U.K.-based drug maker AstraZeneca PLC will pay about $520 million to resolve allegations the company promoted off-label uses for the antipsychotic Seroquel, the Justice Department said.
The drug maker disclosed in October that it had set aside $520 million for the resolution, which includes a civil settlement and corporate integrity agreement.
Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius announced the settlement Tuesday, along with Tony West, Assistant Attorney General of the Civil Division, and acting U.S. Attorney Michael Levy of Pennsylvania’s Eastern District.
Drug makers are barred from marketing off-label, or for uses not approved by the U.S. Food and Drug Administration. Seroquel, whose sales reached $4.9 billion in 2009, is approved to treat schizophrenia, bipolar disorder and depression.
According to the department, AstraZeneca promoted Seroquel to psychiatrists and other physicians for unapproved uses, including aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder and sleeplessness.
The company targeted doctors who did not typically treat patients for its approved uses, such as primary care physicians, and pediatric and adolescent physicians, according to the department.
The drug maker was also accused of enlisting doctors to give speeches promoting off-label uses of the drug, and recruiting them as authors of ghostwritten articles on studies the doctors did not conduct. AstraZeneca then brandished the articles in promotional messages about unapproved uses of Seroquel, the department alleged.
The drug maker allegedly submitted false claims for payment to a variety of federal insurance programs, including Medicaid, Medicare and TRICARE programs, and to the Department of Veterans Affairs, the Federal Employee Health Benefits Program and the Bureau of Prisons.
“Illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets,” Holder said. ”We will not let such actions stand.”
Under the terms of the agreement, AstraZeneca made no admission of wrongdoing.
The federal government will receive about $302 million and state Medicaid programs and the District of Columbia will share the remaining $218 million.
The investigation spawned from whistleblowers’ complaints filed in 2004 and 2006 in federal court in Philadelphia. One of the whistleblowers, James Wetta, was also a relator in the government’s investigation of Eli Lilly & Co. for off-label marketing of its antipsychotic Zyprexa. The drug maker agreed to pay $1.4 billion to resolve the allegations last year.
In a record-breaking settlment last year, Pfizer Inc. agreed to pay $2.3 billion to resolve allegations it improperly promoted pain reliever Bextra.
Allergan, Inc., which makes the wrinkle-remover Botox, filed a lawsuit against the FDA in October challenging the ban on off-label marketing on First Amendment grounds. The company claims the practice infringes commercial free speech and free speech in general.
The AstraZeneca settlement agreement is embedded below.
Eli Lilly has made 40 billion on 10 dollar a pill Zyprexa and it was way oversold and caused diabetes and in some cases sudden death. Zyprexa was pushed by Lilly Drug Reps.
They called it the “Five at Five” (5 mg at 5 pm to keep nursing home patients subdued and sleepy) and “VIVA ZYPREXA” (Zyprexa for everybody) campaigns to off label market Eli Lilly Zyprexa as a fix for unapproved usage.I am a living example of Zyprexa gone/done wrong was given it 1996-2000 off-label for PTSD got sudden high blood sugar A1C 14.7 in January 2000.The stuff was worthless for my condition PTSD and cost me thousands in co-pays gave me diabetes.
Daniel Haszard Zyprexa whistle-blower https://www.zyprexa-victims.com