Paulsen criticizes med-tech approval process

  • Article by: JEREMY HERB , Star Tribune
  • Updated: June 2, 2011 - 8:57 PM

U.S. companies will move overseas if the FDA doesn't improve, he warned.

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Erik Paulsen

Photo: Jim Gehrz, Star Tribune

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WASHINGTON - Food and Drug Administration delays in approving medical devices risk driving medical technology companies to Europe and China, U.S. Rep. Erik Paulsen said Thursday in a congressional hearing.

Paulsen wants to examine importing European methods of approving medical devices so companies don't export their business, he said at a House Government and Oversight Subcommittee hearing. The Minnesota Republican is preparing to draft legislation to streamline the approval process, he said.

"I believe the medical technology industry -- an American success story, one that routinely revolutionizes patient care and creates thousands of high-tech jobs -- is at risk of drying up and moving overseas," Paulsen said.

Jeffrey Shuren, director of the FDA's Centers for Devices and Radiological Health, acknowledged that improvements could be made to the approval process, something the FDA proposed earlier this year for cutting-edge devices.

But Shuren said the federal agency still must ensure that medical devices are safe. "The solution here isn't for us to lower our standards," he said. "It's to get our program more predictable and efficient."

Paulsen appeared as a committee witness, not a member, for Thursday's hearing. The Minnesota Republican's testimony aligns with the congressional delegation's bipartisan support of the medical technology industry, which has 400 companies and 35,000 employees in Minnesota.

Minnesota's delegation pushed to halve a medical device tax in the health reform bill. Paulsen now has a bill to repeal that tax altogether, though he said Thursday that legislation to streamline the device approval process would remain separate.

Paulsen cited the now-defunct Minnesota company Acorn Cardiovascular, which failed to gain FDA approval for a device to treat heart failure after a decade of back-and-forth with the agency. Paulsen said European devices are often brought to market two years before their American counterparts.

Shuren said that devices that qualify for the agency's 510k process, which move on a faster pathway and make up about 80 percent of the market, are approved before their European counterparts about half the time.

High-risk devices, he said, are approved more quickly in Europe. He said the FDA is not trying to stymie companies, however. "We are not moving the goalposts that much," Shuren said.

Jeremy Herb • 202-408-2723 Twitter: @StribHerb

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