It was one year ago today, April 15, 2013, that the Vibe was submitted to the US FDA for clearance. The Vibe has been available as early as three years ago in Europe. What's taking so long?
YOU TELL ME AS ANIMAS WON'T
I'm not sure Animas can tell us anything.
It appears the issue is related to the slow, and frequently overly cautious, attitude of the FDA. I had written to my U.S. senators and representative regarding this issue and they firmly stand behind the FDA. According to them, the fact the Animas Vibe has been available for years in other countries does not mean it is safe for U.S. residents. My personal option is that the FDA requires a major overhaul to make it more efficient and to reduce the excessive red tape in acquiring approvals for products which already have a proven track record elsewhere.
I would recommend everyone write to their representatives and express their views on this matter as I have done. Maybe if enough of use do so the message will be heard.
I have a neighbor who is an executive in a medical product company (I think suturing stuff). Anyway, I asked if there was a way for interested people (like patients) to check on the progress of an FDA application. She said not that she knew of, and it is frustrating - not just to her as a medical company person, but also for her friends (like me) who are awaiting newer and better treatment options. So, so secret.
Phil you are right, been there done that. I think the problem is that they seem to treat this as a drug and it isn't. It is a external product with a proven record and include options for which there is already approval (Pump and CGM)for which patients and medical profession already have been trained.
Track record in Europe is null and void because they must not be "normal humanoids" like US Americans.
The old saying get rid of the RED TAPE by not re-electing (fire) all and any in Washington starting at the top, through the Senate, the House, and anybody appointed by those 435 plus dim-wits.
Yeah Phil, especially your comment about their having proven records. Both the pump and the CGM have been successfully used for years. I worry that the only input sought by the FDA is from MD's. And we all know that we all know more about pumps and CGM's than most MDs.
Call me skeptical, but I think that politics is involved. Did Medtronics make a donation to a political group to stall Animas? Did Johnson and Johnson fail to grease the wheels?
The delay defies reason.
tHINGS LIKE THIS (BASICALLY ANY HEALTH CARE ISSUE) MAKES ME WONDER WITH THE "EPIDEMIC" OF diabetes (ALL TYPES) ISN'T THERE SOMEONE IN A POSITION TO DO SOMETHING EITHER A pwd, FAMILY MEMBER OF A pwd, FRIENDS WITH A pwd? oR MAYBE IF I WORKED AT THE fda, AND OF COURSE THEY WOULD KNOW I HAVE TYPE 1, I WOULDN'T BE ALLOWED TO WORK ON THE EVALUATION PROJECT OF ANYTHING (oops did it again - hit all cpas, Sorry - but then maybe I am shouting) Anyway, I couldn't work on any evaluation of things related to the treatment of D?
Thanks for all the comments. I hope that this FDA delay will bring some substantive improvements in the Vibe design over the European/Canadian model. My impatience is tempered by the reality that the Vibe is not that big a technical jump from the current Ping + stand alone Dex G4. Hence I'm not as anxious to start using it.
Perhaps the FDA should have a patient ombudsman officer that providers an inside look at the twists and turns in the in the approval process. We're all so ready to blame the FDA (including me!) but maybe Animas shares some of the responsibility. I don't know.
I just wish that things moved faster without any compromise on safety and efficacy. Is this expectation unreasonable?
Yeah, I know about the slow action of the FDA, but there is something else I wonder about regarding this. Animas customer service seems to be going down the tubes. Even my CDE can't get any help or action from them. Her opinion is that Johnson and Johnson have decided that they don't want to be in the pump business anymore, because they are behind on some technologies, and so are not willing to invest in customer service and the like. So this makes me wonder, if what my CDE thinks is true, maybe Animas (ie Johnson and Johnson) is not putting full effort into pushing for FDA approval. My CDE thinks this is too bad because she thinks the Animas pump is good but that it is going to go the way of the Cozmo pump.
FrOm what my CDE said, it isn't so much deciding not to stay in the pump business (and I hope they do stay - I really don't like Medtronic and without the competition from Animas - since Omnipod and the T-slim aren't widely covered yet - their customer service can only get worse. Anyway, she heard that it was staffing cutbacks in general.
