After several years of investigating, the feds have filed charges against Johnson & Johnson's ($JNJ) Scios division over its marketing of the heart failure drug Natrecor. Prosecutors have levied a misdemeanor charge of mislabeling Natrecor, Pharmalot reports. The J&J division faces a $200,000 fine.
The charges stem from a probe first prompted by a whistleblower lawsuit that accused Scios execs of promoting Natrecor for chronic heart conditions, when it's approved to treat acute heart failure. The whistleblower suit alleged that sales reps were told to talk up the drug's off-label benefits with doctors; Scios sponsored seminars on Natrecor's off-label use; and the company hired a consultant to create a guide to help doctors bill Medicare for off-label use of the drug.
The Justice Department joined the whistleblower suit, but the case was dismissed two years ago, as Pharmalot notes. Now, the feds have come up with this misdemeanor charge, saying that Natrecor's labeling "lacked adequate directions for use" from 2001 to 2005. The DoJ wouldn't comment for Pharmalot, and all J&J would say is that "the parties have reached an agreement." Compared with settlements in other DoJ marketing probes, that $200,000 agreement looks like pretty small potatoes.
- read the Pharmalot post