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Amy Abernethy, FDA's principal deputy commissioner, sat down with Medtech Insight during CES 2020 to discuss the agency's progress on the Technology Modernization Action Plan, the pre-certification program for digital health products, and the FDA's plans for 2020.



The US Food and Drug Administration's announcement on 8 January that it will hold a public meeting in late March to discuss the agency's efforts to modernize its technology infrastructure came the same day as one of its highest-ranking members, principal deputy commissioner Amy Abernethy, addressed industry members during the Digital Health Summit, part of the Consumer Electronics Show, CES 2020 in Las Vegas. (See photo below, courtesy FDA). 

Abernethy told Medtech Insight that one major part of the Technology Modernization Action Plan (TMAP), which was first introduced on 18 September 2019 and lays out the agency's short-term actions to close the gap between new scientific advances in data gathering and regulatory technology needed to protect public health, is to start a conversation with industry. In particular, the plan describes actions that the agency will take over the next three years to modernize its use of technology to capture real world evidence among other purposes. (Also see "FDA Unveils Technology Modernization Plan To Better Handle ‘Tsunami’ Of Incoming RWE Data" - Medtech Insight, 19 Sep, 2019.)



"This is what was on my mind when I signed up to come to CES – that it was really important to start to show up at all of the different places where the data and tech community is, because if we just sit in Washington and wait for people to come and meet with us, we might not hear all the things we need to hear and understand where things are going," Abernethy said.

As the FDA's principal deputy commissioner, Abernethy helps oversee the agency's day-to-day functioning. Before coming to the FDA, the physician-scientist served as chief medical officer at Flatiron Health Inc. (now part of Roche) where she played a pivotal role in transforming data collected from electronic medical records into information acceptable to FDA regulators.

Abernethy sat down with Medtech Insight during CES 2020 to offer her perspectives on the TMAP and its progress since the agency released the plan last September. She also outlined her hopes and expectations for the public meeting on 27 March to discuss the TMAP, talked about the Software Precertification Pilot Program, as outlined in the FDA's Digital Health Innovation Action Plan, to provide more streamlined regulatory oversight of software-based medical devices; and discussed FDA's plans for 2020. (Also see "Pre-Cert Program Will Start Off Slow With De Novo Framing, But Big Questions Remain" - Medtech Insight, 14 Jan, 2019.)

(Q) Medtech Insight: Why did you decide to come to CES?

(A) Amy Abernethy: I joined FDA in February of last year and took on the role of acting CIO towards the end of March. As I was doing that, it became very clear to me that one of the things that I needed to focus on was the technology modernization activities of FDA. And given that, and my anticipation that we would be developing a strategy around tech modernization, I identified that CES would be one of the meetings to attend. From my perspective, consumer electronics data technology, writ large, is going to be critical across the entire health-care space. This is a place [CES] to sense what all is going on. It's also a place to be a part of the conversation and say, as [the] FDA, this is what we think is important. 

(Q) What have been some of the most intriguing things that you've seen at CES?

(A) Abernethy: As consumer electronics become more and more ubiquitous [it] is going to very naturally bleed into all aspects of our health. I was looking at really thin TVs, and then 3D images coming out of essentially what looked like TV screens, and imagining how that might start to advance the entire space of patient interaction via video to make it feel more and more empathic. I think that the kind of meta messages, that as technology continues to advance, it's going to also advance in line with health care. Figuring out how the FDA has a responsible role in that space, that is [a] right-sized risk and maintains public health and also promotes innovation, is what I see is really important from an FDA perspective.

(Q) With regards to the implementation of the FDA's TMAP, how has this plan progressed so far?

(A) Abernethy: I'm really proud of how this plan is progressing so far. There are three core elements of the plan and each one has essentially a different cadence. The first part of the plan is focused on the technical infrastructure at FDA. And for the first six months or so that I was in the CIO role, that was almost 80% of my day. The second part of the plan is focused on starting to build out examples, or use cases, that showcase how data and technology is going to be used differently at [the] FDA, and what's possible.

And the third part of the plan is focused on opening up the communication streams with the greater community of data and tech innovators, so we can figure out how we right-size, what our voice needs to be in this space, and how we help to maintain public safety, but also promote innovation. With respect to the first area, the technical infrastructure, enough pieces are in place that I'm backing off on my role there. We hired a chief technology officer. We have focused on making sure that we update the culture of the [FDA] to be really in line with where technical builds are going to be now and in the future; we started to outline a “cloud-forward” strategy [how data is stored, managed and processed]. And we really worked on making sure that our cybersecurity focus continues to be par excellence. And now that we have the right people in place, now that there is enough of a cultural shift, I feel like I can back off and I don't need to be the one doing it every day. The second part of the plan, the individual use cases [small pilot projects targeting problems and opportunities that will strategically serve to advance modernization efforts], we announced our first meaningful use-case activity around the seven- and 15-days safety reporting for IND [investigational new drugs] back in October. It's a really good example of where the agency is going.

