J&J to pay $2.2 bn to end US drug probes
Washington: Global healthcare giant Johnson & Johnson and its subsidiaries have agreed to pay more than $2.2 billion to resolve criminal and civil investigations for misbranding anti-psychotic drugs and paying kickbacks to pharmacists, the US Department of Justice said.
The resolution of one of the largest healthcare fraud settlements in the US history included criminal fines and forfeiture totalling $485 million and civil settlements with the US federal and state authorities totalling $1.72 billion, US Attorney General Eric Holder said, Xinhua reported.
The settlement demonstrated the US Department of Justice's firm commitment to prevent and combat all forms of health care fraud, Holder added.
The department charged that Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, which promoted antipsychotic drug Risperdal from 1999 through 2005, for uses not approved by the US Food and Drug Administration (FDA), including controlling anxiety and agitation for elderly dementia patients.
The company also provided incentives for off-label promotion and based sales representatives' bonuses on total sales of Risperdal in their sales areas, not just sales for FDA-approved uses, the US Department of Justice said.
"Johnson & Johnson promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society -- children, the elderly and those with developmental disabilities," said Zane Memeger, US attorney for the Eastern District of Pennsylvania.
The FDA said that it had delivered repeated warnings to Janssen Pharmaceuticals about its "misleading marketing messages" targeted to physicians and initiated a criminal investigation.
"We stand ready to take similar action in the future, if warranted, to protect public health," said John Roth, director, FDA office of criminal investigations.
The Justice Department also alleged that Johnson & Johnson paid millions of dollars in kickbacks to Omnicare, the nation's largest pharmacy specialised in dispensing drugs to nursing home patients, under various guises including "grants" and "educational funding."
These kickbacks were intended to induce Omnicare and its hundreds of consultant pharmacists to promote the use of Risperdal and other Johnson & Johnson drugs in nursing homes, the department said.
"Today we reached closure on complex legal matters spanning almost a decade," Johnson & Johnson vice president and general counsel Michael Ullmann said. "We remain committed to working with the US Food and Drug Administration and others to ensure greater clarity around the guidance for pharmaceutical industry practices and standards."
As part of the deal, the global health care giant, based in New Jersey, has signed a five-year corporate integrity agreement with the US Department of Health and Human Services to scrutinise future practices.