American pharmaceutical company Merck, Sharp & Dohme was sentenced by U.S. District Court Judge Patti B. Saris in Boston to pay a criminal fine in the amount of $321,636,000 in connection with its guilty plea related to its promotion and marketing of the painkiller Vioxx (rofecoxib), the Justice Department announced today. In December 2011, Merck pleaded guilty to violating the Food, Drug and Cosmetic Act (FDCA) for introducing a misbranded drug, Vioxx, into interstate commerce.
Merck’s guilty plea was part of a global resolution involving its illegal promotional activity. In November 2011, Merck entered 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 The settlement and today’s sentencing conclude a long-running investigation of Merck’s promotion of Vioxx, which was withdrawn from the marketplace in September 2004.
Merck’s criminal plea related to the 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 for three indications in May 1999, but did not approve its use for 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.
At today’s sentencing, Judge Saris said in substance that off label promotion has been a big problem, she has seen a barrage of off-label marketing cases, and that she hoped that the size of today’s settlement and the fact that the government continues to press these cases will send a signal to the industry that this is not acceptable conduct.
The parallel civil settlement covered a broader range of allegedly illegal conduct by Merck. The settlement resolved allegations that 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 resolved 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. Finally, like the criminal plea, the civil settlement also recovered damages for allegedly false claims caused by Merck’s unlawful promotion of Vioxx for rheumatoid arthritis.
"The United States will not tolerate unlawful conduct by pharmaceutical companies," said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department's Civil Division. "As the court's sentence makes clear, those who put profits before patient safety by promoting their products for unapproved uses will be prosecuted and held accountable."
“We are pleased to see this case brought to a conclusion with the recovery of over three hundred million dollars in criminal fines, and a total of almost a billion dollars in combined civil and criminal penalties. The severity of these criminal and civil sanctions should serve as a reminder of this Office, and this department’s unwavering commitment to holding drug companies fully accountable for failures to comply with their public safety and marketing obligations, and to recovering taxpayer funds that have gone towards the purchase of illegally marketed products,” announced Carmen M. Ortiz, U.S. Attorney for the District of Massachusetts. “Any marketing activity that ignores the importance of FDA approval, or that makes unsupported safety claims about a drug is unacceptable, and will be pursued vigorously in both the criminal and civil arena.”
As part of the settlement, Merck also agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and
Human Services (HHS-OIG), which will strengthen the system of reviews and oversight procedures imposed on the company. Although Vioxx is no longer on the market, this ongoing monitoring of Merck’s conduct is aimed to deter and detect similar conduct in the future.
“If all pharmaceutical manufacturers complied with the law, there would be no need for law enforcement actions,” said Susan Waddell, Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services. “But until they stop abusing the health care system and putting profits ahead of patient safety, OIG will continue to vigorously pursue corporations that flout the law.”
“Today’s announcement demonstrates the commitment of FDA's Office of Criminal Investigations to pursue investigations of companies that disregard their regulatory obligations and place profits over the public’s health,” said Mark Dragonetti, Special Agent in Charge for the New York Field Office. “We commend the hard work of the U.S. Attorney's Office and our law enforcement counterparts in bringing about this result.”
“In 2004, the FBI began participating in a seven year investigation that led to Merck's decision to plead guilty to a criminal violation of federal law related to its promotion and marketing of Vioxx and to pay nearly a billion dollars in a criminal fine and civil damages,” said Richard DesLauriers, Special Agent in Charge of the FBI in Boston. “Merck now knows that no corporation is immune from being held accountable for criminal and civil violations of law and also knows why the FBI, its federal law enforcement partners, and the U.S. Attorney's Office have earned a national reputation for leading the government’s effort to detect, deter and prevent health care fraud.”
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