News Update - Pfizer pleads guilty and agrees to pay $430 Million.
On May 13, 2004, Reuters reported that Pfizer Inc agreed to pay $430 million and plead guilty to criminal wrongdoing for falsely marketing top-selling epilepsy drug Neurontin. The case involved the marketing of Neurontin for various illnesses that it was not approved to treat, including migraines and back pain. The Attorney generals of all fifty states approved the settlement. The allegations were first made in 1996 in a lawsuit filed by David Franklin, a whistle-blower, who had worked for the drug's maker.
Pzifer will pay $240 million of the settlement to the U.S. Attorney's Office in Boston, which headed the case, for criminal violations of the Food, Drug and Cosmetics Act. $152 million will be distributed to the states and federal government for Medicaid violations. $28 million will be used for a national advertising campaign and remediation program to be overseen by states' attorney generals. The remainder will be distributed to state health agencies and departments.
Under federal regulations, companies may market drugs only for uses approved by the Food and Drug Administration. The regulations only apply to the manufacturers- doctors are allowed to prescribe drugs for unapproved uses at their discretion.
Neurontin Marketed For Unapproved Uses.
According to a March 14, 2002, New York Times article and publicly available court documents from a civil complaint filed by the U.S. government, the manufacturer of the seizure medication gabapentin (Neurontin) illegally promoted the drug to prescribing physicians for at least 11 "off-label" or unapproved medical conditions.
The company is alleged to have paid physicians to appear as authors of medical journal articles on unapproved uses for gabapentin when the articles had actually been written by others working under the company's marketing company. The safety and effectiveness of gabapentin for these uses is suspect. Gabapentin (Neurontin) is currently only approved by the U.S. Food & Drug Administration (FDA) as a supplementary treatment for a specific type seizure after maximum tolerated doses of older drugs are used.
The allegedly promoted and unapproved uses for gabapentin (Neurontin) outlined in the court documents are: bipolar disorder, Pain syndromes, Peripheral Neuropathy, Diabetic Neuropathy, sole treatment for epilepsy (monotherapy), Reflex Sympathetic Dystrophy, Attention Deficit Disorder, Restless Leg Syndrome, Trigeminal Neuralgia, Post-Hepatic Neuralgia, Essential Tremor Periodic Limb Movement, migraine, and drug and alcohol withdrawal seizures.
The allegedly, illegal, promoted uses for gabapentin (Neurontin) made the drug a "blockbuster" drug. Estimated sales of gabapentin in 2001 totaled $1.7 billion. The majority of these sales were for unapproved uses with no evidence that the drug was safe or effective.
Lawyers are currently investigating the ineffectiveness and side effects of Neurontin when prescribed for uses unapproved by the FDA.