US bill to shield drug companies from product liability
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《英国医生杂志》
US federal legislation that could shield drug companies from product liability lawsuits will be reintroduced in the Senate within two months, says Jack Finn, spokesperson for Senator John Ensign of Nevada state.
Senator Ensign sponsored an earlier version of the planned bill (S11) that would prohibit product liability awards for drugs or medical devices that "comply with Food and Drug Administration standards."
The provision, known as the "FDA compliance" or "pre-emption" defence, does not apply if FDA officials were bribed or if the manufacturer withheld information about product safety.
Proponents of the legislation say that rising drug costs and threats to the financial stability of drug manufacturers make the provision necessary as lawsuits create expenses that are passed along to consumers and, in the case of some current drug liability cases, could actually threaten manufacturers with bankruptcy.
In a highly controversial move, the FDA joined with industry in support of the pre-emption defence (BMJ 2004;329:189) when Daniel Troy, then FDA抯 chief counsel, filed "friend of the court" briefs in several cases, including the Dusek v Pfizer case.
In the Dusek case, a federal trial court dismissed a case against Pfizer in which the plaintiff, Alma Dusek, sued Pfizer in the suicide of Cyril Dusek, who was using the antidepressant sertraline (Zoloft) before his death. Ms Dusek argued that Pfizer failed to warn patients and physicians that sertraline could induce suicidal behaviour. But Pfizer and the FDA argued successfully that such a warning would have conflicted with the FDA抯 decision not to require a warning about increased suicidality as, in the FDA抯 estimation, causation had not been proved. The case was dismissed on the grounds of pre-emption.
The pre-emption defence represents a radical departure from earlier years when Margaret Jane Porter, FDA抯 chief counsel in the Clinton era, said the FDA抯 view was that FDA product approval and product liability suits "operate independently, each providing a significant, yet distinct, layer of consumer protection." Her viewpoint was published recently in a white paper issued by the Center for Progressive Regulation, a non-profit research and educational organisation based in Riderwood, Maryland.
Robert Reich, labour secretary under President Clinton, speaking on National Public Radio, told listeners that regulatory agencies across the board are understaffed and have had their budgets "whacked" while "many of them are in the pockets of the very companies and industries they are supposed to regulate." It is the wrong time to shield industry from lawsuits, said Mr Reich, when the FDA is "failing in its core mission to protect consumers from harm."
"You can抰 have it both ways," he said. "Either regulatory agencies have to be made tougher and more independent, and given the resources they need to protect the public, or we抳e got to rely on courts and private lawsuits to make sure companies have every financial incentive to protect the public."(New York Jeanne Lenzer)
Senator Ensign sponsored an earlier version of the planned bill (S11) that would prohibit product liability awards for drugs or medical devices that "comply with Food and Drug Administration standards."
The provision, known as the "FDA compliance" or "pre-emption" defence, does not apply if FDA officials were bribed or if the manufacturer withheld information about product safety.
Proponents of the legislation say that rising drug costs and threats to the financial stability of drug manufacturers make the provision necessary as lawsuits create expenses that are passed along to consumers and, in the case of some current drug liability cases, could actually threaten manufacturers with bankruptcy.
In a highly controversial move, the FDA joined with industry in support of the pre-emption defence (BMJ 2004;329:189) when Daniel Troy, then FDA抯 chief counsel, filed "friend of the court" briefs in several cases, including the Dusek v Pfizer case.
In the Dusek case, a federal trial court dismissed a case against Pfizer in which the plaintiff, Alma Dusek, sued Pfizer in the suicide of Cyril Dusek, who was using the antidepressant sertraline (Zoloft) before his death. Ms Dusek argued that Pfizer failed to warn patients and physicians that sertraline could induce suicidal behaviour. But Pfizer and the FDA argued successfully that such a warning would have conflicted with the FDA抯 decision not to require a warning about increased suicidality as, in the FDA抯 estimation, causation had not been proved. The case was dismissed on the grounds of pre-emption.
The pre-emption defence represents a radical departure from earlier years when Margaret Jane Porter, FDA抯 chief counsel in the Clinton era, said the FDA抯 view was that FDA product approval and product liability suits "operate independently, each providing a significant, yet distinct, layer of consumer protection." Her viewpoint was published recently in a white paper issued by the Center for Progressive Regulation, a non-profit research and educational organisation based in Riderwood, Maryland.
Robert Reich, labour secretary under President Clinton, speaking on National Public Radio, told listeners that regulatory agencies across the board are understaffed and have had their budgets "whacked" while "many of them are in the pockets of the very companies and industries they are supposed to regulate." It is the wrong time to shield industry from lawsuits, said Mr Reich, when the FDA is "failing in its core mission to protect consumers from harm."
"You can抰 have it both ways," he said. "Either regulatory agencies have to be made tougher and more independent, and given the resources they need to protect the public, or we抳e got to rely on courts and private lawsuits to make sure companies have every financial incentive to protect the public."(New York Jeanne Lenzer)