Posted Aug 22, 2007 10:37 am CDT
A federal appeals court has ruled a state lawsuit challenging Nexium advertising claims is pre-empted by federal law and must be dismissed.
The ruling is a big win for pharmaceutical manufacturers, the Legal Intelligencer reports.
The Food and Drug Administration has exclusive authority to regulate pharmaceutical advertising, the 3rd U.S. Circuit Court of Appeals ruled in a 2-1 opinion (PDF). The Philadelphia-based court said ads are extensively regulated under the federal Food, Drug and Cosmetic Act.
A dissenter disagreed, saying the federal government had exclusive power to regulate the sale and labeling of drugs, but not prescription advertising. The FDA lacks resources to police advertising, Senior Judge Robert Cowen argued. “This is not an area of the law inherently requiring national uniformity and ousting all related state law,” he wrote.
The suit had alleged ads for Nexium were misleading because they claimed the heartburn drug was superior to Prilosec. Although a study showed a 40 mg dose of Nexium healed better than a 20 mg dose of Prilosec, the results would not have been the same when equivalent doses were used, the suit said.