Tag Archives: FDA

Part of a well-rounded portfolio of resources.

September 26, 2014 – 9:42 am

Okay, I’ve talked a couple of times about the U.S. Food and Drug Administration, and what they do in terms of testing and approving devices and products that help us manage diabetes. Today, I’d like to share a few more FDA resources with you. I hope you find them helpful.
 
 
Did you know the FDA has a web page devoted to schooling you on illegally sold diabetes treatments?
These are those “miracle cinnamon cure”-type items that pop up in our inboxes now and again. If you’re a well-informed Person With Diabetes, you can probably spot that kind of bunk from a mile away. But some people can’t. Including people who don’t live with diabetes, who don’t understand why we can’t all be cured like Halle Berry. Send those people a link to this page, which also has links to a great video helping to further define garbage products, and a Flickr page that actually shows you what some of these products look like. Case closed.
 
 
While I’m dropping F bombs… In addition to Flickr, the FDA has a presence on Facebook too.
Be the first on your block to friend the FDA! Once you do, you’ll get the latest updates as they are posted, and I suppose you’ll be able to directly leave comments of your own. More avenues of communication can only be good.
 
 
I’ve mentioned this before, but it’s worth mentioning again. MedWatch has been the FDA’s avenue for reporting adverse reactions to drugs or devices for over 20 years now. Today we can report issues by going directly to www.fda.gov/medwatch and completing on online form. Also, MedWatch is a source for safety information on drugs and devices that are a part of our everyday lives. Over the years, MedWatch has helped inform People With Diabetes about problems with blood glucose meters, the drugs Avandia and Actos, and insulin pump infusion sets. Those issues were reported by someone, and someone at the FDA listened. And then reported on it.
 
 
In addition to these sources, you can also follow and converse with the FDA directly on Twitter at @US_FDA. If you want to keep it old school, you can still call the FDA at 1-800-FDA-1088 (1-800-332-1088).
 
 
Maybe the FDA isn’t the first place you think of going to gather information on diabetes. But any well-rounded individual should have a portfolio of important sources of data that includes the U.S. Food and Drug Administration.

That’s the end of my public service announcement. Enjoy your Friday!
 
 
 

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

Talking with the FDA.

September 19, 2014 – 6:17 pm

This post is also published on the Diabetes Advocates website.
Take the Diabetes Advocacy Survey, join us, and become a Diabetes Advocate right now. This post will wait until you come back.

When I first discovered the group of bloggers, reporters, healthcare professionals, and patient advocates that make up the Diabetes Online Community, I remember feeling really good about the support and encouragement I was suddenly finding through the internet.

I did not know much about the U.S. Food and Drug Administration, other than knowing that they had to approve every new drug or device used to help me survive with diabetes. Then I started reading a lot from people who felt that the FDA was holding back progress on these things. How the FDA never took the patient point of view into consideration. How they were a bottleneck, holding back advancement toward better outcomes for us.

Well, I’m not sure if that was entirely true then. But I do know now that it is not true today.

Last year, Strip Safely helped lead a campaign to get more people to comment on FDA draft guidance for glucose meters. We were all encouraged to post comments letting the FDA know how important greater accuracy and post-market inspection is when considering the trustworthiness of new glucose meters and test strips.

We were able to post those comments directly to the FDA because they made it possible to do so, easily, online. As a result of just that one push to comment, the FDA received six hundred comments on this one issue. That’s about six or seven times the number of comments they generally receive on draft guidance. Collectively, and as individuals, the diabetes community spoke and the FDA listened. But that’s not all.

A few weeks ago, I received an e-mail from the Food and Drug Administration about comments I left regarding glucose meters in a point-of-care setting (hospitals, doctor’s offices, etc.). They wanted to speak to me about what I had written them. So we scheduled a time, and I spoke by telephone with Katherine Serrano, Deputy Director of the FDA’s Division of Chemistry and Toxicology Devices.

