According to a recent announcement by the Department of Justice, Scios, Inc., a subsidiary of Johnson & Johnson, has pled guilty to a misdemeanor violation of the U.S. Food, Drug and Cosmetic’s Act. The company has agreed to pay the government a criminal fine of $85 million for mislabeling its heart-failure drug, Natrecor.
The government alleged that Scios misbranded the drug, Natrecor, which is a prescription medication for hospital patients with congestive heart failure. The company acknowledged that it marketed the medication for off-label uses that had not been previously approved by the FDA. However, While Scios ultimately plead guilty to the misdemeanor charge, the company denied any wrongful intent regarding the matter.