In Boston, a federal judge has ordered Merck & Co to pay a $321 million criminal fine after the drug company pled guilty to illegally promoting the painkiller Vioxx as a rheumatoid arthritis treatment for years before it was approved as a treatment by the FDA. Vioxx was approved as a painkiller in 1999, however, the FDA did not approve Vioxx as a treatment for rheumatoid arthritis until 2002, three years after federal prosecutors said Merck started prematurely promoting the drug. The FDA reprimanded Merck for continuing to illegally promote Vioxx in 2001.
The Department of Justice said the settlement included allegations that Merck “made misleading statements about Vioxx’s heart safety to boost sales of the medicine,” Reuters reports. Vioxx was pulled from the marked in 2004 when it was linked to a substantially increased risk of stroke and heart attack.
Merck is also paying the federal government $426 million, and state Medicaid agencies $202 million in a civil settlement regarding the illegal marketing of Vioxx.
Assistant attorney general of the Department of Justice civil division, Tony West, said in a statement, “When a pharmaceutical company ignores F.D.A. 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.”