Tuesday, May 12, 2009

CIRM Backs Biotech Industry Legislation, Aiming for Greater Federal Influence

The California stem cell agency today performed something of a semi-reversal and endorsed industry-supported federal legislation that would set rules for creation of generic biotech drugs.

CIRM
’s board of directors last month supported a move to develop a statement of principles on the legislation, declining to ratify a recommendation by its Legislative Subcommittee that it support the industry bill.

However, this morning the board decided to back the industry measure rather than acting on the statement of principles developed by its staff over the last two weeks. The vote was 16-2 with two abstentions.

The consensus was that the industry needed to be encouraged financially to develop therapies, generally following the arguments made at the board meeting April 28-29.

Board member Joan Samuelson of Healdsburg, Ca., a patient advocate representative on the board, today said,
“The overriding concern is getting therapies to patients.”
Board member Oswald Steward, chair and director, Reeve, Irvine Research Center, University of California, Irvine, said, however, the board “should not act like a political action committee.” He said it “should be respected as much as the National Academy of Sciences.”

Jeff Sheehy
, another board member and director for communications, UCSF AIDS Research Institute, supported Steward’s position, declaring he had “a lot of problems supporting a particular bill.” He said it would take the board “fairly deeply into the legislative process.”

Several board members, including Chairman Robert Klein, argued that CIRM could not become a player on the legislation without taking a specific stand. A statement of principles was meaningless at this point, they said.

The bill backed by CIRM is HR 1548 by Rep. Anna Eshoo, D-Palo Alto, which is favored by the Biotechnology Industry Organization. The board took no position on a rival bill, HR 1427 by Rep. Henry Waxman, D-Los Angeles, which BIO opposes. The Generic Pharmaceutical Association opposes the Eshoo bill.

Some board members were concerned about irritating Waxman, including Gerald Levey, dean of the UCLA School of Medicine. He said he did not “want to see CIRM caught in a political battle because we have enough of those.”

CIRM Vice Chairman Art Torres, a former state legislator who worked with Waxman, indicated that relations with Waxman would not be a problem as long the board did not directly oppose the Waxman bill.

Torres also indicated that the competing proposals may be wrapped into President Obama’s health initiative, which Waxman would carry.

A subtext of today’s session concerned the extent of CIRM’s role as a lobbyist at the federal level. The statement of principles on the legislation made a strong case for federal activities by CIRM as did Klein. CIRM recently hired a powerful Washington lobbyist, the Podesta Group, on a $240,000, 10-month contract, but the board has never had a full-blown discussion about how far it wants to go in lobbying at the federal level. The state of California has its own lobbyist, who works out of the governor’s office, but few, if any, state agencies engage in major federal lobbying efforts.

To be a significant player on the federal scene requires a hefty effort. Spending on lobbyists (nearly 11,000 in all) totaled $3.3 billion last year, and that figure does not reflect all expenditures made in attempts to influence federal legislation and regulations.

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1 comment:

  1. Anonymous4:02 PM

    Has anyone checked to see what members stand to benefit from passage of the Eshoo bill? The industry members of the board include at least on self described former employee of biotech leader, Genentech, are there stock options? What about former Chiron founder and ex-vice-chair, Penhot, does he have stock options? What about the new CIRM counsel, formerly at Genetech, does she have options?
    What about the two UCSF members, the UCSF dean and Sheehy, who now answer to a former Genentech executive, UCSF's new chancellor?

    A tough biosimilars bill, like Waxman's, might save some lives of cancer patients who can't get access to some of the horribly expensive biotech products developed by Genentech. A side effect will likely be lower profits and lower stock prices at the company.

    The whole thing stinks. Using a position on a state board to direct state funds to lobby for a bill to advance one's own private interests over those of patients ought to be against the law. This smells like Cheney and Halliburton!

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