A settlement has reached with the Department of Justice over AstraZeneca Seroquel investigation and British pharmaceutical company. An anti psychotic medication, Seroquel, has come 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.
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 money 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’re allowed to prescribe medication for off label use. However, pharmaceutical drugs aren’t to be marketed for off label uses; the FDA considers that a no-no.
Uses for Seroquel off label
Part of this investigation is whether AstraZeneca Seroquel was marketed for uses that aren’t approved for it yet. According to 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 believes the pharmaceutical giant also gave kickbacks to physicians to prescribe it for those purposes. AstraZeneca denies the allegations despite the fact that they set aside $ 520 million in October for a settlement.
Lawsuits that are pending
There are numerous lawsuits pending against AstraZeneca concerning different 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 and every drug has alternate uses. Aspirin, as an example, is used to thin blood and used as a pain reliever but additionally can be used for treating heart disease. Physicians often prescribe drugs for off label uses which is fine. 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?
. The company probably will comply with federal instructions and will disclose payments to physicians.
Sources for the article
Wall Street Journal
http://online.wsj.com/article/BT-CO-20100427-717519.html?mod=WSJ_World_MIDDLEHeadlinesEurope
