By Jane Akre
April 28, 2010
Pharmaceutical Giant, AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million after being fined by the federal government for illegally marketing the anti-psychotic drug, Seroquel.
Seroquel, also known as quetiapine fumarate, was approved by the FDA in 1997 to treat psychotic disorders. By October 2006, its use had expanded for use for bipolar depression and mania.
The Department of Justice alleges AstraZeneca illegally marketed Seroquel for uses other than those approved by the FDA such as Alzheimer’s disease, anger management, anxiety, ADD, dementia, depression, PTSD, mood disorders, among other uses considered “off-label.”
In 2008, Bloomberg reported that teenagers and the elderly were increasingly being given a class of anti-psychotic drugs not cleared by regulators. In adolescents, the medications are given for depression, autism and hyperactivity, and in the elderly for dementia and insomnia.
Half of Seroquel sales in 2006 were reportedly for off-label use.
In doing so, the company submitted false claims for payments from federal insurance programs including Medicaid, Medicare and TRICARE programs, Veterans Affairs, the Bureau of Prisons, and the Federal Employee Health Benefits Program.