Devices & Diagnostics

FDA hinders medical device innovation, says Sen. Scott Brown

Sen. Scott Brown (R-MA), the junior senator from Massachusetts, took a few swipes at the FDA in a speech before a gathering of biotech leaders in Boston Tuesday, saying that the agency was “throwing a wet blanket” on innovation in the medical device and biotech industry. “Right now, there is a complete breakdown between what’s […]

Sen. Scott Brown (R-MA), the junior senator from Massachusetts, took a few swipes at the FDA in a speech before a gathering of biotech leaders in Boston Tuesday, saying that the agency was “throwing a wet blanket” on innovation in the medical device and biotech industry.

“Right now, there is a complete breakdown between what’s happening at the FDA and what your needs are,” Brown told the assembled group of biotechnology executives. “It’s money, it’s time, it’s innovation. And right now, we’re losing out to competitors overseas.”

Brown added that he took his concerns to Food & Drug Administration commissioner Margaret Hamburg personally in a meeting two months ago, saying that changes at the FDA were “crushing businesses in Massachusetts.”

Brown, who is running for re-election in 2012, has been a vocal supporter of the medical technology industry. In March he helped relaunch a Senate medical technology caucus with Sen. Amy Kloubchar (D-Minn.). Both senators represent communities where the medical device business has sunk deep roots. Minnesota and Massachusetts combined are home to the U.S. headquarters of most of the top 10 medical device companies in the world, accounting for more than 100,000 jobs.

The caucus will focus legislative attention on the medical technology sector, according to the senators. A few of their pet issues are likely to be the 2.3 percent medical device excise tax contained in the national healthcare reform law and changes to the 510(k) program afoot at the FDA.

Brown has been been a staunch critic of the medical device tax, telling MassDevice last year that it amounted to a levy with no purpose or rationale.

“A 2.3 percent tax just because?” Brown told us. “For some of these companies, that’s their entire net profit. That’s jobs, it’s R&D, it’s a whole list of other things. It’s not a necessary tax.”

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

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