Merck & Co. was slapped with a $321.6 million criminal fine for illegally marketing its painkiller Vioxx as a treatment for rheumatoid arthritis before that use was approved by the Food and Drug Administration (FDA).
A U.S. district court judge in Boston sentenced the company to pay the fine after it pled guilty to violating the Federal Food, Drug, and Cosmetic Act for introducing a misbranded drug into interstate commerce, according to The Wall Street Journal.
The fine concludes a long-running investigation into Merck’s promotion of Vioxx, which was withdrawn from the marketplace in September 2004 after it was linked to a higher risk of strokes and heart attacks. The drug was prescribed to some 25 million Americans before it was pulled from pharmacy shelves.
Merck’s guilty plea was part of a larger settlement involving its illegal promotional activity around Vioxx, according to a news release from the U.S. Department of Justice (DOJ). In November 2011, Merck entered into a civil settlement agreement with the DOJ under which it will pay $628 million to resolve additional allegations regarding off-label marketing of Vioxx and false statements about the drug’s cardiovascular safety.
Merck said it previously recorded a $950 million charge in October 2010 because it anticipated the settlement, which resolves a probe that lasted seven years.
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