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FDA is using its muscle —together with the Justice Department—in an effort to interfere with a court order to stop advertisements for the drug Paxil, an antidepressant drug that, like Prozac, has been the center of multiple lawsuits in which it is claimed the drug caused severe withdrawal symptoms.
FDA’s move led Karen Barth, the attorney in the case to state:
“The fact that the FDA is now trying to step in and advocate on the side of the pharmaceutical company is disgusting to me.’
The Guardian reports that in the brief, filed Tuesday, the FDA acknowledged that “there were often side effects when patients stop taking certain medications “abruptly,” but the agency labels drugs as habit-forming only when such drugs “cause drug-seeking behavior, often with the user escalating the dose for psychological or physical gratification.”
http://www.guardian.co.uk/uslatest/story/0,1282,-1962372,00.html
http://www.nytimes.com/aponline/health/AP-Drug-Quality.html
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A federal judge was wrong to ban national TV commercials that claim the anti-depressant Paxil is not habit-forming, the Food and Drug Administration said in a new court filing.
The FDA’s “statement of interest” brief asked U.S. District Judge Mariana Pfaelzer to rescind a decision that grew out of a civil lawsuit. FDA officials said they were worried the ruling improperly interferes with the way the agency regulates drugs and drug companies.
“The FDA is concerned about the ruling,” agency spokesman Lawrence Bachorik said Wednesday. “This is not about a single product or a single company but about FDA’s authority over prescription drug advertising.”
The television commercials were reviewed in advance by the FDA and the agency “had no objections,” according to the brief.
Pfaelzer’s preliminary ruling against Paxil producer GlaxoSmithKline comes about a year after a lawsuit was filed on behalf of 35 patients who claimed they suffered withdrawal symptoms such as nausea, fever, and “electric zaps” to their bodies.
The plaintiffs’ attorney, Karen Barth, said the judge “was well within her jurisdiction” in making the ruling.
“The fact that the FDA is now trying to step in and advocate on the side of the pharmaceutical company is disgusting to me,” Barth said.
In the brief, filed Tuesday, the FDA said there were often side effects when patients stop taking certain medications “abruptly,” but the agency labels drugs as habit-forming only when such drugs “cause drug-seeking behavior, often with the user escalating the dose for psychological or physical gratification.”
Pfaelzer found that in other countries, labels on the drug warn of adverse reactions when use of the drug is discontinued.
The commercials were “misleading and created inaccurate expectations about the ease of withdrawal from the drug,” Pfaelzer ruled Monday.
The judge’s ruling is preliminary and comes at an early state of the court proceedings. A hearing is set for Oct. 7 to decide whether the lawsuit should be converted to a nationwide class-action, Barth said.
In the meantime, company attorneys are appealing the judge’s decision.
“The U.S. Food and Drug Administration - and not the courts - has the expertise and responsibility for reviewing and regulating pharmaceutical ads,” David Stout, president of U.S. Pharmaceuticals at GlaxoSmithKline, said in a statement.
Surging U.S. sales of Paxil and the asthma drug Advair led to a 15 percent increase in second-quarter profits for London-based GlaxoSmithKline PLC. Global sales of Paxil grew 29 percent.
Guardian Unlimited © Guardian Newspapers
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