In an ruling handed down Aug. 16 and revealed yesterday, U.S. District Court Judge Mariana Pfaelzer gave the pharmaceutical marketer until Sept. 1 to remove advertising assertions that the drug isn't habit-forming.
The case was filed by Paxil users who charge the drug causes dependency and severe withdrawal symptoms. In July the plaintiffs 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."
GlaxoSmithKline said it was "disappointed" with the judge's order and said the FDA, not the courts, has the "expertise and responsibility for reviewing and regulating pharmaceutical ads." The company said it would comply and alter the single TV spot that constitutes its entire Paxil campaign by the Sept. 1 deadline.
David Stout, president of pharmaceuticals at the company, said the ads targeted by the judge were reviewed prior to their airing by the FDA and no objection was raised.
Ad group complaints
"We as taxpayers invest millions of dollars every year to maintain the [FDA] as a cutting-edge resource and with the stroke of a pen, the judge overrides all that expertise," said Dick O'Brien, executive vice president of the American Association of Advertising Agencies. "It makes you want to reach for a Paxil."
Dan Jaffe, executive vice president of the Association of National Advertisers, said the case threatens the rules of drug advertising.
"There should be someplace that people should rely on. As I understand it, marketers have looked at this already and the company has a right to rely on that decision which is being second guessed."