Tag Archives: FDA

A window of opportunity is closing.

March 21, 2014 – 10:37 am

I really didn’t expect to write about this again, but… This still needs to be talked about. And for various reasons, this may be my last chance to write about it before our window of opportunity closes.

The U.S. Food and Drug Administration is in the process of drafting guidance for manufacturers of blood glucose meters. The guidance will be for future production of both over-the-counter meters (the ones we, as individuals, use), and the ones used in a clinical, point-of-care (i.e., hospital) setting.

As of right now, the FDA has opened up these draft guidance documents for public comment.

In other words, they want our input, and they’re even welcoming it.

But they will only accept our input until April 7. So please… Right now… Do something for me:

Go now to this one page, follow the instructions, take two or three minutes, and add your voice to something that will be extremely meaningful to me for years to come.
 
 
As I publish this post, only 167 comments have been posted on the OTC guidance.

As I publish this post, only 101 comments have been posted on the point-of-care guidance.

Every man, woman, and child in America with an internet connection should be commenting on this guidance.
 
 
Are you living with diabetes? Is someone you care about living with diabetes? Do you work with someone living with diabetes? Do you drive on a roadway with someone living with diabetes? Do you interact ever with someone living with diabetes? Are you starting to understand why this is important and critical and time-sensitive?

Maybe you don’t care about making meters more accurate. Or maybe you do.

If you’re living with diabetes, improving meter accuracy is important to you, and you know it, and you can do something about it.

If someone you care about is living with diabetes (and someone you care about is), improving meter accuracy is important to you, and you know it, and you can do something about it.

If you aren’t affected by diabetes at all, improving meter accuracy is important to you, and you know it, and you can do something about it.

Do something about it.

Go now to this one page, follow the instructions, take two or three minutes, and add your voice to something that will be extremely meaningful to everyone for years to come.

Future lives hang in the balance of blood glucose meter accuracy, and you can help win the day.

Thanks again to Christel Marchand Aprigliano and Bennet Dunlap for opening my eyes on this issue and leading the charge up the Hill of Guidance.
 
 
I now return you to your regularly scheduled day.
 
 
 

By StephenS | Posted in Diabetes | Also tagged , , | Comments (4)

Make your voice heard. Today. Now.

March 7, 2014 – 9:22 am

SSGuidance

Maybe you’re one of those people who says, “That FDA—they never listen!”. Or maybe you say, “If the FDA wouldn’t wait so long, we could see products come to market sooner!”. Well, glucose meters and test strips are not made in a day. Okay, maybe they are, but bear with me here.

The U.S. Food and Drug Administration (the FDA) is in the midst of an arduous process to update guidance to companies on future manufacture of blood glucose meters. From the Strip Safely website:

“FDA has two draft guidance documents about blood glucose meters that are open for comment until April 7, 2014. A “draft guidance” is basically a preview of what standards the FDA is considering requiring in order for blood glucose meters to be cleared — the law requires that FDA open its draft guidance documents up for comment before publishing a final version.”

So if you’re one of those people who says, “That FDA—they never listen!”, here’s your chance.

The FDA has two open dockets right now through Monday, April 7th. You have an opportunity to raise your voice with the rest of the Diabetes Community, engaging in public discourse and helping the FDA get it right.

The best part is, it’s so easy to lend your voice to this important issue. As usual, Strip Safely has everything you need to know. And not in a creepy, big-brother, overbearing government kind of way. Head on over there now and you’ll find super easy instructions that will help you lend your voice to this increasingly critical guidance.
(hint: read the instructions carefully, or you might miss something important)

If you’re worried about not having enough time to comment, don’t. Strip Safely has links to the dockets for personal use meters and in-clinic meters. And they even have language you can use to join the chorus of D-people who are weighing in on this topic. After rewriting part of the prepared comments and submitting them to the FDA, I looked at my watch to find that a mere fifteen minutes had gone by from start to finish.

If you’re worried about your privacy, don’t. You can submit your comments anonymously. Or you can give them your name and e-mail address. Your choice.

