Noteboom The Law Firm

AstraZeneca Settlement Gives Millions to the VA and Tricare

May 5, 2010 - The Department of Justice (DoJ) sued AstraZeneca, a pharmaceutical company, for fraud. As a result of the settlement flowing from that case, the Department of Veterans Affairs (VA), Tricare, and state Medicaid programs will most likely end up sharing hundreds of millions of dollars. 

The DoJ's case focused on the way AstraZeneca marketed one of their drugs, Seroquel. Seroquel is an anti-psychotic that, according to the Food and Drug Administration (FDA), had only been approved as a treatment for bipolar disorder and schizophrenia. Despite the FDA's limited applications, AstraZeneca marketed and sold Seroquel to health care providers as a treatment for the following conditions, among others:

• Post-traumatic stress disorder (PTSD);
• Anger management;
• Anxiety;
• Sleeplessness;
• Dementia; and
• Depression.

 Doctors commonly prescribe drugs for uses other than for what it was approved by the FDA. Approximately 40%-60% of all prescriptions written are written for uses for which the FDA has not specifically approved. The distinction must be drawn that writing prescriptions for off-label uses is perfectly legal, whereas marketing prescriptions for off-label uses is not.

The DOJ calls this fraud. Drug companies are billing and receiving payment for drugs being used for non-FDA approved uses. More than that, AstraZeneca paid doctors to take credit for ghostwritten articles celebrating Seroquel's efficiency in uses not approved by the FDA. AstraZeneca also paid doctors to appear in resorts to tout the benefits of Seroquel's off-label uses.

The lawsuit's settlement forces AstraZeneca into a Corporate Integrity Agreement putting them under the proverbial microscope. While AstraZeneca did not admit any wrongdoing, they must list all the information from the settlement on their website. More than likely, this will bar AstraZeneca from being able to be a part of federal health care programs.