US pharma giant Merck & Co (NYSE: MRK) has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx (rofecoxib), which was withdrawn from the market in September 2004, the Justice Department and the drugmaker announced yesterday. Merck shares dipped just less than 1% to $33.81, in a downturned US market.
Under the terms of the resolution, Merck will plead guilty to a one-count information charging a single violation of the Food Drug and Cosmetic Act (FDCA) for introducing a misbranded drug, Vioxx, into interstate commerce. Under the terms of its plea agreement with the USA, Merck will plead guilty to a misdemeanor for its illegal promotional activity and will pay a $321,636,000 criminal fine.
Large as the settlement seems to be, it is by no means the biggest; it will be recalled, for example, that the UK’s GlaxoSmithKline reached an agreement in principle with the US government to pay $3 billion mainly relating to marketing of its diabetes drug Avandia (rosiglitazone; The Pharma Letter November 4 and January 18). Other huge settlements have been made by Pfizer, Eli Lilly and AstraZeneca. Merck has also previously agreed to pay $4.85 billion to 27,000 of law suits brought by Vioxx users who alleged that they suffered injuries after taking the drug, or relatives of those who had died, as well as $1.9 billion in legal costs associated with the cases. The company previously recorded a charge of $950 million in October 2010 in anticipation of yesterday's agreements.
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