J&J to pay $2.2B to wrap up long-standing Risperdal marketing probe

By Tracy Staton, FiercePharma

Johnson & Johnson has finally made a deal with the Justice Department. The Big Pharma giant agreed to pay $2.2 billion and plead guilty to a misdemeanor to wrap up a long-standing probe into its marketing of the antipsychotic drug Risperdal.

The company joins a gallery of drugmakers that have agreed to pay billions to settle federal marketing probes. Though J&J’s criminal fine and civil payments are substantial, they don’t top GlaxoSmithKline’s  still-record-setting $3 billion settlement, made last year. And Pfizer still holds the record for largest criminal fine at $1.3 billion.

“Today we reached closure on complex legal matters spanning almost a decade,” said Michael Ullmann, VP and general counsel, in a J&J statement. “We remain committed to working with the U.S. Food and Drug Administration and others to ensure greater clarity around the guidance for pharmaceutical industry practices and standards.”

It’s far from the first time J&J has settled Risperdal-related claims. Texas, for instance, settled its off-label marketing claims against J&J for $158 million. In Arkansas, a jury found the company guilty of fraudulently marketing Risperdal–and a judge ordered the company to pay a $1.2 billion penalty. (That award is under appeal.)

J&J’s settlement wraps up some 8 years of government investigations and whistleblower lawsuits. From 2003 to 2010, Risperdal brought in more than $24 billion worldwide; in the U.S. alone, the drug ginned up $20 billion before it lost patent protection in 2007. Much of that revenue came from off-label sales, investigators have said.

The settlement won’t interfere with J&J’s ability to do business with federal healthcare programs; its Janssen unit will please guilty to a single misdemeanor violation of the Food Drug and Cosmetic Act for overstepping the rules in marketing Risperdal. The settlement also covers allegations related to other J&J drugs, including the antipsychotic Invega and the heart drug Natrecor.

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