Glaxo Can Continue Running Paxil Ads for Now
REUTERS
August 23, 2002 05:36 PM ET
Glaxo Can Continue Running Paxil TV Ads for Now
http://www.reuters.com/news_article.jhtml?type=healthnews&StoryID=1367069
LOS ANGELES (Reuters) - GlaxoSmithKline Plc has won a three-week reprieve from
a federal judge's order to pull its television ads for the popular
antidepressant Paxil, a company spokesman said on Friday.
A group of Paxil users sued the British-based company in federal court in Los
Angeles, claiming Glaxo deliberately played down the severity of withdrawal
symptoms associated with abruptly stopping the drug. The Paxil plaintiffs
claimed the TV ads, which describe the drug as "not habit forming," are harmful
and misleading and not consistent with Paxil ads in foreign countries that
advise users of "withdrawal symptoms." GlaxoSmithKline denied that stopping the
drug causes cravings -- only "discontinuation syndrome" -- and pointed out that
the ads for Paxil, its top-selling product, passed muster with the Food and Drug
Administration. Earlier this week, US District Judge Mariana Pfaelzer granted a
temporary injunction against the ads until the case is decided, but she delayed
the start date of the order until at least Sept. 12.
Pfaelzer made the decision after conferring by telephone late Thursday with
parties to the lawsuit and attorneys for the US Department of Justice, who
represent the FDA.
The Justice Department attorneys contend that the FDA has ultimate authority
over how prescription drugs are marketed in the United States and that
Pfaelzer's order, if allowed to stand, could have "catastrophic" effects on the
drug industry.
Pfaelzer told the attorneys that she would consider only information about how
the FDA approved the Paxil ads, said attorney Karen Barth, who represents the
plaintiffs.
"She said she would be willing to consider factual evidence about what they did
with regard to the content of the ads," Barth said. Barth added that the judge
told Glaxo and justice department attorneys to take their arguments about
whether she had authority to pull the ads to the 9th Circuit Court of Appeals.
Both Glaxo and the Justice Department have asked the judge to reconsider her
preliminary injunction against the ads.
Barth criticized the FDA for backing Glaxo in the case, saying it was
inappropriate for a federal regulator to side with a company against consumers.
Pfaelzer allowed the Justice Department two weeks to research and submit briefs,
and the plaintiffs one week to respond. "They will have that commercial on
longer and the harm will be continuing," Barth said. Glaxo has called its TV ads
"critical" to Paxil sales and a spokesman touted the ads as educational to
depression sufferers who may not otherwise recognize the symptoms of the
disease.
"We feel Paxil is safe and effective and it is a medication that has
successfully treated millions of patients around the world," Glaxo spokesman
Michael Fleming said. "We are pleased the judge has asked for more information
from the FDA and is willing to listen to the FDA." Paxil had sales of $2.7
billion in 2001.
