Now we've come to appreciate that within the overall population, there may be subsets of patients that may not appear to have
an alternative. There may also be subsets for whom this particular drug might have extraordinarily increased risks. The decision
[to approve a drug] is in part based on the serious nature of this problem and the level of risk tolerance for an overall
population. Because if it's an overall population of cancer patients as opposed to an overall population of patients that
have a non-life-threatening condition, that shapes and alters the decision. What is the potential benefit to be gained in
terms of the potential adverse event if the adverse event is life threatening and the benefit is merely a mild improvement
of a symptom and not elimination of a disease? Are there other alternatives? Are there other drugs that could achieve a similar,
if not identical, outcome so that patients are not totally without any hope of alleviation of their problem?
We're making decisions based on populations; eventually, we're going to move more toward making decisions based on subsets
and even perhaps, ultimately, on individuals. So if you can identify ahead of time by virtue of genetic makeup who is at risk
for a serious adverse outcome and you eliminate them from the population, you're able to make approval decisions that are
much more liberal in terms of access. I don't think we're there yet—I think the pendulum still is based on populations.
As you shift to a more individualistic type of treatment, it raises questions about appropriate use. One of the big problems
with the COX-2s is that they were being promoted among people who were perhaps not the most appropriate. What is the appropriate
role for marketing and promotion and what is the FDA's role in that area?
We're emphasizing our own efforts at risk communication. For example, we've changed our label processes to improve how the
information is being presented and disseminated. When we move to an electronic format, we'll have the opportunity to update
that information in real time and provide it more effectively at the point of care or point of service. With the pharmacy
industry, for instance, we look forward to when patients have their prescriptions filled and get an electronic version of
the printout that has the latest and best information FDA has about that specific drug.
At this point, we expect to have some increased resources from the PDUFA negotiations that will enable us to more actively
engage in consultation with the industry around marketing materials and direct-to-consumer advertising. I think it's a part
of how FDA can do even better with regard to the role that it plays—and how it partners with the industry in terms of maximizing
how that information is provided to patients in a way that is appropriate, understandable, and with the correct emphasis.
Industry is, I think, taking more ownership and responsibility for this, from what I've seen, in terms of helping to set standards.
It seems that FDA is really rethinking the way it provides information to consumers. Can you ever see a time when FDA's information
will replace DTC advertising?
I'd like us to find ways to be a very rich and effective resource for the public. When I first arrived at the agency, I said
communication was one of five areas I wanted to focus on. And we have begun to look at how we can improve our own vehicles
We're in the midst of a major commitment to revamp our Web site, and the first phase of that is focused on the pages that
are directed to consumers. We want to have the best Web site for finding out about a drug or any issue.
What's more is that this pathway of modern communication enables FDA and the public to have a much more dynamic interaction.
We are no longer producing the magazine FDA Consumer, which is shifting to an electronic format. Instead of something that comes out from time to time, we're moving to something
that is more relevant, interactive, searchable, and timely.
The other side of the equation is that we don't have to repeat what others are doing. For instance, we are providing AARP
with FDA educational materials that they may add into their publication so we get the benefit of their enormous distribution
and can target messages on the safety of products their members may frequently use.