We learned quite a lot from Vioxx here at FDA. One of the things we learned is that the public wants to know when we know about something. As you may recall with Vioxx, there was a delay of over a year in adding information about heart attacks to the label.
We've started a program here in the last year or two through which.... When we are working on an important safety issue but before we've brought it to resolution, before it has been added to the product's label, we are issuing what we call “early communications of safety findings”, so the public can know this is something of concern to us, that we're working on it, or that we've concluded this and we will be adding it to the product's label. The way it was communicated to the public before was through the product's label. Now we are being proactive in communicating that earlier.
In addition, the legislation that was passed in September of 2007, the Food and Drug Administration Amendments Act, has provisions for us to work on a timeline with companies to get information about important new safety findings in a way that should preclude this long period before the information gets on the label.
So there are two things: the legislation that allows us to get this information to the label in a more timely fashion, and our own proactive public communications.