The data for INDs historically came to us through MedWatch forms. The pharma company would fill out a form with the safety information. The form will be transmitted to us [FDA] as a PDF, and then, our medical reviewers will look at PDFs and try and figure out safety signals. Except, it was coming out of databases and going onto forms, and then, the forms were coming to us. We developed an application programming interface (API) in partnership with industry. And now that the API is getting up and functioning, we've developed a draft guidance around it and we're moving to a place where data is being directly communicated from the sponsor to the agency as individual-structured data, ready to be analyzed, as opposed to the forms that have to be visually inspected. [This] sets us up to be more efficient and to be able to identify signals more easily. It means that we can put the time and smarts of medical reviewers to better use.

And it also is such an important herald of what's possible and what's going to be different in the future. (Also see "New Guidance From FDA Lays Bare Types Of Submissions That Must Be Filed Electronically" - Medtech Insight, 25 Sep, 2019.) The third part of the plan, which is about opening up the communication with the larger community of data and tech stakeholders [starting with a first public meeting on March 27, announced during CES on 8 January], is one example of that. This is what was on my mind when I signed up to come to CES – that it was really important to start to show up at all of the different places where the data and tech community is, because if we just sit in Washington and wait for people to come and meet with us, we might not hear all the things we need to hear and understand where things are going.

(Q) When will you see the first use case for medical devices? 

(A) Abernethy: In the device center, CDRH [Center for Devices and Radiological Health], there's already a number of activities going on in terms of their modernization activities. In the TMAP, we don't have a device-focused task. Frankly, that's the part of the agency that's been thinking the most about how they use data to, for example, monitor real-world performance etc. We're continuing to communicate with them about this. But we don't have a first example [of a use case].

(Q) Are there specific goals that you're hoping to achieve during this meeting or certain feedback that you're looking for from the industry or the stakeholders?

(A) Abernethy: Number one is a visible direction that we're going to develop a data strategy for the agency and make sure that the whole industry knows that's something that we're working on and has the opportunity to comment on it. We're very interested in understanding industries' thoughts in terms of use of data that industry submits to us for new and important purposes in the future, including algorithm development and identifying safety signals, and being able to continue our scientific work. I'm very interested in the public's comments about privacy and how we should be thinking about privacy as an agency. Certainly this is a complex space.

I am interested in the vision of industry about how the agency should be using data in smarter and more rapid ways and [get] examples of problems that we might be solving. Practically speaking, having those examples submitted from industry and from the broader community helps us understand what people are thinking about, and what people are seeing helps us imagine what we need to solve internally. I anticipate we will hear questions about standards: "Should the agency be pushing forward on standards or should the agency stay quiet on standards?" I anticipate that we will hear about concerns of risk of identification at the patient or corporate level and how to help protect against that. I also don't think that one meeting is going to solve the problem. So, if anything, what I've been trying to say is this is intended to be a very public signal that now is the time to start moving forward with the conversation, so we can figure out how to get this right and plan for the future.

(Q) What can you tell us about the progress of the digital health pre-certification program?

(A) Abernethy: One of the things I watch for is, "Are we being smart and facile to anticipate where things are going and try and develop new strategies?" We think about the digital space – the traditional regulatory pathways just don't match up to the way that a software company, an algorithm development company, does their work. And also, the rapidity to which there is change. We're going to need to be creative and thoughtful and very transparent about what potential new pathways can be there. And pre-cert is an example of CDRH trying to be very thoughtful about what is possible given the realities of software development and artificial intelligence and where that space goes. It's very much a pilot, but from my perspective it's our responsibility to do that important developmental work. Because if we're not keeping pace where things are going, we're going to end up with outmoded regulatory pathways that don't match. (Also see "CDRH Will Experiment With Pre-Cert Pilot Participants To Figure Out Right Metrics, Processes" - Medtech Insight, 7 Feb, 2019.)

What are FDA's plans for 2020 as it relates to the medtech industry in particular?

(A) Abernethy: One of the very important aspects of medtech, and I'm going to call it health tech, the largest space of digital capabilities required to advance health, is that the space is massive. And there is a small and important component, which is the software solutions that fit squarely within the space that we directly regulate; software as a medical device, software embedded in devices, etc. One of the things you're going to see in 2020 [at the FDA] as we figure out the right trust infrastructure across this entire space so that whether it is the purchaser, like a life sciences company, or the consumer, like you and I, everybody has the confidence that these are the solutions that are actually performing the way we would expect them to perform, and also are going to be aligned with the overall industry. We don't spend enough time talking about how important all of those spaces are to health. It makes it very hard to figure out if you're one of those companies. [For instance]  "How do I know the product that I'm building is going to be reliable enough for generating reliable-enough data to be something that now my core market, for example, life sciences companies, are going to have confidence to buy?"

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