To settle claims by the federal government that it illegally marketed the recalled drug Vioxx, Merck has agreed to pay nearly $1 billion.
The U.S. Department of Justice (DOJ) announced on Tuesday that it had reached a Vioxx settlement with the pharmaceutical giant and that Merck will plead guilty to violating federal law and promoting Vioxx illegally.
Merck was accused of promoting Vioxx for the treatment of rheumatoid arthritis before it received approval for that use from the FDA in 2002. The drug maker later issued a Vioxx recall in 2004, after the pain medication was found to double the risk of heart attacks and strokes.
Merck will pay a $321,636,000 criminal fine for illegal off-label marketing of Vioxx, the DOJ reports. The company will also pay a $628,364,000 civil fine over off-label marketing and what the DOJ calls false statements over the drug’s cardiovascular safety. The civil fine will be divided between the U.S. government and participating Medicaid states.
Merck has already had to pay $4.85 billion to settle Vioxx lawsuits filed on behalf of individuals who suffered an injury after using the medication. The lawsuits accused the company of failing to warn patients about the potential Vioxx side effects, even though evidence suggested Merck was aware of the risks long before the recall was issued.
Federal investigators say that Merck lied about the safety of Vioxx to increase the drug’s sales, which led to Medicaid agencies in the states and the federal government issuing reimbursements under false pretences.
In addition to money, Merck has agreed to enter into a corporate integrity agreement with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services. The agreement will give the OIG expanded oversight and review procedures over the company in order to monitor Merck’s activities and prevent future illegal marketing tactics.
Federal law makes it illegal for drug manufacturers to promote a drug for a use that has not been approved by the FDA. While such “off-label” marketing is illegal for the manufacturer, doctors have the ability to prescribe whatever drug they see fit.