AstraZeneca Settlement Breaks Records, But Lacks Bite
Drugmaker AstraZeneca has agreed to pay $520 million to settle charges that it illegally marketed its anti-psychotic drug Seroquel, the Department of Justice announced today.
The settlement, which arose from allegations in a civil False Claims Act lawsuit that the company marketed its anti-psychotic drug Seroquel for purposes not approved by the Food and Drug Administration, was the largest ever by a company in a civil-only settlement of off-label marketing claims. However, $520 million (without knowing the details on how the damages were calculated) seems a paltry sum considering that Seroquel sales ranged as high as four billion per year.
The complaint alleged that from January 2001 to September of 2006, AstraZeneca marketed Seroquel to psychiatrists and other physicians to treat aggression, Alzheimer’s disease, anxiety, ADHD, and a slew of other illnesses for which Seroquel was not FDA-approved to treat. The marketing efforts failed to disclose the side effects from such off-label uses, which included extreme weight gain.
As a condition of the settlement, AstraZeneca also entered into a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector general. CIAs are generally designed to implement a series of administrative hoops that ensure compliance with government mandates. Among other provisions, the AstraZeneca CIA provides that a board of directors committee and certain managers must annually review the company’s compliance program and approve its effectiveness. However, the CIA terms essentially places monitoring responsibilities in the hands of the original wrongdoers. Additionally, the CIA does not require the company to take any actions to correct the misinformation given to physicians about the drug.
