Generic products can help us manage the costly disease known as diabetes. In the past few years we got generic pills, including metformin. Now we have genetic test strips for our blood glucose meters.
The U.S. Food and Drug Administration recently approved generic test strips that we can use with most of LifeScan’s OneTouch Ultra meters. Now you can buy them now.
LifeScan, a Johnson & Johnson company, sells more blood glucose meters in the United States than any other meter manufacturer. You are more likely to find their meters on your health plan’s formulary than those made by any other company.
UniStrip Technologies in Charlotte, North Carolina, offers generic test strips for LifeScan’s four best-selling meters in the Ultra family: the OneTouch Ultra, Ultra2, UltraSmart, and UltraMini. PharmaTech Solutions (owned by Shasta Technologies) in Westlake Village, California, offers generic strips for three of these: the OneTouch Ultra, Ultra2, and UltraMini.
However, the U.S. Food and Drug Administration on Tuesday cracked down on the PharmaTech strips, suggesting that people with diabetes use the UniStrip brand instead.
The FDA advised people with diabetes and healthcare professionals to stop using PharmaTech’s GenStrip blood glucose test strips "because the strips may report incorrect blood glucose levels." The FDA says that during a recent inspection it “found extensive violations of federal regulations intended to assure the quality of products.” The FDA "recommends the use of alternative glucose test strips that are designed for use with the LifeScan OneTouch family of glucose meters."
Low cost is the big selling point for generic test strips. You can buy 100 UniStrip1 test strips on Amazon for $24.99 and get free shipping. PharmaTech sells 100 GenStrip test strips there for $31.00 with free shipping on orders over $35.
The head person at each company told me earlier this week that they plan to offer generic test strips for more of the meters that you are likely to find in your health plan’s formulary. These are devices made by Roche in their Accu-Chek line, Diabetes Care by Bayer, and Abbott Diabetes Care.
LifeScan, Roche, Bayer, and Abbott all carefully protect the patents on their test strips because they make a lot more money from selling test strips than from blood glucose meters.
But smart marketers can find ways around them, as the success of UniStrip Technologies and PharmaTech Solutions in challenging LifeScan testifies.
"We are working on generic test strips for Roche, Abbott, and Bayer meters," UniStrip Technologies President Rick Admani told me this week. "We will be providing them." This explains why the company calls its strips for LifeScan meters "UniStrip1" with UniStrip2, UniStrip3, and UniStrip4 poised to follow.
The day before the FDA crackdown, PharmaTech President Keith Berman told me that his company also hoped to offer generic strips for meters made by the three other diabetes meter companies.
The FDA approvals for each generic brand of test strips include confusing language. The one for UniStrips said that they are "for use with LifeScan OneTouch Ultra, Ultra2, UltraSmart and UltraMini blood glucose meters purchased before October 2012." The GenStrip approval said that they are "for use with LifeScan OneTouch Ultra, Ultra2 and UltraMini blood glucose meters purchased before July 2010." But both Admani and Berman assure me that they regularly test compatibility of their test strips with LifeScan products to be sure that they continue to meet the FDA’s accuracy requirements.
Without question, generic test strips from UniScrip Technologies will save you money. The question is how accurate they are, which is of course the big question we have about any blood glucose meter or test strip.
Adami told me that the UniStrips meet both the existing FDA rules and the 2013-enacted ISO guidelines as well. "The accuracy of the generic UniStrip1 meets or exceeds ISO standards and that of the branded test strip in clinical tests."
PharmaTech’s Berman claimed that GenStrips meet the existing FDA standard of falling within 20 percent of accuracy most of the time. But he went on to say that his strips fall just short of the 2013 ISO standard and the new draft FDA rules.
Berman evaluated the accuracy not of his GenStrip product but rather of his competitor, UniStrip, in a comment that he posted on Amazon at "Head to Head to Head." Pointing out that in his experience UniStrips tested considerably higher than GenStrip or LifeScan strips, he concluded that "You get what you pay for with Unistrip."
When I asked Berman if he had written the comment attributed to him by name, he told me that "I evaluated them after buying products on Amazon, and I identified myself as an Amazon user." He did not, however, identify himself as a competitor. Now, with the FDA crackdown he isn’t one.