The all-time poster child for a drug illegally promoted for off-label uses, is Neurontin, marketed by Warner-Lambert, and its Parke-Davis division, until Pfizer acquired the company in 2000.
The term "off-label" means prescribing a drug for indications not listed on the label, upping the recommended dose, prescribing a drug in combination with other medications, or using a drug with a patient population, such as children, not listed on the label.
As part of the approval process, the FDA reviews the drug's labeling, which must include the proposed claims about the drug's risks and benefits, as well as the directions for use.
If an indication is not listed, it means the drug maker has not submitted the required studies to prove the drug is safe and effective for that use. While physicians may prescribe a drug approved by the FDA for an unapproved use, it's against the law for a drug maker to influence doctors to prescribe a drug for uses outside the label.
Pfizer completed the acquisition of Warner-Lambert in June 2000, and four years later in May 2004, Pfizer pleaded guilty to illegally marketing Neurontin for unapproved uses and agreed to pay a $430 million, the second-largest settlement ever in a health care fraud prosecution, to settle charges brought by the US Department of Justice that included defrauding public health care programs.
The case specifically sought to recover the losses to public programs resulting from the off-label promotion of a drug and focused primarily on Medicaid, which spent an estimated $422 million on Neurontin between 1994 to mid-2000.
In the end, Pfizer paid $83.6 million to the federal government and $68.4 million to the 50 states and the District of Columbia. In addition, Pfizer agreed to pay the states a total of $38 million to settle liabilities under state consumer protection laws, and a $240 million criminal fine, according to the DOJ.
However, the settlement with the DOJ did not include damage awards for patients who may have been injured by Neurontin and many patients, or families representing deceased Neurontin victims, have filed lawsuits against the company.
Many of the cases are wrongful death actions based on the company's failure to warn about the risk of suicidality associated with the drug.
Much much more from Evie Pringle here
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