Johnson & Johnson Company in Trouble – what is happening at J&J – DePuy, now this… ???
J&J/Scios: Natrecor mislabeling earns misdemeanour charge
July 12, 2011 |
San Francisco, CA – US attorneys have charged Scios, a division of Johnson & Johnson, with misbranding the heart-failure drug nesiritide (Natrecor) .
Pharmalot.com journalist Ed Silverman reports that the case could have led to felony charges, large fines for the company and some of its executives, and potential exclusion from federal healthcare programs including Medicare, but after a two-year investigation, the US attorney’s office in San Francisco has elected to charge Scios only with a single misdemeanor, carrying a fine of $200 000, double what the company earned from the unlawful conduct.
The US Department of Justice (DoJ) joined whistle-blower lawsuits filed against Scios and Johnson & Johnson by two former Scios sales managers, alleging the company’s sales reps were promoting the drug for serial outpatient infusions in patients with less severe heart failure, which is outside the drug’s approved labeling.
The FDA had previously reprimanded the company and ordered it to withdraw several promotional items for nesiritide that did not include appropriate indication and risk information and therefore were not appropriate “reminder pieces,” according to the agency.
In 2005, several experts raised questions about both the drug’s safety and Scios’s marketing of it, which led to a decline in the drug’s popularity among physicians. Most recently, results of the ASCEND-AF trial showed nesiritide is not more effective than standard treatment for acute decompensated heart failure, but it does not appear to damage the kidneys or increase mortality.