Getting Labeled.

blank labelI’ve been working in the diabetes industry for seven years now at two different companies that both make innovative medications or devices for people with diabetes. And just like the products themselves, the people they make them for are also innovative. As in, they take the instructions for use with these products and basically throw them out the window. Because people with diabetes have been improvising and adjusting for as long as this disease has been around. And that’s because when you’re struggling to make diabetes fit in to your busy life, you inevitably create work arounds.

The toughest part about being a person with diabetes and working in this industry is keeping my words on-label. On-label refers to the package or medication labeling that a product has. When the FDA approves a product or med, they approve it based on the data the company has from their clinical trials. If during a clinical trial, for example, the only people that took an experimental insulin were men over 40 and they all only injected the insulin in their abdomens, then the final package labeling might say something like “this product is intended for the treatment of diabetes in men over the age of 40 and is only proven to be effective when injected into the abdomen” regardless of whether the insulin works in all ages, genders, and injection sites.

Basically, if you didn’t do it in the clinical trial, the FDA won’t put it on the package. And I run in to a challenge with this all the time. Since I also wear a CGM I get questions such as “well how long do those sensors REALLY last?” and “do you wear your sensor on your arm?” As a patient, I’d love to tell you all about how your diabetes gear can vary. As a rep though, I will tell you that the sensors are FDA-approved for use for seven days and approved to be worn in the abdomen. Period. End of story. Because if I don’t stick to the script, the FDA can fine my company big bucks for “off-label” marketing. It’s a fine line as a rep who is also a patient, because my inclination is to always speak from the patient perspective. But this is what the FDA requires and they do this so that companies don’t go out there and say whatever they want to sell products or medications, even if it’s a stretch of the truth. It’s a law built to keep people safe, and to understand what has been proven about a product in clinical trials.

This is why so much of what we all know about diabetes and the “work-arounds” come from the blog world and other online conversations that happen between patients – not companies that sell these items. People with diabetes see a label and immediately think “that’s nice – now how are people really using it?”

Because you have to get creative with this disease – otherwise it takes up more brain space than I have available these days!

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Comments

well put – does the restriction on off-label marketing also now extend to your blog and social media postings?

I’m with Rich. Does this apply to you, because one of the reasons I love your blog is because you “tell it like it is” and that’s what I need. No “sugar coating”…..
Please don’t change, we are counting on you!!

Faye and Rich – as it pertains to the product I sell, I’m under a company policy to not blog about the product by name. So it will be referred to as “CGM” and not it’s brand name so that I can continue to “tell it like it is.” No worries!

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