That would be the intention of the policies we have been trying to develop. You are correct that there is a long-standing obligation on manufacturers to report an adverse drug reaction no matter how it's used, whether it's used, as Marc pointed out, off-label or not. But the intention is to make sure that...all the information you are losing on a population basis. You can use them one by one, but as that adds up in a community of use, you really want to study what's going on there, if you can. That's where the life cycle tools could be introduced, so that you can have varying types of studies, depending on what's really needed either clinically or on the population level.
On May 1st, 2008. See this statement in context.