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The settlement amount includes both the civil (False Claims Act) settlement and criminal fine. Glaxo's $3 billion settlement included the largest civil False Claims Act settlement on record, [1] and Pfizer’s $2.3 billion ($3.5 billion in 2022) settlement including a record-breaking $1.3 billion criminal fine. [2]
2 3 Bextra/Geodon/ Zyvox/Lyrica: Pfizer [7] $2,300,000,000 $1 billion civil ($2.3 billion with criminal component) Off-label promotion/kickbacks: False Claims Act/FDCA 2012 4 4 (tie) Depakote: Abbott Laboratories [8] $1,500,000,000 $800 million civil ($1.5 billion with criminal component) Off-label promotion False Claims Act/FDCA 2009 5 4 (tie ...
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
In 2009, Bextra was at the center of the "largest health-care fraud settlement and the largest criminal fine of any kind ever." [4] [7] Pfizer paid a $2.3 billion civil and criminal fine. Pharmacia & Upjohn, a Pfizer subsidiary, violated the United States Food, Drug and Cosmetic Act for misbranding Bextra "with the intent to defraud or mislead ...
The company's largest products by sales are the Pfizer–BioNTech COVID-19 vaccine ($11 billion in 2023 revenues), apixaban ($6 billion in 2023 revenues), a pneumococcal conjugate vaccine ($6 billion in 2023 revenues), palbociclib ($4 billion in 2023 revenues), and tafamidis ($3 billion in 2023 revenues). [1]
Up until 2009, Pfizer promoted Lyrica for other uses that had not been approved by medical regulators. For Lyrica and three other drugs, Pfizer was fined a record amount of US$2.3 billion by the Department of Justice, [142] [143] [144] after pleading guilty to advertising and branding "with the intent to defraud or mislead". Pfizer illegally ...
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