Risky regulations: Is the FDA's clunky process impeding progress?

May 23, 2011 by MassDevice staff

U.S. House Rep. Erik Paulsen (R-Minn.) promises to revamp FDA policies he says are delaying life-saving technologies from hitting the market.


U.S. Rep. Erik Paulsen (R-Minn.) announced plans to push legislation to modernize and streamline FDA processes at the MedTech Investing Conference in Minneapolis last week.

High on Paulsen's priorities are the development of an "Innovation Pathway" for pioneering medical devices and blocking a proposed $20 billion tax on the medical device industry.

Paulsen said he expects to meet with Dr. Jeffrey Shuren, head of the federal watchdog agency's medical devices arm, to discuss his proposals.

The congressman from Eden Prairie, Minn., is a strong advocate for the medical device community. Paulsen, co-chairman of the House Medical Technology Caucus, gave the keynote address to the Advanced Medical Technology Assn.'s annual conference in Washington, D.C., last year.

The FDA product approval process is "inconsistent, inefficient and unpredictable," he said, according to MinnPost. “The No. 1 risk I hear from venture capitalists and investors … isn’t about market opportunity or product success,” he said. “The risk lies in the regulatory environment … brought on by the FDA.”

Paulsen also reiterated his aversion to the medical device tax, part of the Patient Protection & Affordable Care Act. He's said that the tax, at 2.3 percent of revenue and set to kick in after 2013, will reduce medical technology jobs across the country. The money raised from the medical device tax will help foot the bill for President Obama’s health care reform legislation. 


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