The question is, can the material be presented in a way that improves its positive impact? We've insisted that this information
must guide patients with regard to its appropriate use, not simply so that the drug company can promote its product. And as
we review these ads and things of that sort, we're going to continue to enforce those kinds of expectations.
You've been emphasizing that the pathway for follow-on biologics has to be based on science. It's pretty clear that the people
who are most enthusiastic about FDA approving these products are really focusing more on cost. Do you think you've been successful
in evolving the discussion?
It's a conversation that's taking place. It's dynamic, and I wouldn't draw any conclusions at this point. It would be helpful
for the public to understand that we're committed to having access to drugs. And to me, access means they're affordable, available,
and appropriate. People who are coming at the issue of follow-on biologics or follow-on proteins from the perspective that
this is going to address the issue of affordable drugs—and to some extent, available drugs, because there will be more selection—are
losing sight of the other "A," which is that they're appropriate. And by appropriate it means that when this drug is given
to this person it is going to get this outcome. And so we need a regulatory pathway to make that decision, and that's what
Congress is addressing right now.
But in addition to having the regulatory pathway, we have to recognize that the question over [the equivalency of follow-on]
biologics must be answered by science. And so as we look at the complexity of these products, we'll use different scientific
tools to conclude whether the new product achieves the same outcome as the innovator product. FDA doesn't deal with the issue
of affordability or availability, so what I've been trying to help shed some light on is appropriateness. And we're going
to use a portfolio of scientific tools that will address the complexity of these products. Some of these tools might not yet
exist and will have to be developed, but technology is proceeding at almost warp speed with regard to our ability to understand
protein structure, to get us to that decision point.
We can begin to set a trajectory to move through this in a systematic way. It's consistent with our mission—we've done this
with small molecules—and it is now appropriate to address this with regard to the class of biologics and protein products.
Do you have a sense of where the frontier is for evaluating and characterizing proteins?
I'm not the content expert to really give you that type of visionary insight. But in general, what I've seen is that the technologies
are emerging rapidly. I had a conversation about proteomics for biomarkers with a Nobel laureate who, a year ago, was somewhat
pessimistic in terms of how rapidly we would get to a point of utility. But this conversation was all about incredible breakthroughs
in technology, so that his message was 180 degrees the other way and he was saying, "I hope FDA is ready for this." So here
you can see the weather change almost overnight from "this will take years before you're ever going to get there" to "oh my
goodness, you'd better get ready because it's coming tomorrow." So I think there are experts out there who would say, maybe
it's this frontier or maybe that frontier, but it's changing.
We began by talking about how people look at the agency as in disarray. But when it comes to the pharma industry, people see
a bunch of crooks who put out bad products and use unethical marketing techniques. How does the pharmaceutical industry look