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D.C. Medicaid Program to Receive $3 Million from Drug Settlement

11/8/2013, 1:14 p.m.
Courtesy of dhcf.dc.gov

The District of Columbia’s Medicaid program will receive more than $3 million from a global settlement with pharmaceutical manufacturer Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, Inc., according to D.C. Attorney General Irvin B. Nathan and D.C. Inspector General Charles J. Willoughby.

In the civil settlement with the federal government, most states and the District, the companies will pay more than $1.2 billion to resolve allegations of unlawful marketing practices to promote the sales of their atypical antipsychotic drugs, Risperdal and Invega.

The settlement resolves four qui tam, or whistleblower, lawsuits filed in the United States District Court for the Eastern District of Pennsylvania, under the provisions of the D.C. False Claims Act, the federal False Claims Act and similar state False Claims statutes.

Johnson and Johnson and Janssen allegedly promoted, marketed, and introduced Risperdal and Invega into interstate commerce for uses that were not approved by the Food and Drug Administration (FDA) and for uses that were not medically indicated.

D.C. and the states contend that from 1999 through 2005, the companies promoted Risperdal for off-label uses, made false and misleading statements about the safety and efficacy of Risperdal, and paid illegal kickbacks to health care professionals and long-term care pharmacy providers to induce them to promote or prescribe Risperdal to children, adolescents and the elderly when there was no FDA approval for Risperdal use in these patient populations.

A team from the National Association of Medicaid Fraud Control Units worked closely with the federal government on the investigation and conducted the settlement negotiations with the pharmaceutical manufacturers on behalf of the states.

“Marketing an anti-psychotic drug for off-label uses is a form of Medicaid fraud and, more importantly, poses serious risks to patients’ well-being,” Nathan said. “This settlement makes clear that pharmaceutical companies will be held accountable for such conduct.”

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