1-20-09: A new administration takes over

A new administration means new legislation on reimportation, a fresh look at stem cell research policy and follow-on bills. And that's just the beginning.

For eight long years the Bush administration has been playing defense [1] against embryonic stem cell research. That will be over with the new Congress in 2009. But while the executive ramparts are being disassembled, the science has taken an important new course. Adult stem cells are proving more versatile than ever expected and may well come with a significantly reduced threat of cancer. But look for more federal money to course its way into the field for both ESCs and adult stem cell work.

Reimportation, the great bugaboo of PhRMA, is another likely hot button issue that will get early attention. The industry lobbying groups will wail and gnash their teeth, but lawmakers are likely to find it difficult to avoid a convenient legislative gambit like this. If the federal government is unwilling to dictate lower drug prices, then they will let the Canadians do it for us. That does mean less money for pharma companies, and it's also likely to spur even greater interest in new drug programs that can command a significant premium in the marketplace. Don't overlook the upside.

BIO, meanwhile, still has its sights set on a follow-on bill that will safeguard intellectual property rights for biotech drugs for a significant amount of time. But while the biotech industry was busy on the legislative front, Big Pharma was waking up to the smell of a new market. AstraZeneca, Merck and Eli Lilly all laid out plans to start work on generic biotech therapies in late 2008. With the industry divided, and some heavyweight lobbying work done on behalf of the big developers, look for Congress to shape new legislation that allows the U.S. to start catching up with Europe. You can see this as inevitable, but investors won't be happy about the loss of biotech's protected IP status.

I have one proviso on all the legislative maneuvering ahead: lawmakers have an extraordinary appetite for delay. Legislative campaigns often stretch for years. Fast movement is rare. A new administration won't change those rules, but this one is promising fast action. We might just get it.