Do you mean spontaneous reporting? It's extremely efficient because it does what it intends to do, which is generate a signal. You don't want the system to be swamped with the common and not serious events.
This component, I find, is working efficiently. It covers the entire population, but it doesn't address the other issues related to drug safety. We need data on the risks and on the at-risk populations.
The issue of off-label use actually is included in risk management planning. There need to be provisions and specific actions planned right from phase two with regard to what will be done regarding the potential for off-label use.