Judge Stays Order Halting Paxil Ads
The federal judge who ordered pharmaceutical giant GlaxoSmithKline to halt television ads that claim its bestselling anti-depression drug is not habit-forming has issued a stay of her ruling, pending additional information from the Food and Drug Administration.
But Judge Mariana Pfaelzer of the U.S. District Court in Los Angeles did not address assertions by the FDA and the Justice Department that she had no authority to rule in the matter, according to lawyers involved in the case.
Pfaelzer said in issuing the stay late Thursday that she wanted more information from the FDA on how it reviewed the GlaxoSmithKline advertisements for Paxil, one of the biggest drugs on the market, with sales of $2.7 billion in 2001. The FDA had reviewed and approved the ads before they aired.
The stay leaves unresolved a potential conflict over who has ultimate authority to regulate the pharmaceutical industry’s multibillion-dollar advertising campaigns, the FDA or federal judges.
“Now, there is a question of jurisdiction,” said Ernst R. Berndt of the Massachusetts Institute of Technology’s Sloan School of Management, an expert on direct-to-consumer marketing campaigns. Who has the authority to determine whether a drug advertisement is honest or untruthful, “the FDA and the Federal Trade Commission or the courts? And that will probably take at least a year to figure out.”
The parties in the case--a suit brought by 35 patients who say they suffered extreme withdrawal symptoms when they stopped taking the drug--said they believe this is the first time a judge has tried to block a TV advertisement that had satisfied FDA officials.
Attorney Karen Barth, representing the plaintiffs, said the federal courts are the true arbiters of commercial speech. Justice Department lawyers argue that the FDA has sole jurisdiction over drug advertisements.
Pfaelzer’s injunction against the ads, which was to have begun Sept. 1, now will be delayed by at least two weeks. A GlaxoSmithKline spokeswoman said that the ads in question continue to air.
The company’s shares fell 76 cents to $40.13 on the New York Stock Exchange.
