FEDS ASK JUDGE TO RECONSIDER PAXIL AD RULING

Argue That Order Conflicts With FDA Drug Authority

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WASHINGTON (AdAge.com) -- The Department of Justice has asked a California judge to reconsider her order requiring GalaxoSmithKline to drop its "non-habit-forming" claim from Paxil ads as of Sept. 1.

In a filing late yesterday, the Justice Department said the decision by U.S. District Court Judge Mariana Pfaelzer conflicts with federal law that gives the Food and Drug Administration the right to make decisions on ad claims. The FDA has determined that it had "no objections" to the claim, the filing said.

Paxil users' lawsuit
On Aug. 16, Judge Pfaelzer ruled in favor of a group of Paxil users whose lawsuit charged that the drug causes dependency and severe withdrawal symptoms.

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They asked the court to bar TV ads from Interpublic Group of Cos.' McCann-Erickson Worldwide, New York, that said, in part, "Paxil is non-habit-forming."

'Inconsistent with FDA'
However, the Justice Department's filing yesterday argued that "the removal of the statement 'Paxil is non-habit-forming' [is] inconsistent with FDA's scientific and carefully considered view of appropriate risk communication," and also warned that the case threatens to lead to "50 different versions of labeling of advertisements for nationally marketed prescription products."

GlaxoSmithKline spends $65.1 million on Paxil advertising from McCann.

Advertising interest groups have warned that the judge's ruling against GlaxoSmithKline threatened to lead to state-by-state fighting over ad claims.

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