AstraZeneca has agreed to pay the federal government $520 million to settle allegations that it illegally marketed the drug Seroquel for “off-label” uses – i.e., uses not approved by the FDA. The government alleged that by promoting Seroquel for unapproved uses, AstraZeneca caused the submission of false claims for payment to government healthcare programs, including Medicare and Medicaid. In accordance with the settlement agreement, the federal government will receive $301,907,007, and participating states and the District of Columbia will share up to $218,092,993.
The lawsuit was originally brought by a whistleblower under the qui tam provisions of the federal False Claims Act and several equivalent state statutes. The whistleblower, James Wetta, will receive $45 million from the federal government’s recovery.
The government alleged that AstraZeneca promoted Seroquel, which was approved by the FDA only for treatment of psychotic disorders and bipolar disorder, for the treatment of many other conditions, such as anxiety, depression, aggression, Alzheimer’s Disease, dementia and sleeplessness. According to the government, AstraZeneca accomplished this by improperly influencing continuing medical education programs, by engaging doctors to give talks promoting Seroquel for unapproved uses, and by recruiting doctors to sign their names to articles they did not write, so that AstraZeneca could use the articles and the studies they described to market Seroquel for off-label uses.
The government also alleged that AstraZeneca made illegal payments, or “kickbacks,” to the doctors who agreed to serve as authors of the ghostwritten articles. It further alleged that the company paid kickbacks to doctors in the form of trips to resorts in order to “advise” the company on ways to promote Seroquel for off-label uses, and that it improperly paid doctors to give lectures to other healthcare professionals promoting Seroquel for off-label uses.
In addition to the civil settlement, AstraZeneca has entered into a Corporate Integrity Agreement (CIA) with the Office of Inspector General of the Department of Health and Human Services. The CIA will be in effect for five years and imposes several requirements on AstraZeneca, including the following: a board of directors committee must review the company’s compliance program each year and certify its effectiveness; certain managers must certify each year that the operations they oversee are in compliance; the company must send a letter to doctors regarding the settlement; and the company must publish on its website information about any payments made to doctors.
If AstraZeneca breaches the CIA, it may be forced to pay penalties, or in the case of serious noncompliance, it may be excluded from participation in federal healthcare programs such as Medicare and Medicaid.
Click here to read the DOJ press release, Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing