FDA clears Freestyle test strips for use with OmniPod
Saturday, January 7, 2012 at 12:40PM 
"The FDA has notified the company that the new Abbott Freestyle test strip has been cleared for use with the OmniPod," Insulet confirmed in an email to MassDevice. "The companies are in the midst of updating the product label and will be communicating with customers once that has been completed, hopefully next week."
It's official, after more then a year and I can only imagine how much cost to taxpayers, the FDA finally has said that we can use Abbott's butterfly test strips in our OmniPod PDMs.
I'm not all that excited and am about to be a bit snarky about this announcement because I figured this out over a year ago for free and it only took me two days.
I completely understand and support that medical devices, equipment and the like need to be safe, accurate and durable but come on - test strips? I asked myself last year, "why would Abbott develop and manufacture a test strip that wouldn't work with their business partner's testing devices". I found the common sense answer to simply be, "of course they wouldn't do that". Then I conducted my own test and began using the strips with Arden's PDM in December of 2010, we have never looked back.
I'd like to congratulate the FDA on once again turning something simple into a train wreck, you guys are nothing if not consistent. Maybe now they'll (FDA) have time to clear Insulet's latest OmniPod design, from what I understand it's being held up because the "documentation can be confusing". To be clear, I've seen the documentation, used the new pods and not only couldn't the documentation be any simpler but it's about 99% the same as the current generation's instructions. In my opinion the new OmniPod design is being held up because of bureaucratic and political BS.
Our representatives in D.C. love to say that business should allowed to thrive but they'll take any chance to stand in it's way. Insulet is not a huge or rich company. They make a wonderful product that every day helps countless people live easier and more healthy lives. I'd very much like to see the FDA give them a chance to make a profit so that their amazing insulin pump can be around until type I diabetes is cured. Hopefully that cure, when discovered, won't be held up by the FDA forever...
I assume that most of you, because of necessity, have already implemented the "new" strips but just in case you were waiting for official word, you can find it here it's entirety.
Scott Benner
Insulet has posted a link to updated information.
FDA, FreeStyle, OmniPod in OmniPod Blog, Type I News
Reader Comments (6)
An insightful, informative post, as always. Thanks for all you do, Scott.
Thanks to you Brent for reading the site!
Hey, this is great news that an already-used strip is finally approved. But I think I may be missing something here... why exactly is the FDA to blame on this? I mean, by my logic, this is how it unfolded: 1. Abbott made bad business decisions that led to Navigator being pulled (and ultimately discontinued). 2. The strips that people had been using between Omnipod-Navigator apparently weren't going to work anymore thanks to this Navigator supply concern, so they made some new butterfly strips to resolve this issue. 3. However, Abbott didn't get approval for use of this new strip in ALL its already-existing products and partnerships, and as a result Insulet basically got the shaft. 4.) People back in 2010 reported significant inaccuracy issues with this butterfly strip, and neither company seemed to be taking responsibility. Only THEN did they examine filing for FDA-approval of the new butterfly strip in the Omnipod. 5.) Yes, the FDA process takes a long time and everyone knows that. There's needless delays everywhere. However, with the reported accuracy issues, and fact that Abbott had already gone behind the FDA's back by just putting this strip out there (not to mention the whole Navigator issue), they took additional time and review.
I'm sorry, but to me, the FDA isn't to blame here. It's the shoddy business decision-making at Abbott.
Bottom line: Abbott was covering its butt in the middle of the Navigator issue, put something out assuming or hoping no one would care about the FDA approval element necessary for ALL ABBOTT PRODUCTS AND PARTNERSHIP DEVICES. People ended up on the receiving end, probably for no other reason than simply trusting the companies supplying these devices and supplies were doing what was necessary to ensure their safety and regulatory compliance.
Am I missing something crucial in this whole equation?
Hi Mike!
I am not questioning anything that you've written as you seem to be very well aquatinted with the behind the scenes moves that helped lead us to today. Abbott should have done things better - no doubt.
