AstraZeneca fined $520 million for off-label marketing

Pharmaceutical Technology Europe

AstraZeneca has finalized its agreement with US federal and state entities, under which it will pay $520 million to resolve allegations that it marketed the anti-psychotic drug Seroquel for off-label uses.

AstraZeneca has finalized its agreement with US federal and state entities, under which it will pay $520 million to resolve allegations that it marketed the anti-psychotic drug Seroquel for off-label uses.

The US contends that the company promoted the drug to doctors who do not typically treat schizophrenia or bipolar disorder, for which the drug is FDA approved. Instead, the drug was marketed to physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons for the treatment of unapproved uses including Alzheimer's disease, anger management, anxiety, attention deficit hyperactivity disorder and depression.

As part of the settlement, AstraZeneca has also entered into a corporate integrity agreement with the US Office of Inspector General of the US Department of Health and Human Services (HHS). In the US Department of Justice press statement, HHS Inspector General Daniel R. Levinson said: "As a result of this Corporate Integrity Agreement, the actions of AstraZeneca will be more transparent, its Board of Directors held more accountable, and the names of physicians receiving payments will be disclosed — all leading to better protection for patients."

Read the AstraZeneca press statement

Read the US Department of Justice press statement