Yes, we do. One of the things we have is risk management for drugs. This starts before the drug is approved. We look at what it is about this drug that may cause problems when the drug is on the market and whether there are certain things, based on the drug's chemistry, biology, or certain findings in clinical trials, that we may want to keep a close eye on after the drug is approved.
We have a group in my office that works on risk management. We work with the parts of FDA that are responsible primarily for the pre-market review. And for certain drugs--not the majority, but for certain of them--we can institute risk management plans that will keep an eye on these things after a drug is approved and see if the risks and benefits are changing, post-approval. This is in addition to all our normal safety monitoring that goes on as part of a routine.