Listen up, Friends: it's officially crunch time to let the decision-makers at FDA know what we want to see in terms of accurate glucose meters and strips!
Seriously, this is the first time in more than a decade that the regulatory agency's updated these rules on accuracy, and it's the first time in history the FDA's made a concerted effort to engage with our diabetes patient community via interviews, guest appearances and web chats, to actively seek our input. And we may not get another chance, so let's not let it slip!
Here's what's going on:
In January, the FDA issued new "draft guidance" on accuracy standards that hadn't been updated in the U.S. since 2003. They chose to split the recommendations into two categories, meters purchased over-the-counter and used in everyday settings, and meters used in clinical settings by healthcare professionals. Not surprisingly, the professional "point-of-care" meters are those being held to the utmost Ã¼ber-accuracy standards.
The deadline for public comment was supposed to be one week from now. But word from the FDA is that some key players in industry and beyond asked for more time, so the deadline's being extended until May 7. Official notice of this extension should be published in the federal register soon, we're told.
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As of late Sunday night, there were 333 comments in total for the two sets of guidelines -- 218 on the patient use meter side, and 115 for the professional in-clinic meters. Let's add to that! Please, click on over to the FDA regulation sites and leave a comment now.
(It'll only take a minute or two. Go on, we'll wait...)
- Over-The-Counter Use guidance: http://www.regulations.gov/#!docketDetail;D=FDA-2013-D-1446
- Prescription Point-of-Care guidance: http://www.regulations.gov/#!docketDetail;D=FDA-2013-D-1445
You may already have your own opinions formed. But the folks over at the grassroots StripSafely campaign also have some scripted comments they recommend we submit. The gist of those includes the following sentiments:
- praising the notion of tighter accuracy and front-of-package labels that inform consumers about product accuracy
- reinforcing the notion that insulin is a dangerous drug, therefore accurate meter readings can be a matter of life and death
- calling for better post-market quality surveillance of meters already out on the market
- calling for standardization of MDR (Medical Device Reports) -- expanding the lot information manufacturers need to share in order to prove the safety & efficacy of products
- clarifying the DME (Durable Medical Equipment) classification of meters, to distinguish which meters should be eligible for insurance coverage, since only those that are accurate enough to be used for therapy adjustments should qualify
That's a lot of detail to comprehend, but again, the StripSafely folks have laid it all out pretty clearly for us. Seriously, you can just cut and paste their prepared comments, if you wish.
Why Should You Bother?
As D-Advocate and blogger Christel puts it, commenting on an FDA Point of Care docket may not seem "sexy" or even particularly important in your busy day. But you know what? Every. Comment. Matters. Christel writes:
"Miss Manner's little gaffe ignited a firestorm of responses and comments, but this — having a piece of technology that we rely on for treatment decisions that could send us to the ER or the morgue if it's wrong — this isn't something that warrants a comment?"
We think so!
Our D-Community has a unique chance here to not only weigh in on the proposed rules but to also engage with the FDA decision-makers, impact the discussion, and even influence how D-Device accuracy is shaped in the future.
Remember that currently, meters must be within +/-20% of the true blood sugar value. The new rules would require them to be within +/-15% for personal use meters and +/-10% for those in professional clinic settings. Actually, for the "professional meters," results below 70 mg/dL would have to be even more accurate, coming within 7%!
It's significant that these proposed FDA guidelines go beyond what was adopted internationally last year and are even more strict; we reported in detail on the new FDA draft rules back in January here at the 'Mine -- including an explanation of the new labeling requirements on test strip vials and the outer box for patients to see and possibly use to compare meters.
My Own Comment-Worthy Thoughts
When reviewing the potential new rules, four "big thoughts" came to my mind:
- The overall names of these guidelines are in medical speak and aren't user-friendly. The phrases "over-the-counter" and "point-of-care" seem vague and don't reflect the reality of how these are used. I'd rather have them labeled in regular language, as "For Patient Personal Use" and "Professional Clinical Use" to eliminate any potential confusion.
- It still bothers me to think that hospital and clinical settings get tighter accuracy standards than the rest of us testing at home. After all, we're basing insulin-dosing, food choices, and so much of our lives on what our personal meters say. And on the flip side, patients tend to be in clinical settings, especially hospitals and emergency rooms, for very short-time periods with (hopefully) physician and nurse attention.
