Tag Archives: FDA

It’s Black Friday. And I need your help.

November 28, 2014 – 8:50 am

Did I say I need your help? In fact, we need your help.

For the next week, the U.S. Food and Drug Administration has a docket open, waiting for public comment from you and me and anyone else living with or affected by diabetes. What makes this docket unique is that they are actually asking us to weigh in on how we want to be included in the review of diabetes devices and drugs. Can you believe it?

From the FDA’s official docket:

The Food and Drug Administration (FDA) is announcing the establishment of a public docket for comments on FDA activities performed under the Food and Drug Administration Safety and Innovation Act (FDASIA), Patient Participation in Medical Product Discussions. This notice announces FDA’s intent to gather input from stakeholders on strategies to obtain the views of patients during the medical product development process and ways to consider patients’ perspectives during regulatory discussions.

The thing is, we only have until next Thursday, December 4th, to respond. After that, our opportunity is gone. Can you help? Will you please be an advocate and comment? It’s very easy to do, and so, so helpful.

Here’s the link to the public docket

Here’s the link to leave a comment on this docket

Needless to say, it’s absolutely necessary to let the FDA know how important the patient perspective is in the review of things we use to manage our diabetes and stay alive every day. How can you do that?

Tell your story! Personal stories are more important than statistics. Just speak from the heart and tell them what’s important to you, and why. In addition to your personal story, you might want to include these ideas too (feel free to cut and paste):
 
 

– Thank you. Thanks for the FDA’s openness with the Diabetes Community in 2014. FDA opened a number of dockets for people with diabetes to comment. The docket on glucose meters and MDDS provided specific opportunities for diabetes patients to share our views on accurate glucose measurement, and how great it would be to share that information with our support systems.

– FDA engaged in two significant and well received webinars that the community referred to as #DOCasksFDA. These were unprecedented opportunities for patients to hear from FDA and use social media to talk among themselves about specific issues. These webinars were a significant opening and I feel there is an ongoing need to continue the dialog.

– FDA came out and participated at a number of events including the DiabetesMine Innovation Summit, MasterLab at Friends For Life, Keystone, ADA Scientific Sessions, AACE, DTS, and other events. These help consumers as well as physicians and researchers better interact with the agency.

– 2014 saw the creation of patient driven diabetes solutions under #WeAreNotWaiting initiatives. Notably, the NightScout CGM in the Cloud project. FDA is to be commended for their openness to talking with representatives of this ad hoc effort.

– The efforts of FDA’s consumer representative, Rebecca Killion, is an excellent example of the value a patient can bring to the regulation process. As a member of ADCOM panels, she is a champion of patient views.

– I hope that the dialogue between FDA and people with diabetes continues to grow in both content and diversity in 2015 and beyond. I hope that the #DOCasksFDA process leads to a unique and meaningful PDUFA meeting on diabetes.

Finally, I believe that

  • The patient perspective is unique, and should be included whenever the FDA reviews drugs and devices.  This is the most important part of interaction.  No one can understand diabetes the way those who live with it do.
  • Including the patient viewpoint can reduce the time spent gathering information for both reviewers and submitters.  It can help provide a fresh set of eyes on impactful changes to devices and drugs.
  • Having a patient as part of the process focuses concerns and speeds approval of meaningful improvements.  We’re able to ask questions and provide real-world experience of why something works for the patient, and why it doesn’t.
  • Under MDUFA III, the Patient Preference Initiative is critical to give FDA a meaningful look into how people with diabetes consider the benefit/risk paradigm regarding new devices under review.
  • The idea of a person with diabetes, or a parent of a child with diabetes serving as a Special Government Employee, such as Ms. Killion, is extremely beneficial.


 
 
I know I’m asking a lot, asking you to help with this right now. Think of it as a way to get one more ounce of advocacy in before Diabetes Awareness Month is over. And we need your advoacy. The best part is, you don’t have to even leave your home. If you’re reading this right now, you can make a difference right now. Let’s not only not lose this opportunity… Let’s make the most of this opportunity before it’s gone.

On behalf of myself and all People With Diabetes, Thank You.

Special thanks to Bennet Dunlap, Christel Marchand Aprigliano, and the rest of the Strip Safely team for their help with this effort.
 
 
 

By StephenS | Posted in Advocacy | Also tagged , , | Comments (9)

FDA Workshop– I came, I saw, I listened.

November 17, 2014 – 10:58 am

FDA

I mentioned last week that I would be attending the public workshop at the U.S. Food and Drug Administration, titled Regulatory Science Considerations for Software Used in Diabetes Management.

It was a pretty full day.

