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The 3d U.S. Circuit Court of Appeals has ruled that federal law bars a suit alleging false-advertising claims under state law because the U.S. Food and Drug Administration (FDA) has “exclusive authority” to regulate prescription drug advertising. Pennsylvania Employees Benefit Trust Fund v. Zeneca Inc., No. 05-5340. “To allow generalized state consumer fraud laws to dictate the parameters of false and misleading advertising in the prescription drug context would pose an undue obstacle to both Congress’ and the FDA’s objectives in protecting the nation’s prescription drug users,” Judge D. Brooks Smith wrote on behalf of the court. The ruling upholds the dismissal of a proposed class action accusing Zeneca Inc. of misleading consumers and doctors by advertising the acid reflux drug Nexium as an improvement over Prilosec because it knew that the patent for Prilosec was about to expire and a generic version would soon be hitting the market. The suit, filed in a Delaware federal court, alleged claims under the Delaware Consumer Fraud Act as well as the consumer protection statutes of the 50 states for false, misleading and deceptive advertising. Nexium and Prilosec both treat acid reflux disease. Prilosec was an especially profitable drug for Zeneca, with sales of more than $6 billion in 2000. But the patent for Prilosec was due to expire in 2001, at which point it would have been available for sale as the generic drug omeprazole. In February 2001, Zeneca obtained final approval from the FDA for its labeling on Nexium, the brand name for esomeprazole magnesium. A clinical study of Nexium compared both 20- and 40-milligram doses of Nexium with the approved 20-milligram dose of Prilosec and showed that 40 milligrams of Nexium had a statistically significant healing rate over 20 milligrams of Prilosec. The suit alleged that the higher dose of Nexium was not needed for most patients, and that Zeneca’s advertising campaign was misleading because a fair comparison of 20 milligrams of Nexium with 20 milligrams of Prilosec would not have proven Nexium to be superior. Judge Sue L. Robinson of the U.S. District Court for the District of Delaware dismissed the suit, finding that since the Nexium advertisements complied with the FDA-approved labeling, they were not actionable under the state consumer protection laws. Robinson concluded that the suit was pre-empted because the state law claims conflicted with federal law. The 3d Circuit affirmed. Smith said Robinson’s analysis was correct because the federal Food, Drug and Cosmetic Act (FDCA) and its implementing regulations include extensive rules governing pharmaceutical advertising. “The degree of discretion inherent in the regulations demonstrates that the FDA envisioned itself occupying an ongoing and extensive role in the supervision of prescription drug advertising,” Smith wrote. In the claims against Zeneca under state consumer fraud laws, Smith said, the FDCA is not a “critical element” because the plaintiffs wouldn’t have to show noncompliance with the FDCA to prevail. Nonetheless, Smith said, “allowing these claims to proceed would unnecessarily frustrate the FDCA’s purpose and FDA regulations, as the extent of agency involvement in regulating prescription drug advertising is extensive and specific.” Implied conflict pre-emption of the state consumer fraud laws was therefore required, Smith said, because both the FDCA and FDA regulations provide specific requirements for prescription drug advertising. “The high level of specificity in federal law and regulations with respect to prescription drug advertising is irreconcilable with general state laws that purport to govern all types of advertising,” Smith wrote.

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