OAKLAND, Calif. (CN) – California has reached a $520 million agreement with AstraZeneca Pharmaceuticals LP to settle allegations that it promoted its antipsychotic drug Seroquel for unapproved use, Attorney General Edmund G. Brown Jr. announced Tuesday.
The London-based pharmaceutical company 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, Brown said.
“This company engaged in an illegal, off-label marketing campaign to boost sales of Seroquel,” Brown said. “This practice of promoting drugs for unapproved uses is dangerous and can have serious and unforeseen consequences.”
Seroquel is used to treat psychological disorders.
From 2001 through 2006, AstraZeneca was found to have promoted the drug to psychiatrists and primary care physicians for unapproved uses in the treatment of medical conditions such as aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, dementia and sleeplessness.
The settlement resolves claims that AstraZeneca encouraged doctors to prescribe Seroquel to children, adolescents and dementia patients in long-term care facilities.
Doctors may prescribe medications for off-label uses, but drug makers are prohibited from promoting drugs to treat conditions not approved by the Food and Drug Administration.
AstraZeneca also was accused of making illegal payments to physicians by paying their way to travel to resort locations to “advise” AstraZeneca about marketing messages for unapproved uses.
The doctors also served as authors of articles written by AstraZeneca, Brown said, and ordered studies for unapproved uses of Seroquel.
As part of the settlement, AstraZeneca’s marketing and sales practices will be monitored by the Office of the Inspector General.