We talked about some of the things I had written, and she had a few questions for me. The thought of that seems a little intimidating at first. But rather than just a talk between a Deputy Director at FDA and a guy from Baltimore, it was really a conversation between two people discussing an important topic. I tried to give her my passionate best on the subject, and she remained engaged, asking follow-up questions and allowing me to consider her questions carefully before answering, and even letting me e-mail her later with additional feedback. This does not seem like the actions of a group that does not care what we think.

I don’t know how seriously Ms. Serrano or the FDA considers my views on the subject. But there’s no denying the fact that I was given not one, but two chances to deliver a personal plea for the best possible device guidance on point-of-care glucose monitoring. And I was not going to pass on either one of those opportunities.

Because new innovations often take years to get into the hands of the people who need them most, it’s easy to feel like your voice would get lost among the masses, even when you do take the time to respond to something. But what’s the alternative? You, or people you love, are the patients, the ones most affected by any changes to the status quo. The one way to be sure your concerns are part of the public record is to make them public. The one way to help all people with diabetes get the better outcomes they deserve is to insert your voice into the conversation. And if you’re asked for additional perspective, be sure to speak with the passionate desire for the absolute best results that comes with the perspective that only you possess.

We’re counting on you. Allow yourself to be the voice that makes the difference.
 
 
 

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

Like these links, and keep the D-mojo going.

August 6, 2014 – 8:48 am

Welcome to Wednesday…

I’m going to throw a few links at you today to help you keep your diabetes mojo going strong. I promise: If you click on any of the links below, your requirements in terms of time and effort will be a scant two or three minutes apiece. Quicker if you read fast. Check them out:

You may remember me writing about a U.S. House of Representatives resolution (HR 3710—Medicare CGM Coverage Act) introduced last year. Well, now a bill to get continuous glucose monitors (CGMs) covered by Medicare is making its way through committee in the United States Senate. This one is Senate Bill 2689—Medicare CGM Access Act of 2014. Introduced by Senate Diabetes Caucus co-chairs Susan Collins (R-ME) and Jeanne Shaheen (D-NH), this bill aims to do the same thing: Protect the right of citizens on Medicare to keep their CGM. Make sure you get your senator to get behind this legislation, like, NOW. JDRF makes it easy by providing this link:
https://secure3.convio.net/jdrf3/site/Advocacy?cmd=display&page=UserAction&id=412

Just fill out the form, include your own personal sentiments (like, “I’m going to be Medicare eligible in 13 years… Don’t take away my CGM when I need it most!”). Click Send Now and you’ll have committed an act of Diabetes Advocacy before Starbucks can serve up your latte.

Got an extra minute? There’s also a petition to sign:
http://www.thepetitionsite.com/takeaction/776/978/446/

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Also: The U.S. Food and Drug Administration has proposed new guidance for Medical Device Data Systems (MDDS). Borrowing from the Strip Safely website:

“These are systems that, in the FDA’s words, facilitate “the electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices.” Translation: technology that lets data show up on a device other than the medical device itself. FDA believes that these types of MDDS introduce little additional risk, and the agency is therefore proposing to lessen the regulatory process for MDDS.”

Face it: We would all like to have access, and provide access for our loved ones, to the data from our devices. This is possible, it’s helpful, it’s an idea whose time has come. Agree? Now’s your opportunity to have your voice heard. How do I know they’ll listen? I was contacted by the FDA about comments I posted earlier last year on glucose meter accuracy and post-market inspection.

