The Department of Justice (DOJ) on Tuesday ordered pharmaceutical giant Merck, Sharp & Dohme to pay nearly a billion dollars to settle criminal charges related to marketing its drug Vioxx.
Merck pleaded guilty on misdemeanor criminal charges and will pay a $321 million fine on top of paying $621 million to resolve civil claims, according to a DOJ statement.
The statement said that the company’s off-label marketing of Vioxx, a pain killer, was suspect. Merck also made false statements about the drug’s cardiovascular safety, it said.
“Any marketing activity that ignores the importance of FDA approval, or that makes unsupported safety claims about a drug, is unacceptable,” stated Carmen M. Ortiz, U.S. Attorney for the District of Massachusetts.
Merck allegedly made inaccurate or unsupported claims regarding the Vioxx’s cardiovascular safety to increase sales, the Justice Department said. The drug company also allegedly made similar false statements to state Medicaid agencies over the drug’s safety.