Only in America can this happen

Only in America can this happen

Diabetic Investor has learned that on September 9th, the FDA will be conducting a hearing to discuss … wait for it … post-market surveillance for glucose meters and test strips. Now we must admit when first heard about this we thought it was a very cruel joke but on second thought this is the same agency who wants to regulate lancets as Class II medical devices.

Now just in case anyone is wondering why the BGM industry in this country is headed down the toilet, send your thank notes to the good folks at the FDA and then another to our elected officials for letting this agency run amok. It’s bad enough that these companies have to deal with 72% reduction in reimbursement from Medicare but to then ask these same companies to spend even more money on what will surely be worthless studies  is like pouring salt in an open wound.

Already the major companies are facing stiff competition from ultra-cheap imports, imports the FDA says they will have trouble regulating because they lack the funds to properly inspect foreign manufacturing facilities. Yet the FDA in their infinite wisdom has decided not just to ask these manufacturers to make a more accurate system but now wants to add even more costs with stupid post-market studies, all this so they will have the honor of having the products they make reimbursed at less than $11 for a box of 50 test strips.

Listen, it’s bad enough due to the FDA’s overzealous regulatory fervor that every diabetes device company is going to Europe first with new and innovative products. Yet it’s even worse  the FDA seems to believe that patients with diabetes are akin to heroin addicts, yet instead of sharing needles these patients are commonly sharing their glucose meters and lancets with each other.  According to the FDA these patients don’t just have diabetes but also serious infectious diseases which will transfer to some unsuspecting person because someone shared a glucose meter and lancing device. Now to any reasonable person we know this sounds crazy, more like ludicrous but this unfortunately is how the FDA thinks.

Yet the blame for pushing every major BGM company out of business does not rest solely on the shoulders of the FDA as an equal amount of blame goes to our wonderful elected officials who let this agency run amok with no serious oversight. The FDA is not just overregulating diabetes devices as their zealous over the top ultra-conservative approach has spread to diabetes drugs too. One just might think that someone would remind these people that there nearly 8% of the population has diabetes, the diseases is growing at epidemic rates and ultimately costing the government billions. That people with diabetes and the physicians who treat them need more weapons, not less, so that patients can better manage their diabetes.

Perhaps the saddest aspect of all this is that no one is surprised or shocked by what the FDA is doing. Given that this agency holds the keys to the kingdom it’s understandable that industry doesn’t want to speak out for fear the agency will retaliate with even more regulations, a very scary thought indeed. So in the end the FDA is basically allowed to do their thing without being held accountable.  Hey we don’t call it the wacky world of diabetes without good reason and this is just one more piece of evidence that proves it.