As I mentioned yesterday, I have a lot of questions when it comes to the FDA and how I can be a better advocate and what can I do more? I figured that if I had these questions, that I wouldn’t be the only one, so I decided to interview Bennet Dunlap. There’s not much of an introduction that I have to give here, just read on.
This is a long post, but trust me, it is worth reading every word.
There is a followup post to this scheduled for this week, but we need your help in order to make that post happen. If you have any questions, comments, concerns or anything else, please leave a comment or send me an e-mail via the contact form with your follow up questions for Bennet and we will post the answers next week.
Here we go.
For those that may not know you are, please give us a quick introduction.
Thanks Chris.
I am a former banker, with a newly minted Masters in Health Communication, husband and father. The younger two our four kids live with type 1 diabetes. (T1D.) That means the whole family lives with it. Even the dogs.
I write the blog Your Diabetes May Vary. I started it when our oldest told me I had a different perspective on parenting and diabetes that I should share. I have never been exactly sure what she was talking about. I think it boils down to two things.
First don’t make diabetes the most important thing in life. Put it behind the kids’ dreams and aspirations and make it come along for the ride, kicking and screaming. Most of us parents, particularly at diagnosis, make diabetes the first, most important thing in our family lives. That is okay for a short while but the whole point of being a parent is to foster our kid’s dreams and help them achieve those dreams. All the kids in the family. So diabetes has to be important but not more important than life’s passions.
Second, there is a HUGE difference between serious and solemn. The two are often confused and most often by people for who an air of solemnity is not warranted, bureaucrats, bankers and the like. I take diabetes very seriously and have NO intention of being solemn about it. Laughter is serious business and I will seriously laugh at diabetes.
How long have you been reading FDA documents, regulations, guidelines, etc. What sparked that initial interest?
I started reading about the FDA very early in our diabetes process. Like many folks, I want better care processes. I am a guy and therefor a gadget freak. When our diagnosis came along, continuos glucose sensing was not yet available. As I learned about CGM, I wanted to know when it would be available and started following FDA approvals. Then I wanted to understand why it wasn’t available and I have been chasing down information even since.
People in the DOC look to you and Scott S. when it comes to FDA related items, so what are a few other resources that they can go to in order to get updates?
Well right straight up read Scotts blog and maybe more his Twitter feed. He has a fantastic ability to find news. I regularly follow links off of his twitter feed to news that is breaking that day. He claims it is an RSS feed but I think it is sorcery.
Kelly Close and her team at Diatribe are a good insight into the business side of diabetes. Bernard Farrell is a smart voice on the technical side of devices. I also follow them and a number of the key industry players. I try to translate what I read into a simpler vocabulary at YDMV.net.
Most folks in the DOC at some point write about devices because we rely on them. The real gift is the ability to separate solemnity from the serious. I think this is where Kerri at Six Until Me shines. She is as serious as is humanly possible about living better with diabetes and I don’t think she has any ability for pretentious solemnity at all.
Beyond the DOC are the big diabetes advocacy groups ADA and JDRF. The FDA also has a twitter feed that is worth following @FDADeviceInfo and a site for device approvals. The FDA links are more a matter of after the fact news. I still struggle to find issues of interest that are open for comment with the FDA
What is your number one / top negative thought of the FDA?
I am not sure it is fair to be negative about the FDA, not that I am not regularly negative about the process. I am just not sure that is fair. That said I, like many others, find it frustrating that advances in diabetes care are invented here in the USA and appear in other markets first.
Why that happens a little dance of finger pointing. The FDA says they can’t approve devices unless industry applies for approval. That is true as far as it goes but first industry needs to know the FDA has a process to approve something. Without some basic rules of the road industry can’t really apply. This is very clear with advances in insulin pumps, CGM integration and Low Glucose Suspend (LGS.) The FDA is right that they cant approve stuff that industry has not applied for but until the FDA is unable to define the way they will regulate a devices why apply? The agency was still struggling with draft guidance on how to consider approving LGS while the products came to market in other countries.
Look at it this way, if the teacher says, “I’ll let anyone go to recess early if they can pass the quiz,” but then doesn’t have a quiz, how can we get to recess early?
My real issues with the FDA is they are reactive and not proactive. That is a function of how they are chartered by congress, review stuff and see if it is safe. I want the FDA to be part of a dialog with patients and industry that is forward looking. I want the patients to advocate that the FDA to create regulatory incentives for open diabetes data standards. Patients would benefit. Conceivably a streamlined process for part of the regulatory approval would benefit the agency and industry by not requiring a reinvention of the data wheel and re-regluation of the wheel for each device.
