British pharmaceutical business 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. The drug maker has agreed to pay the Department of Justice $ 520 million in restitution. They will hardly think about guaranteed loans to cover expenses, like the drug itself which sold $ 4.9 billion last year.
AstraZeneca Seroquel was marketed for the wrong purposes
The fight about AstraZeneca Seroquel was based off of the fact that the drug was marketed for purposes other than what it was approved for. The DOJ also alleges there were physician kickbacks of payday money for prescribing the drug for off-label purposes. The drug is used to treat schizophrenia and certain bi polar diseases. If physicians think it is appropriate, they are allowed to prescribe medication for off label use. The FDA considers it a no-no to market pharmaceutical drugs for off label uses.
Off label uses of Seroquel
Part of the investigation is to see whether AstraZeneca Seroquel was marketed for different uses that haven’t been approved for it. According to the Wall Street Journal , AstraZeneca marketed the drug for off label uses, like to treat Alzheimer’s Disease, aggression, post traumatic stress disorder, anxiety and depression. The Justice Departments seems to think that pharmaceutical giant gave kickbacks to physicians for prescribing it for those purposes. .
Lawsuits pending
There are a couple of lawsuits against AstraZeneca concerning the side effects of off label use of the drug, Seroquel. Seroquel isn’t really the first drug to be used off label; drug has an alternate use, so the use of medication for off label purposes is actually somewhat widespread. For instance, although most people use aspirin to thin blood or as a pain reliever, it also can be used to treat heart disease. Many physicians prescribe medications for off label uses, and their use is perfectly fine. Sadly, many physicians prescribe medication for their own purposes involving money when there are other choices accessible which is very troubling.
What the impact is then?
Because the company put the money aside for an AstraZeneca Seroquel settlement months ago, probably not much will come of it. The company will be complying with federal instructions and will disclose any payments to physicians.
Article Resources
Wall Street Journal
http://online.wsj.com/article/BT-CO-20100427-717519.html?mod=WSJ_World_MIDDLEHeadlinesEurope
