Former FDA CDRH director Dr. Jeff Shuren [Phooe courtesy of FDA]
“It would not be surprising if we saw longer review times, at least in the near term,” he said today in a webinar hosted by medtech testing, clinical and regulatory consulting firm NAMSA. “Some of the terminations rescinded were for premarket review folks, and the administration has said they’re looking to protect the premarket review program. But some of those people have decided not to come back. Some people in the program have taken the buyout. Some [due to] for return-to-office or poor morale have decided to move on, or they’re currently looking to move on, and that all of that has an impact on the program.”
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Shuren said CDRH had a high attrition rate when he joined, but recruiting and retention efforts were successful in keeping talented experts at the center.
“Industry had concerns that if their lead reviewer changes — and they were seeing that happening in the middle of the review — it can be very disruptive,” he said. “We spent a lot of time trying to enhance that environment, building a program to better recruit and retain top talent, and getting in people who were seasoned — further in their career — coming in the door with variety of backgrounds.”
“Unfortunately, a lot of the people involved to date in those efforts have also been part of the RIFs,” he later continued, using an abbreviation for reduction in force. “So hopefully that will be addressed moving forward.”
Shuren said the Trump Administration’s request to do more with less might be helped by artificial intelligence tools in premarket review.
“There are lots of opportunities there,” he said. “In fact, the center is already looking at those and starting to invest in tools to leverage that, to make it a more effective, efficient program. Lots to do there. It’ll be important to continue efforts on data management, because you have to make sure the data that’s already there and that’s coming in the door is cleaned up, it’s consistent, you’ve got a taxonomy, there’s tagging, so you can make the best use of that data. And we had an effort underway to do that. It’s not yet done. So hopefully, if anything, that gets expedited. But also, some of the people involved in that were part of the RIFs.”
Shuren said he had three hopes for CDRH.
“Hopefully the career staff will be part of the solutioning. They’re not just good people. They are great people. They are smart. They are dedicated to advancing public health. They are forward leaning, and they are innovative,” he said. “As long as they know what you want to achieve, they’re going to roll up their sleeves and willingly engage to help achieve those objectives. We’ve always at the center looked for ways to be more efficient. It’s just good government done right, and we’ve had a lot of efforts over the years. We’ll never have as much resources as we would like, and we have to be responsible stewards of the resources that we do have. One of the efforts more recently underway was program redesign of some of our core businesses, and that included premarket review. Staff have already come up with ways that they can do that, some innovative approaches and even piloting those. Hopefully those are part of the mix, and they’re built on and new ideas put on the table.”
He said he also hoped that whatever change comes “doesn’t compromise the rigor of the evaluation that’s performed.”
“Having robust science to inform decision making has really been the lifeblood for the agency,” he said. “Patients and providers rely on the FDA to assure those devices are safe and effective, and industry relies on them too for that seal of approval to have consumer confidence. Over time, we’ve become a gold standard in medical devices. We weren’t always there, but we’re there today, and hopefully that isn’t compromised — if anything, [I hope] that image is burnished.”
Finally, he said he hoped for attention and investment in device safety.
“At the agency and at the center, we’ve done a lot for device safety,” he said. “It doesn’t get picked up in the press a lot. It’s not sexy. If there are problems, that makes the news, but when we do things to make things better, not necessarily. But we’ve have for years — and been very public — operated under two pillars: safety and innovation. So hopefully the efforts are not only continued, they’re advanced and new ideas and investments go into device safety.”
Previously: Vision check with FDA CDRH Director Dr. Michelle Tarver
