A new study from the California Healthcare Institute (CHI) peaked my interest this week. The study looked at data maintained by FDA to examine FDA’s performance in approving products. The results show that, beginning in 2007, the time to get products approved has increased. For drugs and biologics, the time FDA takes to review an application has increased by 28%. For medical devices, the FDA review time has increased by 43% for lower risk devices (this pathway is called 510(k)) and by 75% for higher risk devices (this pathway is called PMA).
New therapies to treat and cure type 1 diabetes fall within all of these categories – drugs, biologics, and medical devices, so these trends have implications for all of us. The trend with high risk medical devices is particularly concerning since this is the pathway artificial pancreas technologies fall within. JDRF engaged FDA at the start of the Artificial Pancreas Project so that these critical products will not follow this same trend. And, our most recent initiative to propose a ‘guidance document’ to FDA will provide a pathway provide a clearer pathway for the development of these pathways in the hopes of making eventual approval of these tools go more smoothly.
What do you think about the trends detailed in the CHI report?
I support all advances to help type 1.it is a struggle everyday of my life.you never know when you are going to have a good day.
As a parent of a diabetic child it is often frustrating to think about the wait time for things that could make her life so much easier. Sometimes the endless red tape seems extraneous and all of the extra studies unnecessary.
On the other hand, there are reasons for all of the extra testing and retesting. The last thing anyone wants is to have complications from a potential cure. And if the steps toward a cure are measured and slow, at least they are still advancing the right direction.
It is hard in our society to wait for things. I won't even wait more than 30 seconds for a web page to download without complaining. I want a cure for my daughter, and now would definately be preferable to later...but I also want a permanent and safe cure.
I guess I really feel that I can wait. It won't be easy, but the more testing that is done now, the more likely the artificial pancreas will be close to perfect by the time it gets to us.
Yes, it's a struggle even for a little guy that is only 8 years old and got diagnosed at 2 yrs. At this age, his body is going through changes and it's a challenge every day to make sure we are on top of everything.
The FDA and FDA Panel is corrupt in my opinion..I have seen them approve dangerous products with value and constantly delay important products such as Mankinds inhaled insulin. Its amazing how smoking is illegal which kills 300k people in the usa per year. I can already see them taking years to approve an Artificial Pancrese which is unfortunate.
I find these trends most frustrating. I applaud JDRF's 'engagement' with the FDA and the 'guidance document' sounds like an excellent idea. Let's encourage our advocates to make a big push to get the FDA's approval of the APP. For those of you who want a cure and an end to diabetes complications, join JDRF advocacy and let your voice be heard. The squeaking wheel gets the grease. Access this link now and advocate for diabetes research! http://www.jdrf.org/advocacy
This will and has had a huge impact on the quality of life for my patients with type 1 diabetes waiting for upgrades to make their lives easier and the ability to control diabetes more attainable. It is frustrating for them and for me when they know that things are in the FDA and nothing is happening with them. This has been an ongoing frustration but recently it has gotten worse.
I agree that these trends are concerning. I hope that by engaging the FDA early on in the process it can help reduce that 75% longer rate. What is the current wait time for higher risk devices?
I would hope that the increased time means they're making more effort to be sure the products are safe. I work in pharmacy, and it's really annoying when we get a new generic medication in, and a few months later they're all recalled for some problem, and we don't see them again. I wouldn't want the fear if my son was approved for an artificial pancreas, only to find out after it was put in that it had some sort of problem or defect, and had to be removed.
I agree a clearer pathway for drug therapies and devices needs to be addressed. Also, can someone look into the increased or more correct decreased medical insurance trends. As the medical insurance costs increase the amount of coverage seems to be decreasing.
I also support all advances to help type 1. Not only is it a struggle every day to keep blood sugars at a good levels, but also other health issues that type 1 dabetics have. SO MANY CHILDREN, YOUNG ADULTS AND SENIOR CITIZENS CAN HAVE A HAPPIER LIFE WHEN A CURE IS FOUND FOR THIS DISEASE.!!!!!!!!!!!!!
Instead of blogging about how long it takes the FDA to approve diabetes-related devices, why not do some research into why JDRF continues to fund studies and trials to replicate or confirm the effectiveness of trials already in progress (Dr. Faustman's trial at Mass General Hospital) instead of donating all that money to Dr. Faustman's trial which is the first of its kind to attempt to reverse the autoimmune factor in Type 1 diabetes?
My son is type 1 and yes I want the artifial pancreas on the market as soon as possible but I also know first hand that technology can "move" to fast. My daughter who has a cochlear implant has had one device failure resulting in surgery for reimplantation and then had another implant put in only to have that one recalled. Yes, we all want the artificial pancreas asap but not at the expense of our kids health. The ramifications of a device with problems could be fatal for a diabetic. The FDA has to be diligant in their review of these devices. I think the speed of new technology , in addition to increases in device failures has led to the FDA scrutinizing things longer. I think JDRF's guidance document will help as well as open communication/cooperation is encouraging. Personally I would rather wait the extra time and be assured my son is wearing a safe device that has been thoroughly reviewed.
While I understand the need for caution, I also think it's ridiculous that the approval process takes so long. I recently found out that Animas and Dexcom, for example, won't get approval for their integrated system for -- I've heard -- at least a year. (And I believe that's part of the artificial pancreas project, no?) Abbott's CGM is having some sort of FDA issue that has prevented them from sending out new transmitters and sensors since last May. (I had to send mine back.) When you have diabetes, every day counts -- new devices really can have a profound emotional and physical effect on our ability to treat ourselves. I really wish the FDA would clarify *why* the approval processes are taking so much longer, so that we could better understand whether they're truly necessary, or just red tape.
To add to my last post... if you want to learn about real progress being made ot cure Type 1 diabetes, check out the following website ...
www.faustmanlab.org
Great post! - this helps explain why Europe has allowed Medtronic to release the Paradigm Veo, yet we're still fighting here to convince the FDA that potential high blood sugars are less dangerous than a potentially fatal low.