Bill to shield vaccinemakers raises alarms

A measure to shield drug manufacturers from lawsuits in an effort to encourage them to develop new vaccines is likely to be quietly attached to a "must pass" defense appropriation bill within the next few days.

If the US Secretary of Health and Human Services declares that vaccines were being distributed during a national health emergency, such as a flu pandemic, the bill would make it very difficult for people who felt they had been harmed by vaccines to pursue legal action against the manufacturer.

A broad swath of consumer-rights groups and open-government advocates had succeeded in slowing the progress of a bill containing similar provisions sponsored by Sen. Richard Burr (R) of North Carolina. That measure, introduced in October, would also establish a Biomedical Advanced Research and Development Agency (BARDA) that critics say would be exempted from public and congressional scrutiny. Congressional staffers have been meeting with concerned groups, including a meeting planned for Wednesday, to revise Senator Burr's bill. A revised version isn't expected to be introduced until next year, though its future would be uncertain if the vaccine liability shield is enacted separately first.

"It looks like the liability-protection language is in [the defense bill], which will be very difficult for [members of Congress] to vote against," says Barbara Loe Fisher, president of the National Vaccine Information Center, a consumer watchdog group in Vienna, Va. Backers of the liability shield, led by Senate majority leader Bill Frist (R) of Tennessee, "were very smart in that strategy," says Ms. Fisher, who calls it "a threat to civil rights, to access to the judicial system, and to human rights."

The possibility of an avian flu epidemic, as well as the use of biological weapons, have spurred interest in stepping up production of new vaccines. Shield-law proponents has argued for years that the world's giant drugmakers, so-called Big Pharma, would never take much interest in that arena until they were given strong protections against lawsuits.

You "want to harness" Big Pharma "to really kick this thing off," says Christopher-Paul Milne, assistant director of the Center for the Study of Drug Development at Tufts University in Medford, Mass. "They have the resources and the expertise and the manufacturing capacity to get [development of new vaccines] done in a short period of time."

Today, five or six big companies are making vaccines compared with more than 20 several decades ago, Dr. Milne says. "Some of that is because of the consolidation of the companies," he says, but some is the result of the high risk. To attract Big Pharma, "the potential rewards are going to have to be high," he says. In a national emergency, vaccines might have to be produced quickly, and perhaps without sufficient testing. In that kind of high-risk scenario, "you're talking about the need for liability protection," he says.

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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