When a new drug gets onto the market, it's perhaps been used in 3,000 to 4,000 people during the clinical trial phase. If you are dealing with an adverse drug reaction that occurs, say, in one in 10,000 patients, then you're not going to know about that.
What we're saying is that when these new drugs get used in the population, there needs to be routine, systematic monitoring and collecting of data on their use in order to make sure they're safe.