A settlement has reached with the Department of Justice over AstraZeneca Seroquel investigation and British pharmaceutical business. 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. The drug itself, which sold about $ 4.9 billion last year, probably won’t need guaranteed loans to cover the expenses.
AstraZeneca Seroquel was marketed for the wrong purposes
The qualms over AstraZeneca Seroquel were based on the drug being marketed for purposes other than those it is approved for. 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. Physicians are allowed to prescribe medication for off label use if they think it is appropriate. The FDA considers it a no-no to market pharmaceutical drugs for off label uses.
Part of this investigation is whether AstraZeneca Seroquel was marketed for uses that aren’t approved for it yet. As outlined by 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 thinks pharmaceutical giant gave kickbacks to physicians to prescribe it for those purposes. AstraZeneca set aside $ 250 million in October for a settlement but denies the claims.
Pending lawsuits
There are lawsuits pending against AstraZeneca concerning side effects of off label use of Seroquel. Seroquel isn’t the first drug to try off label purposes; off label medication is actually wide spread because every drug has alternate uses. For example, although most people use aspirin to thin blood or as a pain reliever, it also can be used to treat heart disease. It is generally fine that numerous physicians prescribe medication for off label uses. That said the idea that physicians would prescribe medication not intended for a particular use for cash when a better option is accessible is particularly troubling.
What the impact is then?
Not much will probably come of it given that AstraZeneca Seroquel set aside cash for a settlement months ago. The company will probably disclose payments to physicians and will comply with federal instructions.
Resources
Wall Street Journal
http://online.wsj.com/article/BT-CO-20100427-717519.html?mod=WSJ_World_MIDDLEHeadlinesEurope
