Newspaper article The Christian Science Monitor

Bill to Shield Vaccinemakers Raises Alarms

Newspaper article The Christian Science Monitor

Bill to Shield Vaccinemakers Raises Alarms

Article excerpt

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. …

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