Senate Proposes Fasttrack Improvements of FDA Medical Device Approvals

Those of us who use the Minimed Revel Insulin Pump or their Continuous Glucose Monitor may have heard that they have an improved pump and CGM in the pipeline. Called the VEO and Enlite respectively, these two devices offer improvements over Minimeds current Revel system. The Revel's biggest improvement is that it adds a "low glucose suspend" feature in which the unit temporarily suspends pumping insulin when the CGM determines that the user's blood glucose has dropped below a specific level. The Enlite Sensor is not only more comfortable to insert and wear, but an even more attractive feature is that it has proven to be more accurate than the sensor we now use in America.

"Great! How do I upgrade?"

Well, right now you can't. Even though these two devices have been approved for use in the European Union for a couple of years and thousands benefit from them, they still have to go though the Food & Drug Administration's rigorous approval process. At first glance it sounds like our government is making Minimed recreate the wheel. On the other hand, the FDA is concerned that any medical device is proven to be safe through extensive testing. This raises the question of why can't Minimed use the tests they did to get EU approval and apply that toward obtaining US approval? If a bill introduced in the US Senate becomes law, the hurdles that delay use of medical devices that have an extensive track record of being safe overseas might be able to bring their devices to US patients quicker. You can see some of the features of the proposal here.

If this bill becomes law, I think it could have a substantial impact on improving the lives of people with diabetes by bringing safe and effective medical devices to us sooner.

It’s astonishing that the Senate will do anything with an election coming up! I’m glad to hear they noticed us! Or was it Sonia Sotomayor?

One of the sponsors of the bill is Senator Tom Cole - an MD from Oklahoma who is leaving the Senate when his current term comes to an end. The other is Senator Richard Burr of North Carolina who was re-elected in 2010. It is difficult to find a "political" motivation to this bill.