Monday, October 11, 2004

Primer on "off-label" uses of prescription drugs

"Off-Label" -- And Out Of Bounds?

"Off-label" is a term you're going to hear more and more as political posturing on pharmaceuticals continues. The link contains a primer on the basic issues and facts.

When a drug is submitted for approval, a "label," detailing the uses, potential side effects, contraindications, and known drug interactions, is submitted along with it. If the drug is approved by the FDA, that means the label is approved. The uses section of the label can only contain what was confirmed in (usually) two large Phase III trials. For example, the uses section of the Rituxan drug in the referenced article contains "slow-growing non-Hodgkin's lymphoma who have relapsed or failed to respond to other drugs." And Genentech can only disseminate literature that promotes Rituxan for this use. However, if Rituxan can be used to treat other conditions, or may help suffers of slow-growing non-Hodgkin's in other phases, doctors might be interested, and Genentech would certainly be interested in disseminating this information. Unless there is an article in a peer-reviewed journal saying as such, Genentech's lips have to be sealed. The only other option is to submit an application for a supplemental approval, which is an expensive process (it involves well-controlled clinical trials, a lot of paperwork, and quite a bit of time).

Now is the time to start with this primer and absorb more information before the accusations start flying.