When Mark B. McClellan took office as the 18th commissioner of the Food and Drug Administration in November 2002, he came
with a fascinating set of assets and liabilities. On the one hand, he had never run a regulatory agency, or indeed even worked
for one. On the other, he was both a physician and an economist and had taken a leading role in US healthcare policy. (At
one point, the biggest question about his candidacy was whether President Bush could spare him from the Council of Economic
Advisors.) He had never worked for a pharma company-which meant he could pass Ted Kennedy's litmus test for confirmation-and
he was unproven as a manager. But his understanding of the costs and benefits of healthcare was likely to be a real plus as
the country grappled with the emerging issue of drug prices.
A year into his new job, McClellan has proven visionary and energetic-though the jury is still out on whether he has the managerial
abilities to complete the dizzying array of projects and initiatives he has launched. Under McClellan, FDA is restructuring
the centers for drugs and biologics, revising its approach to good manufacturing practices (GMP), re-engineering its internal
procedures to speed the approval process, and taking on a new range of responsibilities related to the prevention of bioterrorism.
Most significantly, the agency is working to incorporate a risk management philosophy into all of its operations, a move that
will have important implications for pharma.
Along the way, McClellan has been a prolific spokesman for the agency, for public health, and occasionally for the industry,
maintaining a busy schedule of speeches on drug pricing, reimportation, research, and, of course, the economics of healthcare.
On the anniversary of McClellan's first day in office, Pharmaceutical Executive sat down with him to discuss his current thoughts
on policy, pricing, and the industry. What follows is an edited transcript of the conversation.
PE: You've been talking a lot recently about FDA's role in helping to control the cost of drug development. Obviously one way
of doing that is to cut the time it takes to process an NDA, and we've heard a great deal about how you plan to do that. But
beyond that, what role can FDA play in helping the industry to lower costs?
Mark McClellan: It is directly tied to our role in reviewing new applications. Whether a drug gets approved the first time around depends
on the quality of the application-whether it has compelling evidence of safety and effectiveness. In turn, that depends on
the developers. If they design a clinical trial that does not answer questions we need answered, if they perform extra studies
that are not relevant to what the best and latest science has to say about approval decisions, then that's money not well
spent. So we do have a role that impacts the other 90 percent of the development process besides review times.
Not only that, FDA is sitting on top of more data on what works and what doesn't in the development process than anybody else
on the planet. To the extent we can find ways to bring that experience to bear, we can play a role there, too. For example,
there's all this information being developed on microarray results for gene up- and down-regulation, but no one knows what
it means. There's much more that could be learned about what pharmacogenetic testing could mean for developing products. But
unless we work with companies and experts to turn that information into knowledge, it's not really going to have an impact.
PE: You held hearings on direct-to-consum-er advertising a few weeks back. What stood out for you in the testimony?
MM: A couple of themes were notable. One is that studies generally found that DTC advertising does some good when it comes to
letting people know about health problems that are under-treated in the population and getting them into therapy. Very often
people end up not getting the treatment that was recommended, maybe not even a treatment in the same class. But there was
a lot of evidence of increased consumer awareness, getting over embarrassment or other issues that prevent health problems
from being treated, with the result that there was a positive public health impact.
We also heard a lot of concern, especially from doctors, that patients are not getting a good balance of key risk and benefit
information on drug products. One take-home lesson was that FDA needs to be as clear as possible about the best ways to present
evidence in an unbiased way in DTC ads. The small print in newspaper and magazine ads may not be the most effective way to
ensure that consumers get key takeaways about benefits and risks. So we're working with experts in communications, risk communication,
and even marketing to come up with ideas.
PE: You've made it clear that you are concerned about the cost of drugs, access, and the lack of really new drugs coming down
the pipeline, and you have rolled out numerous initiatives and strategic plans to improve the situation. There seems to be
an assumption that if you could reduce the cost of development it would translate into lower-priced products.
PE: But you're an economist. And we know that pricing does not necessarily relate to cost.
MM: It does in a lot of cases. Competition means that if you are going to sell your product, you need to provide high value-which
comes from higher quality or lower cost. That's what people care about. So if we can help companies bring down the costs of
developing new products, that should translate into a pricing impact.
You're right, FDA doesn't set prices-companies do. If I were a CEO, though, I would be very concerned about finding ways to
deliver more value in my products. People are extremely worried about rising healthcare costs. It's going to be difficult
to follow through on the promise of genomics and nanotechnology and other fields if we don't find a way to do it at lower
PE: One of the ways that the price of drugs could come down is if more of them were sold. Many in the industry point to vast
areas of what they regard as under-utilization. Of course, a lot of the debate over drug utilization now makes the assumption
that we mostly suffer from over-utilization. What's your take on the balance between over- and under-utilization?
MM: There is clearly some of both. Many medication errors and adverse events could be prevented if doctors and patients made
better choices about medicines or stopped the use of medicines when warning signs developed. We don't give as much support
to doctors and patients as they deserve when they're making decisions about medical treatments. We need to do more, and that
could reduce some overuse of medicines. At the same time, there are clearly examples of underuse as well. I think that goes
back to the point I was making earlier, that we're not getting as much value out of healthcare spending as we should.
PE: You've commented on the price disparities between the US and other countries. There are also price disparities within the
US market. Do you think that's going to change?
MM: I think it has to. Americans are angry about the current pricing situation. When people without coverage walk into a drug
store, they are paying by far the highest prices in the world. And they don't understand why safe and effective drugs can
be available in Canada or the United Kingdom or other parts of the world at much lower prices than they are here. That's not
I'm trying to talk with leaders from other governments about this issue. All of us want affordable access to innovative medicines,
and we need to find ways to work together to make that possible. Unless countries work together to make regulatory processes
as efficient as possible, and find ways to help people who can't afford it get the medications they need, then I don't think
we're going to see as much innovation as the people of the world deserve.