Johnson & Johnson to pay fine to end US probes

In one of the largest health care fraud settlements in US history, Johnson & Johnson will pay $2.2 billion to end civil and criminal investigations into kickbacks to pharmacists and the marketing of pharmaceuticals for off-label uses, US Attorney General Eric Holder said on Monday, according to The Economic Times.

The resolution of the long-running case with the company and its subsidiaries covers the marketing of the anti-psychotic drugs Risperdal and Invega and the heart drug Natrecor over several years.

From 1999 through 2005, J&J and its subsidiary Janssen Pharmaceuticals Inc promoted Risperdal for unapproved uses, including controlling aggression and anxiety in elderly dementia patients and treating behavioral disturbances in children and in individuals with disabilities, according to the complaint.

The off-label marketing cost US government insurance programs hundreds of millions of dollars in uncovered claims, the complaint said.

Meanwhile, the company paid millions of dollars in kickbacks to Omnicare Inc, the nation's largest pharmacy specializing in dispensing drugs to nursing home patients, under various guises including "educational funding."

Johnson & Johnson's conduct "recklessly put at risk" the health of children, dementia patients and others to whom the drug was prescribed at a time it was only approved by the US Food and Drug Administration to treat schizophrenia, Holder said.

Janssen's sales representatives "aggressively" promoted Risperdal to doctors and other prescribers who treated elderly dementia patients, and through a special "ElderCare sales force" targeted nursing home operators.

"The company also provided incentives for off-label promotion" and based sales representatives' bonuses on total sales, not just sales for FDA-approved uses, the DOJ said.

Under FDA regulations, doctors may prescribe drugs for unapproved, or off-label, use. But pharmaceutical companies are allowed to market their drugs in the United States only for FDA-approved uses.

The FDA said it had delivered repeated warnings to Janssen about "misleading marketing messages" to doctors, and later initiated a criminal complaint.