Proposed changes may squelch
medical technology approvals,
Minnesota representatives argue

Minnesota pols plead with FDA not to toughen fast-track approvals

June 01, 2010
by Brendon Nafziger, DOTmed News Associate Editor
A pair of Minnesota politicians asked the U.S. Food and Drug Administration not to make the fast-track approval process for medical devices any tougher than it is.

Sen. Amy Klobuchar (D) and Rep. Erik Paulsen (R) sent a letter to the agency warning that some proposed changes to the 510 (k) approval process could hurt the economy of the state, a med tech hub home to around 400 medical device companies that employ 50,000 people, according to the letter.

The politicians fear that an "even longer and more complicated approval process" could be financially disastrous, especially to start-ups.

"Already, FDA's increasingly slow and inconsistent approval system has dampened investment in small medical device firms," they write. "In the last two years, venture capital funding alone dropped by one-third."

Almost eight out of 10 jobs in the med-tech sector, and a nearly $5 billion trade surplus in exports from it, could be endangered by a toughened approval process, the politicians wrote.

Medical technology draws bipartisan support in the North Star State; in early rounds of health care reform talks, Klobuchar joined fellow Democrat Sen. Al Franken and Republican Gov. Tim Pawlenty in opposing the billions of dollars in medical device taxes it brought. And last month, Paulsen introduced a bill into Congress hoping to overturn the $20 billion excise tax on medical device companies.

On Wednesday, Paulsen got the 2010 Medical Device Manufacturer's Association's Chairman's Award, according to the Congressman's office.