CDRH head Dr. Jeffrey Shuren batted back several attempts by Republican lawmakers to frame the debate on medical device regulations as a question of the European system being superior to the FDA’s today during a Capitol Hill hearing.
Shuren, the star witness at the House Oversight & Government Reform Subcommittee on Health Care’s “Pathway to FDA Medical Device Approval: Is there a Better Way?” said his agency was not the sole contributor to pushing companies to launch products in Europe before the U.S.
“Over the past decade, most indicators of the medical device industries success have gone upward,” Shuren said. “However, the recession has changed the business model to be more risk adverse and more sensitive to changes at the FDA.”
Shuren said he is “astonished that some in medical device space are calling for us to lower our standards to those of Europe. It’s not in our best interest.”
In an hour’s worth of testimony before the GOP-led panel, Shuren was adamant that the U.S. is not in danger of having the med-tech industry flock across the pond due to a tighter regulatory environment, while still admitting that the federal watchdog agency could better communicate with the industry.
The Center for Devices and Radiological Health chief was particularly dismissive his least favorite study — a November 2010 Stanford University report finding that three-quarters of the cost of bringing a medical device from concept to the U.S. market is spent clearing regulatory hurdles.
“It’s not a credible study, it’s only 10 percent of the industry,” Shuren said during a sharp exchange with Rep. Patrick McHenry (R-N.C.), who pressed the deputy commissioner to provide proof that the European system has a worse safety record than the FDA.
“If you had a problem with the statistical relevance of the [Stanford] study, then I would question you when you say that the EU has a lower safety record than us, if you’re saying there’s no relevant data [to support the argument],” McHenry said. “You’re saying that the Europeans are in a different world and there’s no way for us to know?”
Shuren countered that the de-centralized system in the EU doesn’t provide any public data regarding timeframes or decisions and therefore that any comparisons are apples to oranges.
McHenry then pressed Shuren on whether he’s pleased with the amount of time it takes to move a device through the 510(k) pre-market clearance process. Shuren admitted that he’s “not pleased.” The exchange ended with the four-term congressman saying there’s a problem when government agencies don’t “have any idea about the impact they’re having” on American businesses.
Shuren’s parting message was that he believes the “U.S. standard for medical device approval is the robust standard we should stand behind,” and that the FDA should “do a better job” in running the 510(k) and PMA programs.
Earlier in the day, Rep. Erik Paulsen (R-Minn.) told the panel that America’s “supremacy [in the medical device world] is at stake by bureaucracy within our own borders,” pledging to introduce legislation that would “restore the balance, as well as modernize and streamline the FDA.”
Jack Lasersohn, a general partner at venture capital firm The Vertical Group; David Gollaher, president and CEO of the California Healthcare Institute; and Dr. Rita Redberg, director women’s cardiovascular services in the division of cardiology at the University of Calif. also testified before the committee.