It almost seems that a new era of alternative test strips and other "basic" diabetes products has hit. It's a sign of the times, really, as big-name brands are hurting because of Medicare competitive bidding changes that are limiting access to pricier products in favor of more economical options -- giving producers of generics a fresh entry point into the market.
Last week, a company called UniStrip Technologies announced availability of a new FDA-approved generic test strip, and at the same time, we got word that the green-colored GenStrip alternative test strip we reported on in late 2012 is ramping up marketing after some courtroom successes against Johnson and Johnson's family of LifeScan and OneTouch glucose meters (yes, they were being sued for patent infringement).
On top of that, we learned that the company behind the GenStrip is now developing its own new all-inclusive wireless glucose meter that has strips, a lancet and smartphone app connectivity all weaved into one device, called the Discretion.
These simplified products offer affordability, but perhaps a trade-off in terms of quality of care... We looked into all three to bring you the scoop.
Note that these two new brands of generic strips work with some of the best-selling meter models made by LifeScan:
Questioning the New UniStrip
In early April, a new UniStrip generic made its way to the U.S. market after snagging FDA approval in November.
You can buy a 50-count box of these strips for about $12 on eBay and Amazon right now (something I'm personally hesitant to do, because it seems shady to me) and in the coming months we're told these strips will start appearing on pharmacy shelves and even in big-name retail stores, where we're told they'll sell for somewhere around $9-10.
Developed by newly formed North Carolina-based UniStrip Technologies, they work with the LifeScan OneTouch Ultra family of meters -- but ONLY those made and/or purchased before Oct. 2012, according to the FDA approval statement for this generic strip.
CEO Rick Admani is the man behind UniStrip Technologies. He also happens to be the chief operating officer of Prodigy Diabetes Care that makes the talking glucose meter for the vision impaired and other "off-brand" glucose meters. Admani tells us the two companies are legally separate entities and not related, despite his executive role at both, and the fact that they are located within just 7 miles of each other in North Carolina, share the same general counsel and FDA consultant who applied for regulatory approval of products, and they both use the same marketing agent.
Oh, and the fact that both outsource manufacturing to Taiwan-based OK BioTech -- a manufacturer that purchased a minority stake in Prodigy a year ago.
Why does any of that matter? Well, patient advocates like those behind StripSafely meter accuracy campaign and others in the Diabetes Community have been quite vocal with criticisms of Prodigy products due to some struggles with the FDA over the past year or so, most recently with the FDA calling out a Prodigy meter as being less accurate than others on the market and attaching unique and never-before-seen labeling requirements to a product approval.
So, if this same company putting out questionable quality is now making generic strips, that's something we consumers need to be aware of -- even if the concerns have been addressed and signed off on by regulators, which Prodigy says they have. You be the judge. But honestly to us, customer trust has been compromised here...
Despite that controversy, Admani insists that UniStrip generics are as accurate if not more accurate than leading brand-name products. He says UniStrips meet both the existing FDA rules and also the 2013-enacted ISO guidelines. His company is also engaged in regular conversation with LifeScan, he says, and even revised its generic strip packaging some to appease the big manufacturer and ward off any potential litigation.
Admani tells us they're also developing at least three more UniStrip generics to work with other meters, beyond just the J&J brands.
"We're the new player, and so of course we're the ones that the big manufacturers are going to raise questions about," he said. "But this is a new change in this diabetes world, and it feels like we're going to see more new generic strips. It's going to change the game."
Of course, this isn't the first alternative test strip to make headlines...
We reported before on the Los Angeles biotech company called PharmaTech Solutions that was planning an alternative strip that would also work exclusively with older OneTouch Ultra style meters, created before July 2010: the Shasta GenStrip.
That litigation is still ongoing and PharmaTech lost at the lowest federal court level, but as it turns out the past year has been mostly positive for PharmaTech -- the biggest boost being that an appeals court panel overturned an injunction that had prevented the GenStrip from actually being sold.
Chief Financial Officer Keith Berman tells us that the recent Medicare competitive-bidding changes have caused PharmaTech Solutions to revise its business model; instead of selling directly to patients, the company is now targeting local pharmacies. Indeed, GenStrips can now be found on smaller pharmacy shelves and online at Amazon and eBay for around $15-18.
"The direct-to-consumer mail order market place has pretty much died, and we're surprised by that. Some companies have even disappeared, and it's gone to brick-and-mortar pharmacies where patients go to pay co-pays and pick up their strips," he said. "Pharmacies are under contract, and Medicare bills the patient directly. So, that's presented a huge opportunity for us."
