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Rep. Paulsen allies with medical device industry to relax FDA oversight

On the heels of the Minnesota Independent story last week about U.S. Rep. Erik Paulsen’s cozy financial relationship with the medical device industry, the New York Times reported Tuesday that some health professionals are alarmed by Paulsen’s push to relax Food and Drug Administration (FDA) oversight.

“They have this unwritten assumption that every new device is innovative,” Dr. Rita Redberg, who is the editor of the Archives of Internal Medicine, said, referring to the venture capital funds. But some devices, she said, “are killing people or causing significant harm.”

The Times reports that 10 bills to speed up the FDA’s medical device approval process have already been introduced by House Republicans this month. In the Senate, Sen. Amy Klobuchar has introduced a similar bill.

The U.S. House of Representatives has held four hearings on F.D.A. device approval procedures since February, with the vast majority of witnesses being “investors, entrepreneurs, industry consultants, trade group officials or patients who said that agency delays in approving a device had harmed them or a loved one,” according to the New York Times. No one who was harmed by a faulty device was invited to testify.

As the Minnesota Independent reported last week, Paulsen has been rewarded for his advocacy for the industry with campaign donations from company PACs and executives. The Congressman is currently sitting on $900,000, according to Federal Election Commission records. The medical device and drug industry gives more generously to Paulsen than to other candidates or PACs in the district, according to an analysis by the Center for Responsive Politics.

The Times story shows a steep increase in donations from venture capitalists with an interest in health care after Paulsen testified to Congress in June that FDA processes should be streamlined.

As the Minnesota Independent reported, Paulsen has seen substantial increases in donations from the entire medical device industry since he became a member of the influential House Ways and Means Committee, with one medical private equity firm crowing that “his increasingly high profile in Congress may help bring additional visibility to the medtech sector.”

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