In concept, generic blood glucose test strips sound like a great idea. Made by 3rd party manufacturers (i.e. a company other than the one that makes your meter), they often (claim to) work with a variety of different meters, and tend to be much less expensive than their counterparts. Given that big-name test strips can cost $1 to $1.50 a pop, it makes sense that people with diabetes (not to mention insurance companies and government payers) would be eager for a cheaper solution.
But there’s a problem: those cost savings are only relevant if the generic test strips are accurate. If they’re not accurate, then you may miscalculate your insulin dose. And if you miscalculate your insulin dose, you could die.
(To put it a different way, if a blood glucose test strip doesn’t accurately measure your blood glucose, then it’s not technically a blood glucose test strip. You might as well read tea leaves.)
Personally, I can’t wrap my head around the fact that there is currently no system in place to ensure that test strips that have been cleared by the FDA for sale continue to meet those accuracy standards after they’re on the market. (But it’s true: there’s not.)
I also can’t get over the fact that Medicare continues to insist that there have been no negative effects of its recently implemented competitive bidding program for mail-order diabetes supplies — despite evidence (for example, this study from the American Association of Diabetes Educators) clearly indicating that the program is restricting people’s access to blood glucose testing supplies, and pushing them — often against their will — toward problematic generic meters and strips. (Important note: they’re not allowed to do this! Scroll down on this page for more information.)
But in the rare moment when I think to myself, “Hey, Catherine. Maybe it’s not such a big deal!” something always seems to come up to snap me out of my reverie. An example of this happened just yesterday, when I received a safety notice from the FDA about Shasta Technologies’ GenStrip Blood Glucose Test Strips. (The company previously received an FDA warning letter.) If I may quote:
“During a recent inspection of Shasta Technologies LLC, the FDA found extensive violations of federal regulations intended to assure the quality of products in the manufacturing of GenStrip Test Strips. . . At an inspection earlier this year, and documented in an April 2014 warning letter, the FDA found that Shasta Technologies did not have in place many of the requirements of a quality system. Without assurance of an adequate quality system, the FDA believes that the strips could report incorrect blood glucose levels. . . . To date, the company has been unwilling to voluntarily recall their test strips, resulting in their continued availability. The FDA recommends that use of Shasta Technologies, LLC GenStrip Test Strips be discontinued.“
This is not the first instance where third-party generic test strips (or low-cost meters) have been found to be problematic. (See also: this weird language from the FDA for a meter cleared last December.) Indeed, Mike Hoskins recently did a great feature about the issue, which, given yesterday’s notice, has proved to be disturbingly prophetic.
The company that now makes the GenStrip test strips issued a response to the FDA’s notice today, essentially claiming that the problems have been solved, those particular strips will be replaced at no charge, and that a new, rebranded version (of the same product) is soon to be launched that presumably will not have accuracy issues. Frankly, I’ll believe it when I see it — and also, as far as I can tell, this is not an actual recall, as might seem to be appropriate given the potentially deadly consequences, but rather an offer for proactive and educated customers to get replacements.
It’s worth stressing here that the cost of test strips is obviously quite high, and that there is a need for lower-cost solutions. But cost does not — and cannot — trump accuracy.
If you agree that accuracy is an important issue, and that the makers of 3rd party strips should be held directly accountable for the quality and accuracy of their products, please consider adding a comment to the FDA’s Draft Guidance on Blood Glucose Meters, which is open until an extended deadline of May 7th.
For more information (and suggested comments), visit StripSafely.com (And here are my previous suggestions for other comments you might want to add, in addition to whatever you want to say about the issue of 3rd party strips.)
You can also learn more about the draft guidance as a whole by watching the FDA’s patient network’s March 31st live-chat on the subject (the first ever of its kind!) in which the FDA’s Courtney Lias and Helene Clayton-Jeter sat down with StripSafely.com creator Bennet Dunlap to have an informal conversation about what the guidance says and what the agency would like feedback from the public about.
Also, consider leaving a review (referencing or directly quoting from the FDA’s notice) on the Amazon page for the meters and strips in question — it could help save people’s lives. (Here’s one example — but there are many other test strips made by the same company.) People need to know about these quality concerns, and (especially since the company itself is not doing a recall), Amazon is a great way to spread the word.
Again, the deadline for FDA comments is May 7th (and it only takes a few minutes). Goodness knows the 3rd party manufacturers are going to make their opinions known. Shouldn’t we do the same?