September 20, 2007

Also on the Journal op-ed page today, AEI senior fellow and physician Scott Gottlieb criticizes Congress for slipping a rider into vital funding legislation for the FDA that would greatly expand the tort bar's ability to second guess warning labels for drugs and sue drugmakers:

The furtive give-away is buried in the Food and Drug Administration Revitalization Act (FDARA), a funding bill that needs to pass this week if the agency is to avoid a budget crunch that could force it to fire its drug reviewers. If drug safety is so critical, why would Democrats risk issuing pink slips at the FDA? The provision raises the question of whether the hyperbole and hearings over drug safety these past several years was about improving public health, or merely paying off the lawyers.

Companies and the FDA (under both Republican and Democratic administrations) have argued that when the FDA specifically addresses a safety issue -- often telling companies that they can't include certain warnings in drug labeling because it's not scientifically justified -- state courts are "pre-empted" from and have no business substituting their judgment for the agency's expert finding. Otherwise, drug labeling -- which is an important public health tool -- would get cluttered with dubious and confusing warnings aimed at only shielding firms from lawsuits.

This is a problem not just for companies but for patients; the only way for corporations to defend themselves from these kinds of suits is turn drug labels into a veritable litany of horrors, frightening patients and confusing everyone about what the real medication risks are. This is one area where federal preemption is desperately needed.

Posted by Paul Howard at September 20, 2007 10:01 AM

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