“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.”
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.
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.
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.”
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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.
“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.”
“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.
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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.
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For the full article from STAT News read here.
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