What are the most important things that you are going to be focusing on?
James Greenwood: Clearly right now there is a lot of focus on drug safety. In the wake of Vioxx, etcetera, there have been proposals to change
the structure at the FDA for review of products post-market. That is understandable. The industry and the public policy makers
should always be making sure we are doing the best we can to provide information to patients, healthcare providers, and physicians
so they can make intelligent decisions. Our challenge is to make sure that happens in a way that doesn't compromise our ability
to get wonderful new products to patients. I told my staff that I want us to be at the intellectual front edge of that issue,
and that's what we're doing.
Obviously reimbursement is always important for us. CMS [Centers for Medicare & Medicaid Services] is trying to understand
the cost effectiveness of therapeutics. We have to make sure that it is done well. So we want to be—and will be—at the table
for those discussions. As we all know, FDA is taking a look at the issue of follow-on biologics. That is a critical issue
for the biotechnology community because making biologicals is different from making run-of-the-mill pharmaceuticals. So we
need to understand the safety issues clearly and make sure policy makers are cognizant of them, as well as the important intellectual
property rights of our innovators.
Do you think there will be some kind of a compromise pathway developed in that area? There seems to be enormous pressure,
and there also is a lot of advancement in the technology related to refining biotech production.
I think it's a little early to say at all where this goes. I think the FDA is moving cautiously, but they are moving. We have
to be cognizant of that. And we have to help them follow the science. We are a cutting-edge scientific organization. So we
need to make sure that all the scientific information is brought to bear.
Are you particularly concerned about the focus on pricing these days? Your members make some of the most expensive medicines
in the world.
Here is the thing with pricing. Most of BIO's members, maybe three-quarters of them, don't have products for sale on the health
side. For most of our members, capital formation is everything. They live by the degree to which angels and investment bankers
and others are prepared to provide them with financing.
If the big companies like Amgen, Genentech, and Genzyme do not receive sufficient reimbursement for the products they sell,
then the investors will go put their money into the next Blackberry. That is not good for finding new therapies for cancer,
Alzheimer's, Parkinson's, and everything else. So there is a continuity, if you will, from the researcher with the thought
in his or her head out to the big blockbuster product that has to be taken into consideration.
At the same time, I think the kids in the laboratories who are trying to cure these diseases would feel most gratified and
most motivated to know that their products are available to the widest market—the children in India and Africa, too. I think
the win-win is ultimately to pursue ways to manufacture these products less expensively, so makers can still achieve appropriate
returns on investment, and the money is there to pay for the product. I think that is happening every minute of every day.
You don't have quite the same critical baggage that pharma is plagued with right now. Do you feel a need to maintain that
I don't think biotechnology or BIO needs to define itself as "not pharma." I think we need to define ourselves based on what
our companies are working on.
There is no simple definition of biotechnology that all of our members would agree to. To some extent, there is the large
molecule-small molecule distinction. But many biotech companies do exclusively small-molecule research. To some extent, there
is the large company-small company distinction. But, of course, Amgen is not going to be described as small, and it is a major
biotech company. To some extent, there is kind of the spirited innovation and the desire to find new remedies for terrible
diseases as opposed to the reiteration of an existing product. I think those distinctions cause us on a policy matter on one
particular day to diverge from a pharma position and on another day to collaborate with pharma.