The FDA strikes again
Yesterday Intuity Medical announced they had secured a $20 million credit facility which according to their press release will be used to; “help complete clinical trials and commercialize POGO™, a fully-integrated blood glucose monitoring system.” At the moment the POGO™ is awaiting FDA approval and like the iBGStar from AgaMatrix must deal with the craziness going on at the FDA.
There are actually no major issues with either the POGO™ or the iBGStar but the rub at the FDA is over how patients will clean the systems after they perform a glucose test. Yes in the crazy world we live the FDA seems to believe that patients are sharing their lancing devices and monitors just a heroin addicts share their needles. Although Diabetic Investor is not aware of any hard data or evidence the FDA is concerned that a patient, besides having diabetes, may also have HIV or hepatitis diseases that can transferred via blood contact.
In the strange world we call the FDA, they seem to believe a patient with either HIV or Hepatitis, will perform a glucose test, that there will be left over blood on the monitor and that another patient will come along and borrow the monitor and this left over blood will be transferred to the unsuspecting patient who does not have HIV or hepatitis and this unsuspecting patient will thus become infected. To protect this unsuspecting patient who just happens to borrow a monitor the very moment after the infected patient performs a glucose test, a situation Diabetic Investor is sure happens about as often as the Chicago Cubs winning a World Series (about once every century), the FDA wants the infected patient to clean the monitor after every test and therefore eliminate the possibility that this infected blood is transferred.
Since the FDA never has meet a regulation they don’t like or an unnecessary study that proves nothing more than what’s already obvious, the agency has asked both Intuity and AgaMatrix to conduct some additional studies on how their patients will clean their monitor after every glucose test. Never mind that only the most dedicated and diligent patients will actually do this or that the agency in their wacky thought process is not requiring existing monitors on the market to undergo this process, no the agency once again has decided that once again it’s time to kill a house fly with tactical nuclear weapons.
What makes this new requirement even stranger, and that’s saying something, this zest to cover every conceivable contingency will actually make glucose monitoring less patient friend by adding even more steps to the testing process. Although we have no direct knowledge the FDA will move down this path it seems logical (sorry to use the word logical and FDA in the same sentence) it would not surprise Diabetic Investor if the FDA soon requires all patients to carry with them a special container so they can properly dispose of used test strips. In fact we could see an entire new industry developing here as companies could sell patients special monitor cleaning supplies and used test strip containers.
Considering the extent of this issue it’s also likely that these containers meet some equally stringent and idiotic regulations. Look for the FDA to require that these containers be made to withstand a nuclear blast, category 5 hurricane and be environmentally friendly to boot (heaven forbid these containers end up in a landfill somewhere and contaminate the nations water supply). Given the epidemic growth rate of diabetes it wouldn’t surprise Diabetic Investor if the FDA also required public areas such as restaurants or movie theaters to install the containers so that patients with diabetes could easily dispose of used test strips. Just as its commonplace for public places to offer their patrons antiseptic hand soap, it will soon be commonplace to see them offering glucose monitor cleaning wipes.
Yes we have reached the point with the FDA and glucose monitoring were no issue, no matter how unlikely, no matter how remote has to be studied and regulated. Never mind that this particular issue has never been backed up by any hard data or that the chances of this issue occurring are 1 in every trillion glucose tests, the FDA stands ready to protect the public.
Diabetic Investor thinks it’s about time the FDA read a speech given by President Gerald Ford in 1975 when he said; “You don’t need a lot of bureaucrats looking over your shoulder and telling you how to run your life or how to run your business. We are a people who declared our independence 200 years ago, and we are not about to lose it now to paper shufflers and computers.”