Biotech leader sees challenges ahead

The nation's biotechnology industry holds its annual conference this week, with more than 20,000 attendees at the Boston Convention and Exhibition Center. One of the industry's key leaders is former congressman James C. Greenwood, a Republican from Pennsylvania, who as president of the trade group BIO is its chief lobbyist in Washington. He spoke with Boston Globe reporter Stephen Heuser on a recent visit to Boston.

Q. How has the new Democratic Congress changed the agenda for biotechnology?

A. The Democratic majority offers us some enhanced opportunities in terms of stem-cell research [funding], though there will still be a presidential veto. Hopefully we'll do better with NIH funding and FDA funding. But we face some serious challenges, because Democrats as a whole are less favorably inclined toward industry generally and the biopharma industry specifically.

Q. What's the one thing you'd like the Democrats to understand?

A. The most important policy item for the biotech industry with this Congress is, how much data exclusivity and market exclusivity do branded biologics have before they face competition? We favor competition, but we think that companies should be able to have 14 years of market exclusivity in order to recover their investments in R&D. If you look at the Waxman bill or the Clinton-Schumer bill, they're at zero and we're at 14, so that's a pretty big gulf.

Q. What's the hardest message to get across in the current Congress?

A. That profitability of biotech companies and the health of society are in fact very closely linked. Some members of Congress try to act as if they're in opposition to each other. In the short run, these drugs are going to be expensive. We can get cheaper drugs for a short period of time by tightening the screws on the biotech companies, but we won't get the real miracle cures that are scientifically possible.

Q. If we look at national spending on biotech drugs, the models say it's going up 15 to 20 percent a year. In one sense that's a success story, but does it concern the industry that it's driving up the cost of healthcare?

A. I wouldn't say that -- it's driving it up, but it's not the driver. Biotechnology drugs are still only about 6 percent of Medicare spending.

Q. Some of these drugs are $50,000 or more per year. Couldn't the companies just decide to charge less?

A. Obviously they can set their price where they want to, but they have to take a long-term view, too. They have stockholders, they have a research and development agenda they have to pay for, and they have to create a return on their investment. It's a tough business, because it can cost $1 billion on average to develop a drug, and you've got to get it back somehow.

Q. In the early years of biotechnology, people debated ethics of genetic engineering. What social issues is biotech facing now?

A. Cost and access are issues that we debate. Of course you have the embryo stem-cell issue that the Congress is wrestling with. On the agricultural side you have the animal cloning issue -- the Food and Drug Administration has said that meat and milk from the progeny of cloned animals is identical in every way to regular meat and milk and is perfectly safe, but not everyone is in favor of that.

Q. And the concerns about genetically modified crops, are those also misplaced?

A. They're completely misplaced. The fact is we've been producing and consuming genetically enhanced crops for decades now, and there's not a shred of evidence with regard to safety [problems]. If you're going to feed a growing world population with a diminishing agricultural land base, you have no choice but to increase productivity. You go to developing countries, you see farmers who by virtue of the fact that they use these products, their plants withstand pest invasions which otherwise would wipe them out, and instead they're doing well and sending their kids to school -- I think the ethics are on the side of doing that.