If you were a head of a pharmaceutical company right now, what would you do to be ready for the new world of healthcare?
I'd hire Tommy Thompson.
And for the ones who can't?
I would analyze my company and give it a complete spring cleaning and adjust it to the directions that I want to invest the
money in. I think that's what Pfizer is doing with getting out of the heart space. Pharmaceutical companies are going to have
to look at where their niche is because it costs so much to develop drugs. They have to become much more focused on the areas
of healthcare where they can become experts and specialists—in diabetes or Alzheimer's, mental problems, heart problems, devices,
whatever it is. They can't do the big gamut.
And they've got to find new compounds, so I would work very closely, much more closely than the pharmaceutical companies traditionally
do, with the research centers and the hospitals and the medical schools around this country. And I would put some of my money
into the research labs at the University of Wisconsin for cancer or stem cells.
I would also be working extremely hard to develop—for my own good—a program on a Critical Path with the FDA. I would push
very hard for a Phase IV so I can get my drugs to market faster.
And I would try to change the policies and programs of FDA so the agency is able to recruit scientists and pay them higher
wages so they stay with FDA.
When you were at HHS, you said you wished you could negotiate directly with drug companies over prices for Part D. How do
you feel now?
I'm opposed to it. If you have the Secretary negotiating for a drug you will have the tendency to disrupt the market. We're
seeing too much erosion already of our market system. When you look at having one individual have the awesome power to completely
control the price of drugs, you're going to stifle the innovation of pharmaceutical companies.
What do you think when you look at FDA and its current problems?
As an institution, I see a very bright future. There are four things FDA needs: First, it needs the next president to appoint
a commissioner early on. We went way too long before having a permanent commissioner during the Bush administration. We had
acting commissioners for almost half his presidency. That in itself seems to detract from the structure and the morale of
Second, to maintain standards you have to hire capable people and you will have to pay them appropriately. So you are going
to have to increase the budget—and that's what the Coalition for a Stronger FDA is all about, improving the budget. We were
very successful in the last supplemental appropriation; we received another $150 million dollars for the first half.
The third is retention. We have to make sure that people stay in their jobs for a long time, instead of having the law firms
and biotech and pharma firms hire them away.
The fourth one is the Critical Path, which will get drugs to market faster.
Is the current level of distrust in FDA warranted or exaggerated?
I think it is to a certain degree exaggerated. The caliber of individuals at FDA is outstanding, and they get a bum rap for
the fact that morale is low, the job is immense, the resources are slim, and vacancies are too many. And that's causing the
erosion from what needs to be done at FDA. That's why Congress on a bipartisan basis needs to join with us and work to improve
Who would you like to see serve as the next FDA commissioner?
We have had some good FDA directors in the last eight years—Mark McClellan, Les Crawford, Andy Von Eschenbach. I think they
have been exceptional. I know there has been some criticism, but their hearts are in the right place, I know the direction
they are trying to lead, and I know the effort and the passion in FDA are without equal. But this time, post-Bush, the most
outstanding person I can think of on either side of the aisle is Elias Zerhouni.
I don't know if he would take the job, but Zerhouni would bring a whole new talent set to FDA, which it needs. He is an outstanding
scientist, a wonderful doctor, a great administrator—one of the best, if not the best, administrators in the history of NIH. He has seven or eight patents, he has taken several products to market through
FDA, and has built businesses around them. You can't beat someone with those qualifications.
There's a trend to try to regulate pharma at the state level through legislation and lawsuits. Some argue this is a necessary
market approach. But it creates problems for FDA and for the industry. How do you feel about this approach?
You're not going to stop it. Whether it is right or wrong, it's going to continue. I think you have to find a way to make
sure there are no contradictions between FDA and the state levels.
How do you feel about pre-emption?
I think you have to have it. FDA is the gold standard. When governments internationally gauge their drugs, their marketing,
and their standards, they look to what FDA does. You cannot really function if FDA didn't have pre-emption.
In 2003 you were elected as the chair of the Global Fund to Fight AIDS, Tuberculosis, and Malaria. How do you see global efforts
fitting with domestic healthcare reform?
What we need to do is what I call "global medical diplomacy." It doesn't mean that we shouldn't have an aggressive State Department
and strong military, but this is really going to the heart of what America is all about. Right now, America is looked on with
some degree of suspicion and trepidation. Where better then to put our resources into than improving the medical condition
of places around the world.
It's about improving the hospitals and the training centers in Afghanistan, where we remodeled a women's hospital, and where
750 women showed up on Easter Sunday in 2003 to thank me and the United States. Or in Indonesia, where they were very anti-America.
We sent a hospital ship, Mercy, over there with volunteer doctors and nurses and technicians spent six weeks sailing the islands. As they left the port of
Jakarta, tens of thousands of people were waving the American flag, thanking us for the great medical assistance.
You look to the Global Fund that has more than 300 programs in 135 countries and has doled out billions of dollars and has
something like $8 billion to give out to fight AIDS, TB, and malaria. Add to that the PEPFAR program, which President Bush
started and will probably be the most successful program in his legacy. It's these kinds of things that can capture the attention
of the world—and it's just better than anything else that is going on in the fight against terrorism.