Absolutely. In terms of the definition of serious, it is dependent on the situation. As you know, for an individual patient an adverse reaction can be quite serious...for a group of patients, because they are predisposed to that. The bill actually allows us to collect that type of information.
It's really important to understand when a product goes on the market it can be used for a variety of different purposes in a variety of different populations. Right now we do rely on the companies to come in with that information.
In terms of the new provisions, the bill allows us to ask for specific studies, specific analysis, specific information to come in. That helps us look at that analysis and then decide whether or not changes need to be made.
The changes can run the gamut of communicating to help practitioners and patients, making warnings more prominent on the label, adding warnings to the label, or it could go all the way to requiring that product to come off the market.
Now if you have a serious adverse event that affects a small group of people, you don't want to limit that access for everyone. Based on what the adverse reaction is and what we're seeing, we need to have the tools, the flexibility, to make the appropriate risk decisions.