You may have heard about the BIG diabetes tech meeting this Monday, tackling the issue of uncertain glucose meter and test strip accuracy and what we might do to improve it.
This day-long meeting held by the Diabetes Technology Society was the second of its kind in four months, and organizers describe it as a "landmark" gathering that brought several hundred diabetes leaders and advocates together from academia, industry, patient groups, and the regulatory sector. You'll be happy to hear the Diabetes Online Community (DOC) was there in force, representing our PWD and consumer voice and live-tweeting from the meeting in Bethesda, MD.
So, there's good news and not-so-good news...
The good news: The Diabetes Technology Society pitched a plan that, if established, would create a post-market quality surveillance program for the meters and strips already on the market and being sold to patients. It would require independent analysis of those devices and supplies to make sure they're as accurate and reliable as they need to be, even years after recieving regulatory approval.
The not-so-good-news: It could take a while, and there's a lot more talk that needs to happen first. We may see the creation of a steering committee focused on in-depth exploration of this topic within a couple of months, but naturally that's just a starting point.
And IF the plan is put in place as a mandatory program, it could take as long as five or six years to get going the way many would like to see, experts tell us. First, all the players would have to agree on what the framework and details would involve, and there would possibly be a need to seek Congressional action and funding to get the program off the ground.
In the meantime, the FDA seems fairly content with its current enforcement, and says there's a lack of understanding from the patient side of the D-Community about how much work it really does in going after potential violators.
Bottom Line: Yeah, we're making progress and Monday's meeting was productive... but it looks like a long, challenging road ahead.
We compiled a Storify snapshot earlier this week, with a Twitter-based play-by-play account of meeting highlights from attendees and observers. At some point, we caught a tweet about JDRF and other groups in attendance being in "violent agreement" about the need for action here.
Now, a few days out, we've got some more detailed reactions and "takeaways" from a handful of people involved:
Dr. Robert Vigersky, Walter Reed Health Care Center
Vigersky, an endo at the Walter Reed Medical Center and a leader in diabetes tech, was a key voice at the meeting, serving as a moderator and panel participant. He says everyone agrees that there's a problem with glucose meters and strips and those accuracy concerns can be catastrophic for patient safety (there's twice the risk of hypos with the current +/-20% accuracy standard!). He liked seeing that all stakeholders at the meeting were receptive to the DTS proposal for an independent post-market surveillance program, one that could possibly have a pass/fail grade or even just present data on accuracy findings. The FDA could then possibly use that data to carry out enforcement and monitoring tasks. He likes the idea of increasing transparency and understanding so the public at large has access to accuracy data.
Vigersky says the FDA was "realistic in its view," but he pointed out that some at the meeting -- patients included -- didn't fully grasp what the agency's powers are and what they can or can't do. He said that has to be kept in mind as this process continues, since the FDA is under-resourced and can really only react instead of "proactively nipping things in the bud."
"This certainly isn't going to happen overnight, or even in six months to a year, but there's a lot of momentum behind this and it's not going away," he told us by phone. "What really surprised me was how much unanimity there was behind all of this."
In a news release the day after, D-Advocate Manny Hernandez from the Diabetes Hands Foundation recognized that establishing a new program will take time, but stated: "In the interim, however, patients need additional protections. We look forward to working with FDA and DTS to identify effective near-term solutions." It was not yet clear what those interim steps might be.
D-Advocate and type 2 PWD Bennet Dunlap, who spearheaded the grassroots StripSafely campaign, was also at the meeting and spoke on a panel alongside regulators, industry representatives and diabetes organization leaders. This is how he recaps the meeting in a run-down:
"It was very fascinating, in an amazingly jam-packed room. In the afternoon, there was a suggestion of a third-party review process that would do an annual review of meter test strip systems, acquired in the market. So it wouldn't be cherry-picked by manufacturers. It would be done the way we acquire strips. It was a really fascinating, and at times very heated, conversation between participants. But hopefully... what comes out of it is a really exciting opportunity to have meters and strips inspected annually after they're approved. Just like you'd get a car inspected for emissions, and you go in every year to make sure it's not polluting the air too much. Nobody's going to get everything they want, but if it's done right it could be very useful. Kind of like Consumer Reports on steroids."
Bennet also pointed out that PWDs, and probably the broader patient communities, need to shift their thinking about government agencies and how the FDA operates. They can take a long time, and it might be tough to be proactive instead of reactive, but Bennet (an often vocal critic of the FDA) says he's seen firsthand how the agency is demonstrating an interest in making this work.
The federal agency had a whole crew attending the meeting, which was great to see, especially following our interview with agency directors about the StripSafely issue a few weeks back. We talked again by phone this Tuesday with Dr. Courtney Lias, director of the FDA's division of chemistry and toxicology devices, who was a main speaker at the DTS meeting. Here's her take:
The meeting went very well. Everyone was very open and honest, instead of holding back and reserving judgment -- which is often the case in meetings like that. The take home message: there's a general consensus that an active surveillance program is needed, and we think some version of what DTS is proposing could be made to work. Without industry buy-in, this would be impossible. This would be a new active surveillance tool, rather than a passive one where we sit back and wait for something to happen. I've been involved in a lot of efforts, and there's not always this kind of agreement. That should be applauded, and it's powerful because it may provide the fuel to pull this off.
