The Department of Justice over AstraZeneca Seroquel investigation British pharmaceutical business have come to a settlement. The drug Seroquel, an anti-psychotic medication, has come 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.
Wrong purposes is what AstraZeneca Seroquel was marketed for
The qualms over AstraZeneca Seroquel were depending 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. This specific drug is intended to be used to treat schizophrenia and some bi-polar diseases. 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.
Off label uses of Seroquel
Part of the investigation is into whether AstraZeneca Seroquel was marketed for uses it was not approved for yet. As outlined by the Wall Street Journal , AstraZeneca marketed the drug for off label uses, like to treat Alzheimer’s Disease, post traumatic stress disorder, aggression, anxiety and depression. The Justice Department believes the pharmaceutical giant also 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
You will find many lawsuits pending against AstraZeneca concerning different side effects of off label use of Seroquel. Seroquel isn’t the first used for off label purposes; each drug has alternate use so it is widespread to use medication for off label purposes. For instance, aspirin works as a blood thinner and typically is used as a pain reliever, but it also is used for treating 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 alternative is accessible is particularly troubling.
What the impact is then?
Since AstraZeneca Seroquel set aside money for a settlement months ago, nothing will probably come of it. The company can be complying with federal instructions and will disclose any payments to physicians.
Sources
Wall Street Journal
http://online.wsj.com/article/BT-CO-20100427-717519.html?mod=WSJ_World_MIDDLEHeadlinesEurope
