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. Wesley

    It's a settlement as opposed to a fine so it won't be negotiated down as some are saying.

    As with any drug, Seroquel will help some but not all.

    As with any drug, some will have serious side effects and some won't.

    Frankly, I don't care if it was marketed for off label use. If the FDA doesn't like it then they shouldn't allow doctors to prescribed it off label. That's a double standard. If there are studies showing its effectiveness for other uses then I'm all for allowing it to be used off label. As I am for any drug.

    But this is less about marketing and all about money. As it always is.

    "By doing so, the pharmaceutical group received government insurance payments that officials said were fraudulent."

    In other words, the government paid for treatments for some people and they want their money back. Who cares if people were helped...

    "The government also contended that AstraZeneca violated the federal Anti-Kickback Statute by offering and paying illegal remuneration to doctors it recruited to "advise" the firm about marketing for unapproved and unaccepted uses of Seroquel."

    Doctors were already prescribing it for off label use which is allowed by law. But apparently, you can't tell other doctors to do the same. At least as a paid adviser. I guess that's what blogs are for 🙂

    The FDA does NOT have your best interests at heart; your doctor should. I trust my doctor to advise me properly as to my health. If you don't believe your doctor is capable of doing so please find another.

    Wesley

    April 27, 2010 at 6:39 pm | Report abuse |
  2. Mark737

    Well,,

    Shouldn't the FDA be held equally accountable for letting this happen? After all they are the police of prescription drugs........

    April 27, 2010 at 6:40 pm | Report abuse |
  3. cbcard

    The one way to stop such abuses is to file criminal charges against individuals. Corporate fines mean nothing. Sending executives to jail will get their attention!

    April 27, 2010 at 6:52 pm | Report abuse |
  4. MichaelAlMurashi

    Hey this is old news, did a quick google and sure enough this is word for word from 9 months ago.

    April 27, 2010 at 7:01 pm | Report abuse |
  5. nicole

    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?

    April 27, 2010 at 7:03 pm | Report abuse |
  6. pipetter

    There seem to be similarities between this story and the Pfizer Bextra story also covered by CNN. ( http://www.cnn.com/2010/HEALTH/04/02/pfizer.bextra/index.html)

    My question is, did AstraZeneca also have a "fall guy" like Pharmacia? Otherwise, since this story indicates they violated federal and state medicare/medicaid laws by filing false claims, they would have been prevented from taking part in these programs for ALL of their drugs.

    April 27, 2010 at 7:09 pm | Report abuse |
  7. Brian

    Seriously? Was there a journalist involved in this story at all?

    "This is not your GOP FDA. Thank God, Obama and his people are starting to fine companies for improper behavior"

    The FDA is an independent agency and does not report to the President or White House for a good reason. "Obama" has nothing to do with this at all. It would be illegal for him to even suggest it.

    This is exactly the kind of stupidity that allows this stuff to happen in the first place.

    April 27, 2010 at 7:12 pm | Report abuse |
  8. Bill

    Ever seen the movie The Last Emperor?
    What happens when the Emperor misbehaves? Somebody ELSE is beaten with a stick.

    Guess what? That is exactly what the feds do here.

    When AstraZeneca, Pfizer, or any other company that is "too important" commits a crime such as this, the DoJ works with them to setup a subsidiary company that exists just long enough to:

    1) become the official "producer" of the drug
    2) be "convicted"
    3) pay the fine
    4) declare bankruptcy
    5) drink beer

    And now you know why the SEC "failed" to stop the current financial crisis.

    Laws only apply to the poor.

    April 27, 2010 at 7:12 pm | Report abuse |
  9. Meriska

    HAHA, I'm not surprised. NOBODY is honest anymore. It's all about how much money they can make before they get caught. The hell with the people this drug messed up. Money Money Money, that's all it's about anymore.

    April 27, 2010 at 7:12 pm | Report abuse |
  10. Karen

    I'm glad to see this! I've long been disgusted with all the advertising on TV for prescription drugs. Most of the time the lists of "possible side effects" are longer than the description of what it does for the patient! In my opinion the doctor should be the one who recommends a medication to a patient instead of the patient waltzing into the doctor's office saying "I saw this medicine on TV and it will cure me..." In the case of AstraZeneca, I see that there are charges of kickbacks to physicians, so they should definitely be made to answer for that, but I believe this is an issue that continues to push our health care costs UP!!

    April 27, 2010 at 7:12 pm | Report abuse |
  11. Wesley

    People really are ignorant. A drug company gets fined for its MARKETING practices and all of a sudden people who have been taking the drug for years without any major issues get in a panic. The FDA did not say the drug doesn't work for the FDA approved conditions. They didn't say it's dangerous. Heck, they didn't even say it doesn't work for all the off label conditions for which it is prescribed. All they said was you can't market it for those uses until we say so. Bad drug company. So if you take it and are reaping benefits please stop worrying and continue as before.

    April 27, 2010 at 7:21 pm | Report abuse |
  12. American X

    WTF? no wonder my Dr. keeps shoving this crap at me! My last visit last week he loaded me up with 5 boxes of samples all different strengths – I had my hands full and kept dropping them. I told him that the stuff made me groggy and lethargic. He said "try different doses. I don;t want to see you go off Seroquel completley-" Last night I took 1/4 of a 25mg pill and didn't get out of bed until 10:30 this morning. These things are like Zombie pills – not to menetion they give you the munchies. Can I get a piece of the $500M for being 1 of their victims?? Good Bye Seroquel!

    April 27, 2010 at 7:21 pm | Report abuse |
  13. LOL

    This is great, about time to see the FDA telling them to limit advertising to only the approved uses.

    Personally I can't use this one and was only on it for a few days because I'm allergic.

    April 27, 2010 at 7:27 pm | Report abuse |
  14. Daniel

    Just thank your god that it wasn't pot..

    April 27, 2010 at 7:32 pm | Report abuse |
  15. Jeff

    For all you Dillweeds asking about "How did they illegally market it?" The company marketed it as a treatment for something different that what the FDA approved the drug for. For example, if a drug gets approved by the FDA for use in treating high blood pressure, the drug company cannot go out and tell doctors or consumers it is a treatment for stupidity........got it?

    April 27, 2010 at 8:10 pm | Report abuse |
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