Federal Judge Orders GlaxoSmithKline To Halt Television Ads for Paxil

A federal judge in Los Angeles last week ruled that GlaxoSmithKline must halt its television advertisements for its antidepressant Paxil because the ads are "misleading," even though the FDA approved the spots, the Los Angeles Times reports. The ads claim that the drug is "not habit-forming." The ruling comes in a lawsuit filed last year by 35 patients who claim they experienced "severe withdrawal symptoms," including nausea, fever, dizziness and "electric zaps," after they stopped taking Paxil (White, Los Angeles Times, 8/21). In the ruling, U.S. District Court Judge Mariana Pfaelzer said that the ads "created inaccurate expectations about the ease of withdrawal from the drug" (Bravin et al., Wall Street Journal, 8/21). In December, GSK added warnings to Paxil's labels saying patients should not "abruptly stop taking the drug" because of potential problems. However, officials from GSK and the FDA said that although there are problems when patients stop taking Paxil, it does not mean the drug should be considered addictive or habit-forming. "These problems are just the body's adjustment when you stop taking medicines. It takes more than that to be addictive," GSK spokesperson Mary Anne Rhyne said (Petersen, New York Times, 8/21). While GSK officials acknowledge that patients taking Paxil can experience "discontinuation symptoms," they dispute the term "withdrawal symptoms," claiming it associates Paxil with heroin or "other addictive narcotics" (Wall Street Journal, 8/21). GSK officials said that Pfaelzer's ruling was "improper" and that the company would appeal. The company did not say what it will do about the ads in the meantime (Los Angeles Times, 8/21).

The ruling lays the foundation for a "potential conflict" between the FDA and federal courts over who is responsible for regulating drug advertising, the Los Angeles Times reports. Officials from GSK and the FDA saw Pfaelzer's decision as a "direct assault" on the current regulatory system, in which the FDA has "final say" on whether advertisements are "truthful and accurate" (Los Angeles Times, 8/21). "The FDA -- and not the courts -- has the expertise and responsibility for reviewing and regulating pharmaceutical ads. The Paxil television ad was submitted for FDA review prior to use, and the agency raised no objections to the language at issue," David Stout, president of U.S. pharmaceuticals for GSK, said (AP/Houston Chronicle, 8/21). The Justice Department agreed with Stout, and urged Pfaelzer to reconsider her decision. The Justice Department told Pfaelzer that her decision goes against federal law and is "inconsistent" with the "scientific and carefully considered view" of the FDA. Further, the Justice Department said that when conflicts over FDA-approved commercials arise, "courts should refer the matter to FDA for its initial consideration or should regard FDA's actions" as overriding any state laws (Wall Street Journal, 8/21).