What guarantee do you have as a person with insulin-dependent diabetes that your analogue is safe? Happy to go out and forage for answers, I called the 3 insulin analogue providers to seek knowledge on consumer protection (during business hours). I place my calls to imminent competitors: Sanofi-Aventis, Eli Lilly and Novo Nordisk. There is something to be said for good sportsmanship and great customer service (during business hours). It's another thing entirely when asking a company to own responsibility for the consequences of the product they sell. Checkout the analogue safety check and what the guardians of GMP (good manufacturing practices) are doing to protect YOU.

Sanofi-Avens (beautiful hold music, BTW) handled my call with aplomb. I spoke with Joyce who was happy to provide me with ensurance that the analogues are manufactured in FDA approved plants located in Frankfurt, Germany. None of the raw materials for the manufacturing of Apida or Lantus derive from China. In addition, she insured me that the analogues are put through rigorous evaluations throughout manufacturing that guarantee us (the consumers) that NO heparin happenings will result from the laboratory limbs of Sanofi-Aventis. Beautiful - straight forward answers, certifiable guarantee!

Eli Lilly reliably snuffed my curiosity to the tune of "All of our professionals are still assisting other customers". Counting my time on hold before I got the boot like yesterday - patience is a virtue. Third time's the charm. I'm taking a wild guess here - but Eli Lilly must have their customer support line set to hang-up after 4 minutes and 35 seconds because for the second day in a row - my call to customer support was involuntarily disconnected. At this rate I'm thinking Eli Lilly (NYSE: LLY) either doesn't have enough $$ to staff their customer support line or they don't care enough to answer. I can answer one question (partially) for Eli Lilly - it's about origin of manufacturing. Scott Strumello blogged a great informative piece about Eli Lilly outsourcing to Humera. No harm no foul. It's a great article disclosing who is really manufacturing Humulin R and Humalog and where they are doing it. You may have to subscribe to TuDiabetes to read the article -- and I must say as a member myself-- that could be a great thing!

Novo Nordisk, to me, is like that kid you always wanted to get to know but just wasn't sure how to go about it. Christine initially answered my call - perfect demeanor for customer service: great tone of voice, very helpful in handling my call. Levemir vials are manufactured in Clayton, North Carolina. NovoLog vials and FlexPen are manufactured in Clayton, North Carolinia as well. The Levemir FlexPen is manufactured in Denmark. Christine then courteously transferred me to Aman who ensured me that all Novo Nordisk insulin analogues were manufactured under sanctioned FDA good manufacturing practices. She went above-and-beyond the call to promise to get back to me with further details when I asked about batch testing and information availability to consumers. Aman was almost confident that the batch test results were stored in a database, but not entirely confident they are available to the public. (Update on 5/8/08 at 2:30pm EST) Aman called to inform me that the FDA has information regarding batch tests should there be a need to access information regarding the content analysis.

Just in case, here's the page for the FDA How to Report Problems With Products Regulated by FDA

I'm not going to complain. I'm rather pleased that Sanofi-Aventis (the name just sings - doesn't it?) and Novo Nordisk have a stellar support staff on queue to answer consumer concerns. It's a hard-knock life, this pharmaceutical business. You've got to keep a close watch on every aspect : raw materials, employee compliance, technician GMP loyalty, batch testing boo-yaa, machine operator sobriety - you name it, it's probably part of the magical process to bring you the insulin analogues to keep your motor running. Let's hope the godspeed of GMP is with us all!

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