Well, I don't know if it is just a case of cutbacks. It has been months since my CDE has been in contact with an Animas rep. She says that if the company doesn't readily have help available even to medical professionals who need advice for dealing with their Animas patients there is a real problem. She told me that when she finally gets to speak to a rep, she will tell them that she will not recommend the Animas pump to any new pump patient....not because she doesn't like it, she says it is a good pump, but when, as said above, even medical staff can't get in contact with the rep......
As for myself when I needed to order supplies, I never did get through to customer support. Later, when speaking with tech support, that person got me to the order department.
I haven't had any problems with customer service at Animas, I 'spose I am lucky. Right now, the only pumps covered by my insurance are Animas and Medtronic, and I'm not interested in Medtronic - heard too many stories. Of course, I don't know if that's cuz I've only heard of the complaints, or if things have improved.
This can't be blamed solely on the FDA -- we are talking a year here, from submission to where we are now, and there was additional data requested because Animas didn't submit what it should have known was needed based on 2011 guidance for human factors validation testing. So, the FDA asked for more and that is what was given a Jan. 31, 2014 deadline. Assuming Animas met that deadline, we are now about three months out so hopefully agency approval will be coming soon. There are many who feel the CE Mark approval isn't adequate and patient safety can be compromised, so FDA takes more comprehensive review than the EU does. And again, it's tough to fault the FDA when it's more likely a result of Animas not effectively doing what it needed to for approval of the Vibe here in the States.
Thanks for adding some additional detail I didn't know. Most people seem ready to believe that it must be the FDA's fault. According to what you cited, Animas may have not responded fully to an FDA request.
Somehow I wish that the FDA's twin goals of safety and efficacy did not have to come at the cost of expediency. I also hope you're right that approval may come soon.
Thanks for stopping by to comment!
I order supplies directly from Animas four times per year. There has not been even one glitch in my stream of orders.
I ordered a pump about 18 months ago and left it to Animas to arrange with the doctor's office and insurance company. The transaction flowed smoothly.
I'm sorry to read that your doctor's office CDE has not been given good service. I hope this is the exception and not the rule.
Johnson and Johnson is a very big company with deep pockets. I don't think that they would have entered a business like this without their eyes wide open. I have nothing to contradict the speculation of your CDE but I think that JNJ and Animas are in this business for the long haul. I could be wrong; it wouldn't be the first time.
I think part of my impatience comes form the fact that there weren't any substantive (as far as I know) changes to the Ping to become the Vibe (except losing the remote)and that it took Dexcom only 6 months to get form the Seven to the Dexcom4 platinum. I am looking forward to the Vibe, primarily for wearing just one device on my belt instead of two. I think I will still be the "brains" (such as I have) behind any dosing since I know what I am going to do in the next couple of hours and the pump[/CGM can't know that.
Yes, thanks for making this point about Animas customer service. It has really gone down the tubes in a big way. Now it's as bad or worse than getting through to Comcast or Verizon. Such a shame to see a good company get destroyed. I'd like to see the Vibe, but I'm not certain it will be coming soon.
I purchased my Animas Ping a year and a half ago in order to get in line for the Vibe. I don’t even think much about it anymore, but am counting the days until I can switch to a different pump. Unless the Vibe has a much improved menu system, especially for things like combo boluses, I will be looking at a T-Slim or going back to Medtronic and using Dexcom as a separate device.
Laddie - I got my current Ping about the same time as you. I have complaints about the Ping menu system too, but I can make it do what I want it to do, so I don't mind as much as I used to.
Can you describe your compliant about the combo bolus menu that you don't like?
I'll upgrade to the Vibe when it comes out but I don't think the changes/improvements will be much. Since upgrading to the Vibe will not count as a new purchase, the warranty will run out at the same time as the original Ping pump. This will allow me to consider other choices in December 2016. Unlike the rest of the tech world, things don't seem to happen quickly with pumps and CGMs.