WASHINGTON, D.C. – American pharmaceutical company Merck has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx®, the Justice Department announced today.
Under the terms of the resolution, Merck will plead guilty to a misdemeanor charge of the Food Drug and Cosmetic Act (FDCA) for promoting Vioxx® for treating rheumatoid arthritis before that use was approved by the Food and Drug Administration (FDA). Under the terms of its plea agreement with the United States, Merck will pay a $321,636,000 criminal fine.
Merck is also entering into a civil settlement agreement under which it will pay $628,364,000 to resolve additional allegations regarding off-label marketing of Vioxx® and false statements about the drug’s cardiovascular safety. Of the total civil settlement, $426,389,000 will be recovered by the United States, and the remaining share of $201,975,000 will be distributed to the participating Medicaid states. The settlement and plea conclude a long-running investigation of Merck’s promotion of Vioxx®, which was withdrawn from the marketplace in September 2004.
Merck’s criminal plea relates to misbranding of Vioxx® by promoting the drug for treating rheumatoid arthritis, before that use was approved by the Food and Drug Administration (FDA). Under the provisions of the FDCA, a company is required to specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – any use not specified in an application and approved by FDA – unless the company applies to the FDA for approval of the additional use.
The FDA approved Vioxx® in May 1999, but did not approve its use against rheumatoid arthritis until April 2002. In the interim, for nearly three years, Merck promoted Vioxx® for rheumatoid arthritis, conduct for which it was admonished in an FDA warning letter issued in September 2001. While doctors can prescribe drugs for off-label uses, their manufacturers are only allowed to promote them for their FDA-approved ones.
Merck stopped selling Vioxx® in 2004 after evidence showed that it dramatically increased the risk of heart attack and stroke.
“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.”
This settlement is not an admission of liability or wrongdoing by Merck.
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