven't had any discussions, but I know that I'll always be an FDA-er if you will, I'll always be one who prides myself in being at the agency and I will be cheering from the sidelines, the incredible work that the FDA does moving forward.
Dr. Anand Shah: Well, Dr. Hahn, I think we could probably talk all day, but it's time to wrap up this episode of FDA Insight. Thank you again for your tremendous leadership and stewarding the agency during these challenging times.
Dr. Stephen Hahn: You're welcome, Anand, thank you for your partnership, your incredible leadership on many areas in particularly the PREPP initiative, thank you.
Dr. Anand Shah: Thank you very much. And to our audience, this will be our last episode of FDA Insight with me as the host. We've recorded 25 episodes since this past summer, covering a wide range of topics, from COVID-19, food, safety, vaccines, hand sanitizers, and more.
At the end of every episode, I've repeated the same sentence, which has always been our goal on FDA Insight. That sentence is, “we'll be providing you insight in plain language to help you understand the products that we regulate, the issues that we face and the processes that we follow.”
I hope we've been able to pull back the curtain a bit to provide you that insight on how FDA works to protect the public health, especially during the COVID-19 pandemic.
If you've missed an episode of FDA Insight, you can find all of them listed on Apple Podcasts, Google Podcasts, Spotify, and Pandora. And for the last time, I'm Dr. Anand Shah, thank you for listening.
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