If you’re worried about not making an impact, don’t. We need to submit as many comments as possible. More comments get more notice, making more of an impact. And after April 7, we may not get the chance to comment on this for another ten years. That’s the way it works at the federal level, folks. Your voice on this topic is appreciated and valued and necessary.

One other thing: After you submit your comments, don’t forget to tell everyone you know that the FDA is accepting public comments on guidance for over-the-counter blood glucose meters, and meters designed for healthcare providers in an office or hospital setting.

It’s not often you can do something tangible that you know will have a positive effect on People With Diabetes for years to come. But you know what? This is your chance to do just that. It’s easy. And we need you.

Many thanks to Christel Marchand Aprigliano and Bennet Dunlap for leading the charge up the Hill of Guidance.
 
 
 

By StephenS | Posted in Diabetes | Also tagged , , | Comments (0)

People with Diabetes need a seat at the table– Sign this petition NOW.

September 2, 2013 – 9:54 am

Your help is needed right now– this minute. Take five seconds to go to Change.org and sign a petition urging the U.S. Food and Drug Administration to hold a patient meeting on Diabetes.
 
 
The backstory, from DiaTribe, who is sponsoring the petition:

“The Food and Drug Administration has begun to hold a series of patient meetings to gain a better understanding of specific diseases. Over the next five years, the agency plans to conduct at least 20 such meetings on conditions ranging from Chronic Fatigue Syndrome to Narcolepsy to Irritable Bowel Syndrome.

But not diabetes.

That is unacceptable.

Four “slots” remain open, and we want the FDA to add diabetes to its meeting docket for 2013.”
 
 
It is well known that 26 million Americans are living with diabetes. Nearly 80 million more in my country are at risk of developing diabetes. Despite years, even decades, of advances in care, therapy, drugs, and technology, more people are affected by this disease than ever before.

Not only that… Consider the fact that the federal government was on the hook for over 60 percent of the cost of diabetes last year. In case you’re wondering, the government’s tab amounted to nearly 152 billion dollars. By my definition, that amounts to an epidemic and a fiscal crisis. At the very least, it is proof positive that People With Diabetes need and deserve more attention. Over 3,000 people so far agree with me. Will you be next?

Be one of 5,000 or more to sign the petition. Help People With Diabetes send a clear message to the FDA.

We matter.

We will not be ignored.

Go now, and sign the petition:
http://www.change.org/petitions/us-food-and-drug-administration-sponsor-a-patient-meeting-on-diabetes?q=petition
 
 
 

By StephenS | Posted in Support | Also tagged , , , | Comments (4)

This movement is gaining momentum. Climb aboard the steamroller NOW.

August 20, 2013 – 12:01 pm

If you’re a Person With Diabetes, you know the importance of seeing accurate readings on your glucose meter. In a public meeting last May, officials from the U.S. Food and Drug Administration admitted that there are some glucose meters and test strips out in the marketplace that no longer meet the standards that they were approved for in the first place.

What were they approved for in the first place? In testing with the FDA, test strips are required to meet an accuracy of +/- 20%. That means if my meter says 180 mg/dL, it could actually be as high as 216 and still pass the test. Or it could be as low as 144… and still pass the test. That’s a 72 point difference! That’s a window big enough to drive a truck through. And that’s what is required to pass the test and win approval.

To their credit, the FDA is working to lower the threshold and make test strips even more accurate. So what’s the problem?

Well, once the test strips are approved for use in the USA, they aren’t subject to further scrutiny. In other words, there is no program in place to ensure the continued accuracy of test strips once they’re approved. So the test strips I’m using, that met a 20% standard of accuracy when approved, might now have an accuracy of +/- 40%, according to some experts. At that measure of accuracy, my 180 mg/dL reading might actually be 252. Or 108. A difference of 144 mg/dL.

Since dosing insulin is dependent on my blood glucose reading and how many grams of carbohydrates I’m eating, if there are 45 grams of carbs in my meal:

– That 20 percent standard means a dose as low as 3.3 units. Or a dose as high as 5.1 units.

