No this isn’t a joke

No this isn’t a joke

Just in case anyone is wondering why this year’s conference is one of the more boring conferences in terms of news, exciting new products or innovative new drugs it’s because there are none. One can’t help but wonder what this conference will be like in the coming years, or if the conference as it’s structured today is still relevant. Yes it’s true that as always there are lots of posters, presentations and scientific information but from a business perspective the exhibit hall is becoming a huge waste of capital. In retrospect perhaps Abbott (NYSE:ABT) and Bayer had it right and everyone else had it wrong.

Speaking strictly from a device perspective Diabetic Investor can understand why these companies see exhibiting as a poor allocation of capital. Capital that will be needed as the FDA in their infinite wisdom is considering – wait for it – regulating lancets and lancing devices.  To prove this is not a joke and the FDA is about to go completely off the reservation check out this link http://www.fda.gov/AdvisoryCommittees/Calendar/ucm353703.htm.

Yes next Wednesday the industry will gather in Gaithersburg, Maryland for an open meeting which according to the FDA; “the committee will discuss and make recommendations regarding the possible reclassification of blood lancet devices.  The committee will discuss whether new scientific data are sufficient to support the reasonable assurance of safety and effectiveness to develop special controls that support regulation of blood lancets from class I to class II and class III.  The four subsets of blood lancets have been identified with the following indications for use:

• Blood lancet with an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which includes an integral sharps injury prevention feature that allows the device to be used once and then renders it inoperable and incapable of further use and which is used to puncture the skin to obtain a drop of blood for diagnostic purposes;
• Blood lancet without an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which is used to puncture the skin to obtain a drop of blood for diagnostic purposes;
• Blood lancet for single patient use only is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used only for a single patient to puncture the skin to obtain a drop of blood for diagnostic purposes; and
• Multiple use blood lancet for multiple patient use is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used for multiple patients to puncture the skin to obtain a drop of blood for diagnostic purposes.”

Perhaps this is the reason that every and we mean every company that Diabetic Investor spoke with who had a new device noted that they planned on launching their new device in Europe first and will come to the USA later. Given the increasingly nutty FDA Diabetic Investor really can’t blame them. Dealing with the FDA has never been easy but it seems as if this dysfunctional agency is bound and determined to turn the United States of America, the world’s lone remaining superpower, into a third world country when it comes to medical devices.

Keep in mind that already glucose monitoring companies are barely making any money at all on lancets and lancing devices, items which are needed to perform glucose monitoring and basically given away for free. Items which if regulated as a Class II medical device would do nothing more than increase costs for these companies and provide only the slimmest of benefits to patients. Diabetic Investor isn’t exactly sure what prompted this increased scrutiny of lancets or lancing devices, it’s almost as if the folks at the agency got on their pogo sticks started jumping around and one day landed on the lancet issue.

As much as Diabetic Investor keeps thinking the wacky world of diabetes can’t get any wackier, events such as these remind us that the journey to ultimate wackiness is just beginning. We can’t wait until the FDA moves from lancet regulation to regulating meter skins and meter carrying cases. We sure as heck wished this was a joke however sadly it is not.