Sign the Petition: Tell the FDA to Get a Move On!
Here’s another opportunity to tell the FDA to get a move on with its consideration of the artificial pancreas (the nitty gritty: guidance around out-patient trials) – take a minute and add your name to the petition!
The first phase of the artificial pancreas, a pump that suspends insulin during low blood sugar, is already approved and in use in EVERY COUNTRY where pumps are sold, EXCEPT THE US. The FDA is concerned that allowing pumps to suspend insulin during a low could cause high blood sugar afterwards – or DKA.
Well, Medtronic has sold 55,000 units of its first-phase artificial pancreas, the Veo, with no recorded incidents of DKA, and many annecdotal and documented incidents of dangerous low blood sugars averted.
In the US, the next step is out-patient trials of the artificial pancreas. The JDRF proactively submitted proposed guidance around these trials to the FDA, and the FDA responded with guidance that is cumbersome (like requiring every version of every separate CGM to go through trials to prove safety and effectiveness) and could drag trials to a halt.
The FDA is risk-averse, does not fully understand that regulating blood sugars is a dangerous process as it is (the FDA believes that allowing any automatic regulation of blood sugar is inherently dangerous), and really, really needs to hear from everyone that lives are at stake.
Please take a minute to sign the petition.
If that made you feel good (it should!) there are a few other things you can do:
- Tell the FDA, while you’re at it, that they should move on mobile medical apps as well (also allowed outside the US): http://www.ydmv.net/2011/10/hi-fda-its-me-again.html
If you want to help the JDRF in its efforts to get the artificial pancreas into our hands:
- Sign up to become an advocate (you’ll get emails asking for help with online campaigns – takes maybe an hour of your time a year and has a huge impact).
- Sign up for the Promise to Remember Me campaign: meet with your state legislators in person and tell them what the artificial pancreas could mean for you, your family, or your loved ones. The focus of the Promise campaign this year is on getting the FDA moving – your legislators need to hear from you! They have many other things pulling at their attention right now – we need to keep this on their radar, and in-person meetings are very effective at doing that.