– That 40 percent deviation could mean a dose of 3.0 units. Or a dose of as much as 6.0 units of insulin.

Imagine if my dinner bolus is 6.0 units, but it should have been 3.0 units. Since my target is to get back to 100 mg/dL, and one unit of insulin should drop me about 40 mg/dL, an over-bolus of 3 units means I could drop 120 points lower than expected, resulting in severe hypoglycemia or even death. Are you with me so far? Do you understand how critical test strip accuracy really is? Good.

This is why the Strip Safely (http://www.stripsafely.com) campaign is in full force, helping to spread the word about the importance of test strip accuracy. You can do your part too, by sending a letter, either by snail mail or by e-mail, to your elected officials in Washington. Need a little help getting started?

– A sample letter you can use is available here.

– You can find your elected officials HERE.

Hint: Our elected officials have Twitter and Facebook accounts too. So does the FDA. In fact, they have many Twitter handles, including @US_FDA, @FDADeviceInfo, and @FDAMedWatch. If you decide to send something via Twitter, be sure to include the hashtag #StripSafely.

You might be saying, “Hey Steevo, you wrote about this before… why bring it up again?”. Because it’s that important. Let’s keep the momentum going. Let’s help improve the safety of people living with diabetes, and improve the peace of mind of our loved ones affected by diabetes. It’s that important. And your help is needed and appreciated and keeps the momentum going.
 
 
 

By StephenS | Posted in Diabetes | Also tagged , , | Comments (0)

#StripSafely Update. And a question.

August 5, 2013 – 9:34 am

Safety of the test strips we use, and the meters we plug them into, is a great big deal to everyone living with diabetes. It also means a lot to the people who love me and count on me to be there for them.

So I aligned my views with those in the Diabetes Online Community who also believe that A) The 20 percent +/- factor that’s currently allowed for test strips is NOT NEARLY GOOD ENOUGH, and B) The fact that the FDA has no post-approval mechanism in place to verify the continued accuracy of test strips they approved earlier, or pull them from the market if they’re not, IS NOT OKAY.

As a measure of support, and to help in getting these wrongs righted, I wrote my elected officials in Washington. U.S. Representative Dutch Ruppersberger, D-MD, and U.S. Senators Barbara Mikulski and Ben Cardin, also D-MD, received e-mails from me expressing my concern and asking them to assist.

That was nearly three weeks ago.

But hey– a week ago I received an e-mail response from Senator Mikulski, the longest-serving woman in United States Senate history. I’ll share it right here, but be sure to come back after reading, because I want to ask about something.

Letter

Other than the fact that this was pretty much a form letter, I was actually happy to have received a response at all. Seriously, even if they’re not busy all the time, senators get requests from a seemingly endless stream of attention-grabbers and favor-seekers on a constant basis.

No, what really struck me were the two images at the bottom of the letter. You know, the Facebook and Twitter icons.

So I want to ask: What if a coordinated effort was put together to bombard Facebook and Twitter accounts of U.S. Representatives and U.S. Senators for the #StripSafely cause? It could start with House and Senate committee members responsible for FDA oversight, and perhaps move on to people with oversight of the U.S. Commerce department. Somewhere in there, we could get around to House Speaker John Boehner and Senate Majority Leader Harry Reid.

I don’t know… Maybe it all sounds a little too “Mr. Smith Goes to Washington”. But don’t we believe in our own cause just as much as Jimmy Stewart did in that movie? And I have to ask: Don’t you think that together, we could make some kind of impact? If there are so many people in on the #DSMA Twitter Chats every Wednesday, wouldn’t the same kind of numbers all tweeting or messaging at the same time, about the same thing, to the same people, get an elected official to take notice?

What do you think, Diabetes Online Community? Good idea? Bad idea? Feel free to leave your ideas below.

For more on this important issue, visit the Strip Safely central at www.stripsafely.com
 
 
 

By StephenS | Posted in Diabetes | Also tagged , , , , | Comments (2)