Last week the Justice Department announced that Merck, Sharp, & Dohme, an American pharmaceutical company, has agreed to resolve criminal charges and civil claims in relation to their promotion and marketing of the painkiller, Vioxx (rofecoxib) by paying $950 million. Yes, you read that right; just shy of $1 billion.
Under the resolution terms, Mereck will plead guilty to a one-count information charging a single violation of the Food Drug and Cosmetic Act for the misbranding of Vioxx into interstate commerce and will pay a $321 million criminal fine. Mereck is also entering into a civil settlement agreement where it will pay $628 million to resolve additional allegations regarding off-label marketing of Vioxx and false statements about the drug’s cardiovascular safety.
Apparently the misbranding of Vioxx occurred when Mereck’s promoted the drug for use against rheumatoid arthritis, before that use was approved by the FDA. Under the provisions of the Food, Drug and Cosmetic Act, a company is required to specify the intended uses of a product in its new drug application to the FDA. Once approved, the drug may not be marketed or promoted for so-called “off-label” uses.
Merck representatives made inaccurate, unsupported, or misleading statements about Vioxx’s cardiovascular safety in order to increase sales of the drug, resulting in payments by the federal government. It also resolves allegations that Merck made false statements to state Medicaid agencies about the cardiovascular safety of Vioxx and that those agencies relied on Merck’s false claims in making payment decisions about the drug.
“When a pharmaceutical company ignores FDA rules aimed at keeping our medicines safe and effective, that company undermines the ability of health care providers to make the best medical decisions on behalf of their patients,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. “As this plea agreement and civil settlement make clear, we will not hesitate to pursue those who skirt the proper drug approval process and make misleading statements about the safety and efficacy of their products”
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