Pfizer Formally Pleads Guilty to Fraud in Whistleblower Lawsuit Over Marketing of the Epilespy Medication Neurontin
Pfizer on Monday formally pleaded guilty to charges that the Parke-Davis unit of the company's subsidiary Warner-Lambert, which Pfizer acquired in 2000, increased sales of epilepsy drug Neurontin through illegal promotions for off-label uses, the AP/Philadelphia Inquirer reports (AP/Philadelphia Inquirer, 6/8). Pfizer last month announced that it agreed to plead guilty to criminal wrongdoing and pay a settlement of $430 million in a whistleblower lawsuit alleging illegal marketing of Neurontin to treat conditions other than those approved by FDA. Under law, physicians can write prescriptions for medications for uses not approved by FDA, but pharmaceutical companies are prohibited from marketing treatments for unapproved uses. FDA rules allow pharmaceutical companies to provide physicians with educational information about off-label uses of medications. A federal investigation and similar actions by states, both of which resulted from the whistleblower suit, sought to recoup Medicaid expenditures for Neurontin prescriptions that resulted from the allegedly illegal promotional practices. According to court documents, Parke-Davis concealed and misstated some clinical information about Neurontin's ability to treat conditions that were not included in its FDA approval and paid physicians millions of dollars to promote Neurontin for such off-label uses. Justice Department officials said that Parke-Davis aggressively marketed Neurontin to treat attention deficit disorder, bipolar disorder, drug and alcohol withdrawal seizures, Lou Gehrig's disease, migraine headaches and restless leg syndrome. About 90% of prescriptions for Neurontin -- which accounted for $2.7 billion, or 6%, of Pfizer's total revenue last year -- were for off-label uses (Kaiser Daily Health Policy Report, 5/17). Martin Teicher, vice president of Warner-Lambert, entered the plea on behalf of the company; a Pfizer attorney noted that Teicher was not involved in any of the illegal activities. As part of the settlement, David Frank, the scientist who filed the suit, will receive $26.6 million. According to the Inquirer, the fine is the second-largest ever imposed in a health care fraud prosecution. Pfizer has repeatedly stated that the allegations mentioned in the suit took place before the company acquired Warner Lambert in 2000 (AP/Philadelphia Inquirer, 6/8).
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