Just as Johnson & Johnson ($JNJ) is wrapping up its long-running Risperdal marketing investigation, the feds are eyeing its promotions for another drug: its antibiotic Doribax. The U.S. Justice Department demanded Doribax marketing information in April, J&J disclosed in its latest filing with the Securities and Exchange Commission.
As Dow Jones reports, J&J also faces inquiries from the Massachusetts U.S. Attorney's Office, which wants to know more about its Acclarent unit's device marketing. Investigators are interested in the Relieva Stratus MicroFlow Spacer, used to treat sinus problems, and related products, J&J's filing notes.
Like Risperdal, Doribax has been tagged with safety questions. J&J notified doctors earlier this year that the drug didn't work as well in pneumonia patients as another treatment, and that Doribax patients in that trial were more likely to die. The drug isn't approved as a pneumonia treatment; its FDA-approved indications are in urinary-tract and abdominal infections.
The new scrutiny comes as J&J and the Justice Department put the finishing touches on their Risperdal marketing settlement. In that same SEC filing, J&J noted that it had reached an agreement in principle to wrap up the Risperdal claims. Marketing allegations related to two other drugs--the antipsychotic drug Invega and the heart drug Natrecor--would also be included. The deal has yet to be finalized, however, and J&J didn't put a dollar figure on it. Sources have said it could reach $2.2 billion.
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