Bill to shield vaccinemakers raises alarms

Senator Burr's bill, the Biodefense and Pandemic Vaccine and Drug Development Act, would require plaintiffs to prove "willful misconduct" by drugmakers. " 'Willful misconduct' is usually pretty egregious activity," Milne says. "It's going to be hard to sort all that out to a jury or a judge. It's a pretty high threshold."

"I would have to prove some scientist at Merck or some CEO somewhere had made a determination to hurt me," said Chris Mather, a spokeswoman for the Association of Trial Lawyers for America, characterizing the bill to the Associated Press last month.

If a liability shield is embedded in the defense bill, it may not contain secrecy provisions that raised strong protests from open-government advocacy groups. The Burr bill would nearly exempt BARDA from the Freedom of Information Act (FOIA) or the Federal Advisory Committee Act, which reports on the activities of government agencies.

BARDA would also be screened from the kind of normal cost-accounting procedures other agencies must follow, says Pete Weitzel, coordinator of the Coalition of Journalists for Open Government, whose member organizations include the American Society of Newspaper Editors and the Society of Professional Journalists. Those groups, along with seven other CJOG members, signed a letter Nov. 3 asking that the secrecy measures be stripped from Burr's legislation.

The level of secrecy that BARDA would operate under "is to the best of my knowledge unprecedented," Mr. Weitzel says. "I don't know of any other agency in the government that has been given that kind of authority." Even the CIA and the Defense Intelligence Agency are subject to some aspects of FOIA, he says.

"[The Burr bill] was breathtaking in its scope in the way it wanted to completely exclude this new agency from FOIA," adds Lucy Dalglish, executive director of the Reporters Committee for Freedom of the Press.

Rep. Dave Weldon (R) of Florida, a medical doctor, has been among those worried that too-strong liability protections for drugmakers might cause people to hesitate to take vaccines in the event of a pandemic. In 1976, the government's swine-flu vaccine program collapsed when public fears spread about potential harm from the vaccine.

In a letter last week to congressional leaders, a group of a half-dozen consumer advocacy groups, including Public Citizen and the Consumer Federation of America, wrote: "Broadly shielding [drug] manufacturers from responsibility for gross negligence, recklessness, and other egregious behavior, and leaving victims with no recourse, may cause more public harm than the pandemic disease itself."

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