British pharmaceutical company AstraZeneca has just reached a settlement with the Department of Justice over AstraZeneca Seroquel investigations. Seroquel, an anti psychotic medication, has been under fire for being marketed for unapproved purposes. $ 520 million in restitution is what the drug maker is willing to pay the Department of Justice. It will hardly make them think about guaranteed loans to cover for the expense, as the drug itself sold about $ 4.9 billion worth last year.

AstraZeneca Seroquel marketed for wrong purposes

The drug being marketed for purposes other than those it is approved for is what the qualm over AstraZeneca Seroquel is based on. The DOJ says that there were physician kickbacks of payday cash for those that prescribed the drug for off label purposes. The drug Seroquel is quetiapine, which is used to treat schizophrenia and certain bi-polar disorders. If physicians think it is appropriate, they are allowed to prescribe medication for off label use. Pharmaceutical drugs are not to be marketed for any off label uses; the FDA says no to that.

Off label uses of Seroquel

Part of the investigation is into whether AstraZeneca Seroquel was marketed for uses it hasn't been approved for yet. According to the Wall Street Journal , AstraZeneca marketed the drug for off label uses, such as to treat post traumatic stress disorder, anxiety, Alzheimer's Disease, aggression, and depression. The Justice Department believes the pharmaceutical giant also gave kickbacks to physicians to prescribe it for those purposes. AstraZeneca set aside $ 520 million in October for the purposes of a settlement, but it denies the allegations.

Pending lawsuits

There are lawsuits pending against AstraZeneca concerning side effects of off label use of Seroquel. Seroquel isn't the first drug to be used off label; every drug has an alternate use, so the use of medication for off label purposes is actually somewhat widespread. Aspirin, as an example, is used to thin blood and used as a pain reliever but also can be used for treating heart disease. Physicians often prescribe drugs for off label uses which is fine. However, the idea that a physician would prescribe drug for their own money purposes when something else is available, is really troubling.

What the impact is then?

Not much will probably come of it since AstraZeneca Seroquel set aside money for a settlement months ago. The company will probably disclose payments to physicians and will comply with federal instructions.

Resources for the article

Wall Street Journal

http://online.wsj.com/article/BT-CO-20100427-717519.html?mod=WSJ_World_MIDDLEHeadlinesEurope