CIRM Goes to Washington: Patents, Tornados and Bench Warming

As California stem cell directors this week consider once again their federal lobbying efforts, the Wall Street Journal offers an insight into just what it takes to have an impact in the august halls of Congress.

Can you say $27.6 million?

That's what a coalition of financial services organizations spent during the first quarter to change an accounting rule – albeit an important one – and lobby on other issues. The coalition also pumped $286,000 into the campaign organizations of lawmakers on a key committee.

Compare that to the $240,000 CIRM is spending for a federal lobbyist for 10 months work.

The issue that is coming up this week is CIRM's support for industry-backed legislation dealing with creation of generic biotech therapies. The agency currently has endorsed a measure by Rep. Anna Eshoo, D-Palo Alto, but has taken no position on a competing measure by Rep. Henry Waxman, D-Los Angeles, a far more important and powerful lawmaker.

The generic issue is complex enough on its own. But it apparently is going to be wrapped into the Obama administration's health plan, which Waxman will be carrying in the House. The rationale is that generic biotech therapies will cut costs, thus helping to trim the mammoth price of the health care deal. If the generic therapies are delayed because of industry-sought patent exclusivity, it means higher health care costs, according to supporters of the Waxman approach.

John Carroll of FierceBiotech recently wrote:

“Waxman has been pushing a bill that provides a five-year window of market exclusivity for biologics, something the biotech industry views with the kind of alarm a farmer feels when he sees a tornado heading for the barn. But there are a lot of numbers in play on the Hill. A competing bill offers 14 years of exclusivity and the president's budget proposal for 2010 pencils in a seven-year period.“

A Wall Street Journal blog this spring said the time may be ripe for a compromise and noted that some Big Pharma companies are warming to the idea of selling the copy-cat drugs themselves. The blog drew 18 comments, some of which indicated a high level of industry insight.

CIRM directors are oozing into a significant – for CIRM – federal lobbying role. But it is tiny in the world of Washington. Some on the board are concerned about mission creep and wasting time, money and focus on an effort where CIRM will never be more than a bench-warmer, if that. Directors are dealing with lobbying in what California stem cell Chairman Robert Klein calls an “incremental” fashion. Certainly CIRM can legally lobby Congress and probably should in some cases. But directors have never had a full-blown discussion on when, where and why.