Bird Flu: Science and Policy

[DewDiligence]

Group Points to Liability Shield for Flu Remedy Firms

http://www.boston.com/globe/business

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By Diedtra Henderson
May 5, 2006

WASHINGTON -- A consumer advocacy group says the pharmaceutical industry ''blanketed" Congress in 2004 and 2005, employing at least 158 lobbyists and spending $91.2 million, including on flu vaccine or pandemic issues.

The group, Public Citizen, said about 84 of those lobbyists had federal ties, including seven former members of Congress, two senior health policy aides to Senate Majority Leader Bill Frist, and the son of Speaker of the House J. Dennis Hastert.

The group says it pored through e-mails and other documents exchanged between drug industry lobbyists, the White House and, Frist, a Republican from Tennessee. In December, Frist added a liability waiver to a must-pass defense bill to broadly shield most doctors and companies that make, deliver, or administer pandemic flu remedies.

Frist could not be reached for comment yesterday.

Three members of Congress instrumental in the law's passage -- Frist, Hastert, an Illinois Republican, and Republican Senator Richard Burr from North Carolina -- received a total of more than $1.2 million in campaign contributions from pharmaceutical and biotechnology companies since 1999, according to Public Citizen.

Senator Edward M. Kennedy, Democrat of Massachusetts, this week sought to counter Frist's action. Kennedy attached an amendment to another must-pass bill that would provide $289 million this year to compensate victims harmed by pandemic flu treatments.

The White House this week updated a $7.1 billion plan that outlines how the government would contend with a lethal flu outbreak by speeding vaccine production, stockpiling medicine, and tracking likely US entry points for the flu. Experts estimate that 200,000 to 2 million Americans would die and that travel would be disrupted should such a pandemic occur.

Congress already approved $3.8 billion to fund the plan. Bills facing votes in the Senate would add to that tally.

Last fall, as the number of people infected with avian flu rose in Asia, the Bush administration made pandemic planning a high-profile goal and invited drug manufacturers to the White House.

As early as mid-November, Dave Boyer, director of federal government relations for BIO, which lobbies on behalf of biotechnology companies, said he was concerned the proposed measure would leave drug companies vulnerable to lawsuits. People killed or seriously injured could sue if they proved a drug maker's actions amounted to ''willful misconduct."

The Washington, D.C.-based organization's 1,100 members include America's top 10 drug manufacturers, who control more than half of the nation's drug market. Between 1998 and 2005, BIO more than tripled its lobbying budget from $1.7 million to $5.8 million, Public Citizen reported.

As early as Dec. 1, Republican leaders in the House and Senate vowed to attach the liability shield to a Defense Department appropriations bill, according to Public Citizen. Alarmed Democrats received assurances that such a tactic would not occur.

On Dec. 18, Republicans and Democrats met to ensure that the House and Senate versions of the defense bill matched. The 422-page bill they reviewed did not include a liability waiver for drug companies. Four hours later, Frist asked Hastert to authorize adding another 40 pages that included the liability waiver in a move that Kennedy derided as ''an absolute travesty."

Jim C. Greenwood, BIO president, said chief executives from the nation's major vaccine manufacturers told him a strong liability waiver was essential. The companies willingly offered to stop production of profit-making drugs to devote their manufacturing capacity to help the nation fend off a pandemic. But not if it meant ''being driven out of business and eaten alive by lawsuits," Greenwood said. Because of the threat of a pandemic, he said, the waiver had to be granted quickly.

But Public Citizen alleges the waiver ''far exceeded the scope of the Bush administration's proposal, which would have applied the shield only to drugs and vaccines created specifically to combat the avian flu."
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