Just this week, parent company Decision Diagnostics announced that it had acquired the GenStrip and all its trademarking rights from the original company, Shasta Technologies, following a new advertisement that started airing last month in select parts of the country (and they say another new one should be debuting before long):
So, it looks like GenStrip is hitting the market at full speed.... but is it keeping pace with ongoing concerns about accuracy within the regulatory world and patient community?
Talking Test Strip Accuracy
This topic has gained a lot of steam in the past year, with the pending FDA draft guidelines on accuracy still open for public commentary until May 7, 2014. In those guidelines, the FDA has specific language addressing quality measures third-party strip makers and that's something we, as a D-Community, should be supporting.
When asked about accuracy, both UniStrip and GenStrip developers cite big brand name manufacturer recalls and say they expect none of those. And they quickly downplay any concerns about quality, insisting that their products meet current accuracy rules, but at more affordable prices.
Published data on the new UniStrip shows those generic strips do fall within the existing and proposed rules just like most of the current competing products from big-name manufacturers.
But we didn't get the same "pro-accuracy vibe" when it comes to GenStrip. CFO Berman tells us that GenStrips do meet the existing FDA standard of falling within 20% of accuracy benchmarks most of the time, but he said the strips fall just short of the 2013 ISO standard and the new draft FDA rules. Yes, GenStrip data shows that 93% of the time the GenStrips are within +/- 15%, but the FDA's draft rules call for 99% be within that range when glucose levels are 75 mg/dL or above. Yet according to Berman, the company's not concerned with beefing up accuracy to meet those standards, if it's not required to do so.
"GenStrip is already cleared (by FDA)," Berman told us. "We do not have to make GenStrip comply to the new guidance -- which is only for new filings, not previously cleared filings."
Uh, huh. Well, good to know that GenStrips will meet the minimum requirement at least. And regarding quality assurance, Berman did mention that while FDA's existing guidelines call for a 95% success rate for new lots of strips to be released, GenStrip actually shoots for 97% each time.
Not surprisingly, neither company had much to say about the notion of post-market surveillance (checks to make sure existing products remain accurate), that patients have also been pushing for with the StripSafely campaign.
All-In-One Glucose Meter in the Works
PharmaTech is going beyond the GenStrip and actually developing a new all-inclusive combo meter with the ability to transmit test results wirelessly and securely to any cell phone device that supports text messaging, Berman tells us.
Called the Discretion (awkward name?), it would not use the GenStrips since those designed specifically for OneTouch Ultra meters. So another set of proprietary strips would be necessary.
The meter itself almost looks like an old-school Walkman cassette player from the 80s and 90s, yet Berman tells us the size is "small enough to fit into an 11-year-old's hand." It would have a lancet device built in and a replaceable cartridge of test strips inside, all self-contained.
This Discretion meter's actually being developed with kids older than 10 in mind, but Berman says it could also be a big seller for PWDs who travel a lot or who don't want to carry a full test kit around everywhere. The data could be sent by text message to up to 5 smartphones automatically and a free app would allow you to view that D-data.
The vision is to have this product showcased in big-name retail stores where it could be even be displayed at check out aisles, selling for $29.95 and you could buy replacement strips in an 8-10 pack for $4.95, Berman tells us, adding that clinical studies are expected to start in May, and they expect to file with FDA directly once those studies are complete.
We've seen too many "all-in-one" devices that have faltered to get very worked up about the Discretion, but it is always exciting to see innovation coming from all corners of the market.
And when it comes to generics, there are always reservations about quality and accuracy. We have seen the manufacturing facilities of many large Pharma companies up close and personal and had in-depth conversations that illustrate the justification for higher test strip costs (i.e. the enzymes, precious metals, chemicals, and other materials that make up the strips, plus the burden of building and maintaining manufacturing plants). And despite recalls that pop up periodically, we have to admit that it's comforting at times knowing there's some credibility in the manufacturing process behind the products we're buying.
That said, as long as these new generic strips and off-brand meters are meeting accuracy requirements and providing quality that meets patient needs, then there's no reason we can't also be excited about these new, lower-cost options.
** UPDATE #1 - April 29, 2014: The U.S. FDA issued a safety warning about the GenStrips, saying they may produce inaccurate readings and shouldn't be used. A recent FDA inspection of the manufacturing facility found "extensive violations" and found that many of the requirements for a quality system weren't in place. To date, the company's been unwilling to voluntarily recall their test strips and so the FDA advices everyone to stop using these generic strips.
** UPDATE #2 - April 30, 2014: In a response to the FDA warning, Decision Diagnostics and its subsidiary PharmaTech Solutions that acquired the GenStrip in mid-March says it will replace all of the older GenStrips produced by the previous owner, Shasta Technologies. They've also rebranded the strip as PharmaTech GenStrip 50.