My position regarding the FDA is a very simple one... It doesn't take over a year to verify that a test strip works. They can say it does and that there are procedures but I do not and will never accept that as an answer.
It doesn't take a year... something else is in play.
Thanks so much for being part of the discussion!
Best,
Hi Scott,
Thanks for your thoughts on the strips too. I do believe that the FDA and Abbott had issues, internal at that, when it came to these strips. And I do follow Mike's timeline of events. I think Aboott preemptively introduced these butterfly strips, much to Insulet's detriment. I actually, likewise, do not fault the FDA for the holdup. I do rest the blame mostly on Abbott, who should have known better. They even messed up with the supply and demand for the those old strips for cryin out loud. I do think Abbott, in the last two years, has made some pretty poor decisions, and we have felt the fall out from it.
I do have problems with the butterfly strips. So much so that I used the OneTouch meter for about 2 months while I did some investigating, why my daughters A1C rose while on these strips, and why her PDM average did not match her A1C. I have been using the butterfly strips the last month, although I have changed the code to 17, to make up for the fact that the new butterfly strips consistently read low in her PDM, and substantially lower as her BG rises.
For some people, they are great, but there are some of us out here who still question their reliability, even outside of the FDA's meter error of +-20%.
Thanks for your write up about it, I do enjoy listening to all viewpoints.
Best,
Penny
Hi Penny!
I'm sorry that you are having so much trouble with the test strips, that sucks! You said, "there are some of us out here who still question their reliability", and that is always going to be the case - these products are never going to work perfectly or at the same level for everyone. That consideration highlights (for me) the main difference between the FDA and the regulators in Europe.
Our FDA takes forever to allow products to market while people overseas are using diabetes tech that is generations ahead of what we have available to us. Why is that? In Europe the idea is if a million people need this and we know it won't work for 100,000, well it still helps 900,000 - that's a win and we shouldn't hold back those 900k people. This concept keeps innovation as well as healthcare on the cutting edge.
The FDA scrutinizes to last moment, endeavoring (perhaps in good faith but I believe often due to lobbyist pressure) to make a product perfect for all, which we know it can never be. Eventually they say, "close enough" and clear the product. Meanwhile those 900k people are receiving care lesser then they could have been and the remaining 100k have lost a year that they could have been looking for their next best thing. In that same time Europe has leaped past us.
My commentary isn't about Abbott or any other company. I'm sure that most are at times poorly run but this site isn't a watchdog for such things. My concern lies firmly with the FDA and how some of their best practices aren't so good.
I want the tech to get to us as fast as is safely possible. If the test strips don't deserve clearance then reject them and let Abbott get on refining them. A full year to say yes is a clear waste of time, resource and money. If Abbott did something "wrong" in this I accept that. However, we don't understand the dance that goes on between industry and the FDA. I do know that the direction the FDA gives is at times muddy at best and it leaves the people in industry confused about how to proceed. When they ask, the FDA never clarifies. Pharma companies can't even get answers about reporting in regards to launching a FaceBook page. If the FDA can't figure out social media guidelines I shudder to imagine their processes for something like an insulin pump.
My bottom line: My iPhone gets better every year for a number of reason... Market place competition, the need to keep up with buyer expectation and on. If Apple had to jump through the hoops that a pump manufacturer has to they might decide to go build a different product. I don't want Insulet or any other company to decide that they should be in a different business. We need a better balance between the people innovating and the people regulating and we need an end to lobbying pressure about such things. I can't repeat the conversation that I had with a Congressional aide last year, they had 20+ years at the FDA under their belt but it wasn't a conversation that brought a lot of hope to my heart - I can say that. There is a ton of corporate bullying going on most of which is aimed at tamping down innovation from new and mostly smaller companies. The giants only want us to be healthier if they can sell it to us.
Thanks so much for reading and commenting!
Best to you and yours!