Hey Abbott!

The part of me that remembers to post something every day is already on vacation. I’ll be at the beach next week, much like last year, except I don’t have a week’s worth of content ready for you. I think I’m going to try out the different posting options I have at my fingertips from the comfort of my beach towel, so don’t expect anything insightful. Not like I’m particularly insightful on a regular basis, but you get the idea. But I digress.

I’ve mentioned my “catch-all” Google Reader query for “diabetes” before, right? Right. As you can guess, most of the stories over the past couple of weeks have dealth with the FDA and Avandia. There’s been a lot of talk about the FDA’s ruling, and subsequent actions, but that’s not what this is about. Although, it does involve the FDA.

Today’s Google Reader overload included some mentions of a little company called “Abbott Diabetes Care.” Check this out (and I quote):

“This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at 21 CFR Part 820. We received your response dated March 26, 2010, in addition to responses dated April 23, 2010 and May 25, 2010 from Mary C. Getz, Division Vice President Quality Assurance and Compliance, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address your March 26, 2010 response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:”

Key words to focus on are “not in conformity” and “violations”. In a nutshell, the FDA isn’t too pleased with how Abbott is manufacturing its glucose meters. Aside from the part where I have a FreeStyle Flash (Bart Allen), my concern is that the average, unassuming person with Diabetes may never hear about this. The full text of the letter can be found at FDA.gov, but I can’t imagine this is something Abbott would actively promote. Hey everyone! Look what we got in the mail today! For the less informed, they will never hear about this, they will never know this ever happened and they could carry on, using a potentially faulty device that is supposed to be the primary technology responsible for their Diabetes management.

Here’s another nugget: “Please notify this office in writing within 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, which may include notification of your current and past customers. Your response should also include an explanation of how you plan to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrective action you have taken.  If your planned corrections will occur over time, please include a timetable for implementation of those corrections.  If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.”

I don’t ever recall registering my meter with Abbott or any other entity. How can they possibly reach every customer of their devices? I fear for those who lack the resources or ability to stay informed. I fear for those who are just trying to get through the day without a hassle, and don’t have the time to look up and assess a situation. I’m talking about this on a blog that will be read by people who have just as much if not more access to this kind of information than I do, what about everyone else?

Also, on a lighter note, I fear that if I have to replace Bart Allen for a new meter I wont be able to think of a clever name to keep with my super hero theme. It really is perfect: FreeStyle Flash…The Flash…Bart Allen. I’m telling you, it was fate.

Also. Ludacris….Diabetes Advocate? That’s ludicrous!