You only have until August 25 to submit your thoughts. Get the skinny right here:
http://www.stripsafely.com/sample-page/comment-on-mdds/

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Finally… Just in case you forgot about it, don’t forget about the first Diabetes UnConference, taking place out in Las Vegas next March. Brainchild of Christel Marchand Aprigliano of ThePerfectD, it will be a conference of diabetes peers from all over, setting the agenda together in the first hour, and asking and answering questions throughout the weekend. I already have four ideas, at least one of which may have some merit. If you’d really like to attend a diabetes conference by People With Diabetes, for People With Diabetes, this might be for you. I understand rooms are filling up fast. This is really turning into a thing. Find out more about the Diabetes UnConference and register too by going to:
diabetesunconference.com

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So… what about you? Have you read or written anything lately that is awesome? Oh… I just remembered: Kelley at Below Seven just published this month’s list of Best of the ‘Betes blog posts yesterday. Now… Where was I? Oh yes… If there’s something that moved you recently, please be sure to leave a link to it below. I’d love to read it!
 
 
 

By StephenS | Posted in Like these links | Also tagged , , , , , | Comments (1)

I’m looking at you…

April 30, 2014 – 9:06 am

I’m looking at you… you person, who has up until now procrastinated and not submitted comments on blood glucose meter and test strip accuracy to the U.S. Food and Drug Administration.

You have one week left.

SSGuidance

For one more week, two draft guidance documents are open for comment from the community at large. One is for equipment used in a clinical setting, like doctor’s offices and hospitals. The other has to do with the meters and strips we all use as consumers (read: patients).

Due to enthusiasm from the Diabetes Community, the FDA has added an extra month to their deadline for people to leave comments on these important documents. But that extra month ends next Wednesday.

Have you commented yet? (Hint: you don’t even have to be a person with diabetes to comment)

Have you spread the word about this important draft guidance?

Is the answer c) None of the above?

Don’t worry. The important information on the draft guidance, and how to leave comments, and even some sample text you can use when commenting, is all available on the Strip Safely site.

Let’s say you’ve left comments already. Well… Have you read the information about third party strips documented so well at Strip Safely and over at Diabetes Mine?

Did you know you could add additional comments expressing your concern over third-party accountability? Guess how long you’ve got to do that? That’s right… one more week.

Don’t miss out on lending your voice to this important issue. It is needed and wanted and appreciated. So please, take this not-so-gentle reminder to heart, and help ensure better accuracy of the glucose meters and test strips that are used multiple times every day. Time is running out. Procrastination is not an option any longer.

Many thanks to Christel Marchand Aprigliano and Bennet Dunlap for leading the charge up the Hill of Guidance.
 
 
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By StephenS | Posted in Diabetes | Also tagged , , , , , | Comments (1)

#StripSafely Is Opening Doors Again.

March 28, 2014 – 9:06 am

I just have a minute to get this down before running to catch a flight out of town… Monday is a big day for all of us who have been pounding the Strip Safely drum for nearly a year.

The best part is that you get to be part of it.

Bennet Dunlap and FDA expert Courtney Lias will head up a conversation with us. Yes, us too—we’re invited! You can register for this important call and listen to, and engage in, direct conversation between the Diabetes Community and the Food & Drug Administration (FDA).

Click here to register for this one-of-a-kind event.

Find out more about how the FDA regulates medical devices. Find out more about what the FDA is doing to ensure accuracy of blood glucose meters. This is your chance to hear the answers to any number of diabetes-related questions directly from the FDA.

I know many of you have expressed frustration, feeling like the FDA doesn’t listen to us. Well, in fact… lately, they are listening.

Monday’s conversation is a golden opportunity for the Diabetes Community to grab the ear of the government agency here in the USA that regulates our meters, our pumps, our CGMs, and more.

It promises to be a very important hour. Don’t miss it. Don’t miss sharing this with everyone you know. As Christel said yesterday, this is where all the cool kids will be on Monday.

The chat happens Monday, March 31st from 1:30p.m. to 2:30p.m. Eastern Time.

Click here to register for this meaningful event.

In case you didn’t know… This is a big deal. This kind of access is miles beyond what we could have imagined just a couple of years ago. Please take advantage of this unique opportunity, and don’t forget to share it with your DOC friends. Your voice is needed and appreciated. Be part of the conversation, or just listen in.
 
 
 

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