Lipitor’s Legal and Marketing Challenges

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In September 2005, another class-action suit was initiated by consumer advocacy groups against Pfizer for promoting Lipitor to women and the elderly. The plaintiffs accused Pfizer of deceptive marketing as there was no evidence that Lipitor reduced the risk of heart disease in these segments of the population.

In March 2006, some labor unions sued Pfizer, accusing it of off-label 2 promotion of Lipitor, which led to the unions and other third-party payers, and state Medicaid plans paying billons of dollars in unwarranted Lipitor prescriptions, over the past five years. They claimed that Pfizer had illegally marketed Lipitor to people who had high blood cholesterol but with low risk of heart attack. In such cases, according to federal guidelines only lifestyle modifications like diet and exercise were warranted.

It was also reported that the US Attorney’s Office in Brooklyn, New York, USA, was investigating the marketing practices of Pfizer in the case of Lipitor. Pfizer denied these allegations of off-label marketing and said that there was no merit to the case. They also announced that they were co-operating with the federal investigation.

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[2] In the US, the FDA requires numerous clinical trials to prove a drug’s safety and efficacy in treating a given disease or condition. If satisfied that the drug is safe and effective, the drug’s manufacturer and the FDA agree on specific language describing dosage, route and other information to be included on the drug’s label. Off-label use is the practice of prescribing drugs for a purpose outside the scope of the drug’s approved label, most often concerning the drug’s indication. Though off-label use of a drug by a doctor is not illegal, it is illegal for the marketer to promote or market an off-label use of the drug.

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