- Further to the above, this recent report shows how much personal meter accuracy matters, and how the lack of accuracy in these meters right now often leads to hospitalizations and emergency room visits. At a time when everyone's trying to cut medical costs, it seems like having the same tight-standards for both types of meter uses would be best.
- Some folks (probably wisely) are pointing out the need to strike a balance between patients' need for more accuracy and what device manufacturers are actually able to produce -- especially in the face of competitive-bidding and cost-cutting challenges companies are already facing. A recent DiaTribe report talks about this issue, and including a very concerning comment from Dr. David Sachs of the NIH:
"I think that it's going to be very difficult for manufacturers to meet these criteria. If (the FDA doesn't) make them more lax, there will be no glucose meters approved in the future." That's surely a bit of an overstatement, but hardcore pushback from manufacturers could be an unintended consequence, so it's good to take into consideration that compromise on some level will be the reality.
Those are my initial thoughts that I've submitted to FDA, combined with some of the other great "copy-and-paste" points shared on StripSafely.
Talking with the FDA - Today at 1:30 EDT!
D-Advocate and StripSafely organizer Bennet Dunlap coordinated this and will be hosting the chat, and interviewing Courtney Lias, FDA's Director of CDRH/Division of Chemistry and Toxicology.
If you're reading this early enough, you can still register for the web chat here, which takes place from 1:30-2:30pm EDT today.
"Whether you want to just listen to the interview to get informed, ask relevant questions to better understand the medical device regulatory process, or speak your mind on the newest draft guidance document ... you should join in the conversation."
- Bennet Dunlap, YDMV
This is huge -- because it essentially puts patients on the same level as device manufacturers, medical and academic players, and associations like hospital nurses and chemical lab workers who have engaged in webinars, teleconferences, and panel discussions about these accuracy guidelines. Nice! Patients finally have a respected collective voice! Way to go Bennet for coordinating and hosting this chat!
We also connected with Courtney Lias recently about some specific questions on the proposed guidelines.
She told us that the FDA wants to hear as many patient perspectives as possible (yay!), and that will be an important consideration in adopting these rules. One of the most important parts she sees is the new labeling aspect.
"Manufacturers won't be able to change a lot without labeling it. Labeling is not something that manufacturers want to do on the outside of the box, but it's what people want," Lias said. "That's unique and is a huge deal, and it will do a lot to make sure those meters and strips are better once they're on the market."
Lias says the new accuracy regulations don't directly address post-market surveillance, but the labeling is something that will impact post-market meters and test strips, because going forward, consumers will always be able to judge how old their products are and what the accuracy specs were at the time they were released. She also says the FDA's working on separate guidance that would help standardize MDR protocols for companies, a process that's very scattered right now and is critical in evaluating post-market accuracy of meters and strips. That guidance will likely be finalized this year and hopefully published for public review and comment sometime in 2015, she said.
When it comes to post-market surveillance, Lias also noted that the agency's limited in what it can do, as it's bound by Congressional action that restricts its scope in some areas. She says weaving some issues together, like requiring stricter labeling and amending the rules on adverse event reporting, are ways to address these important issues without adding extra cost and burden to the federal government's budget.
The Diabetes Tech Society, and What's Next?
The California-based Diabetes Technology Society, a group of academic experts, is closely tied into this whole issue, having kicked off a lot of the conversation and action last year. At its September 2013 meeting, the concept of a steering committee on glucose meter and strip accuracy was born and we've been waiting impatiently for updates on that. Sadly, there are none. Our calls and emails to DTS director Dr. David Klonoff were not acknowledged.
He's a busy man, understandably, but it seems ironic that the monolithic and infinitely busier FDA is more responsive to the patient community these days than a small, focused group of diabetes technologists.
We sure would love to know what DTS is up to, particularly at such a key time, when the FDA is talking so much about meter and strip accuracy and welcoming public comments on the topic.
But, carrying on the mantra of #WeAreNotWaiting... We're not waiting for the DTS steering committee to emerge out of nowhere, to announce something that's probably far off into the future anyway, if it's even feasible. Instead, the best course of action right now is to light up the FDA comment board and share our perspectives as patients -- because yes, #WeAreNotWaiting is more than just a hashtag.