FDA Asks Judge To Reconsider Paxil Ruling
Agency Concerned Ruling Interferes With Regulation
LOS ANGELES -- The Food and Drug Administration is asking a federal judge to reconsider a ruling banning national TV commercials that claim the antidepressant Paxil is not habit-forming.
In a new court filing, FDA officials said they are concerned that the ruling improperly interferes with the way the agency regulates drugs and drug companies.
According to the brief, the television commercials were reviewed in advance by the FDA and the agency "had no objections."
U.S. District Judge Mariana Pfaelzer's preliminary ruling Monday against Paxil producer GlaxoSmithKline came about a year after a lawsuit was filed on behalf of 35 patients. They claimed they suffered withdrawal symptoms such as nausea, fever, and "electric zaps" to their bodies.
The judge ruled the company's commercials were "misleading" and created inaccurate expectations of how easy it would be to quit taking the drug.
The judge noted that in other countries, labels warn of adverse reactions when Paxil is discontinued.
GlaxoSmithKline attorneys are appealing the judge's decision. "We are very disappointed in the ruling. The U.S. Food and Drug Administration -- and not the courts -- has the expertise and responsibility for reviewing and regulating pharmaceutical ads," said David Stout, president of U.S. Pharmaceuticals at GlaxoSmithKline, in a press release. "The Paxil television ad was submitted for FDA review prior to use, and the agency raised no objections to the language at issue."
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