Retirements from the Food and Drug Administration are hardly shocking, especially in the wake of pandemic burnout. But when longtime medical device director Jeff Shuren announced his departure in July, the device world was stunned. Industry leaders, patient advocates, and FDA colleagues alike had grown accustomed to the ambitious, politically-savvy regulator.
“It’s sort of hard to imagine the FDA without him,” said Yale cardiologist and health outcomes researcher Harlan Krumholz. “He’s been the face of CDRH for forever.”
Shuren landed at the Center for Devices and Radiological Health after serving in various policy roles in the commissioner’s office, with stints as an FDA detailee on the Senate health committee and as a director at the Centers for Medicare and Medicaid Services. All in all, he’s worked in the government for 28 years.
That’s rare, especially given the revolving door between government and industry. Shuren’s tenure in government almost rivals that of veteran FDA drug chief Janet Woodcock.
Shuren took over a chaotic device center in 2009, and was tasked with earning back the trust of both the public and the device industry. Device makers told STAT that Shuren has succeeded with industry, making the regulatory process more predictable and spearheading innovative projects.
He’s been less successful with the public. Though Shuren worked to engage more patients in the review process and improve postmarket data collection, risky devices still slip through the cracks — a key example is the 2021 botched recall of Philips’ sleep apnea machines. Some patient advocates said he catered too much to manufacturers and could have done more to protect patients.
STAT interviewed a dozen former colleagues, patient advocates, and industry representatives about Shuren’s legacy. The device leader made his name as a regulator who was able to get things done, patiently working around bureaucracy and Congressional squabbles. He was a reliable advocate for medical device regulation, seeking the same resources and recognition offered to other centers within the FDA.
“Not everything he’s done has succeeded, but he’s been willing to try,” Krumholz said. “It’s unusual to have someone in government who is willing to innovate.”
Shuren, 61, declined an interview with STAT through the FDA’s press office. He hasn’t yet said what his next move will be. Given his reputation as tireless, true retirement seems unlikely — he’s well-connected in the device industry, and could easily get a job in the private sector.
Michelle Tarver, an ophthalmologist and epidemiologist who’s also worked at the devices center since 2009, has taken over the acting director. Shuren is still working in the commissioner’s office as the FDA searches for a permanent replacement, which could take until the end of the summer. Device makers are hoping the next leader brings more of the same, whereas patient advocates want someone more explicitly focused on safety.
There was tremendous unrest at the device center when Shuren first took over.
Nine FDA scientists had recently sent Congress and the incoming Obama administration a letter claiming they were forced to approve high-risk medical devices. Shuren’s predecessor Daniel Schultz stepped down in August 2009 amid the controversy. Diana Zuckerman, president of the National Center for Health Research, helped advise the Obama transition team as they sought to fill vacancies in the agencies.
“I said we needed a new director of CDRH who had a better understanding of science than the people who had been there before,” Zuckerman said.
In addition to the dissident FDA scientists, outside researchers were criticizing the agency for its device approval process. Zuckerman was one of them, co-publishing a study showing that most recalled medical devices had been cleared through the 510(k) program, a pathway for products considered “substantially equivalent” to devices already on the market. Another study from University of California, San Francisco researchers lambasted the study designs of cardiovascular devices that had been approved by the FDA. The Government Accountability Office also published a report taking issue with the device approval process.
Zuckerman said she spoke with Shuren at the start of his tenure and was heartened by his focus on public health. He had strong credentials as both a neurologist and an attorney. Shortly after starting his role, Shuren told the New York Times that the center would push device makers to generate higher quality clinical data.
“It is not acceptable, and that is the reason we are making the changes in the program we are making,” he said in the December 2009 article.
FDA reviewers started asking more questions, applying harsher scrutiny to device trial designs and data. Then device makers started to turn on the center, claiming that the regulation process had become too onerous and uncertain. At a 2010 industry conference in Minneapolis, device makers complained directly to Shuren. Investors were pulling out and stunting startups, they said.
“At certain times in the past, the pendulum has swing far to one side or the other,” Shuren responded, according to Minnesota Public Radio. “To fulfill our mandate we must embrace both parts of our mission — that is what it means to truly take a balanced public health approach.”
Every regulator has to balance both safety and innovation, protecting patients from harmful products without gatekeeping the ones that might help them. Shuren’s former colleagues say he navigated this tension well, lending support to initiatives that championed both ideals. Zuckerman and other patient advocates say he focused too much on innovation, and not enough on shoring up the agency’s checks and balances to improve patient safety.
Along with current acting devices leader Michelle Tarver, Shuren was instrumental in launching the patient engagement advisory committee in 2015, creating a formal body for patient input during medical device reviews. He frequently met with staffers working to beef up FDA’s postmarket surveillance efforts. Terrie Reed, an executive at health data company Symmetric Health Solutions, helped lead the device center’s project requiring manufacturers tag their products with unique device identification numbers. The goal was to make devices more trackable, serving patients by keeping an eye on safety and efficacy.