What is your number one / top positive thought of the FDA?
I think they want to be better and we need to help them do that.
Over the past few years the DOC has moved from having an adversarial relationship with industry to seeing industry as a needed player in health process. That has happened as a result of conscious relationship building efforts. Because the FDA functions at the instruction of Congress, it is, in part a political entity. Maybe more appropriately, it is an entity that pays attention to Congress, which is a political entity. Let me be clear, I don’t think the FDA makes political decisions in approving devices, I think they live in a political town and are responsible to the mother of all political entities, Congress.
One huge problem with this is there is no reward for FDA doing a good job, but only hearing in front of Congress is when something goes wrong. Ever have a boss like that? It sucks.
So the DOC has the opportunity to use the political process to be heard. If we can figure out how to shine a light on the FDA helping the diabetes care process then maybe, just maybe, the DOC can help create a way for the FDA to be seen doing a good job.
Diabetes is unique, self care is the norm. Sophisticated devices and a potentially very dangerous drug, insulin, are self administered routinely. While much regulation is about safety and efficacy of health care professional administered medications, diabetes care is only practical because we the patients do most of the dosing and adapting to variations ourselves as taught by our health care team.
As a patient, or caregiver, or anybody that has an “interest” with diabetes, how can we help eliminate the negative from above, and increase the positive from above?
This is a particularly brilliant question. As a community we need to find current issues with the FDA and industry, translate them from regulatory double speak and motivate PWD to be engaged.
If the FDA knows to expect a wave of comments on any issue involving diabetes care they will act in anticipation. To do that, we need to craft personal comments on the issues that are approachable, interesting maybe even entertaining (serious not solemn.) It will take tons of letters and emails. That doesn’t mean everyone has to read all the long and solemn FDA dockets. It means a few folks need to slog through the dull stuff to distill key points. Those with the gift of sharing from emotion can help all the DOC to speak with a voice that the political process hears and shares with the regulatory agency.
Imagine a relationship where Congress hears success stories about the FDA.
Could you provide an estimated process flow of a product being approved by the FDA, for example, company submits request, FDA reviews and declines, company creates additional testing, submits new document, FDA reviews, etc? And, if so, how long does a process like this normally take?
I wish I could.
There are different processes. They take different times. Two key ones PMA and 510. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm
There are scholarly articles on the ins and outs of those in medical journals and the popular press. http://scholar.google.com/scholar?as_ylo=2011&q=pma+510(k)&hl=en&as_sdt=0,39 There are issues of funding and time tables. Those are addresses in legislation called MDUFA.
I am fairly sure I would be giving a fatal dose of boring if I tried to explain it and I would no doubt be wrong as well as boring.
I think a better reply is to advocate for what we can do as a community.
Communities can influence the process. We can be aware of opportunities to comment on regulation, we can simplify the complexity, we can share key talking points, we can put those points into personal stories and share those real human issues with the regulators and Congress.
The negative we face now is regulatory delay. The process of regulating tools needed to make life with diabetes second to kids’ individual dreams shouldn’t take longer than high school.
If we want that slow process to speed up, we have a first amendment right to “petition government for redress of grievances.” If we don’t, who will? Diabetes doesn’t pause for institutional delay. Neither should we.
Some may be overwhelmed by reading FDA documents and timid to comment on them, do you have any advice for reading and understanding them?
You have to be a sick and twisted individual with no real life to like reading the documents. So subcontract it. Outsource it. There are a few sick twisted individuals with no real lives who can do it for you. I am one. (After those sick twisted comments my friends Scott, Kelly and Bernard may bail on me and who can blame them? So much for me bing politically astute.)
Seriously (but not solemnly) this is exactly what a community does, shares responsibility. A few of us can read up and try to make the material not so overwhelming (however looking at how long my replies here maybe, not so much less overwhelming as one may hope.) The deal then is in return for not having to read all the stuff, others take the message, personalize it and be counted in the process and write the FDA and Congress.
Scott and I have often talked about drafting form letters. He’ll help find stuff. With others, we can draft letters. What we need is a small army to personalize those letters and get them to Congress and the FDA.
Any last comments, concerns, resources, links, shout outs?
Dude, I have run on for four pages. Nobody is reading anymore. LOL. I tried to get the shout out in early when I still had an audience.
I hope you all are still with us and haven’t left yet. If you are like me, then you are probably going back to re-read this a few times. There are a bunch of links in here that can be useful, so please go check them all out.
As I mentioned way back in the beginning, there is a follow up post next week for Bennet to answer any additional comments that you may have. So please leave a comment, share, or send me an e-mail through the contact form.
Hope you enjoyed.