AstraZeneca to Pay $520M over Drug Marketing

Company Promoted Antipsychotic Drug Sroquel for "Off Label" Uses Not Approved by FDA

Attorney General Eric Holder says the federal government has reached a $520 million settlement with pharmaceutical manufacturer AstraZeneca, resolving allegations surrounding the company's antipsychotic drug Seroquel.

The case involves AstraZeneca promoting Seroquel for so-called "off-label" uses that are not approved by federal drug regulators, including insomnia and psychiatric conditions besides schizophrenia and bipolar disorder.

"As part of this scheme, AstraZeneca was accused of illegally promoting Seroquel to physicians and violating the federal Anti-Kickback statute, all in furtherance of supporting the drug's use for a host of illnesses for which it was never approved," Holder said in prepared remarks released Tuesday. "According to the settlement, AstraZeneca's illegal marketing of the drug led to millions of dollars in false claims against federal and state programs like Medicare and Medicaid."

The fine is the largest amount ever paid by a company in a civil settlement for off-label marketing, Holder said.

[GL53]

I may be wrong but I beleive Seroquel was suppose to go "generic" last year saving huge amounts of money for users of this excellent drug. Somehow Astra negotiated a 2 year extension in the US (not Canada) in exchange for a "study" of the use of this drug in new areas. Shouldn't the penalty be that they lose their "exclusivity deal" that the FDA made with them so that all of the users of this drug could benefit with lower prices?
(Please correct me if my facts are incorrect.)

[lkelly6694]

Who gets the $520 million??

[porcine_aviator]

It goes into the general fed treasury. It will be treated as just another form of revenue.

[ericv857]

I am taking the drug for sleeping diorder, what do I do

[larrryshrine]

Off label is fine, if prescribed by a competent doctor. It is the "marketing" of off label uses that was in question. I have used that drug for sleep, and for some, it works well.

[larrryshrine]

I believe in the tight control of drugs by the government. But you have to agree that it smacks of that dirty word "socialism". Sometimes government oversight and social programs make for a better America.

[porcine_aviator]

Socialism has nothing at all to do with enforcing a reasonable law. It is against the law for a drug company to create a work-around to drug safety laws. Should drugs be used off-label? Sure. Should corporations be allowed to engage in all-out marketing campaigns to do so? Absolutely not, it's irresponsible and can KILL people.