It’s difficult to make the FDA’s new guidance on blood glucose test strips sound sexy, but I’m going to try. Imagine this situation: you’re sitting in front of a fire with your boyfriend/girlfriend/spouse/lover/partner, relaxing on some soft cushions or maybe a bearskin rug. The lights are low. Candles twinkle. Wine glasses are in hand. Soft jazz is playing. As you look at your boyfriend/girlfriend/spouse/lover/partner, your heart quickens. He/she/it moves in for a kiss. Your body begins to tremble. Your pulse races. Your head is dizzy; you feel a light mist of sweat on your skin. Now you try to pull him/her closer, but your hand’s kind of shaking, the sweat is actually dripping down your back, and you realize that you’re not exactly sure where you are or why you’re sitting on a bearskin rug. . . Wait a second. This isn’t romance. It’s a low blood sugar!
“How did this happen?” you ask yourself, stuffing your face with a chocolate-dipped strawberry. You tested your blood sugar right before dinner. You dosed your insulin off of that number. Could it be that your glucometer was wrong?
That, in a nutshell, is a gamble all of us take every single day. Whether it’s a romantic Friday night or just an office coffee break, people with type 1 diabetes (and insulin-dependent type 2s) are constantly making calculations of insulin – an incredibly dangerous medication – that could literally kill us if we get them wrong. We need the numbers on our glucometers to be right. And that’s why the FDA’s approach toward glucose test strips matters.
With that out of the way, here’s what just happened: in early January 2014, the Food and Drug Administration came out with new draft guidance for blood glucose test strips and their accompanying meters. An FDA guidance document, when finalized, is a summary of the FDA’s current thinking on what information the FDA will look for when deciding whether to give FDA clearance to a manufacturer for its meters and strips. It’s kind of like getting a list of test questions before your exam, so that you know how to prepare ahead of time.
I listened in on a phone call last week run by Courtney Lias, who is the Director of the Division of Chemistry and Toxicology Devices at FDA, and whose responsibilities include devices used for diabetes management, including blood glucose meters, Artificial Pancreas device systems, and continuous glucose monitoring systems (CGMs). I had met her earlier this year at the Diabetes Technology Society’s September meeting about test strips and was impressed by how sincerely she seemed to listen to the concerns of people with diabetes. Last week’s call reaffirmed that.
The FDA’s new draft guidance does not address post-market surveillance issues (for more on those, visit StripSafely.com), but it is important nonetheless, for reasons I shall now attempt to bullet point (this is not a comprehensive list of what they do; for the truly dorky among you, check out the links below):
- This is the first time that the FDA has created two separate guidance documents for blood glucose test strips: one for “point-of-care” prescription meters (i.e. hospital or doctor’s office use) and one for “over-the-counter” (i.e. home use). They considered requests to classify meters for use either for people with Type 1 or Type 2 but – very wisely, in my opinion – decided not to make that divide. As it was carefully phrased in the call, “Some would argue that everyone who has diabetes deserves an accurate meter, and there is some evidence that inaccuracies would be detrimental to anyone receiving a blood glucose value.” Yes, some would argue that.
- The biggest differences between the two meter types, in my opinion, would be the accuracy requirements. The big take-home here is that both would be tighter than what is currently required.
- The allowable range of error for ones for home use would be tightened from the current plus or minus 20% to plus or minus 15% for the entire range of glucose values the meter claims to measure. (If it dramatically falls off after, say, 50 mg/dl, then it should say something like “below 50 mg/dl.”) 95 percent of meter readings need to fall into this tighter band of accuracy; 100 percent need to be within 20 percent of the real value. Companies would need to provide at least 350 tests (as opposed to the current 100-150) to demonstrate this, plus an additional 50 each in hyper- and hypo-samples, to prove that the meter’s still accurate in these more difficult ranges.
- The “point-of-care” meters (hospital ones) would have even tighter requirements: the margin of error would be 10% instead of 15% and would apply to all readings over 70 mg/dl; for those under 70 mg/dl, the margin of error would be plus or minus 7 mg/dl. (That’s pretty damn accurate!) More details in the link above; these meters would require similar numbers of tests as the ones for home glucose meters.
- There would be disinfection requirements (i.e. the meters will have to be easy to disinfect, especially those for point-of-care use), to try to limit the spread of infectious diseases like hepatitis B.
- This is a biggie: meters would describe their accuracy results on the outside of the packaging so that customers could use this information when deciding which meter to buy. This hopefully would help clarify that not all meters are equally accurate, and – at least in my opinion – might provide some incentive for companies to up their game (and maybe even provide the Centers for Medicare and Medicaid Services with a tool to ensure that the strips and meters they cover are indeed accurate).
- Also a biggie: the FDA would review the manufacturers’ “test strip lot release” criteria (currently this isn’t part of the review process for clearance). This basically means that there’d be more scrutiny around what standards a lot of test strips needs to meet before it can be “released” for sale. While this is still a pre-, not post-market thing, it would make it easier for the FDA to go after companies whose test strips are found to have problems once their meters are already in the market. As Lias explained, “We know that if a manufacturer gets a meter cleared and doesn’t manufacture it well, the test strips they put on the market may not actually meet the levels of performance that was seen in premarket studies. So we want to look at their lot release methodology to make sure they have a robust method to ensure that the strips they’re releasing to the market perform the same as the strips that were cleared. This is a new change in this area.”