Remember, this was a day off from work. You know, that thing I do to make money so I can actually attend these things in person. I woke up earlier than I do when I actually go to work, and instead of leaving the house between 7:00 and 8:00, driving a mile and then getting on a train, I left at 6:00 and drove to FDA headquarters in Silver Spring, Maryland, over an hour away through almost rush hour traffic.

The proceedings started at 8 a.m., and the day started with presentations related to something that I’ve really taken notice of this year: Interoperability.

When I go to meetings and workshops where a lot of presentations are made, I try to go over each person’s message and convey that to you here. This time, I’m not going to do that. Instead, I will refer you to the webcast replay that’s available over at the FDA’s website, where you can get video, audio, and presentation slides. I will, however, share a little of what I experienced on that day.

I always learn a lot when interoperability is discussed. It’s such an interesting subject to me, and it’s an idea that’s long overdue in the diabetes world. I didn’t expect to get much out of the bolus calculator presentations, but I was wrong about that. The talks were very good, and the panel discussion at the end was great to see.

The presentations were all informative and interesting. Particularly, those from Howard Look of Tidepool, who made an excellent presentation, making the case for interoperability based on the simple fact that we need to reduce the burden of diabetes on the patient, and interoperability would most definitely be a step in the right direction. Dr. Joe Cafazzo talked about the research his team is doing in Toronto, working to understand and map out a strategy for a standard of device data interoperability. As someone in the Q & A session mentioned (a corporate representative in the room), think about when you purchase a lamp and it has the UL symbol, or think about how HTML is the standard code throughout the internet. If we can arrive at a standard for diabetes devices, it might make it easier for a company to deliver trusted product to consumers (us), and then market it by saying it meets the standard.

Adam Brown of diaTribe was fantastic speaking about insulin bolus calculators, how they work, and what the impacts of bolus calculators are to people living with diabetes, backing everything up with lots and lots of supporting data (the FDA really likes that). Dr. Howard Wolpert from Joslin Diabetes Center and Jane Seley of New York Presbyterian Hospital gave fact-based talks that confirmed the anecdotal stories they shared about dealing with diabetes patients on the front lines over the course of many years of service.

The panel discussion surrounding bolus calculators was interesting. Most of the discussion had to do with the many bolus calculator apps that are out on the market now. While a calculator within my insulin pump must be approved by the FDA, apps that perform the same function do not right now. The moderator of the panel was convinced that these bolus calculators should be regulated. Adam Brown and Howard Wolpert made a convincing case (in my eyes, anyway) that, in Adam’s words, “a patient using a bad bolus calculator is still better off than a patient just winging it”.

At the end, Dr. Courtney Lias (look her up) shared a few things with us. She appreciated everyone’s viewpoints, and indicated that the FDA intends to continue the discussion. Not sure how yet, but they are willing to commit to having more discussions in the future on these subjects. What is not on the table: Restricting bolus calculators. The important thing, she said, is that the FDA get the right touch between innovation, patient safety, and the idea of benefit vs. risk for people living with diabetes. She reminded us that the patient is key… safe, effective tools to manage diabetes is everyone’s goal… and one person’s diabetes is not like another’s, so not every solution will meet the needs of every PWD.

In addition to all this, I got to sit down at lunch with a person working on the Nightscout project, and with another industry representative. It was great getting a chance to share my story with them firsthand (though I’m not using Nightscout—or a CGM right now).

And during the public comment portion of the proceedings, I was allowed to speak…

Photo of my best side courtesy of Bennet Dunlap

Photo of my best side courtesy of Bennet Dunlap

I’m usually a good public speaker. I enjoy getting up in front of people and talking. This, however was not my best performance, though I think I got my message across. It was basically the same thing I published here earlier. You’ll probably be better off if you go to that and read it to yourself, rather than listening to my ramblings.

Anyway, there were a couple of people left to speak after I was finished, and while I sat there listening to them, something strange happened. I was almost overcome with a wave of emotion. I started to ask myself “What did I just do?” and “Four years ago I wasn’t involved in anything outside of my own neighborhood… How did I get here?”.

I think it was just a feeling that I had something to say, and I said it, and damn anyone who might try to belittle it. Including you, industry representative on the aisle who gave me that sour look as I walked back to my chair. I understand that companies want to advocate for what’s in their best interests. Well, that’s what I was doing too. Advocating for what is best for me as a patient. I understand and respect their concerns, but when they clash with what I need and deserve as a patient, I’m going to advocate for me and not be sheepish about it.

In the final assessment, I can say it was a day in which I was able to learn a lot, meet new people, and share my needs with the federal agency that plays such a big role in our lives. All of that made it well worth losing a little sleep and schlepping to D.C. in the dark. The timing (November 13) made it feel like an early World Diabetes Day gift.
 
 
 

By StephenS | Posted in Advocacy | Also tagged , , | Comments (3)

Interoperability Awareness.

