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The federal government might have just found some much needed health care money. Drug maker Pfizer has agreed to pay $2.3 billion in fines to settle criminal and civil charges surrounding its promotion of the drug Bextra.
The felony to which Pfizer pled guilty as part of the settlement was violation of the Food, Drug and Cosmetic Act by marketing the drug with the intent to deceive and mislead. Like many recent drug marketing cases to make the headlines, the Bextra case involved "off-label" marketing. See FindLaw's Blotter for a breakdown of the record setting criminal fine against Pfizer, the largest ever levied by the federal government.
As discussed regarding Eli Lilly (our previous criminal fine record holder) and it's marketing of Lexapro, "off-label" refers to uses of a drug which are not specifically approved by the Food and Drug Administration (FDA).
When a drug maker applies for FDA approval of a drug, it must specify the uses for which it seeks approval. Drug companies are only allowed to promote the drug for uses approved by the FDA. If a use is not specified in the approval application, or is specifically refused by the FDA, then it is an "off-label" use. Promoting the drug at dosages higher than that approved by the FDA also constitutes off-label promotion.
A doctor may still prescribe the drug for an off-label use, but marketing the drug for such a use is forbidden.
According to the plea agreement in the case of Pfizer and the anti-inflammatory drug Bextra, Pfizer was actually marketing the drug for off-label uses which the FDA specifically denied approval due to safety concerns.
As detailed in the whistleblower complaint that touched off the Bextra investigation, Pfizer aggressively promoted the drug for uses including the treatment of acute pain, pre-operative and post-operative pain, all of which were specifically denied approval by the FDA, despite attempts by Pfizer to expand Bextra's approved uses. For the narrow uses that had been approved, Pfizer promoted the drug in dosages far exceeding the approved dosage.