If approved, which would ultimately be a political decision, FDA will surely require tight controls on its marketing. In fact, like an increasing number of new pharmaceuticals, particularly those for orphan (niche; specialized) indications (specific uses; small patient populations), such as to which Sativex is currently targeted, Sativex may not even be distributed at all, such as available through local or even hospital pharmacies. Rather, it could simply be directly sold by the manufacturer (or its U.S. rep) to only qualified, registered users in localities where the product is otherwise fully legal. This direct manufacturer distribution route effectively prevents all off-label prescriptions (broader use by others) and the companies like it because it forces patients to come to them with the patients becoming part of post-approval clinical trials, reduces marketing costs, allows them to pocket markups that otherwise go to middlemen, etc. Thus, if it follows this route, which might be required for political reasons alone, few may ever get to receive it, other than those multiple sclerosis (MS) patients experiencing the specific neuropathic pain and/or other specific MS side effects for which the product is being tested and, presumably, will receive approval.
