A Chat With Jeff Shuren: FDA Device Center Chief Worries About Agency Staffing; Talks MDUFA V, Pandemic, More
The head of the US agency’s device center spoke with Medtech Insight in an exclusive wide-ranging interview about his priorities for the future, the nuances of the MDUFA V user-fee negotiations, how COVID-19 has changed the agency, and more.
Jeff Shuren, director of the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), recently talked to Medtech Insight about lessons learned from the COVID-19 pandemic, warned that some agency staff are only staying on until the crisis is over, and how the Medical Device User Fee Amendments (MDUFA V) negotiations are going.
Listen to our podcast, or read a lightly edited transcript below:
Also, staying abreast and optimally ahead of new technologies, as well as generating and getting access to critical data to support timely decision-making, such as to resolve postmarket safety signals quickly rather than continued uncertainty from patients and providers about the impacted devices, continue to be big challenges.
“Our IT systems are outdated and siloed.”And lastly, our IT systems are outdated and siloed. Our staff are constantly having to go in and out of different systems to get their work done and end up doing a lot of things manually. We spend extra time to find or incorporate information. Under our Digital Transformation initiative, we’re in the process of implementing interoperable agile platforms and moving our data to the cloud, but it takes time and a lot of money.
However, we’ve been planning this transition as well as saving and securing funds for several years to help make this happen.
In addition, we had a leverage about 130 people full-time or part-time to address issues related to shortages of critical medical devices and the work increased dramatically, but our staff did not. Every office in CDRH has been impacted particularly since we had to reallocate some of our staff and resources from product areas less impacted to those with increased submission volumes and to engage in other COVID-related work.
The reality is that many of our staff are burned out and we could very well lose talented people as we continue to prioritize COVID-related work. I know of some people who have stayed just to help address the pandemic but plan to leave once we are back to the new normal.
To address this we’ve made changes in our processes and policies, conducted submission triage and prioritizations to better manage the workload, aggressively hired with a record year of net new employees. But we are also very grateful for the one-time funding we received from Congress, which has allowed us to hire additional termed staff and temporarily use contractor support to address some of the critical COVID response work.
We’ve also focused on wellness for CDRH colleagues, including through the creation of a virtual wellness center, and most recently launching a pilot on giving our staff breaks before and after internal one-hour meetings.
“FDA is transitioning to standard operations for domestic inspections beginning July 1 and will continue to prioritize mission critical work for foreign inspections.”The agency explained its plans in the recently published resiliency roadmap for FDA inspectional oversight. And consistent with the roadmap, the FDA is transitioning to standard operations for domestic inspections beginning July 1 and will continue to prioritize mission critical work for foreign inspections.
However, there are inherent challenges in planning foreign inspections in light of the time involved. So the agency estimates that given the length of time required to plan foreign inspections, no foreign surveillance inspections conducted by inspectors traveling from the US will likely be achievable before September 2021 when using US-based staff.
However, the FDA’s foreign offices were already performing a limited number of foreign surveillance inspections during this year.
The device program has and will continue to participate in the Medical Device Single Audit Program – MDSAP – and this participation has continued throughout the public health emergency. In fact, we’ve leveraged MDSAP audit reports in lieu of FDA surveillance inspections. For example, in 2020 MDSAP audits that we received were conducted over 2,800 medical device manufacturing facilities and the MDSAP program was able to pivot to perform some types of audits remotely.
And then the agency has been exploring the use of other approaches to complement its inspection program. For example, our Office of Regulatory Affairs [the lead office for all the FDA’s field activities] implemented a voluntary remote regulatory assessment that it has been using with medical device facilities for the past few months. And right now these assessments, which are not inspections by the way, involve interactions with facilities using established virtual platforms. And in the future they’re going to be looking at the use of other tools and probably pilot those and certainly encourage any companies who are participating in these assessments to provide their feedback to the agencies so have a better understanding of what’s working, what’s not working and what can be improved.
