AstraZeneca has reached a $520 million settlement in a federal investigation into off-label marketing of Seroquel, the pharmaceutical company’s high-selling schizophrenia drug. The U.S. alleged that the company marketed the drug for uses never approved by the Food and Drug Administration, including Alzheimer’s disease, dementia and sleeplessness. From the Department of Justice press release:
The United States contends that AstraZeneca promoted the unapproved uses by improperly and unduly influencing the content of, and speakers, in company-sponsored continuing medical education programs. The company also engaged doctors to give promotional speaker programs on unapproved uses for Seroquel and to conduct studies on unapproved uses of Seroquel. In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel.
The United States also contends that AstraZeneca violated the federal Anti-Kickback Statute by offering and paying illegal remuneration to doctors it recruited to serve as authors of articles written by AstraZeneca and its agents about the unapproved uses of Seroquel. AstraZeneca also offered and paid illegal remuneration to doctors to travel to resort locations to “advise” AstraZeneca about marketing messages for unapproved uses of Seroquel, and paid doctors to give promotional lectures to other health care professionals about unapproved and unaccepted uses of Seroquel. The United States contends that these payments were intended to induce the doctors to prescribe Seroquel for unapproved uses in violation of the federal Anti-Kickback Statute.
In a statement about the terms of the settlement, AstraZeneca said it denies the allegations. Glenn Engelmann, the pharmaceutical giant’s U.S. general counsel, released a statement saying it was “in the best interest of AstraZeneca to resolve these matters and to move forward with our business of discovering and developing important, life-changing medicines — while avoiding the delay, uncertainty, and expense of protracted litigation,” The New York Times reported.
The settlement makes AstraZeneca the fourth major pharmaceutical company to pay to settle federal charges of illegal marketing of antipsychotic medications in the last three years, according to The Times. The company “still faces more than 25,000 civil lawsuits filed on behalf of patients contending that the company did not disclose the drug’s risks,” The Times reports.
The settlement money will be split between the federal government and state Medicaid programs. Also as part of the settlement, AstraZeneca will be required to begin posting payments to doctors on their website.
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