AstraZeneca illegally promoted quetiapine (Seroquel) to treat aggression, anger; pays $510m fine in US to

Anglo-Swedish pharmaceutical firm AstraZeneca has been made to pay a $510 million for illegally promoting its quetiapine (Seroquel) for diseases the anti-psychotic drug has not been approved in US.

AstraZeneca unlawfully marketed Seroquel for uses such as aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness.

The Food and Drug Administration (US FDA) has never approved Seroquel for the indications mentioned above, the US justice department confirmed.

US FDA originally approved Seroquel in September 1997 to treat symptoms of psychotic disorders.

In September 2000, US FDA proposed narrowing Seroquel’s approval to the short term treatment of schizophrenia only.

US FDA later approved Seroquel for short term treatment of acute manic episodes associated with bipolar disorder and for bipolar depression.

AstraZeneca’s US division agreed to pay the fine for marketing Seroquel for “off-label” uses not included in the drug’s approved product label, the Justice Department said.

AstraZeneca announced that the company has finalised a previously announced agreement in principle with federal and state entities in the United States to resolve civil allegations relating to the company’s past marketing and promotion of its atypical antipsychotic, Seroquel.

The final agreement is with the United States Attorney’s Office for the Eastern District of Pennsylvania, the United States Department of Justice, various other federal agencies, the National Association of Medicaid Fraud Control Units (NAMFCU) and the two qui tam relators.

Under the terms of the agreement, AstraZeneca denies the allegations but will pay a previously disclosed $520 million that was taken as a reserve in 2009, along with certain accrued interest.

A portion of the payment will be distributed to states participating in the NAMFCU settlement.

As part of the settlement, AstraZeneca has entered into a corporate integrity agreement with the Office of Inspector General of the United States Department of Health and Human Services. The corporate integrity agreement will be in effect for five years.

A 2009 study found that as many as 20% of physicians who prescribed Seroquel for dementia treatment were unaware that the drug hadn’t been approved for that use.

AstraZeneca has a primary focus on the discovery, development and commercialisation of prescription medicines.  As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009.