The devil's in the details. One way to do this is to make it mandatory using the federal rule-making process, which could take 5-6 years. But that's only one route. There are other models and mechanisms, as we saw presented at the meeting. This proposed DTS program could give us signals on where we need to act and what we could do better. This could enhance our enforcement, but we don't need this to carry out enforcement or to fix issues.
We find that last sentence interesting -- apparently FDA sees the proposed program only as an extension to the surveillance they're already doing -- whereas patient groups believe the current system is unacceptably inept.
Lias told us that she's taking back to the FDA the patient perspectives she heard about enforcement, particularly as it relates to how warning letter actions and responses are communicated. There are legal limitations as to what can be shared publicly in enforcement situations, she says, so often people are simply not aware of FDA follow-up or might misunderstand the process and think "nothing's being done," when it really is. Lias says: "We take to heart what we heard, about wanting more information on this enforcement process, and we will try to do what we can."
Next up: the FDA is hoping that new ISO standards adopted internationally earlier this year will get approved for enforcement in the U.S. this year. They're currently under administrative review before the public comment period begins. The FDA is also creating new guidance for manufacturers on how they report Adverse Events (known as MDR) to make it more consistent industry-wide, which could help the FDA monitor and enforce violations and also help the patient community more clearly see what's being done.
Dr. Aaron Kowalski, VP of Treatment Therapies at JDRF (and Veteran Type 1)
Kowalski was actually pleased with the FDA response, telling us:
"There was universal agreement that if you're going to have strips on the market, they have to meet the standards the FDA approves. The heart of the matter is how you get there. The FDA needs to more rigorously employ the tools they have now... but I didn't get the sense there was a push-back on enforcement. Some of that isn't out in the public and can be hard to understand, especially when you're talking in vague and ambiguous terms. That's one thing we are trying to get our arms around: is it enough?
"Coming out of this meeting, there's a way forward. It's going to be hard going forward, but we have tremendous alignment with the diabetes organizations and the patient community, and even the FDA. You really have to commend them for taking a proactive stance, because they could have just left it to the community to deal with. But they went out of their way to reach out and ask what can be done better. The number one priority: we need better diabetes health outcomes. This all goes hand-in-hand, and it starts with accurate finger-testing as we move toward the artificial pancreas. We (at JDRF) are fully aligned with the rest of the community on this, and this isn't going to get lost in the shuffle."
At the meeting, a handful of industry execs from various meter and strip manufacturers voiced their support of the DTS proposal, and said they're interested in talking more about the details.
The medical technology industry group Advanced Medical Technology Association (AdvaMedDx), which is focused on diagnostics policy matters, had issued a release a few days prior to the meeting, stating the obvious: their members support quality and accurate glucose monitoring products, and transparency in data and meter performance standards. No surprise there. We talked with Khatereh Calleja, an attorney who's the group's vice president of technology and regulatory affairs, about her insights from the meeting.
She says AdvaMedDx was "encouraged by the discussion," and "believes the FDA has significant authority over those who don't meet safety requirements." It was impossible to get a straight answer on whether the group thinks the regulators do enough. Calleja would only say the FDA should act "as part of a larger holistic approach on accuracy" that this "isn't a one-pronged approach." Naturally AdvaMedDx "supports participating in the steering committee process in the future and hopes that payers also get engaged."
Another issue not to be ignored at the DTS meeting was the Center for Medicare & Medicaid Services (CMS) and how that federal agency appears more concerned with cost than quality in its move toward competitive bidding. AdvaMedDx told us that it's pushing for an outside contractor to perform medical audits of PWDs getting supplies, and if quality issues are discovered in supplied products, then maybe the FDA could get involved. Ya think?!
Dr. David Klonoff, founder of the Diabetes Technology Society who's an endo at Mills-Peninsula Health Services in California, says he will begin immediately forming the new steering committee -- including academia, organizations, industry, PWDs, payers, and regulators -- so that everyone has a voice in this process. The membership could be finalized in the next 4-8 weeks. Communication will continue with the FDA on what it's currently doing and how the process can be improved, Klonoff says, and he would like to see Congressional action and possible funding to ensure consistent action and regulatory enforcement.
This is a movement we're all part of, and it's one that the grassroots StripSafely campaign has crystallized for patients to continue pushing. We need to continue making our voices heard as this process plays out. What we cannot do is let it lose steam, and be brushed aside.
As reported from the meeting, by @diaTribeNews:
"Movements have a time." Dr. David Klonoff on BGMSP "To delay is to deny!" #DTS #Stripsafely