AstraZeneca Seroquel settlement reached
British pharmaceutical company AstraZeneca has just reached a settlement with the Department of Justice over AstraZeneca Seroquel investigations. The drug Seroquel, an anti-psychotic medication, has come under fire for being marketed for unapproved purposes. The drugmaker has agreed to pay the Department of Justice $520 million in restitution. 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.
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 also alleges there were physician kickbacks of payday cash for prescribing the drug for off-label purposes. The drug Seroquel is quetiapine, which is used to treat schizophrenia and certain bi-polar disorders. Physicians may prescribe a medication for an off-label use if they deem it appropriate. However, pharmaceutical drugs aren’t to be marketed for off label uses; the FDA considers that a no-no.
Off label uses of Seroquel
Part of the investigation is into whether AstraZeneca Seroquel was marketed for uses it hasn’t been approved for yet. According to the Wall Street Journal, AstraZeneca marketed the drug for off label uses, such as 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 $520 million in October for the purposes of a settlement, but it denies the allegations.
There are lawsuits pending against AstraZeneca concerning side effects of off label use of Seroquel. Seroquel isn’t the first drug to be used off label; every 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. That said, the idea that physicians would prescribe medication not intended for a particular use for money when a better alternative is available is particularly troubling.
So what’s the impact?
Because the company put the money aside for an AstraZeneca Seroquel settlement months ago, probably not much will come of it. The company will be complying with federal instructions and will disclose any payments to physicians.