November 12, 2014 – 10:21 am

I’ve been living with Type 1 Diabetes for 23 years.

Like everyone else who was diagnosed with Type 1 around the time I was (1991), there were just a few options. Those options included, thankfully by then, glucose meters that gave us a reading from a drop of blood we provided. We used the data from those meters as a base for our dietary decisions and our insulin dosing. Also, as a basis for the imagined success or failure of our diabetes management.

Today, with little exception, we’re using the same system. The tools are better, probably more accurate, but we’re using the same system. Whether we’re using a continuous glucose monitor, an insulin pump, a Low Glucose Suspend system, or something else, we’re still using the same drop of blood to guide our decision-making process and the decision-making process of the systems we use.

And that’s okay, except it’s not, because we still can’t get what that drop of blood, or that CGM, or that insulin pump, or that LGS system is doing to work all on the same platform, informing the same data sources. That holds us up from sharing our data with our families (I’m familiar with Nightscout—I’m talking about all of our data). It keeps me from informing healthcare professionals on a real-time basis, at regular appointment times and if, God forbid, I wind up in the emergency room unable to speak for myself. It keeps researchers from being able to use my data to inform and support their discoveries. It keeps the diabetes devices that I wear from working efficiently, keeping me from achieving better outcomes with less effort. I’m talking big picture here: Not just “Can my CGM talk to my pump?”. I mean “Can my meter readings and CGM graphs and pump settings and prescription dosage and anything else health-related reside in one space?”.

Let’s face it: We’re now talking about cars that can drive themselves and using drones to deliver packages to our homes. Meanwhile, our diabetes devices are still dependent on years-old technology that is mostly confined within the length, breadth, and depth of the device itself.

If my data is all available via one source, where I control who can see it, but once I make it available, it’s easily accessible? That’s the jackpot in this discussion. And guess what? If that ever happens, I’m still going to want an insulin pump. I’m still going to want a CGM. I’m not going away as a customer.

To talk about the proprietary nature of software that a company has developed just doesn’t hold water anymore. The software that comes with your device doesn’t have a separate line item on the invoice. It’s baked into the price. Protecting “intellectual property rights”, in this case, is a 20th Century complaint for a 21st Century world. And it’s an 18th Century argument when it comes to what is best for the patient. I’ve said it before, and I mean it: Patient trumps Proprietary.

People With Diabetes need and are deserving of 21st Century technology that will not only help us reach better outcomes, but will help everyone who helps us reach better outcomes. Please join me in speaking out for greater awareness, and improved access to our data.
 
 
Tomorrow I’ll be attending the U.S. Food and Drug Administration’s Public Workshop – Regulatory Science Considerations for Software Used in Diabetes Management.

This is the message I’m taking with me.
 
 
 

By StephenS | Posted in Advocacy | Also tagged , | Comments (5)

#DOCasksFDA: Excitement, disappointment, perspective.

November 5, 2014 – 11:00 am

Like so many others, I looked/listened/Tweeted in on the #DOCasksFDA presentations on Monday afternoon (or morning, depending on where you live). A conversation between the diabetes community and the U.S. Food and Drug Administration, it promised to open a window to the FDA’s role in our diabetes lives.

I was quite interested in what was going to be said, and how it would be presented. There were numerous presentations by FDA staff and government policy makers, and diabetes community movers and shakers.

Let me just say this, for people who haven’t been at a gathering of this type, and especially for those catching it via the webcast: I do understand that seeing everything via a webcast is not the same as being in the room. But only a few were going to actually be in the room, and that doesn’t mean the rest of us were going to be left totally in the dark. For people who have complained for so long about being left out of the process (define your process here), this was an important step, even if it meant registering for the webcast as a participant, then having to log in as a guest, which probably meant the same thing anyway.

Twitter-KarenBittrSweet

If you don’t know this already, the response was tremendous. In fact, so many people were logged into the webcast that it overwhelmed the web servers at the FDA.

Twitter-DiabetesMine

Honestly, I thought it was possible that we just overwhelmed the meeting capacity of the Adobe® Connect session that was set up for this event. Regardless, it was almost certainly a case of a huge amount of people trying to look through a tiny keyhole all at the same time.

In a way, that’s a good thing, right? We showed the FDA how big a group we are, and how seriously we take the FDA’s role in reviewing and approving drugs and devices. This is proof positive that we have serious questions and concerns, and a big desire to know more.

Twitter-gborkman

On the other hand, it was disappointing to have a large slice of the meeting completely lost. I mean, I started work at 7:00 a.m, worked straight through without a break until the webcast began at 1:00, then worked another two hours after, just so I could take it all in live. So when the webcast went down, then just the audio came back for me, then even that went down again, I felt a real sense of loss.

