Diabetes Support Coming to a Cell Phone Near You

Continuing our social media theme from last week’s post...

If anyone was confused about whether the FDA might regulate pharma company marketing on Facebook and other social media channels, Novartis has unintentionally helped clear the air.

Novartis recently received a warning letter from the FDA for using a Facebook widget that provided users with information about Tasigna, which is indicated for Ph+ chronic myeloid leukemia, but failed to also provide the FDA-required risk and safety information. Novartis has since removed the widget, and although there still exists quite a bit of uncertainty surrounding FDA regulation of social media marketing activity (at least until the final rules are published), the pharma industry can now be certain that omitting risk information in the name of Internet-style brevity is asking for enforcement action.

So mark one for the FDA in the compliance column. Mark one for the FDA in the approval column as well, with WellDoc, Inc.’s announcement last week that its DiabetesManager System has received clearance for use by adult patients with type 2 diabetes.

This is new territory for the FDA, as the DiabetesManager System requires patients to use their cell phone to enter personal health information into the system and to receive personalized decision support information back. I have not personally used this tool, but I can see how applications like this one can be useful in diabetes and other conditions in which behavior modification is an essential component in management in both adults and children.

What are the pros and cons to this kind of technology approach? I’d like to hear your thoughts.