Tell us about some of those disagreements and how you’re addressing those with the with industry, and also tell us a little about the TAP program and kind of how you envision that.
As you’ve noted over the past decade, those numbers continued to go up and up and up.
I’ll say on the flip side, MDUFA has been primarily focused on the premarket review portion of the total product life cycle, whereas many of the challenges facing device makers occurred during the development and evaluation phase prior to premarket review; the true “Valley of Death.”
In fact, many of the holdups and adverse decisions made during premarket review stem from not getting it right; if you will the companies are not getting it right in the development and evaluation phase.
There are also challenges encountered after FDA authorization such as coding, coverage reimbursement and adoption by health care providers. If given the right support during the development and evaluation phase, many device makers could be better positioned to succeed with payers, providers and patients.
During the pandemic we saw the transformative impact of near and real-time interactions between developers and CDRH experts getting devices developed, evaluated and authorized quickly.
However, that level of engagement by the FDA is not feasible on an ongoing basis because we don’t have the capacity to do so, let alone to even engage in greater interactions with many sponsors who participate in our Breakthrough Devices program.
Pre-submission meeting requests are popular. The number of requests we receive grows every year, but it can hit a three-month process, focus on addressing limited questions, and if there are more questions you have to request another pre-sub and the cycle starts again.
And we would like to provide meeting a greater level of premarket engagement than during COVID with more touch points, real-time interactions, and a more proactive strategic and problem-solving approach. We call it the TPLC advisory program, or TAP. It includes building at our review capacity to allow for these kinds of real-time interactions and adds a new member to the team that we call a TAP advisor who will provide a concierge style of strategic support, address basic questions and ensure that the right experts and support are available quickly when you need. If implemented, we believe it would be the biggest game-changer we’ve seen since the first MDUFA was enacted almost 20 years ago. We also would like to see investments in a more robust signal management program.
It’s critical for not just assuring that authorized devices remain safe and effective once on the market, but to also inform future device modifications and new technologies subject to premarket review. And that said, I would be concerned about a program that looks backwards, not forwards.
Right now though, we’re still in the midst of negotiations, so it’s too early to project any outputs.
But other companies are not in that situation. And our experience has been that a number of the players are very willing to come to the table, and that’s the patient community, that’s been in the provider community, and on occasion in the payer community.
But one of the things we’d also like to see as we roll out the program is for us to have the capacity to build a better relationship with payers.
I have to tell you and not all payers are the same. It’s not one-size-fits-all and we have a number of payers who have been actively interested and taking advantage of those opportunities if they’re offered.
And the need to provide such assurances for all tests was further underscored by our experiences with COVID-19 tests. We continue to look forward to working with Congress, HHS and others on that legislation.
“I believe we will continue to have more virtual interactions rather than face-to-face meetings.”In regard to regulatory Legos, or agile regulation, the current device regulatory framework was enacted by Congress about 45 years ago, and it wasn’t designed for the modern technologies of today. It’s no longer fit for purpose.
Besides engagements, another lesson learned from the pandemic is the importance of regulatory flexibility that we were able to provide under our emergency use authorization authorities once a public health emergency is declared but not at other times. The flexibility to narrowly tailor the regulatory pathway for a given type of technology and use that can be rapidly designed to focus on the right things to reasonably assure safety and effectiveness, in the least burdensome manner and applied in a risk-based approach.
We think this agile regulatory approach, which would require legislations … would better assure patient safety while providing voluntary streamlined pathways for industry. There would be options. This isn’t about changing the US regulatory standard, but rather how to a best meet them instead.
I also think we’ll see more work being performed in a virtual shared environment, both externally, such as Remote Regulatory Assessments or hybrid inspections, premarket review, as well as internally at the FDA as more people will be teleworking, as we’ve discussed just a moment ago.
That includes opportunities where so many of us work together more closely, collaboratively and quickly than ever before. My hope is that we implement and build on these lessons learned so that we all, in particular patients and consumers, are better for it.