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Monday, October 19, 2009: Congressman Erik Paulsen sponsored a hearing on a proposed tax in medical technology companies Monday at Plymouth City Hall. Behind him is Rob Kieval of CVRx.

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Jill Burcum: Paulsen's diligence

  • Article by: JILL BURCUM
  • Star Tribune
  • June 4, 2011 - 9:18 PM

U.S. Rep. Erik Paulsen's in-depth knowledge of complex medical device regulatory issues -- a key concern of a leading Minnesota industry -- played a critical role in this page's endorsement of the Third District Republican in 2010.

Paulsen has continued his hard work into his second term. On Thursday, the cochair of the House Medical Technology Caucus testified before an important congressional committee.

The topic: the industry's ongoing concerns about the unpredictable federal regulatory review process.

It's clear from Paulsen's testimony why many device companies see him as the go-to guy in Congress. Paulsen has put in the time to understand these complicated issues.

Many device firms feel that the U.S. Food and Drug Administration (FDA) moves the goalposts on them or doesn't provide all the information they need to steer their products through the regulatory process.

"Additionally, companies have been frustrated with what appear to be FDA stalling techniques," Paulsen testified. "Many entrepreneurs I've met with have had agency reviewers pursue one line of questioning early in the review process and then switch to a new, previously unaddressed topic after the third or fourth submission.''

The FDA earlier this year announced a major initiative to overhaul a key component of its review process. The device industry is also on edge as a landmark report from the Institute of Medicine nears completion.

That report's conclusions, expected this summer, will likely drive changes at the FDA.

Medical device safety is paramount. The FDA shouldn't speed up its process simply because it's good for industry.

At the same time, the perception that the industry is being jerked around instead of regulated isn't healthy. Addressing this will take time.

Paulsen's testimony this week gave voice to the concerns that many firms have about their powerful regulator but often are uncomfortable sharing publicly. Airing these concerns is an important step toward finding balanced solutions.

Jill Burcum is a Star Tribune editorial writer.

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