We face all these challenges. I think our challenges are very similar.
In terms of reporting adverse events, we do not have a requirement in the United States for physicians, nurses, pharmacists, patients, or anyone else at the point of care to report an adverse event related to a drug to either the manufacturer or to the FDA. We understand that only a fraction of the adverse events that are really happening are reported. It's often quoted to be 1% to 10%. The real percentage is probably not known, but probably varies from drug to drug.
What's most important about these systems, though, isn't the number of reports you get, but the quality of reports you get. We get over 450,000 reports a year, but a lot of them are lacking the kind of critical information we'd need or want to make an accurate determination of what role, if any, the drug played in the adverse event. We can go back and get follow-up information. We can do that. That's very time-consuming and resource-intensive, and we don't have the resources for that.
With regard to other kinds of surveillance systems--these systems that rely on large databases of health care information and electronic medical records--FDA doesn't own them. The drug companies don't own them. These are owned by independent parties. In the United States, with a private health insurance system, they're often owned by health insurers or health plans. One of the challenges we're going to have is how to get everybody together: the FDA, other government agencies, the companies, the people who hold the data--health systems, hospital systems, practitioners, and academics who have the skill to look into these data. How do we bring all these people together--and handle important issues of patient privacy and confidentiality and things like that—to look at this data to see what's happening?
So FDA is just starting some initiatives.