Investigation and pending class action lawsuit against Pfizer and its subsidiary, Parke-Davis, accusing the companies of circumventing FDA regulations to promote scientifically unproven "off-label" use of their drug Neurontin.
The class action lawsuit alleges that in 1995 Parke-Davis decided that it did not want to undertake the clinical trials that FDA requires in order to approve new uses for a prescription drug. Parke-Davis instead created an illegal promotional campaign to get more patients to use the drug, Neurontin, which had only been approved for epilepsy. Disguised as "medical education" for the doctors or "'consulting" for the company, that campaign included illegal cash kickbacks to physicians and other sales ploys to pump up sales of the drug for non-FDA approved uses.
The class action complaint cites an internal Parke-Davis memo that reads: "Did it make sense for Parke-Davis to do rigorous and expensive clinical trials to prove to the FDA that Neurontin worked for the [other uses?]. It did not."
The suit asks the court to order Pfizer to immediately stop promoting Neurontin off-label use, to disgorge the profits it received through illegal practices, and to publish notice of the truth regarding Neurontin.
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