PharmExec | Tom Norton
Years ago, while sitting in an Rx company lunch room, I was listening to one of the company’s top sales reps discuss the commercial progress a recently launched prescription was making. The rep said that the product was selling “OK” under its FDA approved, indicated therapeutic area. However, he quietly said, “It’s not the approved indication that going to make this drug a winner.”
I had heard of non-approved usage of Rxs before, but this was first time I had learned of anything quite this specific. Curious, I probed a bit further and asked, “What do you mean?” He looked at me directly and said, “You know, it’s all the other ‘off label’ medical issues that the docs believe this drug will address.”
Traditional “Off Label”
Through the years the US drug industry has experienced a lot of this sort of thing. Although companies make an enormous effort to obtain an FDA approval with a very specific indication, it always comes as a bit of a shock to learn that the medical community is not only using the product for that hard to achieve FDA approval — but also for several other non-approved indications.