The Justice Department announced that Merck, known outside the U.S. as MSD for Merck, Sharp & Dohme, has agreed to pay $950 million to resolve pending criminal charges and civil claims. Under the agreement, Merck will plead guilty to a single violation of the Food, Drug and Cosmetic Act for introducing a misbranded drug into interstate commerce -- that drug being Vioxx. Under the plea deal, Merck will plead guilty to a misdemeanor for illegal promotional activity and will pay a criminal fine of $321,636,000. The criminal plea deal relates to Merck's promotion of Vioxx for rheumatoid arthritis between 1999 and 2002, before it actually was approved for that condition in April 2002.
Also, as part of a civil settlement agreement, Merck will pay $628,364,000 to resolve allegations having to do with off-label markeing of Vioxx and false statements about Vioxx's cardiovascular safety. Of the civil settlement, the United States will be paid $426,389,000, while $201,975,000 will go to participating Medicaid states. Merck also will enter into a corporate integrity agreement with the Office of the Inspector General of the Department of Health and Human Services. Vioxx was voluntarily removed from the market in 2004. Even so, the issues surrounding the withdrawal of Vioxx have reverberated for 7 years, raising many questions about drug safety -- including procedures for drug approval and marketing.
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