As of November 4th, Johnson & Johnson agreed to a $2.2 billion deal in the settlement of pending criminal and civil charges that “alleged the healthcare giant illegally marketed its Risperal antipsychotic [along with Invega and Natrecor], and also paid kickbacks to physicians and Omnicare, the largest nursing home/pharmacy [company in the US,] to boost prescriptions.” (pharmalive.com)
There are essentially two issues at play here. First, Johnson & Johnson encouraged off-label use of several drugs. This in itself is illegal, as the uses of drugs must be approved by the FDA. Next is the issue of kickbacks – illegal greasing of pharmacies and physicians to sell more medications. J&J’s Risperal is approved by the FDA as an antipsychotic in the treatment of ailments like schizophrenia, but now it is revealed that the company paid doctors and Omnicare to prescribe the drug for the treatment of “anxiety, agitation, depression, hostility and confusion,” in elderly patients and young adults.
The US Department of Justice stated Monday that “In addition to imposing substantial monetary sanctions, the resolution will subject J&J to stringent requirements under a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG). This agreement is designed to increase accountability and transparency and prevent future fraud and abuse.”
DOJ continues: “‘J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,’ said U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger. ‘This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.’”
According to the New York Times, though the company “did not admit to any wrongdoing,” it has pled guilty to the illegal marketing of its products. Let’s not analyze what it means if an entity pleads guilty to a crime and maintains that it did nothing wrong — does Johnson & Johnson believe illegal marketing of strong antipsychotics to children is morally acceptable?
David Ingram and Ros Krasny of Reuters reported Monday that other pharmaceutical giants have made similar settlements in recent years: “Pfizer Inc in 2010 agreed to pay $2.3 billion to settle allegations it improperly marketed 13 drugs, including kickbacks to healthcare providers.
Last year, Britain’s GlaxoSmithKline Plc agreed to pay $3 billion to resolve criminal charges that it improperly targeted its Paxil depression treatment to children, sold its Wellbutrin antidepressant for unapproved uses and failed to inform U.S. regulators of safety risks seen with its Avandia diabetes drug.”