Merck Agrees to $950 Million in Fines for Unlawful Promotion of Vioxx
On November 22, 2011, the U.S. Justice Department announced that Merck had agreed to a settlement of $950 million in connection with the allegedly unlawful promotion of the painkiller Vioxx. Found here, the criminal information details the charges against Merck, showing how the companys promotional practices resulted in a violation of the Federal Food, Drug and Cosmetic Act (FDCA). In November 1998, Vioxx was approved for the relief of symptoms associated with osteoarthritis, treatment of dysmenorrheal and general pain management. On April 11, 2002, the U.S. Food and Drug Administration (FDA) approved Vioxx for the treatment of rheumatoid arthritis, an additional indication. However, in its case against Merck, the Government alleged that the company had been promoting Vioxx for the treatment of rheumatoid arthritis long before it had been approved for this use. According to the Government, this unlawful off-label promotion by Merck resulted in a violation of the FDCA, as Vioxx was considered misbranded under the Act. Ultimately, Merck agreed to plead guilty to a misdemeanor and $950 million in fines.
In the Merck case, because the company was actively involved in marketing Vioxx for uses that were not approved by the FDA, it was charged with introducing a misbranded drug into interstate commerce. Under 21 U.S.C. § 352(f)(1) a drug is deemed misbranded if it fails to bear adequate directions for use. Under the FDCA and its accompanying regulations, the FDA approves drugs for specific uses by requiring sponsors to submit data showing drugs are safe and effective for their intended uses and limits the promotion of drugs to these specified uses by approving proposed labeling. Because Vioxx was promoted for a use not shown in the product labeling, it was considered misbranded by the FDA as the label failed to display this indication and thus lacked adequate directions for use.
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