No. We as an association think that is a nice outline of the system. We see the post-marketing surveillance very much as part of a process that begins with initial clinical trials and evaluation and the licensing of drugs, and then moves through the product cycle to keep an eye on what happens once these things are out there. And more importantly, or equally importantly, we see it as a feedback loop so that the physicians who use these drugs have access to what is going on with them in the real world as it happens, in a way that they can use.
The difficulty we've had with some of the current mechanisms, again, as far as post-market surveillance and adverse reporting are concerned, is that they are concentrated simply on adverse reporting. There isn't really anything else that we've seen. The clinicians who use these drugs are baffled by the process. The definitions of what they're supposed to report on aren't clear always. The process by which they are reported has been improved of late but still is something of a black box. Once you send the form in, you don't really know what happens afterwards. There is the great fear that in some way they are, by reporting these adverse reactions, either wasting someone's time with something that's trivial or potentially putting themselves in a situation where a torrent of paperwork is going to be unleashed on them, in addition to whatever else is going on at the time.
The current process really needs a lot of attention to make it into the sort of Cadillac version that we've suggested, and it needs attention from all directions.