British pharmaceutical company AstraZeneca has just reached a settlement with the Department of Justice over AstraZeneca Seroquel investigations. An anti psychotic medication, Seroquel, 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. 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 drug being marketed for purposes other than those it is approved for is what the qualm over AstraZeneca Seroquel is based on. The DOJ also alleges there were physician kickbacks of payday money for prescribing the drug for off-label purposes. This specific drug is supposed to be used to treat schizophrenia and some bi-polar diseases. Physicians might prescribe a medication for an off-label use if they deem it appropriate. The FDA considers it a no-no to market pharmaceutical drugs for off label uses.
Seroquel off label uses
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 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.
Lawsuits that are pending
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 each drug has alternate uses. 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. Many physicians prescribe medications for off label uses, and their use is perfectly fine. That said the idea that physicians would prescribe medication not intended for a particular use for money when a better choice is available is particularly troubling.
So what’s the impact?
Not much will probably come of it since AstraZeneca Seroquel set aside cash for a settlement months ago. The company probably will comply with federal instructions and will disclose payments to physicians.
Sources
Wall Street Journal
http://online.wsj.com/article/BT-CO-20100427-717519.html?mod=WSJ_World_MIDDLEHeadlinesEurope