For the full details, see the above links.
Now, to answer a couple questions:
Q: Why are the accuracy requirements different? Why can’t they be the same for home and hospital use?
A: The basic answer was that the FDA doesn’t think that manufacturers would be able to produce the volume of strips needed to meet the lay public’s demands at those levels of accuracy. But as Lias put it, “With the technological advances in manufacturing that manufacturers may develop in order to meet this healthcare providers’ criteria, we hope they might apply some of that to the lay population and drive the accuracy better for both populations.”
To that point, I think it is important for us as patients to request that language be added to the draft guidance documents that makes this ultimate goal – 5-10% accuracy for all meters – explicit. The hope would be that eventually these higher standards could be phased in to apply to all meters. More on how to comment below.
Q: Will these new standards drive prices up?
A: No, the FDA does not believe that they will, thanks to competitive forces and market demand.
Q: What about all the meters that are already on the market? What happens to those?
A: Those meters will not be required to get new clearance under these proposed higher standards, so the short answer to that question is: nothing. They’ll still be on the market. However, Lias believes that technological advancements would mean that they would eventually be phased out. And – this is important – she said that if we want to see these standards apply to ALL meters on the market, not just new ones, we should make that point in the public comments.
Q: What effect will this have on health insurance reimbursement policies (particularly Medicare)? How much interaction does FDA have with CMS?
A: The FDA has not worked directly with CMS or other payers in the development of this guidance; however, CMS has indicated that it often looks to FDA clearance for guidance on coverage decisions. So while they’re not directly linked, raising the bar for FDA clearance could raise the bar on the type of strips that could be reimbursed. “These new guidance documents are also meant to provide more standardization – especially the lot release criteria part of document – to attempt to get more consistency, so there’s not this alleged discrepancy between different meters,” Lias explained. And, she concluded, “We’re happy to hear suggestions on that area as well.”
Q: I find this issue fascinating and desperately wish I could have heard last week’s call. What can I do?
A: Call (888) 567-0443 and you can hear the whole hour-long recording of it. True story!
WHAT YOU CAN DO:
For those who don’t know how this process works, after the FDA publishes a draft guidance document, it has to open that document for 90 days of public comment before it issues a final guidance document. Those comments can come from anyone – industry, healthcare providers, professional organizations, or you or me. And I think we should comment! If you’re game, here’s what I’d consider including in your letter (the deadline for comments is April 7):
- Praise what you like about the new guidance documents. As Lias pointed out, the FDA needs to hear what people like in addition to what they don’t – they might change something we really like if we don’t make our opinions heard on both the negative and the positive. (I’m quite sure, for instance, that some manufacturers will claim that the new standards are too strict.) Also, do the FDA a favor: if you’re complaining about some aspect of the draft guidance, make sure you provide a concrete suggestion for how you’d like to see it fixed.
- On that note, here’s what I’d like (feel free to crib). First, I would like to see them include language – as noted above – that indicates that the FDA hopes that the tighter accuracy requirements for point-of-care meters will eventually apply to all meters, and that wise industry players will start preparing for that shift. (This is not a normal type of statement for this type of document, but is still worth mentioning.)
- I would also like FDA to make an even stronger statement about the importance of blood glucose meter accuracy for all people with diabetes. More specifically, I want FDA to indicate that meters that do not consistently meet these higher standards, both pre- and post-market, cannot be considered to be “durable medical equipment” (DME) because inaccurate meters “cannot be used directly for making therapy adjustments.” This phrasing is important because it comes directly from CMS, the organization that makes Medicare coverage decisions, and might help ensure that all of us – including Medicare recipients – continue to have access to high quality meters and strips. This is a big deal!
- On a similar note, request that the proposed outside-of-box labeling requirements explicitly indicate whether a meter has received FDA clearance to “make therapy adjustments” – a statement that would only be allowed if the meter met the new tighter accuracy standards. Again, this could be a useful tool in helping health insurance payers like Medicare determine which meters they will cover. (They should not cover meters that cannot be used to make therapy adjustments.)
- Request that the FDA establish a post-market surveillance program – perhaps with the help of a 3rd party organization – to ensure that glucose meters and test strips continue to meet accuracy standards even after they are on the market. As the StripSafely.com campaign has emphasized, such a system does not currently exist (the FDA is aware of this concern and working on it, but it’s always good to emphasize its importance). The new requirements for lot clearance are a great step in the right direction, but we need more.
Comments can be submitted online independently for both the point-of-care (hospital) and over-the-counter (home) guidance documents. The deadline is April 7, 2014. If in doubt as to which guidance document to choose, I’d suggest submitting them for both.
Submit comments online for over-the-counter (home) meters here: http://www.regulations.gov/#!submitComment;D=FDA-2013-D-1446-0001
Submit comments online for point-of-care (hospital) meters here: http://www.regulations.gov/#!submitComment;D=FDA-2013-D-1445-0001
If you prefer to submit things by real mail, write to this address (and be sure to include the docket and document number!).
Division of Dockets Management (HFA-305)
Food and Drug Administration, 5630 Fishers Lane, rm. 1061
Rockville, MD 20852.
Docket number for home/OTC meters: FDA-2013-D-1446
Document number: 2014-00022
Docket number for point-of-care/prescription/hospital meters: FDA-2013-D-1445
Document number: 2014-00023
Thank you all. And now you may go back to whatever you were doing on that bearskin.