As the duly elected representatives of the great state of Minnesota, Sens. Amy Klobuchar and Al Franken along with Rep. Erik Paulsen have championed the medical device industry, giving speech after speech and writing letter after letter to the Food and Drug Administration about upcoming changes to its 510(k) approval program.
While that’s well and good, I doubted the campaign would do much. For one thing, the FDA already seems hell-bent on imposing stricter standards on device makers. Secondly, it didn’t seem like anyone outside Minnesota gave two earmarks about the issue. (I’m willing to bet most people think 510(k) is a retirement savings program.)
But with the FDA close to releasing its recommendations on the 510(k), Minnesota brought out the big guns. On Wednesday, a bipartisan group of 15 senators sent a letter to FDA Commissioner Dr. Margaret Hamburg urging her agency, among other things, to adopt a more deliberate, cautious approach to amending 510(k) versus the radical wholesale restructuring that medical device firms are fearing.
The letter is significant not just for what it says but who signed it: Klobuchar/Franken, Scott Brown/John Kerry (Massachusetts), Pat Roberts (Kansas), Ben Nelson/Mike Johanns (Nebraska), Kay Hagen (North Carolina), John Cornyn/Kay Bailey Hutchinson (Texas), Olympia Snowe (Maine), Evan Bayh (Indiana), Debbie Stabenow (Michigan), Bob Casey Jr. (Pennsylvania), and John Barrasso (Wyoming).
Liberal Democrats. Conservative Republicans. East Coast. Midwest. South. Suddenly, the issue is not just a Minnesota gripe but a concern of national importance.
Credit must be given to Klobuchar and Franken for rounding up such an eclectic and diverse group of senators. One only wishes, though, that Hamburg could have received such a letter earlier in the year.
Some of the state names are not surprising: Minnesota, Massachusetts, Indiana and North Carolina boasts sizable medical technology clusters. What surprises me is the absence of Barbara Boxer and Diane Feinstein from California, home to some of the most innovative startups in medical devices today.
Also missing: senators from Florida and Arizona, states with large elderly populations — people who probably benefit the most from new medical devices.
The letter demonstrated clear command of the issues and sums up nicely the arguments against a stricter 510(k): stifling innovation and economic growth, losing out to Europe and Asia, unclear regulatory time lines.
Rather than whine and moan, the letter also offers advice to the FDA:
Given the potential for enormous disruption in the innovation process, we believe FDA must proceed cautiously. We believe FDA should focus first on non-controversial proposals, but before any proposed to the 510(k) is implemented, it is essential that FDA provide stakeholders ample notice and opportunity for comment.
In addition, we believe FDA must operate in a transparent fashion and provide greater detail on the specifics of each proposal before moving forward. And FDA should carefully consider the impact of any proposed change on the ability of companies to innovate in a predictable and consistent regulatory environment so they can continue to bring medical advances to patients.
Let’s hope the FDA listens. Two senators are okay. Fifteen is much better.
Someone should do a analysis to effectively point out what the FDA is fixing in the approval process as it exists today. Are patients being harmed or injured due to a loose 510K approval process? Look at how much money a company has to spend and years it takes to get PMA approval in the US, compared to getting a CE Mark. The rigid system in the US implies that the European regulatory system treats their citizens as guinea pigs. Yet there are studies to show that there are no problems with the current 510k system, nor are Europeans getting faulty devices. How many recalls have we had with 510k approved products??? Unfortunately the Menaflex situation has made the FDA feel the need to make the system even stricter, because of how influential the media is on making US citizens cry foul. Just watch as more and more companies go outside the US first, potentially never coming back. The rest of the world will get access to the latest medical device technology and the US will fall farther and farther behind. Thankfully these politicians are finally putting pressure on the FDA, but as the article points out, perhaps a little too late.