Twitter-StephenSType1
 
 
Still, I think a sense of perspective needs to prevail here.

Twitter-StripSafely

This is the first time a forum like this has been live streamed between the FDA and the diabetes community. If events like this were reccurring, I would feel good knowing the worst technical problems occurred the first time around, and things got better after that. I’m bummed about missing so much, but I’m willing to forgive a little more the first time around.

Also, we did have the Twitter feed (hashtag: #DOCasksFDA) to rely on when things went awry. It’s not the same as being there, but it is something.

And the best part is that the presentations will be available soon online. I’m hoping that includes recordings of the parts of the webcast those of us not in the room missed.

Most of all, it’s important to note two important things about that afternoon:

1. The FDA is engaging with us.

Twitter-FDA-Patients

2. The diabetes community showed an amazing amount of interest, concern, and advocacy during those three hours, webcast or not. This was Tweeted by Manny Hernandez in the first half hour, and the conversation only accelerated from there:

Twitter-askmanny

Considering the technical difficulties, I hope something like this can be done again very soon. The need exists. The desire is certainly there. I am very grateful to the FDA for agreeing to do this, and for trying to solve technical problems when they happened. I’m grateful to Kelly Close, Adam Brown, and the DiaTribe team for facilitating this event. And I couldn’t be prouder of the rest of the diabetes community, who turned out in oversized numbers to voice our interest in interacting with this government agency. It can only get better from here, yes?
 
 
 

By StephenS | Posted in Events | Also tagged , , | Comments (5)

Reminders, reminders. And more reminders.

October 29, 2014 – 9:31 am

Here are a few reminders of things happening right now where you can make a difference:
 
 
Tweet your elected officials! Tell them to #Vote4DM!

VOTE4DIABETESM

Maybe you were getting ready for last week’s DSMA Twitter chat and you started noticing all of the tweets going out from the Diabetes Community to House members and Senators here in the USA. Do you know where that started? It started at Strip Safely, who started the campaign and even provided this nifty web page that made it super easy for people to Tweet their elected officials about coordinating the federal response to diabetes, covering CGMs for senior citizens on Medicare, and permitting Certified Diabetes Educators to provide already approved education benefits to their patients.

Guess what? There will be a brand new Tweet-In again tonight (October 29) beginning at 8:00 p.m. eastern time. Once again the Diabetes Community will be showing strength in numbers by massively tweeting the lawmakers we elected and letting them know how important it is (less than a week before election day) to make diabetes an integral part of the legislative landscape. And soon.

It will take less than five minutes for you to be an advocate.

At 8:00 eastern time tonight (US)– You can help by going to this page, finding your congressperson and senators, and clicking on the specific links listed to either encourage the people (that we elected) to take up the cause, or to thank them for already doing so.

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Five days until #DOCAsksFDA

I’m very much looking forward to the conversation (via webcast) that will be taking place on Monday, November 3 beginning at 1:00 p.m. eastern time (US). This is a chance for you to learn more about the U.S. Food and Drug Administration, how and why they review devices and drugs, and how we, as a community, can work with the FDA toward better outcomes in all areas.

To RSVP for the webcast, go to this Diatribe link or this FDA link, get all the information, and register. Once you’ve done that, you’ll get a look at the agenda and a link to join the webcast on Monday. I hope you’ll be there!

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Don’t forget about the Big Blue Test

Hashtag-Big-Blue-Test

The Big Blue Test is going strong. As of this writing, there were over 1600 Big Blue Tests recorded so far. But that’s a far cry from the goal of 35,000 set for this year’s event.

Don’t forget… Now until November 19, every Big Blue Test that is logged will result in a $1.00 (US) donation to non-profit diabetes groups that are working tirelessly to provide education, support, and supplies to people who need them. My guess is maybe you’ve forgotten to log all of your activity. Well what are you waiting for?

Here’s how it works:

1. Test your blood glucose. If you do not have diabetes, you can skip this step.

2. Get active. For 14 to 20 minutes, get up and get moving. You can , walk, run, clean the house, swim, tap dance…whatever!

3. Test again. On average, Big Blue Testers seen their blood glucose level drop 20% after 14-20 minutes of exercise.

4. Share your results. Answer the questions in the right column of the page at bigbluetest.org. And don’t forget to talk about your experience on social media using the hashtag #bigbluetest.
 
 
 
So there you have it. Three great ways to learn, stay active, and hold congressional feet to the fire for People With Diabetes. It’s not always about big projects with huge budgets and lots of manpower. Sometimes it’s as simple as saying, “Yeah, I can do that” and making a small effort.

And while I’m at it, let me say: Thank You for your advocacy. Your efforts continue to make a difference.
 
 
 

By StephenS | Posted in Advocacy | Also tagged , , , | Comments (1)