“He met with me every week and tried to support the UDI team whichever way he could,” Reed said. “It emboldened us to take risks that I don’t think we would have taken otherwise.” For example, Shuren encouraged Reed to collaborate with other government agencies.
Reed said it would have been easy to be a hands-off center director, focused only on high-level strategy. But Shuren wanted to know the nitty-gritty details and help out where he could.
Momentum on the UDI and other surveillance projects slowed, however, after a few years. Though the FDA requires device makers to tag their products with UDIs, providers are not required to include these identifiers in health records, making it impossible to track devices on a national scale. The FDA awarded a nonprofit $3 million to build a device safety database in 2016, but that project has yet to come to fruition.
Reed said Shuren and other government leaders lost interest in those projects.
“At the time I left in 2019, I was kind of feeling like the shiny star lost its shine,” Reed said. “There were new shiny stars.”
Shuren worked hard to increase the number of medical device submissions. He led the launch of the breakthrough devices program, a regulatory pathway meant to hasten the development of devices addressing unmet patient needs. So far, the initiative has delivered financial gain to companies, but the benefit to patients is far from clear.
Alex Cadotte, who worked at FDA’s digital health center until 2021, noted that Shuren prepared the center to regulate an influx of digital health products. Though the FDA is still figuring out exactly how to regulate artificial intelligence, Cadotte said his European clients at device consulting firm MCRA typically go to the U.S. first for advice on submitting their AI products.
“They pretty much know that the FDA is further ahead than the EU when it comes to handling AI,” Cadotte said. “They often feel better prepared going to the United States for feedback.”
Scott Whitaker, president of medical technology lobby AdvaMed, said Shuren demystified the regulatory process for device makers and pushed the FDA to stick to agreed-upon device review timelines. Shuren increased the number of medical devices authorized by the FDA each year by five-fold during his tenure.
“They began to view us as an entity they regulated, but also as partners in the innovation ecosystem,” Whitaker said. “They knew that in order to improve patient lives and get new technologies to patients, it required us to work together.”
Some patient advocates said industry leaders speak too warmly about FDA and about Shuren. Linda Radach, a patient advocate in Washington harmed by metal-on-metal hip devices, said the FDA process still does not protect patients enough.
“I think he truly does believe that his customers are not patients, but industry,” Radach said. “He’s just way too close to them.”
Zuckerman and Rita Redberg, another researcher who has published studies critical of the FDA, said Shuren did not appropriately prioritize patient safety. The vast majority of devices still go through the 510(k) pathway, meaning most products do not have to provide the FDA or the public with clinical data. The device center has made incremental changes to the pathway.
“After a few years, Dr. Shuren focused much more on innovation and became greatly appreciated by the device industry and not particularly appreciated by consumer and patient groups,” Zuckerman said.
It’s true that Shuren worked closely with industry, particularly while negotiating the terms of the user fees device makers are required to pay to the FDA each year. The negotiations occur every 5 years. In 2022, device makers paid the agency $228 million, making up 35% of the center’s budget. In 2007, user fees made up 17% of the center’s budget. That number grew to 36% in 2016.
Shuren’s colleagues said he excelled at user fee negotiations, finding ways to up device maker contributions and get more resources for the center.
“He was very aware of where things are, and what things people would resonate with, and where he could push as much as he could to a certain direction,” said Google digital health director Bakul Patel, former head of the FDA’s digital health center.
Reed agreed that Shuren threw himself into getting more money for the center, occasionally showing a competitive edge with FDA’s better-funded drug center.
“He gave the impression like he wanted CDRH to get as much money and as much attention as CDER,” Reed said. “I always felt like it was a sibling rivalry going on.”
That savvy didn’t stop with industry. Shuren is known as a smooth political operator, trusted by both parties in Congress as well as the three administrations he’s served under. He has been deeply involved in the effort to regulate lab-developed tests, codifying FDA’s power in an April final rule after Congress failed to act in 2022. Jeff Allen, president of Friends of Cancer Research, said Shuren was thoughtful and resolute in their conversations about LDT policy.
“He never shied away from engaging, whether that was with external organizations like ours or even policymakers,” Allen said.
Stakeholders across the medical device space can agree that Shuren’s led a steady, predictable device center — even those who disagree with the ways in which he maintained the status quo. Compared to the tumultuous takeover in 2009, whoever permanently replaces Shuren should have an easier time.
Fans of Shuren hope that his successor will continue working to grow the device center and its ability to accurately assess new technologies. Some patient advocates are excited to see Tarver, with her background in patient engagement, step into the role.
Krumholz said whoever replaces Shuren will need to continue working to boost FDA funds and figure out how to regulate the ever-growing category of medical devices.
“You’re going to need to find someone who’s up for a challenge,” Krumholz said. “Someone who’s willing to engage with the community and with Congress to help them understand what resources are needed for a modern FDA.”
https://www.statnews.com/2024/08/06/fda-medical-device-center-cdrh-jeff-shuren/
