AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million to resolve whistleblower allegations that AstraZeneca illegally marketed the anti-psychotic drug Seroquel for off-label uses, federal officials announced yesterday.
The Wilmington, DE-based company finalized the previously announced civil settlement to resolve allegations that—by marketing Seroquel for uses not approved by the Food and Drug Administration—the company caused false payment claims to Medicaid, Medicare, TRICARE, the Department of Veterans Affairs, the Federal Employee Health Benefits Program, and the Bureau of Prisons, the Departments of Justice and Health and Human Services said in a joint media release.
"Today's settlement sends a clear warning to any individual or company seeking to defraud our healthcare system and returns hundreds of millions of dollars of taxpayer money to the Medicare trust fund where they belong," HHS Secretary Kathleen Sebelius said.
AstraZeneca issued a brief statement on its Web site announcing the settlement but denying the allegations. Prosecutors said that AstraZeneca self-reported its conduct in 2006 and cooperated in the investigation.
The federal government will receive $302 million from the civil settlement, and state Medicaid programs will share up to $218 million, depending on the number of states in the settlement. Whistleblower James Wetta could receive more than $45 million from the federal share of the civil recovery.
Federal prosecutors allege that between January 2001 and December 2006 AstraZeneca illegally promoted Seroquel to psychiatrists and other physicians for uses that included aggression, Alzheimer's disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness.
Prosecutors said AstraZeneca targeted its illegal marketing towards doctors who do not typically treat schizophrenia or bipolar disorder, such as geriatricians, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons.
Prosecutors said AstraZeneca unduly influenced the speakers conducting company-sponsored continuing medical education programs. The drug maker also hired doctors for promotional programs on unapproved uses for Seroquel, to conduct studies on unapproved uses of Seroquel, and to serve as authors of articles that were ghostwritten by medical literature companies. AstraZeneca used the studies to promote unapproved uses of Seroquel.
Prosecutors also contend that AstraZeneca violated the federal Anti-Kickback Statute by paying doctors it recruited to serve as authors of articles written by AstraZeneca and its agents about the unapproved uses of Seroquel. AstraZeneca also illegally paid doctors to travel to resorts to "advise" AstraZeneca about marketing messages for unapproved uses of Seroquel, and paid doctors to give promotional lectures to other healthcare professionals about unapproved and unaccepted uses of Seroquel.
The settlement includes a five-year corporate integrity agreement.
John Commins is a content specialist and online news editor for HealthLeaders, a Simplify Compliance brand.