A Fremont-based subsidiary of the Johnson & Johnson pharmaceutical company pleaded guilty to a misdemeanor in federal court in San Francisco Wednesday and agreed to pay an $85 million fine for marketing a heart drug for an off-label use.
Scios Inc. pleaded guilty before U.S. District Judge Charles Breyer to one count of misbranding the drug Natrecor.
The drug is approved by the U.S. Food and Drug Administration for use with patients with acute congestive heart failure who have shortness of breath. It is administered intravenously.
The criminal charge filed by the U.S. Justice Department in July alleged that Scios was improperly marketing the drug for use on a regular basis by heart patients who were not acutely ill.
Promoting a drug for an unapproved, or off-label, use is known as misbranding.
Assistant U.S. Attorney General Tony West said, “Putting misbranded drugs into interstate commerce is serious because it undercuts the FDA’s role in keeping our medicines safe and effective.”
Scios issued a statement saying, “Scios acknowledges that Natrecor was misbranded and used in a way not approved by the FDA because its labeling lacked adequate directions for that use, but denies any wrongful intent in connection with this plea.”
The Justice Department said it has a separate civil false claims lawsuit pending in federal court in San Francisco against Scios and Johnson & Johnson.
That lawsuit alleges that the companies’ promotion of off-label use of the drug resulted in false claims being submitted to Medicare and other federal healthcare programs.
Julia Cheever, Bay City News
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