Serious U.S. regulatory lags are driving the medical device business to Europe – with startups, clinical trial sites and market approvals all migrating eastward at a rapid clip. At the same time, the Food and Drug Administration has stated it has the vision for the U.S. to be the world’s leader in medical device innovation and manufacture.
FDA Commissioner Margaret Hamburg addressed this contradiction at the AdvaMed2014 conference in Chicago, but was met with some skepticism in a follow-up discussion by Mark Deem, managing partner of medical device incubator The Foundry LLC.
“It’s not a race to who’s first – it’s a race to get the best possible product to people,” Hamburg said, adding that in terms of market penetration, “approval in Europe doesn’t mean it’s broadly available in the healthcare systems of those countries.” The expedited approvals can be attributed to the fact that they have a different system for review and determining reimbursement, she said.
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“If you look at how quickly a product actually gets into the market, some of the numbers aren’t quite as striking as the review timing,” Hamburg said.
But Deem wasn’t quite sold. His counterpoint – with issues like inversion looming and startups perhaps more wont to thrive in Europe, there’s been a “wholesale offshoring of what’s traditionally a U.S. industry,” Deem said.
Clinical trials are a particularly sore point – the FDA traditionally takes much longer to approve trial designs, so companies head outside the U.S. when they bring their device or diagnostic to the clinic.
“People naturally need to make progress where progress can be made, so it’s going overseas,” Deem said. “The industry has institutionalized this as the way to do business.”
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The FDA has noticed this trend. Its expedited premarket approval, or PMA program, launched earlier this year is aimed at devices that fill unmet needs for “life-threatening or irreversibly debilitating” disorders, is one step the regulators are making to bring device manufacture stateside again. But despite the initiative of the PMA, Deem worries that it’s taken so long for the FDA to realize it’s been shellacked by Europeans that it could be too little, too late.
“The horse has largely left the barn,” he said. “No we’re to the point where we’re just moving our early-stage medical device companies lock, stock and barrel overseas,” he said.
Perhaps EU regulators will meet at some kind of midpoint – the FDA may be working to reduce approval times, but Hamburg said Europe’s “in a moment of examination of their regulatory system for devices” after some safety issues emerged. The FDA is working with the Europeans, Hamburg said, to transform regulatory practice – harmonizing standards and approaches, databases and ways clinical trials can be used for regulatory approval.
“The world is globalized,” Hamburg said. “The science that underlies the products we regulate, the companies we regulate, the supply chains for products – we are finding ourselves working much more closely with our regulatory counterparts around the world.”
