J&J Pays $2.2 Billion to End FDA Drug Probes

J&J Pays $2.2 Billion to End FDA Drug Probes

November 5th, 2013 // 2:38 pm @

Johnson and Johnson is going to pay over $2 billion to bring an end to various civil and criminal investigations regarding kickbacks to pharmacists and for marketing drugs for various off label uses. The US Attorney General made this announcement on Monday.

This case is finally being resolved and dealt with the marketing of two anti-psychotic drugs – Risperdal and Invega, as well as the heart drug Natrecor.

According to FDA and DOJ, from 1999 to 2005, J&J was promoting Risperdal for uses that were not approved by FDA, such as reducing aggression and anxiety in patients with dementia, and for treating behavior problems in children.

This off label marketing cost Medicare and Medicaid hundreds of millions of dollars. Under this settlement, Janssen is going to plead guilty to one misdemeanor violation for promoting Risperdal.

Janssen paid out many millions in kickbacks to Omnicare, which is the biggest pharmacy in the country for drugs for nursing homes. DOJ stated that J&J and Janssen put the health of dementia patients and children at risk, when Risperdal and Invega only were to be used for people with schizophrenia.

Janssen’s sales reps were aggressively selling Risperdal to physicians and others who treat old people with dementia. The firm also was giving incentives to salespeople for off label promotions.

FDA had given several warnings to Janssen and J&J about giving misleading marketing information to doctors. J&J has stated that the settlement of these civil allegations are not an admission of wrongdoing, and J&J still denies the civil allegations by the government.

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