The Department of Justice over AstraZeneca Seroquel investigation British pharmaceutical company have come to a settlement. Seroquel, an anti psychotic medication, has been under fire for being marketed for unapproved purposes. The drug maker will be paying the Department of Justice $ 520 million in restitution. The drug itself, which sold about $ 4.9 billion last year, probably won’t need guaranteed loans to cover the expenses.
AstraZeneca Seroquel marketed for 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 suggests there were kickbacks of payday cash for prescribing the drug for off label purposes. This specific drug is designed to be used to treat schizophrenia and some 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.
Uses for Seroquel off label
Part of the investigation is to see whether AstraZeneca Seroquel was marketed for different uses that haven’t been approved for it. As outlined by the Wall Street Journal , AstraZeneca marketed the drug for off label uses, like 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 $ 520 million in October for the purposes of a settlement, but it denies the allegations.
Lawsuits pending
You will find numerous lawsuits pending against AstraZeneca concerning different side effects of off label use of Seroquel. Seroquel isn’t really the first drug to be used off label; each drug has an alternate use, so the use of medication for off label purposes is actually somewhat widespread. 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. Nevertheless, the idea that a physician would prescribe drug for their own cash purposes when something else is available, is really troubling.
What the impact is then?
Because the company put the cash aside for an AstraZeneca Seroquel settlement months ago, probably not much will come of it. The business probably will comply with federal instructions and will disclose payments to physicians.
Wall Street Journal
http://online.wsj.com/article/BT-CO-20100427-717519.html?mod=WSJ_World_MIDDLEHeadlinesEurope
