Connecticut Pol Writes Letter to Hamburg Urging Stricter Device Approval Regulations

Industry has plenty of supportive voices in Congress, voices that span both ends of the political spectrum, from Tea Partiers Rep. Michele Bachmann (R-MN) and Sen. Scott Brown (R-MA) to liberal stalwarts Sen. John Kerry (D-MA) and Sen. Al Franken (D-MN). The one thing that ties them all together: they represent states that have a heavy industry presence. And, for the most part, they've been dominating the discussion over medical device safety and the 510(k) process.

April 15, 2011

2 Min Read
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Industry has plenty of supportive voices in Congress, voices that span both ends of the political spectrum, from Tea Partiers Rep. Michele Bachmann (R-MN) and Sen. Scott Brown (R-MA) to liberal stalwarts Sen. John Kerry (D-MA) and Sen. Al Franken (D-MN). The one thing that ties them all together: they represent states that have a heavy industry presence. And, for the most part, they've been dominating the discussion over medical device safety and the 510(k) process.

But Wednesday's Senate hearing on device safety and approval processes gave rise to some dissenting opnions, with Sen. Herb Kohl (D-WI) and Sen. Richard Blumenthal (D-CT) seeming to view industry and FDA with a skeptical eye. On Friday, Rep. Rosa DeLauro (D-CT) wrote a letter to FDA comissioner Margaret Hamburg decrying the way FDA currently handles device approvals.

"It is simply unacceptable that [patients] should continue to rely on an inadequate approval process of the devices that are implanted during the surgery,” DeLauro wrote, according to The New Haven Independent Web site. DeLauro, who has a hip replacement herself, echoed the concerns expressed by Diana Zuckerman and the GAO's Marcia Crosse at the hearing, and urged FDA not to wait for the Institute of Medicine's review to address the issue of high-risk devices going through the 510(k) process.

In contrast to DeLauro's letter, consider that in December of last year, 15 members of Congress wrote a joint letter to Hamburg urging her not to take a stricter approach to the device approval process, a group that included Franken, Brown, and Kerry, along with Sen. Pat Roberts (R-KS), Sen. John Cornyn (R-TX), and Sen. Olympia Snowe (R-ME). Or consider the letter Kerry wrote recently echoing that opinion.

Given the relative unpopularity of DeLauro's opinion among her colleagues, I wouldn't expect her to have nearly as much influence over Hamburg as the pro-industry legislators. But it is interesting to note that any pro-reform voices exist at all in Congress.

What do you think? Are you confident that industry has enough Congressional support? 

— Thomas Blair

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