The drug manufacturer will plead guilty to a single violation of the U.S. Food Drug and Cosmetic Act for introducing a misbranded drug, Vioxx, or rofecoxib, into interstate commerce, U.S. Justice Department officials said Tuesday.
Under the plea agreement, Merck will plead guilty to a misdemeanor for its illegal promotional activity and will pay a $321.6 million criminal fine for promoting Vioxx for treating rheumatoid arthritis before that use was approved by the FDA, court documents said.
The FDA approved Vioxx for three uses in May 1999, but did not approve its use against rheumatoid arthritis until April 2002, Justice officials said. 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, officials said.
Under a civil settlement agreement, Merck will pay $628.3 million to resolve additional allegations regarding off-label -- prescribing drugs for an unapproved use -- marketing of Vioxx and false statements about the drug's cardiovascular safety.
Of the total civil settlement, $426.4 million will be recovered by the United States, and the remaining share of $202 million 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 The settlement and plea conclude a long-running investigation of Merck's promotion of Vioxx, which was withdrawn from the marketplace in September 2004.
The civil settlement resolves allegations that Merck representatives made inaccurate, unsupported or misleading statements about Vioxx's cardiovascular safety to increase sales of the drug. 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.