Attorney General Edmund G. Brown Jr. today announced that California, along with other jurisdictions, has reached a $520 million settlement with AstraZeneca Pharmaceuticals LP, to settle allegations it engaged in the “dangerous practice” of promoting drugs for unapproved uses in marketing Seroquel, its blockbuster antipsychotic drug.
London-based AstraZeneca will pay states and the federal government a total of $520 million in damages and penalties. California’s share is $31 million for Medi-Cal, which provides health care to the state’s poor, and other state programs.
“This company engaged in an illegal, off-label marketing campaign to boost sales of Seroquel, a powerful antipsychotic drug that should be prescribed with great caution,” said Brown. “This practice of promoting drugs for unapproved uses is dangerous and can have serious and unforeseen consequences.”
Seroquel is an antipsychotic medication used to treat psychological disorders. From 2001 through 2006, AstraZeneca was found to have promoted the drug not only to psychiatrists, but also to primary care physicians and other healthcare professionals for unapproved uses in the treatment of medical conditions such as aggression, Alzheimer’s disorder, anger management, anxiety, attention deficit hyperactivity disorder, dementia and sleeplessness.
Doctors may prescribe medications for off-label uses, but drug makers are prohibited from promoting drugs for treatment of medical conditions not approved by the Food and Drug Administration (FDA.)
In its marketing campaign, AstraZeneca was also alleged to have made illegal payments to physicians, paying their way to travel to resort locations to “advise” AstraZeneca about marketing messages for unapproved uses, to serve as authors of articles written by AstraZeneca and its agents, and to conduct studies for unapproved uses of Seroquel.
The settlement resolves claims that, as a result of these promotional activities, AstraZeneca encouraged physicians to prescribe Seroquel for children, adolescents and dementia patients in long-term care facilities for uses not medically accepted or FDA-approved. Among other side effects, the drugs have been shown to cause significant weight gain in children. The company also failed to adequately disclose studies that show Seroquel increases the risk of diabetes.
As part of the settlement, AstraZeneca will enter into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s marketing and sales practices.
This settlement is based on qui tam cases, or whistle-blower lawsuits, that were filed in the United States District Court for the Eastern District of Pennsylvania.
A National Association of Medicaid Fraud Control Units team, including members from California and other states, participated in the investigation and entered into the settlement negotiations with AstraZeneca on behalf of the states.