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.
On Aug. 16, judge ruled in favor of a group of Paxil users whose lawsuit charged that the drug causes dependency and severe withdrawal symptoms.
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."
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," said the filing, which 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 judges ruling against GlaxoSmithKline threatened to lead to fighting out ad claims state by state.
Ira Teinowitz, AdAge.com. August 21, 2002
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