April 27th, 2010
01:43 PM ET

Drug maker to pay $520 million fine for illegal marketing

Pharmaceutical firm AstraZeneca has agreed to pay a $520 million fine to settle claims that it illegally marketed its antipsychotic drug Seroquel, the Department of Justice said Tuesday.

AstraZeneca is charged with fraudulently marketing Seroquel and promoting the drug to patients and physicians for uses that the Food and Drug Administration never approved, Attorney General Eric Holder said at Tuesday's settlement announcement.

The pharmaceutical giant has also been accused of violating anti-kickback laws by paying doctors to refer the drug to patients, while at the same time bringing in money from government health care programs.

"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," Holder said.

The settlement fine of $520 million, which will be paid to federal and state taxpayers, is the most money ever paid by a business in a civil-only settlement for charges of off-label marketing, the Department of Justice said.

"These were not victimless crimes," said Holder. "Illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers' pockets."

Read full CNNMoney.com story

soundoff (315 Responses)
  1. H2oShy

    Here is more:

    http://www.justice.gov/opa/pr/2010/April/10-civ-487.html

    April 27, 2010 at 8:18 pm | Report abuse |
  2. Steve

    I am a physician who prescribes Seroquel for my patients for a condition (hallucinations and delusions in patients with Parkinson's disease) not officially approved by the FDA. When the drug was first released, I read about it and felt that it would be useful for my patients, which it is. I called the drug company and asked them to bring samples. Never did the pharmaceutical representative recommend the drug for off-label use. Yes, he may have dropped off a pen with the name of the drug on it a few years ago. Nothing was inappropriate.

    April 27, 2010 at 8:30 pm | Report abuse |
  3. DirtyBob

    Did they get to form a shell company to lay the charges on like Pfizer did? If you're going to be corrupt, at least be consistent with it.

    April 27, 2010 at 8:33 pm | Report abuse |
  4. daniel anderson

    Jeff get a life,you know nothing,we are in the lawsuit,get your facts straight before you go name throwing,i signed the court papers and spoke with my attorney!you no absolutely nothing!

    April 27, 2010 at 8:34 pm | Report abuse |
  5. slozomby

    which is still probalby less than they made.

    April 27, 2010 at 8:43 pm | Report abuse |
  6. daniel anderson

    The United States alleges that AstraZeneca illegally marketed Seroquel for uses never approved by the FDA. Specifically, between January 2001 through December 2006, AstraZeneca promoted Seroquel to psychiatrists and other physicians for certain uses that were not approved by the FDA as safe and effective (including aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness). These unapproved uses were not medically accepted indications for which the United States and the state Medicaid programs provided coverage for Seroquel.

    April 27, 2010 at 8:45 pm | Report abuse |
  7. Bob

    So my daughter, then 14, was prescribed Seroquel by a psychiatrist. It made her pass out while taking a walk. Should not have been allowed to be prescribed. Wonder if he wasn't getting paid for prescibing what was an off-=use for the drug.

    April 27, 2010 at 9:09 pm | Report abuse |
  8. Longshot

    Chances are 1) AZ is well protected when it comes to $520 million - the company reserves for this sort of thing because they know it's coming one day. 2) inside a large pharma $520 mil is chump change 3) they may not have to pay it all at once 4) from an accounting standpoint, it probably lowers their tax bill.

    At twice the amount it's a bargain.

    April 27, 2010 at 9:10 pm | Report abuse |
  9. Longshot

    Follow-Up comments. Many drugs have off-label indications. (For example, there are seizure drugs which will help with weight loss, but they can't be marketed for weight loss.) These off-label indications are marketed in subtle ways using medical "educators" and other techniques. These subtler methods are unlikely to stop in any pharma including AZ (though AZ will have to be more cautious for a year or two)

    April 27, 2010 at 9:21 pm | Report abuse |
  10. Bill Games

    Yes! We finally fined them. This will show em! They only made about 50 billion in the last 10 years. 500 million is sure to send the message!

    April 27, 2010 at 9:30 pm | Report abuse |
  11. Blue NC

    "what does this mean for my son who is 9 and has been taking 300mg of seroquel daily for about 3years to treat Bi-polar disorder? "

    I'm not a parent or even a mother but I think it should be illegal to give a nine year old hardcore sleeping pills unless it is a really extreme (violent) case. What's worse is you made him take it every night for three years.
    I would rather give my kid pot than sleeping pills. Or at least Valium, because Valium is a lot safer than a knockout pill.

    April 27, 2010 at 9:35 pm | Report abuse |
  12. herbert

    This like any drug is not meant for everyone. Even us non medical proffesionals no that. I was prescribed every sleep medicine known and none of them worked!!! I was finally prescribed Seroquel and my life is sooooooooooooooooooo much better. Typical government to try and get money for a marketing booboo!!!!!!!!

    April 27, 2010 at 9:44 pm | Report abuse |
  13. chris

    After reading these comments, it's easy to see why America is the laughing stock of the world. Not even just from the quality (or lack thereof) of the writing; rather the content and bitching and moaning instead of actual intelligent discussion.

    One half: "How dare you speak badly of Big Pharma!? They keep us alive because we're too dumb to do it ourselves by making proper, healthy decisions in our personal lives!"

    The Other Half: "Bring down Big Pharma! They make money and hate people! They're evil and only care about profits and are responsible for millions of deaths per year!"

    Everyone is certainly welcome to their own opinions but there wasn't even a story posted with this headline until a few minutes ago.
    There is a lot of gray area in something like this. NO corporation is in business to help people. Those are called 'non-profit organizations.' The rest are around to make as much money as possible under any conditions.

    It is ridiculous that pharma companies advertise on TV. People shouldn't even know anything about some of these drugs they're asking for by names. Leave that to the doctors.

    April 27, 2010 at 10:05 pm | Report abuse |
  14. djs987

    What does this mean? Everyone is ok with the public becoming Legal drug addicts. People are a lot easier to control that way....

    April 27, 2010 at 10:12 pm | Report abuse |
  15. Dr. Bob

    Looks like the price of Seroquel just went UP (to cover the cost of this judgement)

    April 27, 2010 at 10:21 pm | Report abuse |
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